Trial Outcomes & Findings for Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases) (NCT NCT00549757)
NCT ID: NCT00549757
Last Updated: 2014-04-21
Results Overview
Occurrence was defined as the first event of the following composite primary endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF) * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. * Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8606 participants
Primary outcome timeframe
Time from randomization to the first event (Maximum 50 months)
Results posted on
2014-04-21
Participant Flow
Per data monitoring committee (DMC) recommendation all patients were required to permanently stop study medication by 06Jan2012. A follow-up period (actual duration, 9 months in average) post study drug discontinuation on 7590 patients was implemented upon request of Health Authority following the recommendation of DMC to cease study treatment.
Participant milestones
| Measure |
Aliskiren
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
Placebo
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
|---|---|---|
|
Active Treatment Phase: Max. 50 Months
STARTED
|
4296
|
4310
|
|
Active Treatment Phase: Max. 50 Months
Full Analysis Set
|
4274
|
4287
|
|
Active Treatment Phase: Max. 50 Months
Safety Set
|
4272
|
4285
|
|
Active Treatment Phase: Max. 50 Months
COMPLETED
|
0
|
0
|
|
Active Treatment Phase: Max. 50 Months
NOT COMPLETED
|
4296
|
4310
|
|
Extension Period (in Average 9 Months)
STARTED
|
3773
|
3817
|
|
Extension Period (in Average 9 Months)
COMPLETED
|
3148
|
3182
|
|
Extension Period (in Average 9 Months)
NOT COMPLETED
|
625
|
635
|
Reasons for withdrawal
| Measure |
Aliskiren
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
Placebo
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
|---|---|---|
|
Active Treatment Phase: Max. 50 Months
Adverse Event
|
590
|
462
|
|
Active Treatment Phase: Max. 50 Months
Abnormal laboratory value(s)
|
98
|
58
|
|
Active Treatment Phase: Max. 50 Months
Abnormal test procedure result(s)
|
7
|
7
|
|
Active Treatment Phase: Max. 50 Months
Unsatisfactory therapeutic effect
|
47
|
53
|
|
Active Treatment Phase: Max. 50 Months
Subject withdrew consent
|
38
|
38
|
|
Active Treatment Phase: Max. 50 Months
Lost to Follow-up
|
41
|
29
|
|
Active Treatment Phase: Max. 50 Months
Administrative problems
|
2857
|
3019
|
|
Active Treatment Phase: Max. 50 Months
Death
|
188
|
200
|
|
Active Treatment Phase: Max. 50 Months
Patient's request
|
353
|
380
|
|
Active Treatment Phase: Max. 50 Months
Incorrect Entry
|
69
|
55
|
|
Active Treatment Phase: Max. 50 Months
Missing data
|
8
|
9
|
|
Extension Period (in Average 9 Months)
Death
|
143
|
136
|
|
Extension Period (in Average 9 Months)
Lost to Follow-up
|
52
|
47
|
|
Extension Period (in Average 9 Months)
Withdrawal by Subject
|
9
|
16
|
|
Extension Period (in Average 9 Months)
Patient's request
|
421
|
436
|
Baseline Characteristics
Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
Baseline characteristics by cohort
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
Total
n=8561 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 Years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
64.4 Years
STANDARD_DEVIATION 9.87 • n=7 Participants
|
64.5 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1393 Participants
n=5 Participants
|
1342 Participants
n=7 Participants
|
2735 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2881 Participants
n=5 Participants
|
2945 Participants
n=7 Participants
|
5826 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Occurrence was defined as the first event of the following composite primary endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF) * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. * Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)
|
17.6 percentage of participants
|
16.3 percentage of participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)
|
5.5 percentage of participants
|
4.8 percentage of participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 Months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)
|
0.4 percentage of participants
|
0.2 percentage of participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 Months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)
|
3.3 percentage of participants
|
3.2 percentage of participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 Months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)
|
3.4 percentage of participants
|
2.7 percentage of participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 Months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)
|
2.7 percentage of participants
|
2.5 percentage of participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 Months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)
|
4.6 percentage of participants
|
4.7 percentage of participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 Months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)
|
4.7 percentage of participants
|
5.0 percentage of participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)
|
8.4 percentage of participants
|
8.0 percentage of participants
|
PRIMARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.
Occurrence was defined as the first event of the following composite primary endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF) * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. * Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)
|
8.0 percentage of participants
|
8.0 percentage of participants
|
PRIMARY outcome
Timeframe: from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)
|
2.1 percentage of participants
|
1.9 percentage of participants
|
PRIMARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Resuscitated Sudden Death (Extension Phase)
|
0.1 percentage of participants
|
0.1 percentage of participants
|
PRIMARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)
|
1.4 percentage of participants
|
1.1 percentage of participants
|
PRIMARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)
|
0.9 percentage of participants
|
1.0 percentage of participants
|
PRIMARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)
|
1.4 percentage of participants
|
1.5 percentage of participants
|
PRIMARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.
To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)
|
2.4 percentage of participants
|
2.5 percentage of participants
|
PRIMARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)
|
1.7 percentage of participants
|
1.5 percentage of participants
|
PRIMARY outcome
Timeframe: from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With All Cause Mortality (Extension Phase)
|
3.8 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF)
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)
|
13.4 percentage of participants
|
12.1 percentage of participants
|
SECONDARY outcome
Timeframe: Time from randomization to the first event (Maximum 50 months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.
Occurrence was defined as the first event of the following secondary renal composite endpoint: * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. * Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)
|
5.6 percentage of participants
|
5.5 percentage of participants
|
SECONDARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).
Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF)
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)
|
5.0 percentage of participants
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).
Occurrence was defined as the first event of the following secondary renal composite endpoint: * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. * Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)
|
3.3 percentage of participants
|
3.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from randomization to the first event (Maximum 50 months)Population: Safety Set (SAF) - All patients who received at least one dose of trial medication. Patients were analyzed according to the treatment they received.
AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures
Outcome measures
| Measure |
Aliskiren
n=4272 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4285 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)
Angioedema / angioedema-like events
|
4.4 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)
Colorectal events
|
2.4 percentage of participants
|
2.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 6 , last measurement (maximum at 50 months)Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Last observation carried forward (LOCF) computation technique was used for month 6 data. At each visit, only patients with values at both baseline and this time point are included.
Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit. Change from Baseline = Post - Baseline.
Outcome measures
| Measure |
Aliskiren
n=4274 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4287 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)
Baseline to Month 6 (n= 4021, 4040)
|
0.841 mg/mmol
Interval 0.82 to 0.862
|
0.945 mg/mmol
Interval 0.922 to 0.968
|
|
Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)
Baseline to Last Measurement (n= 4045, 4080)
|
0.872 mg/mmol
Interval 0.842 to 0.903
|
1.043 mg/mmol
Interval 1.009 to 1.079
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Month 3 and Month 6Population: Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. At each visit (baseline, Month 3 and Month 6) , only patients with values at both baseline and post-baseline time point are included.
The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows: Estimated GFR (mL/min/1.73 m\^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black) Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms.
Outcome measures
| Measure |
Aliskiren
n=4113 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=4130 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)
|
-2.048 mL/min/1.73 m^2
Standard Error 0.15
|
-0.825 mL/min/1.73 m^2
Standard Error 0.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)Population: Extension-phase Analysis Set (EAS) - All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).
AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.
Outcome measures
| Measure |
Aliskiren
n=3773 Participants
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Placebo
n=3817 Participants
In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
|---|---|---|
|
Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)
Angioedema/ Angioedema-like event
|
0.8 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)
Colorectal events
|
0.7 percentage of participants
|
0.8 percentage of participants
|
Adverse Events
Core-phase: Aliskiren
Serious events: 1988 serious events
Other events: 3205 other events
Deaths: 0 deaths
Core-phase: Placebo
Serious events: 1893 serious events
Other events: 3069 other events
Deaths: 0 deaths
Extension-phase: Aliskiren
Serious events: 704 serious events
Other events: 995 other events
Deaths: 0 deaths
Extension-phase: Placebo
Serious events: 682 serious events
Other events: 1023 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Core-phase: Aliskiren
n=4272 participants at risk
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Core-phase: Placebo
n=4285 participants at risk
In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.
|
Extension-phase: Aliskiren
n=3773 participants at risk
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
Extension-phase: Placebo
n=3817 participants at risk
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Localised infection
|
0.33%
14/4272
|
0.23%
10/4285
|
0.03%
1/3773
|
0.08%
3/3817
|
|
Investigations
Respiratory rate increased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Troponin increased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.08%
3/3817
|
|
Infections and infestations
Lower respiratory tract infection
|
0.23%
10/4272
|
0.14%
6/4285
|
0.13%
5/3773
|
0.08%
3/3817
|
|
Investigations
Urinary sediment present
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Urine output decreased
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Headache
|
0.21%
9/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.08%
3/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.05%
2/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
55/4272
|
0.84%
36/4285
|
0.34%
13/3773
|
0.42%
16/3817
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.05%
2/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.07%
3/4272
|
0.16%
7/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.02%
1/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Acute coronary syndrome
|
0.63%
27/4272
|
0.79%
34/4285
|
0.13%
5/3773
|
0.18%
7/3817
|
|
Cardiac disorders
Acute left ventricular failure
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
48/4272
|
1.5%
64/4285
|
0.56%
21/3773
|
0.50%
19/3817
|
|
Cardiac disorders
Angina pectoris
|
2.2%
93/4272
|
2.0%
85/4285
|
0.58%
22/3773
|
0.58%
22/3817
|
|
Cardiac disorders
Angina unstable
|
1.2%
52/4272
|
1.0%
43/4285
|
0.27%
10/3773
|
0.29%
11/3817
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Aortic valve stenosis
|
0.12%
5/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Arrhythmia
|
0.23%
10/4272
|
0.30%
13/4285
|
0.03%
1/3773
|
0.08%
3/3817
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.23%
10/4272
|
0.21%
9/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
59/4272
|
1.5%
64/4285
|
0.16%
6/3773
|
0.45%
17/3817
|
|
Cardiac disorders
Atrial flutter
|
0.28%
12/4272
|
0.14%
6/4285
|
0.16%
6/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Atrial tachycardia
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Atrioventricular block
|
0.12%
5/4272
|
0.12%
5/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Atrioventricular block complete
|
0.35%
15/4272
|
0.23%
10/4285
|
0.11%
4/3773
|
0.05%
2/3817
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.14%
6/4272
|
0.14%
6/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Bradyarrhythmia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Bradycardia
|
0.37%
16/4272
|
0.35%
15/4285
|
0.05%
2/3773
|
0.10%
4/3817
|
|
Cardiac disorders
Bundle branch block left
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Cardiac arrest
|
0.70%
30/4272
|
0.54%
23/4285
|
0.19%
7/3773
|
0.13%
5/3817
|
|
Cardiac disorders
Cardiac asthma
|
0.05%
2/4272
|
0.05%
2/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Cardiac disorder
|
0.05%
2/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Cardiac failure
|
4.0%
173/4272
|
4.0%
173/4285
|
1.8%
67/3773
|
1.3%
50/3817
|
|
Cardiac disorders
Cardiac failure acute
|
0.33%
14/4272
|
0.37%
16/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
Cardiac disorders
Cardiac failure chronic
|
0.33%
14/4272
|
0.35%
15/4285
|
0.05%
2/3773
|
0.16%
6/3817
|
|
Cardiac disorders
Cardiac failure congestive
|
2.1%
90/4272
|
1.7%
71/4285
|
0.48%
18/3773
|
0.55%
21/3817
|
|
Cardiac disorders
Cardiac fibrillation
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Cardiac tamponade
|
0.02%
1/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Cardiac valve disease
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.28%
12/4272
|
0.30%
13/4285
|
0.05%
2/3773
|
0.08%
3/3817
|
|
Cardiac disorders
Cardiogenic shock
|
0.14%
6/4272
|
0.19%
8/4285
|
0.03%
1/3773
|
0.10%
4/3817
|
|
Cardiac disorders
Cardiomegaly
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Cardiomyopathy
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.05%
2/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.05%
2/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
67/4272
|
1.7%
71/4285
|
0.66%
25/3773
|
0.52%
20/3817
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Coronary artery occlusion
|
0.16%
7/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.08%
3/3817
|
|
Cardiac disorders
Coronary artery stenosis
|
0.30%
13/4272
|
0.30%
13/4285
|
0.08%
3/3773
|
0.05%
2/3817
|
|
Cardiac disorders
Diastolic dysfunction
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Dilatation ventricular
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Hypertensive heart disease
|
0.12%
5/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.16%
7/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.12%
5/4272
|
0.07%
3/4285
|
0.08%
3/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Left ventricular failure
|
0.19%
8/4272
|
0.23%
10/4285
|
0.08%
3/3773
|
0.05%
2/3817
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Mitral valve incompetence
|
0.09%
4/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Cardiac disorders
Mitral valve stenosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
87/4272
|
1.5%
65/4285
|
0.61%
23/3773
|
0.79%
30/3817
|
|
Cardiac disorders
Myocardial ischaemia
|
0.87%
37/4272
|
0.82%
35/4285
|
0.21%
8/3773
|
0.21%
8/3817
|
|
Cardiac disorders
Nodal arrhythmia
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Palpitations
|
0.09%
4/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Pericardial effusion
|
0.12%
5/4272
|
0.14%
6/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Pericarditis constrictive
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Postinfarction angina
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Right ventricular failure
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Sick sinus syndrome
|
0.19%
8/4272
|
0.12%
5/4285
|
0.11%
4/3773
|
0.10%
4/3817
|
|
Cardiac disorders
Silent myocardial infarction
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Sinus arrhythmia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Sinus bradycardia
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
3/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Tachycardia
|
0.12%
5/4272
|
0.14%
6/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Trifascicular block
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.07%
3/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
10/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.08%
3/3817
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Cardiac disorders
Ventricular tachycardia
|
0.16%
7/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.10%
4/3817
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Congenital, familial and genetic disorders
Congenital arterial malformation
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Congenital, familial and genetic disorders
Familial hypocalciuric hypercalcaemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Congenital, familial and genetic disorders
Haemoglobinopathy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Congenital, familial and genetic disorders
Rathke's cleft cyst
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Ear and labyrinth disorders
Vertigo
|
0.40%
17/4272
|
0.21%
9/4285
|
0.03%
1/3773
|
0.10%
4/3817
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Endocrine disorders
Cushing's syndrome
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Endocrine disorders
Goitre
|
0.09%
4/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Endocrine disorders
Hyperparathyroidism
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Endocrine disorders
Hypothyroidism
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Endocrine disorders
Primary hyperaldosteronism
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Amaurosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Eye disorders
Blindness
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Blindness unilateral
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Cataract
|
0.77%
33/4272
|
0.75%
32/4285
|
0.32%
12/3773
|
0.16%
6/3817
|
|
Eye disorders
Cataract diabetic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Cystoid macular oedema
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Detachment of macular retinal pigment epithelium
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Diabetic eye disease
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Diabetic retinopathy
|
0.54%
23/4272
|
0.42%
18/4285
|
0.05%
2/3773
|
0.10%
4/3817
|
|
Eye disorders
Diplopia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Ectropion
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Eye haemorrhage
|
0.07%
3/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Eye disorders
Eyelid oedema
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Eye disorders
Eyelid ptosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Glaucoma
|
0.09%
4/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Iris adhesions
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Lenticular opacities
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Macular degeneration
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Eye disorders
Macular fibrosis
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebellar infarction
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Macular hole
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Macular oedema
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Ocular hypertension
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Periorbital oedema
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Pterygium
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Retinal artery occlusion
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Retinal detachment
|
0.14%
6/4272
|
0.14%
6/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Retinal haemorrhage
|
0.09%
4/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Retinal tear
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Retinopathy
|
0.07%
3/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Eye disorders
Retinopathy proliferative
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Eye disorders
Vision blurred
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Visual impairment
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Eye disorders
Vitreous adhesions
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Eye disorders
Vitreous haemorrhage
|
0.40%
17/4272
|
0.26%
11/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Abdominal distension
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
13/4272
|
0.30%
13/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.12%
5/4272
|
0.07%
3/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Ascites
|
0.05%
2/4272
|
0.09%
4/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Colitis
|
0.09%
4/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.02%
1/4272
|
0.00%
0/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Gastrointestinal disorders
Constipation
|
0.09%
4/4272
|
0.16%
7/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Crohn's disease
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Dental caries
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Diabetic enteropathy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Diabetic gastroenteropathy
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
12/4272
|
0.35%
15/4285
|
0.11%
4/3773
|
0.10%
4/3817
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Diverticulum
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.12%
5/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.09%
4/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Dyspepsia
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Dysphagia
|
0.09%
4/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Enteritis
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Enterocolitis
|
0.05%
2/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Faecaloma
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Food poisoning
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.02%
1/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastric perforation
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastric polyps
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.16%
7/4272
|
0.28%
12/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
10/4272
|
0.37%
16/4285
|
0.05%
2/3773
|
0.08%
3/3817
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.05%
2/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastroduodenitis haemorrhagic
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastrointestinal dysplasia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.40%
17/4272
|
0.33%
14/4285
|
0.13%
5/3773
|
0.08%
3/3817
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.07%
3/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Haematemesis
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Haematochezia
|
0.07%
3/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.05%
2/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Hernial eventration
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Ileus
|
0.07%
3/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.05%
2/4272
|
0.05%
2/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.19%
8/4272
|
0.21%
9/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Intestinal angina
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.05%
2/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Gastrointestinal disorders
Intestinal mass
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
4/4272
|
0.09%
4/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.09%
4/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Ischaemic pancreatitis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebral infarction
|
0.70%
30/4272
|
0.63%
27/4285
|
0.11%
4/3773
|
0.26%
10/3817
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.40%
17/4272
|
0.40%
17/4285
|
0.05%
2/3773
|
0.16%
6/3817
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Lip swelling
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.02%
1/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Melaena
|
0.12%
5/4272
|
0.12%
5/4285
|
0.08%
3/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Nausea
|
0.26%
11/4272
|
0.19%
8/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Oesophagitis
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
5/4272
|
0.09%
4/4285
|
0.11%
4/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.19%
8/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.19%
8/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Rectal polyp
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Retroperitoneal mass
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Sciatic hernia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Gastrointestinal disorders
Stress ulcer
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Subileus
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Swollen tongue
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.19%
8/4272
|
0.26%
11/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Volvulus
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
22/4272
|
0.42%
18/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
General disorders
Adverse drug reaction
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
General disorders
Asthenia
|
0.35%
15/4272
|
0.09%
4/4285
|
0.16%
6/3773
|
0.13%
5/3817
|
|
General disorders
Cardiac death
|
0.19%
8/4272
|
0.16%
7/4285
|
0.08%
3/3773
|
0.05%
2/3817
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/4272
|
0.00%
0/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
General disorders
Chest discomfort
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Chest pain
|
0.09%
4/4272
|
0.16%
7/4285
|
0.11%
4/3773
|
0.03%
1/3817
|
|
General disorders
Chills
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Death
|
0.49%
21/4272
|
0.35%
15/4285
|
0.34%
13/3773
|
0.45%
17/3817
|
|
General disorders
Device battery issue
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
General disorders
Device dislocation
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Device electrical finding
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
General disorders
Device failure
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
General disorders
Device lead issue
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
General disorders
Device malfunction
|
0.07%
3/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
General disorders
Discomfort
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Disease progression
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Drug intolerance
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Face oedema
|
0.26%
11/4272
|
0.23%
10/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
General disorders
Facial pain
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Fat tissue increased
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Fatigue
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Gait disturbance
|
0.02%
1/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
General disorders
General physical health deterioration
|
0.05%
2/4272
|
0.09%
4/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
General disorders
General symptom
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Generalised oedema
|
0.23%
10/4272
|
0.26%
11/4285
|
0.13%
5/3773
|
0.08%
3/3817
|
|
General disorders
Granuloma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Hyperplasia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Hyperthermia
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Impaired healing
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
General disorders
Inflammation
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Influenza like illness
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Localised oedema
|
0.05%
2/4272
|
0.07%
3/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
General disorders
Malaise
|
0.05%
2/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
General disorders
Medical device complication
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
General disorders
Multi-organ failure
|
0.00%
0/4272
|
0.12%
5/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
General disorders
Non-cardiac chest pain
|
0.87%
37/4272
|
0.91%
39/4285
|
0.21%
8/3773
|
0.05%
2/3817
|
|
General disorders
Oedema
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Oedema due to cardiac disease
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Oedema peripheral
|
1.1%
45/4272
|
0.96%
41/4285
|
0.19%
7/3773
|
0.24%
9/3817
|
|
General disorders
Pain
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
General disorders
Pelvic mass
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Perforated ulcer
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Pyrexia
|
0.59%
25/4272
|
0.30%
13/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
General disorders
Spinal pain
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Sudden cardiac death
|
0.44%
19/4272
|
0.30%
13/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
General disorders
Sudden death
|
0.47%
20/4272
|
0.37%
16/4285
|
0.24%
9/3773
|
0.10%
4/3817
|
|
General disorders
Swelling
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
General disorders
Systemic inflammatory response syndrome
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Ulcer
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
General disorders
Ulcer haemorrhage
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Bile duct stone
|
0.16%
7/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Hepatobiliary disorders
Biliary cirrhosis primary
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Biliary colic
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Hepatobiliary disorders
Biliary cyst
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Cholangitis
|
0.14%
6/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Hepatobiliary disorders
Cholecystitis
|
0.30%
13/4272
|
0.28%
12/4285
|
0.08%
3/3773
|
0.16%
6/3817
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
8/4272
|
0.26%
11/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.02%
1/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
13/4272
|
0.47%
20/4285
|
0.11%
4/3773
|
0.05%
2/3817
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Dilatation intrahepatic duct acquired
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatic artery aneurysm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.16%
7/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatic failure
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Hepatobiliary disorders
Hepatitis
|
0.05%
2/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Jaundice
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Immune system disorders
Anaphylactic shock
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Immune system disorders
Contrast media allergy
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Immune system disorders
Drug hypersensitivity
|
0.05%
2/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Immune system disorders
Iodine allergy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Immune system disorders
Secondary immunodeficiency
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Abdominal abscess
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Abdominal infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Abdominal sepsis
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Abscess limb
|
0.05%
2/4272
|
0.14%
6/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Infections and infestations
American trypanosomiasis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Anal abscess
|
0.05%
2/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Appendicitis
|
0.12%
5/4272
|
0.05%
2/4285
|
0.08%
3/3773
|
0.03%
1/3817
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Infections and infestations
Arthritis infective
|
0.02%
1/4272
|
0.00%
0/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Bacteraemia
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Bacterial infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Biliary abscess
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Bone abscess
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Breast abscess
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Bronchitis
|
0.51%
22/4272
|
0.51%
22/4285
|
0.11%
4/3773
|
0.29%
11/3817
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Bronchopneumonia
|
0.49%
21/4272
|
0.51%
22/4285
|
0.16%
6/3773
|
0.00%
0/3817
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Candidiasis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Carbuncle
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Catheter site infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Cellulitis
|
0.96%
41/4272
|
0.96%
41/4285
|
0.42%
16/3773
|
0.26%
10/3817
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Chronic hepatitis B
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Chronic sinusitis
|
0.07%
3/4272
|
0.05%
2/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Clostridium difficile colitis
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Cystitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Cystitis klebsiella
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Dengue fever
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Device related infection
|
0.23%
10/4272
|
0.12%
5/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Infections and infestations
Device related sepsis
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Diabetic foot infection
|
0.12%
5/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Diabetic gangrene
|
0.09%
4/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.08%
3/3817
|
|
Infections and infestations
Diarrhoea infectious
|
0.05%
2/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Diverticulitis
|
0.09%
4/4272
|
0.19%
8/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Infections and infestations
Eczema infected
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Endocarditis
|
0.12%
5/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.10%
4/3817
|
|
Infections and infestations
Endocarditis bacterial
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Endometritis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Endotoxic shock
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Enteritis infectious
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Enteritis necroticans
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Enterocolitis infectious
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Erysipelas
|
0.42%
18/4272
|
0.35%
15/4285
|
0.16%
6/3773
|
0.16%
6/3817
|
|
Infections and infestations
Escherichia bacteraemia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Escherichia sepsis
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Febrile infection
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Furuncle
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Gallbladder abscess
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Gangrene
|
0.33%
14/4272
|
0.54%
23/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Gastritis viral
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Gastroenteritis
|
0.75%
32/4272
|
0.54%
23/4285
|
0.19%
7/3773
|
0.21%
8/3817
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
HIV infection
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Herpes zoster
|
0.14%
6/4272
|
0.14%
6/4285
|
0.11%
4/3773
|
0.00%
0/3817
|
|
Infections and infestations
Incision site infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Infected bites
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Infected bunion
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Infected fistula
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Infected skin ulcer
|
0.14%
6/4272
|
0.19%
8/4285
|
0.08%
3/3773
|
0.00%
0/3817
|
|
Infections and infestations
Infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Infective spondylitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Influenza
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Infections and infestations
Keratitis bacterial
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Kidney infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Listeria sepsis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebral haematoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Liver abscess
|
0.09%
4/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Lobar pneumonia
|
0.16%
7/4272
|
0.19%
8/4285
|
0.08%
3/3773
|
0.10%
4/3817
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Lung abscess
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Lung infection
|
0.49%
21/4272
|
0.51%
22/4285
|
0.16%
6/3773
|
0.05%
2/3817
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Lymphangitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Malaria
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.26%
11/4272
|
0.26%
11/4285
|
0.11%
4/3773
|
0.05%
2/3817
|
|
Infections and infestations
Mastoid abscess
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Meningitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Meningitis aseptic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Myelitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Myiasis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Nasopharyngitis
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Nosocomial infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Oesophageal candidiasis
|
0.05%
2/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Orchitis
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Osteomyelitis
|
0.47%
20/4272
|
0.40%
17/4285
|
0.08%
3/3773
|
0.21%
8/3817
|
|
Infections and infestations
Osteomyelitis chronic
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Otitis externa
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Otitis media chronic
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Paronychia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Parotitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Perihepatic abscess
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Periodontitis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Peritoneal abscess
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Peritonitis
|
0.14%
6/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.08%
3/3817
|
|
Infections and infestations
Peritonsillar abscess
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pharyngitis
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pneumonia
|
2.8%
121/4272
|
2.3%
100/4285
|
1.1%
42/3773
|
1.0%
39/3817
|
|
Infections and infestations
Pneumonia bacterial
|
0.05%
2/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pneumonia legionella
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pneumonia pseudomonas aeruginosa
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Post procedural cellulitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Post procedural infection
|
0.09%
4/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Post procedural sepsis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Postoperative wound infection
|
0.07%
3/4272
|
0.16%
7/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Prostate infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Infections and infestations
Proteus infection
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pulmonary sepsis
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.09%
4/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Purulent discharge
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pyelonephritis
|
0.23%
10/4272
|
0.07%
3/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
Infections and infestations
Pyelonephritis acute
|
0.12%
5/4272
|
0.19%
8/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Pyonephrosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Q fever
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Renal abscess
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Respiratory moniliasis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Respiratory tract infection
|
0.26%
11/4272
|
0.30%
13/4285
|
0.05%
2/3773
|
0.16%
6/3817
|
|
Infections and infestations
Rhinitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Schistosomiasis liver
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Scrotal infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Sepsis
|
0.66%
28/4272
|
0.63%
27/4285
|
0.24%
9/3773
|
0.47%
18/3817
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Septic shock
|
0.35%
15/4272
|
0.33%
14/4285
|
0.13%
5/3773
|
0.18%
7/3817
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Skin infection
|
0.02%
1/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Soft tissue infection
|
0.07%
3/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Splenic abscess
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Staphylococcal infection
|
0.12%
5/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.11%
4/3773
|
0.00%
0/3817
|
|
Infections and infestations
Staphylococcal skin infection
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Streptococcal sepsis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Subcutaneous abscess
|
0.09%
4/4272
|
0.05%
2/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Infections and infestations
Syphilis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Tongue abscess
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Tooth abscess
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Tracheitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Tuberculosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Infections and infestations
Upper respiratory tract infection
|
0.09%
4/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Ureteritis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Urethritis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Urinary tract infection
|
1.3%
56/4272
|
1.0%
44/4285
|
0.27%
10/3773
|
0.39%
15/3817
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Urosepsis
|
0.12%
5/4272
|
0.33%
14/4285
|
0.11%
4/3773
|
0.05%
2/3817
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Viral diarrhoea
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Viral infection
|
0.05%
2/4272
|
0.14%
6/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Infections and infestations
Viral pericarditis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Infections and infestations
Wound infection
|
0.07%
3/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.12%
5/4272
|
0.07%
3/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Contusion
|
0.07%
3/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.08%
3/3817
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Face injury
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Fall
|
0.54%
23/4272
|
0.23%
10/4285
|
0.05%
2/3773
|
0.13%
5/3817
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.19%
8/4272
|
0.21%
9/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.16%
7/4272
|
0.30%
13/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.05%
2/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.09%
4/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Haemodialysis complication
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Head injury
|
0.16%
7/4272
|
0.14%
6/4285
|
0.03%
1/3773
|
0.13%
5/3817
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.21%
9/4272
|
0.33%
14/4285
|
0.08%
3/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.23%
10/4272
|
0.19%
8/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Laceration
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.12%
5/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.07%
3/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.05%
2/4272
|
0.05%
2/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Peritoneal dialysis complication
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.05%
2/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Post procedural diarrhoea
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.21%
9/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
9/4272
|
0.14%
6/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Scratch
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.05%
2/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
4/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.05%
2/4272
|
0.14%
6/4285
|
0.08%
3/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.05%
2/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.07%
3/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.02%
1/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.05%
2/4272
|
0.00%
0/4285
|
0.08%
3/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.23%
10/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.05%
2/4272
|
0.02%
1/4285
|
0.08%
3/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Injury, poisoning and procedural complications
Wound
|
0.12%
5/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.08%
3/3817
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Injury, poisoning and procedural complications
Wound haematoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Blood creatine increased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Blood creatine phosphokinase increased
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Blood creatinine increased
|
0.47%
20/4272
|
0.35%
15/4285
|
0.13%
5/3773
|
0.00%
0/3817
|
|
Investigations
Blood glucose abnormal
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Blood glucose increased
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Blood pressure decreased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Blood pressure increased
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Brain natriuretic peptide increased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Investigations
Electrocardiogram ambulatory abnormal
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Glomerular filtration rate abnormal
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
HIV test positive
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Haemoglobin decreased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
International normalised ratio increased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Investigations
Occult blood
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Occult blood positive
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Prostatic specific antigen increased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Investigations
Weight decreased
|
0.07%
3/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Investigations
Weight increased
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Acidosis
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Dehydration
|
0.61%
26/4272
|
0.37%
16/4285
|
0.13%
5/3773
|
0.21%
8/3817
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.0%
44/4272
|
1.1%
49/4285
|
0.29%
11/3773
|
0.21%
8/3817
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.91%
39/4272
|
0.84%
36/4285
|
0.24%
9/3773
|
0.26%
10/3817
|
|
Metabolism and nutrition disorders
Diabetes with hyperosmolarity
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.14%
6/4272
|
0.12%
5/4285
|
0.13%
5/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.14%
6/4272
|
0.12%
5/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.02%
1/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Metabolism and nutrition disorders
Gout
|
0.23%
10/4272
|
0.28%
12/4285
|
0.08%
3/3773
|
0.08%
3/3817
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
43/4272
|
1.1%
45/4285
|
0.21%
8/3773
|
0.29%
11/3817
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.0%
44/4272
|
0.51%
22/4285
|
0.21%
8/3773
|
0.18%
7/3817
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Hyperproteinaemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.09%
4/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
66/4272
|
1.3%
57/4285
|
0.48%
18/3773
|
0.39%
15/3817
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.09%
4/4272
|
0.16%
7/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.19%
8/4272
|
0.26%
11/4285
|
0.05%
2/3773
|
0.13%
5/3817
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.02%
1/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.14%
6/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.08%
3/3817
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.02%
1/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Obesity
|
0.09%
4/4272
|
0.05%
2/4285
|
0.11%
4/3773
|
0.03%
1/3817
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Sodium retention
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.19%
8/4272
|
0.16%
7/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
3/4272
|
0.23%
10/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.23%
10/4272
|
0.26%
11/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Bone formation increased
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.09%
4/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.02%
1/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.21%
9/4272
|
0.26%
11/4285
|
0.03%
1/3773
|
0.13%
5/3817
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.16%
7/4272
|
0.26%
11/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.16%
7/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.09%
4/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.07%
3/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Myopathy toxic
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.07%
3/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
24/4272
|
0.82%
35/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.09%
4/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.16%
7/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
2/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.09%
4/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.09%
4/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.19%
8/4272
|
0.14%
6/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.09%
4/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.07%
3/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.05%
2/4272
|
0.09%
4/4285
|
0.08%
3/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer metastatic
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma malignant
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.16%
7/4272
|
0.19%
8/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign laryngeal neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.21%
9/4272
|
0.19%
8/4285
|
0.13%
5/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.07%
3/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.07%
3/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.05%
2/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast adenoma
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.05%
2/4272
|
0.12%
5/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the duodenum
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.14%
6/4272
|
0.16%
7/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.19%
8/4272
|
0.21%
9/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Craniopharyngioma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endocrine neoplasm malignant
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid mesothelioma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrosarcoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.02%
1/4272
|
0.19%
8/4285
|
0.05%
2/3773
|
0.08%
3/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage IV
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glottis carcinoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.09%
4/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal papilloma
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.05%
2/4272
|
0.14%
6/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage I
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.28%
12/4272
|
0.26%
11/4285
|
0.05%
2/3773
|
0.08%
3/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.09%
4/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.08%
3/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.09%
4/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.07%
3/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumour
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.02%
1/4272
|
0.02%
1/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxofibrosarcoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.05%
2/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.05%
2/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteochondroma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.07%
3/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinoma metastatic
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.61%
26/4272
|
0.44%
19/4285
|
0.05%
2/3773
|
0.21%
8/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.05%
2/4272
|
0.05%
2/4285
|
0.08%
3/3773
|
0.05%
2/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage IV
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.12%
5/4272
|
0.02%
1/4285
|
0.08%
3/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.14%
6/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue cancer
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Splenic neoplasm malignancy unspecified
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.07%
3/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.05%
2/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.05%
2/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.12%
5/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine neoplasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal cord neoplasm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Apallic syndrome
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Aphasia
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Autonomic neuropathy
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Basal ganglia infarction
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Basilar artery occlusion
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Brain injury
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Brain oedema
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Brain stem infarction
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Brain stem stroke
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Carotid artery disease
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Carotid artery occlusion
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Carotid artery stenosis
|
0.23%
10/4272
|
0.42%
18/4285
|
0.08%
3/3773
|
0.10%
4/3817
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Cerebral ischaemia
|
0.16%
7/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebral thrombosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
93/4272
|
1.5%
66/4285
|
0.61%
23/3773
|
0.58%
22/3817
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Cognitive disorder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Coma
|
0.09%
4/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Complicated migraine
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Convulsion
|
0.12%
5/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Nervous system disorders
Dementia
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Demyelination
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Depressed level of consciousness
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Diabetic autonomic neuropathy
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Diabetic coma
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Diabetic neuropathy
|
0.26%
11/4272
|
0.28%
12/4285
|
0.05%
2/3773
|
0.16%
6/3817
|
|
Nervous system disorders
Dizziness
|
0.44%
19/4272
|
0.28%
12/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Dysarthria
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Embolic stroke
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Encephalitis
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Epidural lipomatosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Epilepsy
|
0.16%
7/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Grand mal convulsion
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.07%
3/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Hemianopia homonymous
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Hemiparesis
|
0.19%
8/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Hemiplegia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Hydrocephalus
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Nervous system disorders
Hypoaesthesia
|
0.07%
3/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.05%
2/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.07%
3/4272
|
0.05%
2/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Ischaemic stroke
|
0.40%
17/4272
|
0.35%
15/4285
|
0.08%
3/3773
|
0.16%
6/3817
|
|
Nervous system disorders
Lacunar infarction
|
0.19%
8/4272
|
0.14%
6/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Lateral medullary syndrome
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Lethargy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Loss of consciousness
|
0.16%
7/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.08%
3/3817
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.05%
2/4272
|
0.05%
2/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Motor dysfunction
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Motor neurone disease
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Movement disorder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Myelitis transverse
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Myelopathy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Nerve compression
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Neuralgia
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Neuroglycopenia
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
1/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Paraesthesia
|
0.05%
2/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Parkinsonism
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Phantom pain
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Polyneuropathy
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Presyncope
|
0.12%
5/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Sciatica
|
0.07%
3/4272
|
0.16%
7/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Simple partial seizures
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Somnolence
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Spinal claudication
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Spinal cord haemorrhage
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Spinal cord oedema
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.12%
5/4272
|
0.09%
4/4285
|
0.08%
3/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Subdural effusion
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Syncope
|
0.94%
40/4272
|
0.77%
33/4285
|
0.19%
7/3773
|
0.16%
6/3817
|
|
Nervous system disorders
Thalamic infarction
|
0.07%
3/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Transient ischaemic attack
|
0.56%
24/4272
|
0.58%
25/4285
|
0.11%
4/3773
|
0.24%
9/3817
|
|
Nervous system disorders
Tremor
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Ulnar neuritis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.09%
4/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Vascular encephalopathy
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.14%
6/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.08%
3/3817
|
|
Nervous system disorders
Vocal cord paresis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Aggression
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Agitation
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Anger
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Anxiety
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Bipolar disorder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Confusional state
|
0.21%
9/4272
|
0.07%
3/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Delirium
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Depression
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.08%
3/3817
|
|
Psychiatric disorders
Disorientation
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Echopraxia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Major depression
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Mental disorder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.10%
4/3817
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Psychogenic pain disorder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Psychotic disorder due to a general medical condition
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Psychiatric disorders
Social avoidant behaviour
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Stress
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Psychiatric disorders
Transient psychosis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Anuria
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Azotaemia
|
0.09%
4/4272
|
0.09%
4/4285
|
0.05%
2/3773
|
0.10%
4/3817
|
|
Renal and urinary disorders
Bladder cyst
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Bladder prolapse
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Bladder spasm
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Bladder stenosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Calculus bladder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Calculus ureteric
|
0.16%
7/4272
|
0.07%
3/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Calculus urinary
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Diabetic end stage renal disease
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Diabetic nephropathy
|
1.4%
60/4272
|
1.3%
57/4285
|
0.37%
14/3773
|
0.37%
14/3817
|
|
Renal and urinary disorders
Dysuria
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Glycosuria
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Haematuria
|
0.16%
7/4272
|
0.23%
10/4285
|
0.05%
2/3773
|
0.08%
3/3817
|
|
Renal and urinary disorders
Henoch-Schonlein purpura nephritis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Hydronephrosis
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Hydroureter
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Intercapillary glomerulosclerosis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
6/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Nephropathy
|
0.07%
3/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.14%
6/4272
|
0.19%
8/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Nocturia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.05%
2/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Oliguria
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Polyuria
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Proteinuria
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Renal amyloidosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Renal colic
|
0.07%
3/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Renal cyst
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Renal failure
|
1.1%
45/4272
|
0.56%
24/4285
|
0.29%
11/3773
|
0.39%
15/3817
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
73/4272
|
1.3%
56/4285
|
0.72%
27/3773
|
0.60%
23/3817
|
|
Renal and urinary disorders
Renal failure chronic
|
1.7%
74/4272
|
1.2%
53/4285
|
0.69%
26/3773
|
0.86%
33/3817
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Renal hypertension
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Renal impairment
|
2.0%
84/4272
|
1.5%
64/4285
|
0.40%
15/3773
|
0.34%
13/3817
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Ureteral polyp
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Urethral obstruction
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Urethral stenosis
|
0.07%
3/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Renal and urinary disorders
Urinary incontinence
|
0.14%
6/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Urinary retention
|
0.12%
5/4272
|
0.16%
7/4285
|
0.05%
2/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.30%
13/4272
|
0.42%
18/4285
|
0.11%
4/3773
|
0.03%
1/3817
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Prostatitis
|
0.12%
5/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Spermatocele
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Urogenital prolapse
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Vaginal cyst
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Reproductive system and breast disorders
Vulval oedema
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.44%
19/4272
|
0.40%
17/4285
|
0.19%
7/3773
|
0.08%
3/3817
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.28%
12/4272
|
0.26%
11/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
10/4272
|
0.09%
4/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Asthma late onset
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.05%
2/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.68%
29/4272
|
0.54%
23/4285
|
0.42%
16/3773
|
0.24%
9/3817
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.14%
6/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
55/4272
|
1.2%
52/4285
|
0.29%
11/3773
|
0.26%
10/3817
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.14%
6/4272
|
0.12%
5/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.09%
4/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.07%
3/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.12%
5/4272
|
0.14%
6/4285
|
0.08%
3/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.05%
2/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.09%
4/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal cyst
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
12/4272
|
0.37%
16/4285
|
0.13%
5/3773
|
0.18%
7/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.05%
2/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.05%
2/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4272
|
0.07%
3/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.23%
10/4272
|
0.26%
11/4285
|
0.13%
5/3773
|
0.13%
5/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.02%
1/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.14%
6/4272
|
0.14%
6/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/4272
|
0.09%
4/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary necrosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.51%
22/4272
|
0.30%
13/4285
|
0.11%
4/3773
|
0.08%
3/3817
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.05%
2/4272
|
0.14%
6/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.02%
1/4272
|
0.19%
8/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.68%
29/4272
|
0.28%
12/4285
|
0.27%
10/3773
|
0.24%
9/3817
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.28%
12/4272
|
0.23%
10/4285
|
0.08%
3/3773
|
0.10%
4/3817
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic haemorrhage
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway resistance syndrome
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord cyst
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.19%
8/4272
|
0.12%
5/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Diabetic dermopathy
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.54%
23/4272
|
0.51%
22/4285
|
0.11%
4/3773
|
0.18%
7/3817
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.07%
3/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.07%
3/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.82%
35/4272
|
0.49%
21/4285
|
0.13%
5/3773
|
0.08%
3/3817
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Social circumstances
Activities of daily living impaired
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Social circumstances
Drug abuser
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Accelerated hypertension
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Aortic aneurysm
|
0.19%
8/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Aortic stenosis
|
0.12%
5/4272
|
0.09%
4/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Vascular disorders
Arterial disorder
|
0.09%
4/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Vascular disorders
Arteriosclerosis
|
0.09%
4/4272
|
0.16%
7/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Arteriosclerosis Moenckeberg-type
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Arteriovenous fistula
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.09%
4/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Circulatory collapse
|
0.14%
6/4272
|
0.12%
5/4285
|
0.03%
1/3773
|
0.03%
1/3817
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
8/4272
|
0.12%
5/4285
|
0.13%
5/3773
|
0.00%
0/3817
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Distributive shock
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Femoral artery occlusion
|
0.07%
3/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Vascular disorders
Flushing
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Haematoma
|
0.14%
6/4272
|
0.05%
2/4285
|
0.05%
2/3773
|
0.03%
1/3817
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Haemorrhage
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Hypertension
|
0.89%
38/4272
|
1.1%
47/4285
|
0.19%
7/3773
|
0.34%
13/3817
|
|
Vascular disorders
Hypertensive crisis
|
0.33%
14/4272
|
0.42%
18/4285
|
0.08%
3/3773
|
0.08%
3/3817
|
|
Vascular disorders
Hypertensive emergency
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Hypotension
|
0.73%
31/4272
|
0.75%
32/4285
|
0.08%
3/3773
|
0.29%
11/3817
|
|
Vascular disorders
Hypovolaemic shock
|
0.07%
3/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Infarction
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Intermittent claudication
|
0.23%
10/4272
|
0.19%
8/4285
|
0.03%
1/3773
|
0.05%
2/3817
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Labile hypertension
|
0.00%
0/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Vascular disorders
Leriche syndrome
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Lymphocele
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Lymphoedema
|
0.05%
2/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Neovascularisation
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Orthostatic hypotension
|
0.28%
12/4272
|
0.19%
8/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.54%
23/4272
|
0.72%
31/4285
|
0.21%
8/3773
|
0.26%
10/3817
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Peripheral artery stenosis
|
0.21%
9/4272
|
0.30%
13/4285
|
0.08%
3/3773
|
0.10%
4/3817
|
|
Vascular disorders
Peripheral circulatory failure
|
0.00%
0/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Peripheral embolism
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Peripheral ischaemia
|
0.30%
13/4272
|
0.26%
11/4285
|
0.05%
2/3773
|
0.05%
2/3817
|
|
Vascular disorders
Peripheral vascular disorder
|
0.12%
5/4272
|
0.23%
10/4285
|
0.03%
1/3773
|
0.08%
3/3817
|
|
Vascular disorders
Phlebitis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Shock
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.05%
2/3817
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/4272
|
0.07%
3/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Subclavian artery stenosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Subclavian steal syndrome
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Temporal arteritis
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Thrombophlebitis
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Thrombosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Vascular disorders
Varicophlebitis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Varicose ulceration
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Varicose vein
|
0.02%
1/4272
|
0.05%
2/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Vascular stenosis
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Vasculitis
|
0.02%
1/4272
|
0.02%
1/4285
|
0.03%
1/3773
|
0.00%
0/3817
|
|
Vascular disorders
Vena cava thrombosis
|
0.02%
1/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Venous insufficiency
|
0.02%
1/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/4272
|
0.02%
1/4285
|
0.00%
0/3773
|
0.03%
1/3817
|
|
Vascular disorders
Venous thrombosis limb
|
0.05%
2/4272
|
0.00%
0/4285
|
0.00%
0/3773
|
0.00%
0/3817
|
Other adverse events
| Measure |
Core-phase: Aliskiren
n=4272 participants at risk
In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
|
Core-phase: Placebo
n=4285 participants at risk
In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.
|
Extension-phase: Aliskiren
n=3773 participants at risk
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
Extension-phase: Placebo
n=3817 participants at risk
With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.3%
270/4272
|
6.3%
270/4285
|
2.5%
94/3773
|
2.0%
76/3817
|
|
Gastrointestinal disorders
Constipation
|
4.7%
202/4272
|
5.6%
241/4285
|
1.3%
48/3773
|
1.2%
45/3817
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
405/4272
|
7.1%
305/4285
|
1.5%
56/3773
|
1.1%
41/3817
|
|
General disorders
Oedema peripheral
|
15.3%
655/4272
|
15.6%
670/4285
|
3.4%
130/3773
|
2.9%
112/3817
|
|
Infections and infestations
Bronchitis
|
5.1%
217/4272
|
4.9%
211/4285
|
0.95%
36/3773
|
1.6%
61/3817
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
398/4272
|
8.6%
369/4285
|
2.2%
83/3773
|
2.3%
89/3817
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
214/4272
|
5.0%
215/4285
|
1.3%
48/3773
|
1.5%
58/3817
|
|
Infections and infestations
Urinary tract infection
|
6.7%
286/4272
|
5.7%
243/4285
|
1.9%
72/3773
|
2.3%
88/3817
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
38.6%
1650/4272
|
28.7%
1229/4285
|
7.2%
270/3773
|
6.6%
252/3817
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.8%
334/4272
|
6.9%
297/4285
|
2.6%
98/3773
|
2.3%
87/3817
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
295/4272
|
7.0%
299/4285
|
1.4%
52/3773
|
1.3%
51/3817
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
360/4272
|
8.0%
344/4285
|
1.4%
54/3773
|
1.2%
46/3817
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
292/4272
|
7.3%
311/4285
|
1.5%
57/3773
|
1.1%
42/3817
|
|
Nervous system disorders
Dizziness
|
7.4%
314/4272
|
7.1%
305/4285
|
1.2%
45/3773
|
1.5%
57/3817
|
|
Nervous system disorders
Headache
|
4.4%
188/4272
|
5.1%
219/4285
|
1.1%
42/3773
|
0.73%
28/3817
|
|
Renal and urinary disorders
Renal impairment
|
8.2%
352/4272
|
7.5%
321/4285
|
1.9%
72/3773
|
2.3%
87/3817
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
256/4272
|
6.5%
280/4285
|
1.4%
53/3773
|
1.2%
47/3817
|
|
Vascular disorders
Hypertension
|
8.9%
380/4272
|
9.6%
410/4285
|
3.2%
121/3773
|
2.8%
105/3817
|
|
Vascular disorders
Hypotension
|
11.6%
496/4272
|
7.5%
321/4285
|
0.90%
34/3773
|
1.5%
58/3817
|
Additional Information
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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER