Trial Outcomes & Findings for Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications (NCT NCT00097786)
NCT ID: NCT00097786
Last Updated: 2023-11-08
Results Overview
Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9306 participants
Primary outcome timeframe
Mean patient duration of 4.2 years
Results posted on
2023-11-08
Participant Flow
Initially enrolled 9518, 212 excluded.
Participant milestones
| Measure |
Valsartan 160 mg od + Nateglinide 60 mg ac
For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum \[ac, before meals\]) and valsartan 80 mg (once daily \[od\] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
|
Valsartan 160 mg od + Placebo Nateglinide
For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
|
Nateglinide 60 mg ac + Placebo Valsartan
For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
|
Placebo
Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2316
|
2315
|
2329
|
2346
|
|
Overall Study
Complete FU for Progression to Diabetes
|
1709
|
1712
|
1734
|
1762
|
|
Overall Study
Complete Follow-up for Extended CV EPs
|
1969
|
1985
|
1987
|
2015
|
|
Overall Study
Complete Follow-up for Core CV EPs
|
1948
|
1963
|
1966
|
1988
|
|
Overall Study
COMPLETED
|
2020
|
2023
|
2016
|
2036
|
|
Overall Study
NOT COMPLETED
|
296
|
292
|
313
|
310
|
Reasons for withdrawal
| Measure |
Valsartan 160 mg od + Nateglinide 60 mg ac
For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum \[ac, before meals\]) and valsartan 80 mg (once daily \[od\] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
|
Valsartan 160 mg od + Placebo Nateglinide
For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
|
Nateglinide 60 mg ac + Placebo Valsartan
For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
|
Placebo
Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
|
|---|---|---|---|---|
|
Overall Study
lost to follow-up for all-cause death
|
296
|
292
|
313
|
310
|
Baseline Characteristics
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
Baseline characteristics by cohort
| Measure |
Valsartan 160 mg od + Nateglinide 60 mg ac
n=2316 Participants
For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum \[ac, before meals\]) and valsartan 80 mg (once daily \[od\] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
|
Valsartan 160 mg od + Placebo Nateglinide
n=2315 Participants
For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
|
Nateglinide 60 mg ac + Placebo Valsartan
n=2329 Participants
For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
|
Placebo
n=2346 Participants
Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
|
Total
n=9306 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 6.75 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 6.91 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 6.82 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 6.88 • n=4 Participants
|
63.8 years
STANDARD_DEVIATION 6.84 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1174 Participants
n=5 Participants
|
1140 Participants
n=7 Participants
|
1194 Participants
n=5 Participants
|
1203 Participants
n=4 Participants
|
4711 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1142 Participants
n=5 Participants
|
1175 Participants
n=7 Participants
|
1135 Participants
n=5 Participants
|
1143 Participants
n=4 Participants
|
4595 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Mean patient duration of 4.2 yearsPopulation: Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.
Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.
Outcome measures
| Measure |
Valsartan
n=4631 Participants
All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
|
Non-valsartan
n=4675 Participants
All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
|
|---|---|---|
|
Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan
|
33.1 Percentage of patients
|
36.8 Percentage of patients
|
PRIMARY outcome
Timeframe: Mean patient duration of 5.6 yearsPopulation: Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.
The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.
Outcome measures
| Measure |
Valsartan
n=4631 Participants
All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
|
Non-valsartan
n=4675 Participants
All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
|
|---|---|---|
|
Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan
|
14.5 Percentage of patients
|
14.8 Percentage of patients
|
PRIMARY outcome
Timeframe: Mean patient duration of 5.8 yearsPopulation: Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.
The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Outcome measures
| Measure |
Valsartan
n=4631 Participants
All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
|
Non-valsartan
n=4675 Participants
All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
|
|---|---|---|
|
Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan
|
8.1 Percentage of patients
|
8.1 Percentage of patients
|
PRIMARY outcome
Timeframe: Mean patient duration of 4.2 yearsPopulation: Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.
Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.
Outcome measures
| Measure |
Valsartan
n=4645 Participants
All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
|
Non-valsartan
n=4661 Participants
All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
|
|---|---|---|
|
Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide
|
36.0 Percentage of patients
|
33.9 Percentage of patients
|
PRIMARY outcome
Timeframe: Mean patient duration of 5.6 yearsPopulation: Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.
The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.
Outcome measures
| Measure |
Valsartan
n=4645 Participants
All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
|
Non-valsartan
n=4661 Participants
All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
|
|---|---|---|
|
Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide
|
14.2 Percentage of patients
|
15.2 Percentage of patients
|
PRIMARY outcome
Timeframe: Mean patient duration of 5.8 yearsPopulation: Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.
The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Outcome measures
| Measure |
Valsartan
n=4645 Participants
All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
|
Non-valsartan
n=4661 Participants
All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
|
|---|---|---|
|
Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide
|
7.9 Percentage of patients
|
8.3 Percentage of patients
|
Adverse Events
Valsartan 160 mg od + Nateglinide 60 mg ac
Serious events: 1031 serious events
Other events: 1970 other events
Deaths: 0 deaths
Valsartan 160 mg od + Placebo Nateglinide
Serious events: 1040 serious events
Other events: 1932 other events
Deaths: 0 deaths
Nateglinide 60 mg ac + Placebo Valsartan
Serious events: 1035 serious events
Other events: 1951 other events
Deaths: 0 deaths
Placebo
Serious events: 1049 serious events
Other events: 1934 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valsartan 160 mg od + Nateglinide 60 mg ac
n=2297 participants at risk
For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum \[ac, before meals\]) and valsartan 80 mg (once daily \[od\] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
|
Valsartan 160 mg od + Placebo Nateglinide
n=2283 participants at risk
For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
|
Nateglinide 60 mg ac + Placebo Valsartan
n=2305 participants at risk
For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
|
Placebo
n=2316 participants at risk
Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Paratracheal lymphadenopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.52%
12/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
27/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.4%
32/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.00%
23/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.91%
21/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Angina pectoris
|
4.0%
92/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.3%
99/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
3.1%
71/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
3.2%
74/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Angina unstable
|
2.0%
46/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.8%
63/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.6%
61/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.6%
60/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Aortic valve disease
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Arrhythmia
|
0.57%
13/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.53%
12/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
60/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.0%
46/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.5%
57/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.7%
63/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Atrial flutter
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Bradycardia
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Bundle branch block left
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac arrest
|
0.48%
11/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac asthma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac failure
|
0.70%
16/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.1%
26/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.69%
16/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.78%
18/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac failure acute
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.96%
22/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.4%
32/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.6%
37/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.5%
35/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac fibrillation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiogenic shock
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiomegaly
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiomyopathy
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
43/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.6%
37/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.2%
50/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.8%
42/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Coronary artery dissection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.65%
15/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Dilatation ventricular
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Electromechanical dissociation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Left atrial dilatation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Left ventricular failure
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Microvascular angina
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Mitral valve disease
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
46/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.8%
41/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.0%
46/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.0%
46/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.87%
20/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.74%
17/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.95%
22/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.82%
19/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Palpitations
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Pericardial effusion
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Postinfarction angina
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Reperfusion arrhythmia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.47%
11/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Sinus bradycardia
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Sinus tachycardia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Subendocardial ischaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Tachycardia
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Ventricular failure
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Anal fissure
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Congenital, familial and genetic disorders
Myocardial bridging
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Ear canal stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Neurosensory hypoacusis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Vertigo
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Adrenal cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Goitre
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Hyperthyroidism
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Hypothyroidism
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Parathyroid disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Secondary hyperthyroidism
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Thyroid disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Amaurosis fugax
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Blindness
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Blindness transient
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Cataract
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.83%
19/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.73%
17/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Dacryostenosis acquired
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Diplopia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Endocrine ophthalmopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Exophthalmos
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Glaucoma
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Hyalosis asteroid
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Lens dislocation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Macular hole
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Maculopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Panophthalmitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal artery occlusion
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal ischaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal tear
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal vascular thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Retinopathy hypertensive
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Visual impairment
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Vitreous haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.78%
18/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.57%
13/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.65%
15/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.65%
15/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.65%
15/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.83%
19/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.78%
18/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.82%
19/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Anal polyp
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Appendix disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Bezoar
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Colitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.47%
11/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Diverticulum
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Duodenal fistula
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Duodenitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Dysphagia
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Enterocele
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Enterocolonic fistula
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Faecaloma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Flatulence
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastritis
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.47%
11/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal telangiectasia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrolithiasis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gastrooesophageal sphincter insufficiency
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Haematochezia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Ileus
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.78%
18/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.96%
22/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.95%
22/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.95%
22/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Intestinal strangulation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Ischiorectal hernia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Large intestinal stricture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Melaena
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Nausea
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Pancreatic duct obstruction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Papilla of Vater stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Peritonitis
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Subileus
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
14/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.66%
15/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Asthenia
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Cardiac death
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Catheter related complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Catheter thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Chest discomfort
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Chest pain
|
0.65%
15/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Chills
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Chronic fatigue syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Death
|
0.44%
10/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.83%
19/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.60%
14/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Exercise tolerance decreased
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Facial pain
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Fat necrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Fatigue
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Foreign body reaction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Gait disturbance
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
General physical health deterioration
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Generalised oedema
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Hernia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Hernia obstructive
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Hyperplasia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Hypothermia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Impaired healing
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Implant site haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Inflammation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Injection site haematoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Local swelling
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Malaise
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Multi-organ failure
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
45/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.4%
33/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.4%
33/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.0%
46/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Oedema
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Oedema peripheral
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Pain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Pelvic mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Polyp
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Pyrexia
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Submandibular mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Sudden cardiac death
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Sudden death
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Vestibulitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Biliary colic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Biliary fistula
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Biloma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholangitis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.65%
15/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.44%
10/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.44%
10/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
26/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.2%
28/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.1%
48/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.3%
30/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Cryptogenic cirrhosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Gallbladder cholesterolosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Gallbladder fistula
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatic infarction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Jaundice
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Jaundice hepatocellular
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Perforation bile duct
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Porcelain gallbladder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Immune system disorders
Allergy to chemicals
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Immune system disorders
Anaphylactic reaction
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Immune system disorders
Drug hypersensitivity
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Immune system disorders
Iodine allergy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Abdominal infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Abscess
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Abscess limb
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Acute sinusitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Appendicitis
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Appendicitis perforated
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Arthritis bacterial
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Arthritis infective
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bacillus infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bacteraemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bacterial sepsis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Biliary tract infection bacterial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Borrelia infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bronchiectasis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bronchitis
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.53%
12/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bronchopneumonia
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Carbuncle
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Catheter related infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Cellulitis
|
0.61%
14/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.83%
19/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Cholecystitis infective
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Chronic sinusitis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Citrobacter infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Clostridial infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Cystitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Dengue fever
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Device related infection
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Diverticulitis
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Douglas' abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Ear infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Ear lobe infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Empyema
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Endocarditis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Endocarditis bacterial
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Endometritis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Epidemic nephropathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Epididymal infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Erysipelas
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Escherichia sepsis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Gangrene
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Gastroenteritis
|
0.44%
10/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.53%
12/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Gastroenteritis staphylococcal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Gastroenteritis viral
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Graft infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
HIV infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Helicobacter gastritis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Hepatitis non-A non-B
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Hepatitis viral
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Herpes zoster
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Herpes zoster infection neurological
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Incision site infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Infected bites
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Infected sebaceous cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Infected skin ulcer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Infection
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Influenza
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Kidney infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Labyrinthitis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Laryngitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Lobar pneumonia
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Localised infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Lung infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Lymphangitis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Malaria
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Meningitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Meningitis viral
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Miliary pneumonia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Morganella infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Nasal abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Nasopharyngitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Neisseria infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Neuroborreliosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Neutropenic sepsis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Orchitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Osteomyelitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Otitis media
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Paronychia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pelvic abscess
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Peridiverticular abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Perihepatic abscess
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Peritoneal infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pharyngitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pilonidal cyst
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pleural infection bacterial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pneumonia
|
2.0%
47/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.4%
33/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.8%
41/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.9%
43/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pneumonia bacterial
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Post procedural infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Postoperative wound infection
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Proteus infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pseudomonas infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pyelonephritis acute
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Pyothorax
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Respiratory tract infection
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Rhinitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Scrub typhus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Sepsis
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.69%
16/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Septic embolus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Septic shock
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Shunt infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Skin infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Staphylococcal infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Staphylococcal osteomyelitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Streptococcal sepsis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Superinfection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Tracheitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Tracheobronchitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Tularaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Urinary tract infection
|
0.70%
16/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.61%
14/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.74%
17/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.60%
14/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Urosepsis
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Vestibular neuronitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Viral infection
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Wound abscess
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Wound infection
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Accident
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication neurological
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Anal injury
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Anxiety postoperative
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft aneurysm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Bite
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cold exposure injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Corneal scar
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Device breakage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Drug dose omission
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Failure of implant
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
46/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.1%
47/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
2.6%
59/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.6%
36/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Gallbladder injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Injury
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Intraocular lens dislocation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.47%
11/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose intentional
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Radial nerve injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.61%
14/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Urinary bladder rupture
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Vascular bypass dysfunction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Wound
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Antinuclear antibody increased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Blood amylase increased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Blood potassium increased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Body temperature increased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
C-reactive protein increased
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Heart rate decreased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Heart rate irregular
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Liver function test abnormal
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Prostatic specific antigen increased
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Vascular resistance systemic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Investigations
Weight decreased
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Central obesity
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.52%
12/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.65%
15/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Lipomatosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Obesity
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.53%
12/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.52%
12/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.61%
14/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Bone erosion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Bursa disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Crystal arthropathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.57%
13/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.53%
12/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.47%
11/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Limb deformity
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.48%
11/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.4%
77/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.0%
92/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.0%
92/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.0%
93/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.47%
11/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Plica syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Spinal fusion acquired
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer stage II
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.70%
16/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.61%
14/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.69%
16/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign bone neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colonic neoplasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign laryngeal neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of orbit
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of prostate
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign uterine neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast adenoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.87%
20/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.1%
24/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.87%
20/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.60%
14/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast fibroma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondroma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia stage 0
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.83%
19/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.70%
16/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endocrine neoplasm malignant
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female reproductive neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gliosarcoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangiopericytoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial meningioma malignant
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna stage unspecified
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma of breast
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.69%
16/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.69%
16/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant fibrous histiocytoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Aphasia
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma of eyelid
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant urinary tract neoplasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to chest wall
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to gastrointestinal tract
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to kidney
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to large intestine
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.48%
11/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.44%
10/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pancreas
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to small intestine
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to soft tissue
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to stomach
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to the mediastinum
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm benign
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paget's disease of the vulva
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer metastatic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.6%
37/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.6%
36/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.5%
34/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.3%
30/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage I
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage II
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal adenoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage I
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rosai-Dorfman syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma uterus
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsillar neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsillar neoplasm benign
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Undifferentiated sarcoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine neoplasm
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal cancer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Amnestic disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Basilar artery stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.52%
12/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.53%
12/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.69%
16/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.60%
14/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cataplexy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebellar atrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebellar haematoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral atrophy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral infarction
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebrosclerosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebrospinal fluid rhinorrhoea
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.96%
22/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.5%
34/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.2%
28/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.7%
40/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cerebrovascular stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cervical myelopathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Coma
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Complex partial seizures
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Convulsion
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Dementia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Dizziness
|
0.52%
12/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.47%
11/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Dizziness postural
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Drop attacks
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Dysaesthesia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Encephalomalacia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Epilepsy
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Facial paresis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Headache
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Hemiparesis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Horner's syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Hydrocephalus
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Hypoaesthesia
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Ischaemic stroke
|
0.70%
16/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.60%
14/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Lacunar infarction
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Leukoaraiosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Loss of consciousness
|
0.44%
10/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Memory impairment
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Migraine
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Morton's neuralgia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Multiple system atrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Nerve root compression
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Nerve root lesion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Nystagmus
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Paralysis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Paraplegia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Parkinson's disease
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Partial seizures
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Presyncope
|
0.44%
10/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Radiculitis cervical
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Sciatica
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Senile dementia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Spinal claudication
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Spinal cord compression
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Spinal vascular disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Stupor
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Syncope
|
1.4%
33/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.3%
29/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.1%
26/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.5%
34/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Tonic convulsion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Transient global amnesia
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
26/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.2%
27/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.78%
18/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.0%
24/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Tremor
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Vasculitis cerebral
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Vertebral artery thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Wallenberg syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Affect lability
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Anxiety disorder
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Confusional state
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Delusion
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Depression
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Depression suicidal
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Emotional distress
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Intentional self-injury
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Major depression
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Mental status changes
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Obsessive thoughts
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Restlessness
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Schizophrenia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Somatoform disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Stress
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Azotaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Bladder perforation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Calculus urinary
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Dysuria
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Haematuria
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Hydroureter
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Hypotonic urinary bladder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Nephritis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.57%
13/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Pollakiuria
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal atrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal colic
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal cyst
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal failure
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.65%
15/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal failure acute
|
0.61%
14/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal impairment
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal mass
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal pelvis fistula
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Ureteric perforation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urethral disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urethral ulcer
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.18%
4/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urinary retention
|
0.26%
6/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Vesical fistula
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.83%
19/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.74%
17/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.2%
28/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.2%
27/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Cervix inflammation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Colpocele
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Cystocele
|
0.30%
7/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Endometrial atrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Mammary duct ectasia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Nipple exudate bloody
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Ovarian atrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Rectocele
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Testicular infarction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Uterine cervical laceration
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.47%
11/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Vaginal laceration
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Reproductive system and breast disorders
Vaginal ulceration
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Anoxia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.57%
13/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Brain hypoxia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial wall thickening
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.91%
21/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.78%
18/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.78%
18/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
18/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.66%
15/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.2%
28/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.69%
16/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal polyp
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal polyp
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.87%
20/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.74%
17/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.30%
7/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.35%
8/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.35%
8/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rubra pilaris
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Social circumstances
Activities of daily living impaired
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Social circumstances
Exposure to chemical pollution
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Social circumstances
Victim of crime
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aneurysm
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aortic aneurysm
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.44%
10/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.61%
14/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aortic dilatation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aortic dissection
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aortic intramural haematoma
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Aortic stenosis
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arterial disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arterial insufficiency
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arterial occlusive disease
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arterial thrombosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arteriosclerosis
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Arteritis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Artery dissection
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Circulatory collapse
|
0.39%
9/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Deep vein thrombosis
|
0.52%
12/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.31%
7/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Embolism
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Essential hypertension
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Exsanguination
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Flushing
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Haematoma
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Haemodynamic instability
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Haemorrhage
|
0.13%
3/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Haemorrhagic infarction
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hypertension
|
0.83%
19/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.66%
15/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.5%
35/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
1.2%
27/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hypertensive crisis
|
0.52%
12/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.57%
13/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.56%
13/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.43%
10/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hypotension
|
0.96%
22/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.83%
19/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.91%
21/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.52%
12/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Iliac artery embolism
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Iliac artery occlusion
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Iliac artery stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Intermittent claudication
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.48%
11/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.39%
9/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Ischaemia
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.22%
5/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.26%
6/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Peripheral embolism
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Poor peripheral circulation
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Shock
|
0.09%
2/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Subclavian steal syndrome
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Thromboangiitis obliterans
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Thrombosis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Varicose vein
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.13%
3/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.22%
5/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.17%
4/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Vasculitis
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Vein pain
|
0.04%
1/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Venous occlusion
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.09%
2/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Venous thrombosis limb
|
0.17%
4/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.00%
0/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
0.04%
1/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
Other adverse events
| Measure |
Valsartan 160 mg od + Nateglinide 60 mg ac
n=2297 participants at risk
For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum \[ac, before meals\]) and valsartan 80 mg (once daily \[od\] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
|
Valsartan 160 mg od + Placebo Nateglinide
n=2283 participants at risk
For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
|
Nateglinide 60 mg ac + Placebo Valsartan
n=2305 participants at risk
For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
|
Placebo
n=2316 participants at risk
Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
5.0%
114/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.8%
110/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.4%
125/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.1%
119/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Ear and labyrinth disorders
Vertigo
|
4.6%
106/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.1%
117/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.7%
108/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.3%
100/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Eye disorders
Cataract
|
6.4%
148/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
7.0%
160/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.3%
146/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
7.0%
163/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
128/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.2%
118/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.8%
134/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.8%
134/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
142/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.5%
126/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.4%
124/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.4%
126/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Constipation
|
4.7%
108/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.2%
95/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.5%
127/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.8%
135/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
305/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
13.1%
299/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
12.1%
278/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
12.0%
277/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
142/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.2%
142/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.6%
152/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.3%
147/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
197/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
7.7%
176/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
7.9%
181/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
8.3%
193/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Fatigue
|
10.2%
234/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
8.8%
202/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
9.6%
222/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
9.8%
228/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Non-cardiac chest pain
|
5.2%
120/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.1%
116/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.6%
128/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.4%
126/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
General disorders
Oedema peripheral
|
9.9%
228/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
8.7%
198/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
11.5%
264/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
12.3%
284/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Bronchitis
|
9.5%
218/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
10.2%
234/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
10.8%
249/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
9.8%
226/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Influenza
|
13.1%
301/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
13.5%
309/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
13.0%
299/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
13.6%
315/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Nasopharyngitis
|
17.2%
396/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
18.0%
410/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
17.7%
408/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
16.6%
385/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Sinusitis
|
5.5%
127/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.3%
122/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.8%
134/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.0%
138/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.8%
270/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
12.0%
274/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
10.8%
250/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
12.0%
278/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Infections and infestations
Urinary tract infection
|
8.8%
202/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
8.3%
190/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
9.8%
225/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
8.9%
207/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.0%
115/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.3%
122/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.9%
137/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.7%
110/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
19.8%
455/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
11.9%
271/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
19.7%
454/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
10.8%
251/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
369/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
16.5%
377/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
16.4%
377/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
15.8%
367/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.3%
398/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
15.7%
358/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
14.7%
339/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
14.1%
326/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.9%
158/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
7.1%
163/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.1%
141/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.5%
151/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
9.8%
226/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
8.5%
194/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
9.7%
224/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
10.4%
241/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.2%
280/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
12.0%
273/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
11.9%
275/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
10.3%
238/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Dizziness
|
19.2%
440/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
16.6%
379/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
17.2%
397/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
15.2%
351/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Nervous system disorders
Headache
|
10.5%
242/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
12.7%
289/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
13.3%
306/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
13.4%
311/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Depression
|
6.4%
146/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
7.2%
165/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
7.3%
169/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.8%
158/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Psychiatric disorders
Insomnia
|
5.1%
117/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.1%
94/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
4.3%
100/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.0%
115/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
238/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
9.6%
220/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
10.2%
234/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
9.7%
224/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
122/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
5.4%
124/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.6%
152/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
6.3%
146/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hypertension
|
12.8%
293/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
13.2%
302/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
17.0%
392/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
19.2%
444/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
|
Vascular disorders
Hypotension
|
31.9%
732/2297 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
31.4%
717/2283 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
25.2%
582/2305 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
23.4%
542/2316 • The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.
Patients were recruited over a two year period and were followed for Adverse Event reporting until the target number of patients had experienced an extended cardiovascular endpoint. Hence, the follow-up time was not the same for all patients.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER