Trial Outcomes & Findings for An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED) (NCT NCT00092677)
NCT ID: NCT00092677
Last Updated: 2024-05-16
Results Overview
Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1873 participants
Primary outcome timeframe
Entire follow-up (median = 4.35 years)
Results posted on
2024-05-16
Participant Flow
Phase III. Study Initiation Date (FPI) was 06-Jan-2003 and Study Completion Date (LPO) was 17-Apr-2008. Primary therapy period 02-Mar-2001 to 31-Mar-2008 includes start date of therapy from the Simvastatin in Aortic Stenosis (SAS) study. 173 study centers worldwide (Denmark, Finland, Germany, Great Britain, Ireland, Norway, and Sweden)
Included patients with asymptomatic aortic stenosis as assessed on echocardiography, not requiring lipid-lowering therapy, and without known coronary heart disease or diabetes mellitus. 4 week placebo/diet run-in period was followed by treatment period lasting until 4 years after the last patient was randomized.
Participant milestones
| Measure |
EZ/Simva 10/40 mg
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
944
|
929
|
|
Overall Study
COMPLETED
|
939
|
918
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
EZ/Simva 10/40 mg
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Adminstrative
|
5
|
9
|
Baseline Characteristics
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
Baseline characteristics by cohort
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
Total
n=1873 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.7 years
n=39 Participants
|
67.4 years
n=41 Participants
|
67.5 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
363 Participants
n=39 Participants
|
360 Participants
n=41 Participants
|
723 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
581 Participants
n=39 Participants
|
569 Participants
n=41 Participants
|
1150 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
940 participants
n=39 Participants
|
928 participants
n=41 Participants
|
1868 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=39 Participants
|
1 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
High-density Lipoprotein Cholesterol (HDL-C)
|
1.49 mmol/L
STANDARD_DEVIATION 0.43 • n=39 Participants
|
1.49 mmol/L
STANDARD_DEVIATION 0.43 • n=41 Participants
|
1.49 mmol/L
STANDARD_DEVIATION 0.43 • n=35 Participants
|
|
Low-density Lipoprotein Cholesterol (LDL-C)
|
3.62 mmol/L
STANDARD_DEVIATION 0.93 • n=39 Participants
|
3.59 mmol/L
STANDARD_DEVIATION 0.91 • n=41 Participants
|
3.60 mmol/L
STANDARD_DEVIATION 0.92 • n=35 Participants
|
|
Peak Transaortic Jet Velocity
|
3.09 m/sec
STANDARD_DEVIATION 0.55 • n=39 Participants
|
3.10 m/sec
STANDARD_DEVIATION 0.54 • n=41 Participants
|
3.09 m/sec
STANDARD_DEVIATION 0.54 • n=35 Participants
|
|
Total Cholesterol
|
5.76 mmol/L
STANDARD_DEVIATION 1.04 • n=39 Participants
|
5.73 mmol/L
STANDARD_DEVIATION 0.99 • n=41 Participants
|
5.74 mmol/L
STANDARD_DEVIATION 1.02 • n=35 Participants
|
|
Triglycerides (TG)
|
1.42 mmol/L
STANDARD_DEVIATION 0.71 • n=39 Participants
|
1.42 mmol/L
STANDARD_DEVIATION 0.68 • n=41 Participants
|
1.42 mmol/L
STANDARD_DEVIATION 0.69 • n=35 Participants
|
PRIMARY outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)
|
333 Participants
|
355 Participants
|
SECONDARY outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)
|
308 Participants
|
326 Participants
|
SECONDARY outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)
|
148 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacementPopulation: Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication. 180 patients were excluded from peak transaortic jet velocity due to missing measurements.
Mean change from baseline in peak transaortic jet velocity
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=859 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=834 Participants
|
|---|---|---|
|
Change From Baseline in Peak Transaortic Jet Velocity
|
0.613 m/sec
Standard Deviation 0.586
|
0.618 m/sec
Standard Deviation 0.612
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that experienced cardiovascular death
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Cardiovascular Death
|
47 Participants
|
56 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that experienced aortic valve replacement (AVR)
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Aortic Valve Replacement (AVR)
|
267 Participants
|
278 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that experienced Congestive Heart Failure (CHF) due to progression of aortic stenosis (AS)
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS)
|
25 Participants
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that experienced nonfatal myocardial infarction (MI)
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Nonfatal Myocardial Infarction (MI)
|
17 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that experienced coronary artery bypass grafting (CABG)
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Coronary Artery Bypass Grafting (CABG)
|
69 Participants
|
100 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that experienced percutaneous coronary intervention (PCI)
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Percutaneous Coronary Intervention (PCI)
|
8 Participants
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that experienced hospitalization for unstable angina
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Hospitalization for Unstable Angina
|
5 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that experienced nonhemorrhagic stroke
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Nonhemorrhagic Stroke
|
33 Participants
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that died (any cause)
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Death (Any Cause)
|
105 Participants
|
100 Participants
|
POST_HOC outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: Intention-to-Treat
Number of participants that died due to cancer
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=944 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Death Due to Cancer
|
39 Participants
|
23 Participants
|
POST_HOC outcome
Timeframe: Entire follow-up (median = 4.35 years)Population: One patient from the 944 patients randomized to ezetimibe/simvastatin 10/40 mg did not receive study medication and was not included.
Number of participants with incident cancer
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=943 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=929 Participants
|
|---|---|---|
|
Incident Cancer
|
105 Participants
|
70 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of follow-up (median = 4.35 years)Population: Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.
Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=937 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=916 Participants
|
|---|---|---|
|
Percent Change in Time Weighted Average Total Cholesterol From Baseline to End of Follow-up
|
-34.8 Percent Change
Standard Deviation 13.5
|
-2.7 Percent Change
Standard Deviation 11.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of follow-up (median = 4.35 years)Population: Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.
Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=937 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=916 Participants
|
|---|---|---|
|
Percent Change in Time Weighted Average Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to End of Follow-up
|
-53.8 Percent Change
Standard Deviation 18.7
|
-3.8 Percent Change
Standard Deviation 20.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of follow-up (median = 4.35 years)Population: Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.
Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=937 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=916 Participants
|
|---|---|---|
|
Percent Change in Time Weighted Average High-density Lipoprotein Cholesterol (HDL-C) From Baseline to End of Follow-up
|
6.5 Percent change
Standard Deviation 17.7
|
2.5 Percent change
Standard Deviation 16.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of follow-up (median = 4.35 years)Population: Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.
Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.
Outcome measures
| Measure |
EZ/Simva 10/40 mg
n=937 Participants
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
n=916 Participants
|
|---|---|---|
|
Percent Change in Time Weighted Average Triglycerides From Baseline to End of Follow-up
|
-14.9 Percent Change
Standard Deviation 27.6
|
5.1 Percent Change
Standard Deviation 30.4
|
Adverse Events
EZ/Simva 10/40 mg
Serious events: 471 serious events
Other events: 703 other events
Deaths: 0 deaths
Placebo
Serious events: 465 serious events
Other events: 706 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EZ/Simva 10/40 mg
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
12/943
|
0.86%
8/929
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.11%
1/943
|
0.00%
0/929
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.11%
1/943
|
0.22%
2/929
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
AV dissociation
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/943
|
0.22%
2/929
|
|
Cardiac disorders
Acute myocardial infarction
|
0.21%
2/943
|
0.00%
0/929
|
|
Cardiac disorders
Angina pectoris
|
0.32%
3/943
|
0.86%
8/929
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Aortic valve incompetence
|
0.11%
1/943
|
0.11%
1/929
|
|
Cardiac disorders
Aortic valve stenosis
|
7.3%
69/943
|
6.5%
60/929
|
|
Cardiac disorders
Arrhythmia
|
0.21%
2/943
|
0.22%
2/929
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
45/943
|
2.9%
27/929
|
|
Cardiac disorders
Atrial flutter
|
0.85%
8/943
|
0.11%
1/929
|
|
Cardiac disorders
Atrial tachycardia
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Atrioventricular block
|
0.21%
2/943
|
0.22%
2/929
|
|
Cardiac disorders
Atrioventricular block complete
|
0.64%
6/943
|
0.54%
5/929
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.11%
1/943
|
0.32%
3/929
|
|
Cardiac disorders
Bradyarrhythmia
|
0.21%
2/943
|
0.00%
0/929
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Cardiac arrest
|
0.21%
2/943
|
0.11%
1/929
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Cardiac failure
|
0.53%
5/943
|
0.65%
6/929
|
|
Cardiac disorders
Cardiac failure acute
|
0.11%
1/943
|
0.11%
1/929
|
|
Cardiac disorders
Cardiac failure congestive
|
0.11%
1/943
|
0.11%
1/929
|
|
Cardiac disorders
Cardiac tamponade
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Cardiovascular disorder
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
2/943
|
0.54%
5/929
|
|
Cardiac disorders
Coronary artery stenosis
|
0.21%
2/943
|
0.00%
0/929
|
|
Cardiac disorders
Dressler's syndrome
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Extrasystoles
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Myocardial infarction
|
0.74%
7/943
|
0.75%
7/929
|
|
Cardiac disorders
Myocardial ischaemia
|
0.32%
3/943
|
0.00%
0/929
|
|
Cardiac disorders
Myocarditis
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Palpitations
|
0.21%
2/943
|
0.32%
3/929
|
|
Cardiac disorders
Pericardial effusion
|
0.53%
5/943
|
0.75%
7/929
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.11%
1/943
|
0.11%
1/929
|
|
Cardiac disorders
Sick sinus syndrome
|
0.42%
4/943
|
0.65%
6/929
|
|
Cardiac disorders
Silent myocardial infarction
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Sinoatrial block
|
0.21%
2/943
|
0.00%
0/929
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.21%
2/943
|
0.11%
1/929
|
|
Cardiac disorders
Tachyarrhythmia
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Tachycardia
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/943
|
0.11%
1/929
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.11%
1/943
|
0.00%
0/929
|
|
Cardiac disorders
Ventricular fibrillation
|
0.32%
3/943
|
0.11%
1/929
|
|
Cardiac disorders
Ventricular tachycardia
|
0.11%
1/943
|
0.11%
1/929
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.11%
1/943
|
0.00%
0/929
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.11%
1/943
|
0.11%
1/929
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.11%
1/943
|
0.11%
1/929
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.11%
1/943
|
0.00%
0/929
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/943
|
0.11%
1/929
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.11%
1/943
|
0.00%
0/929
|
|
Ear and labyrinth disorders
Vertigo
|
0.64%
6/943
|
0.75%
7/929
|
|
Endocrine disorders
Goitre
|
0.00%
0/943
|
0.22%
2/929
|
|
Endocrine disorders
Hyperthyroidism
|
0.21%
2/943
|
0.00%
0/929
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/943
|
0.11%
1/929
|
|
Eye disorders
Cataract
|
0.32%
3/943
|
0.65%
6/929
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/943
|
0.11%
1/929
|
|
Eye disorders
Diplopia
|
0.00%
0/943
|
0.11%
1/929
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/943
|
0.11%
1/929
|
|
Eye disorders
Glaucoma
|
0.11%
1/943
|
0.32%
3/929
|
|
Eye disorders
Retinal artery occlusion
|
0.32%
3/943
|
0.11%
1/929
|
|
Eye disorders
Retinal detachment
|
0.21%
2/943
|
0.22%
2/929
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Abdominal pain
|
0.95%
9/943
|
0.54%
5/929
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/943
|
0.32%
3/929
|
|
Gastrointestinal disorders
Anal polyp
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Anal stenosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.11%
1/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Constipation
|
0.32%
3/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Crohn's disease
|
0.11%
1/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Diverticulum
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.32%
3/943
|
0.32%
3/929
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Dyspepsia
|
0.11%
1/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Dysphagia
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.74%
7/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Gastritis
|
0.11%
1/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.11%
1/943
|
0.32%
3/929
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.21%
2/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Haematemesis
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.11%
1/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Heyde's syndrome
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.11%
1/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Ileus
|
0.21%
2/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.11%
1/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.6%
15/943
|
1.6%
15/929
|
|
Gastrointestinal disorders
Intestinal ulcer
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.21%
2/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Nausea
|
0.21%
2/943
|
0.54%
5/929
|
|
Gastrointestinal disorders
Necrotising oesophagitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Pancreatitis
|
0.21%
2/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Peritonitis
|
0.21%
2/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.42%
4/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/943
|
0.11%
1/929
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.11%
1/943
|
0.00%
0/929
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.11%
1/943
|
0.22%
2/929
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
2/943
|
0.00%
0/929
|
|
General disorders
Alanine aminotransferase increased
|
0.21%
2/943
|
0.00%
0/929
|
|
General disorders
Aspartate aminotransferase increased
|
0.32%
3/943
|
0.00%
0/929
|
|
General disorders
Blood creatine phosphokinase increased
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Blood creatinine increased
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Blood potassium increased
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Blood sodium decreased
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Blood urine present
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
C-reactive protein increased
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Cardiac output decreased
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Ejection fraction decreased
|
0.11%
1/943
|
0.11%
1/929
|
|
General disorders
Electrocardiogram abnormal
|
0.21%
2/943
|
0.00%
0/929
|
|
General disorders
Haemoglobin decreased
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
International normalised ratio
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
International normalised ratio decreased
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
International normalised ratio increased
|
0.32%
3/943
|
0.43%
4/929
|
|
General disorders
Occult blood positive
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Platelet count decreased
|
0.11%
1/943
|
0.11%
1/929
|
|
General disorders
Prostatic specific antigen increased
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Pulmonary function test decreased
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Total lung capacity decreased
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Weight decreased
|
0.11%
1/943
|
0.11%
1/929
|
|
General disorders
Adverse drug reaction
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Asthenia
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Atrophy
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Catheter related complication
|
0.11%
1/943
|
0.11%
1/929
|
|
General disorders
Catheter site haemorrhage
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Chest discomfort
|
0.21%
2/943
|
0.11%
1/929
|
|
General disorders
Chest pain
|
2.2%
21/943
|
1.6%
15/929
|
|
General disorders
Death
|
0.21%
2/943
|
0.32%
3/929
|
|
General disorders
Drowning
|
0.21%
2/943
|
0.11%
1/929
|
|
General disorders
Fatigue
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
General physical health deterioration
|
0.00%
0/943
|
0.22%
2/929
|
|
General disorders
Hernia
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Impaired healing
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Inflammation
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Malaise
|
0.11%
1/943
|
0.11%
1/929
|
|
General disorders
Mechanical complication of implant
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Multi-organ failure
|
0.11%
1/943
|
0.32%
3/929
|
|
General disorders
Necrosis
|
0.11%
1/943
|
0.00%
0/929
|
|
General disorders
Non-cardiac chest pain
|
0.53%
5/943
|
0.32%
3/929
|
|
General disorders
Oedema peripheral
|
0.21%
2/943
|
0.00%
0/929
|
|
General disorders
Pain
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Pyrexia
|
0.64%
6/943
|
0.22%
2/929
|
|
General disorders
Sudden cardiac death
|
0.00%
0/943
|
0.11%
1/929
|
|
General disorders
Sudden death
|
0.74%
7/943
|
0.65%
6/929
|
|
General disorders
Ulcer
|
0.11%
1/943
|
0.00%
0/929
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
2/943
|
0.32%
3/929
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.11%
1/943
|
0.11%
1/929
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.11%
1/943
|
0.43%
4/929
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.11%
1/943
|
0.00%
0/929
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.11%
1/943
|
0.00%
0/929
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/943
|
0.11%
1/929
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/943
|
0.11%
1/929
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/943
|
0.11%
1/929
|
|
Immune system disorders
Corneal graft rejection
|
0.00%
0/943
|
0.11%
1/929
|
|
Immune system disorders
Secondary immunodeficiency
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Anal abscess
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Appendicitis
|
0.11%
1/943
|
0.11%
1/929
|
|
Infections and infestations
Arthritis bacterial
|
0.11%
1/943
|
0.11%
1/929
|
|
Infections and infestations
Arthritis infective
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Bronchitis
|
0.21%
2/943
|
0.11%
1/929
|
|
Infections and infestations
Bronchopneumonia
|
0.32%
3/943
|
0.11%
1/929
|
|
Infections and infestations
Cellulitis
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Chronic sinusitis
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Clostridium difficile colitis
|
0.32%
3/943
|
0.00%
0/929
|
|
Infections and infestations
Cystitis
|
0.11%
1/943
|
0.11%
1/929
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/943
|
0.43%
4/929
|
|
Infections and infestations
Endocarditis
|
0.74%
7/943
|
1.2%
11/929
|
|
Infections and infestations
Endocarditis bacterial
|
0.11%
1/943
|
0.11%
1/929
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Erysipelas
|
0.21%
2/943
|
0.65%
6/929
|
|
Infections and infestations
Febrile infection
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Fungal infection
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Gangrene
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Gastroenteritis
|
0.74%
7/943
|
0.11%
1/929
|
|
Infections and infestations
Groin abscess
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Haematoma infection
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Herpes zoster
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Infection
|
0.21%
2/943
|
0.32%
3/929
|
|
Infections and infestations
Influenza
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Intestinal gangrene
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Klebsiella sepsis
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Laryngitis
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Localised infection
|
0.00%
0/943
|
0.22%
2/929
|
|
Infections and infestations
Lower respiratory tract infection
|
0.21%
2/943
|
0.32%
3/929
|
|
Infections and infestations
Lung infection
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Mastoiditis
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Neuroborreliosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Orchitis
|
0.21%
2/943
|
0.00%
0/929
|
|
Infections and infestations
Peritonsillitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Pneumonia
|
3.0%
28/943
|
3.3%
31/929
|
|
Infections and infestations
Pneumonia bacterial
|
0.21%
2/943
|
0.11%
1/929
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Post procedural infection
|
0.21%
2/943
|
0.22%
2/929
|
|
Infections and infestations
Postoperative wound infection
|
0.11%
1/943
|
0.11%
1/929
|
|
Infections and infestations
Pseudomonas infection
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/943
|
0.22%
2/929
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Pyothorax
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Rash pustular
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Respiratory tract infection
|
0.11%
1/943
|
0.11%
1/929
|
|
Infections and infestations
Sepsis
|
0.64%
6/943
|
0.65%
6/929
|
|
Infections and infestations
Sinusitis
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Skin infection
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Staphylococcal sepsis
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Sternitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Streptococcal sepsis
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Subcutaneous abscess
|
0.11%
1/943
|
0.00%
0/929
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/943
|
0.22%
2/929
|
|
Infections and infestations
Urinary tract infection
|
1.1%
10/943
|
1.4%
13/929
|
|
Infections and infestations
Urosepsis
|
0.21%
2/943
|
0.00%
0/929
|
|
Infections and infestations
Viral infection
|
0.32%
3/943
|
0.11%
1/929
|
|
Infections and infestations
Wound infection
|
0.11%
1/943
|
0.11%
1/929
|
|
Infections and infestations
Wound infection staphylococcal
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
2/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Contusion
|
0.21%
2/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Device failure
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Device occlusion
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.11%
1/943
|
0.22%
2/929
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Fall
|
0.74%
7/943
|
0.32%
3/929
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.32%
3/943
|
0.54%
5/929
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.21%
2/943
|
0.65%
6/929
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.11%
1/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Head injury
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.42%
4/943
|
0.43%
4/929
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.21%
2/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/943
|
0.22%
2/929
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.11%
1/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.11%
1/943
|
0.22%
2/929
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.21%
2/943
|
0.32%
3/929
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Open wound
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Overdose
|
0.11%
1/943
|
0.22%
2/929
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.11%
1/943
|
0.43%
4/929
|
|
Injury, poisoning and procedural complications
Postoperative constipation
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.11%
1/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.21%
2/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.21%
2/943
|
0.32%
3/929
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
2/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.11%
1/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.11%
1/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/943
|
0.22%
2/929
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.11%
1/943
|
0.00%
0/929
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.11%
1/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.11%
1/943
|
0.22%
2/929
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/943
|
0.11%
1/929
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.11%
1/943
|
0.00%
0/929
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/943
|
0.00%
0/929
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.11%
1/943
|
0.00%
0/929
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/943
|
0.11%
1/929
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/943
|
0.11%
1/929
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.11%
1/943
|
0.11%
1/929
|
|
Metabolism and nutrition disorders
Podagra
|
0.00%
0/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.42%
4/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.42%
4/943
|
0.22%
2/929
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.11%
1/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.32%
3/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Articular calcification
|
0.00%
0/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.32%
3/943
|
0.22%
2/929
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
CREST syndrome
|
0.00%
0/943
|
0.22%
2/929
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.11%
1/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.42%
4/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Limb deformity
|
0.00%
0/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.11%
1/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.21%
2/943
|
0.22%
2/929
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.11%
1/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
19/943
|
2.3%
21/929
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.21%
2/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/943
|
0.22%
2/929
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/943
|
0.22%
2/929
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.11%
1/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.21%
2/943
|
0.32%
3/929
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.21%
2/943
|
0.54%
5/929
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.11%
1/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.00%
0/943
|
0.11%
1/929
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.11%
1/943
|
0.00%
0/929
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.21%
2/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.11%
1/943
|
0.32%
3/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.95%
9/943
|
0.43%
4/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.21%
2/943
|
0.43%
4/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.11%
1/943
|
0.22%
2/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.85%
8/943
|
0.22%
2/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.21%
2/943
|
0.43%
4/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.11%
1/943
|
0.22%
2/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.11%
1/943
|
0.32%
3/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.42%
4/943
|
0.22%
2/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.21%
2/943
|
0.22%
2/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bladder
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to gallbladder
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.21%
2/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/943
|
0.22%
2/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.11%
1/943
|
0.32%
3/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.2%
21/943
|
1.5%
14/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.32%
3/943
|
0.32%
3/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.11%
1/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.42%
4/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/943
|
0.11%
1/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.11%
1/943
|
0.00%
0/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.11%
1/943
|
0.22%
2/929
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Balance disorder
|
0.11%
1/943
|
0.11%
1/929
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Cerebral infarction
|
0.21%
2/943
|
0.11%
1/929
|
|
Nervous system disorders
Cerebrovascular accident
|
0.21%
2/943
|
0.43%
4/929
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/943
|
0.22%
2/929
|
|
Nervous system disorders
Convulsion
|
0.21%
2/943
|
0.22%
2/929
|
|
Nervous system disorders
Dementia
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Dizziness
|
0.74%
7/943
|
0.32%
3/929
|
|
Nervous system disorders
Encephalitis
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Epilepsy
|
0.74%
7/943
|
0.22%
2/929
|
|
Nervous system disorders
Facial palsy
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Global amnesia
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Headache
|
0.11%
1/943
|
0.22%
2/929
|
|
Nervous system disorders
Hemiparesis
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Motor neurone disease
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Narcolepsy
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Presyncope
|
0.21%
2/943
|
0.54%
5/929
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Senile dementia
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Somnolence
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/943
|
0.11%
1/929
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.11%
1/943
|
0.11%
1/929
|
|
Nervous system disorders
Subdural hygroma
|
0.11%
1/943
|
0.00%
0/929
|
|
Nervous system disorders
Syncope
|
1.5%
14/943
|
2.0%
19/929
|
|
Nervous system disorders
Syncope vasovagal
|
0.21%
2/943
|
0.11%
1/929
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
11/943
|
1.2%
11/929
|
|
Psychiatric disorders
Anxiety
|
0.21%
2/943
|
0.00%
0/929
|
|
Psychiatric disorders
Completed suicide
|
0.11%
1/943
|
0.00%
0/929
|
|
Psychiatric disorders
Confusional state
|
0.32%
3/943
|
0.00%
0/929
|
|
Psychiatric disorders
Delusional disorder, persecutory type
|
0.00%
0/943
|
0.11%
1/929
|
|
Psychiatric disorders
Depression
|
0.32%
3/943
|
0.22%
2/929
|
|
Psychiatric disorders
Major depression
|
0.21%
2/943
|
0.00%
0/929
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/943
|
0.11%
1/929
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.11%
1/943
|
0.00%
0/929
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/943
|
0.11%
1/929
|
|
Psychiatric disorders
Psychosomatic disease
|
0.00%
0/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/943
|
0.22%
2/929
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Calculus bladder
|
0.11%
1/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Calculus urinary
|
0.21%
2/943
|
0.22%
2/929
|
|
Renal and urinary disorders
Haematuria
|
0.32%
3/943
|
0.32%
3/929
|
|
Renal and urinary disorders
Hydronephrosis
|
0.11%
1/943
|
0.00%
0/929
|
|
Renal and urinary disorders
Nephritis interstitial
|
0.00%
0/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.32%
3/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Renal failure
|
0.11%
1/943
|
0.54%
5/929
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Renal impairment
|
0.21%
2/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/943
|
0.22%
2/929
|
|
Renal and urinary disorders
Urinary incontinence
|
0.11%
1/943
|
0.00%
0/929
|
|
Renal and urinary disorders
Urinary retention
|
0.32%
3/943
|
0.43%
4/929
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/943
|
0.11%
1/929
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.32%
3/943
|
0.97%
9/929
|
|
Reproductive system and breast disorders
Cystocele
|
0.21%
2/943
|
0.00%
0/929
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/943
|
0.11%
1/929
|
|
Reproductive system and breast disorders
Epididymitis
|
0.11%
1/943
|
0.00%
0/929
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/943
|
0.11%
1/929
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.11%
1/943
|
0.00%
0/929
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/943
|
0.11%
1/929
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/943
|
0.22%
2/929
|
|
Reproductive system and breast disorders
Prostatism
|
0.11%
1/943
|
0.00%
0/929
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.11%
1/943
|
0.00%
0/929
|
|
Reproductive system and breast disorders
Spermatocele
|
0.11%
1/943
|
0.11%
1/929
|
|
Reproductive system and breast disorders
Uterine malposition
|
0.11%
1/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.11%
1/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Cheyne-Stokes respiration
|
0.11%
1/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.32%
3/943
|
0.54%
5/929
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
12/943
|
1.3%
12/929
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.21%
2/943
|
0.11%
1/929
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia chronic
|
0.11%
1/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.95%
9/943
|
0.11%
1/929
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.11%
1/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.11%
1/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/943
|
0.11%
1/929
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.11%
1/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/943
|
0.11%
1/929
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.95%
9/943
|
0.75%
7/929
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/943
|
0.11%
1/929
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.32%
3/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.32%
3/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
2/943
|
0.43%
4/929
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/943
|
0.11%
1/929
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.11%
1/943
|
0.00%
0/929
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.32%
3/943
|
0.43%
4/929
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.21%
2/943
|
0.11%
1/929
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/943
|
0.11%
1/929
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.11%
1/943
|
0.00%
0/929
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/943
|
0.11%
1/929
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/943
|
0.11%
1/929
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.11%
1/943
|
0.00%
0/929
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.11%
1/943
|
0.00%
0/929
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.11%
1/943
|
0.11%
1/929
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.21%
2/943
|
0.22%
2/929
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/943
|
0.11%
1/929
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.00%
0/943
|
0.11%
1/929
|
|
Social circumstances
Cardiac assistance device user
|
0.11%
1/943
|
0.00%
0/929
|
|
Vascular disorders
Angiodysplasia
|
0.11%
1/943
|
0.11%
1/929
|
|
Vascular disorders
Aortic aneurysm
|
0.64%
6/943
|
0.43%
4/929
|
|
Vascular disorders
Aortic dissection
|
0.11%
1/943
|
0.00%
0/929
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/943
|
0.11%
1/929
|
|
Vascular disorders
Arteriovenous fistula
|
0.11%
1/943
|
0.00%
0/929
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/943
|
0.11%
1/929
|
|
Vascular disorders
Circulatory collapse
|
0.11%
1/943
|
0.11%
1/929
|
|
Vascular disorders
Deep vein thrombosis
|
0.11%
1/943
|
0.22%
2/929
|
|
Vascular disorders
Femoral artery aneurysm
|
0.11%
1/943
|
0.11%
1/929
|
|
Vascular disorders
Haematoma
|
0.32%
3/943
|
0.32%
3/929
|
|
Vascular disorders
Haemorrhage
|
0.42%
4/943
|
0.11%
1/929
|
|
Vascular disorders
Hypertension
|
0.00%
0/943
|
0.32%
3/929
|
|
Vascular disorders
Hypertensive crisis
|
0.21%
2/943
|
0.22%
2/929
|
|
Vascular disorders
Hypotension
|
0.21%
2/943
|
0.00%
0/929
|
|
Vascular disorders
Intermittent claudication
|
0.21%
2/943
|
0.32%
3/929
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
2/943
|
0.00%
0/929
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/943
|
0.22%
2/929
|
|
Vascular disorders
Phlebitis superficial
|
0.11%
1/943
|
0.00%
0/929
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/943
|
0.11%
1/929
|
|
Vascular disorders
Shock
|
0.11%
1/943
|
0.00%
0/929
|
|
Vascular disorders
Shock haemorrhagic
|
0.11%
1/943
|
0.00%
0/929
|
|
Vascular disorders
Thrombophlebitis
|
0.11%
1/943
|
0.11%
1/929
|
|
Vascular disorders
Varicose vein
|
0.21%
2/943
|
0.11%
1/929
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/943
|
0.11%
1/929
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.00%
0/943
|
0.22%
2/929
|
|
Vascular disorders
Venous stasis
|
0.00%
0/943
|
0.11%
1/929
|
|
Vascular disorders
Venous thrombosis
|
0.21%
2/943
|
0.11%
1/929
|
|
Vascular disorders
Venous thrombosis limb
|
0.11%
1/943
|
0.00%
0/929
|
Other adverse events
| Measure |
EZ/Simva 10/40 mg
Ezetimibe 10 mg + Simvastatin 40 mg
|
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
50/943
|
3.6%
33/929
|
|
Cardiac disorders
Angina pectoris
|
3.8%
36/943
|
4.7%
44/929
|
|
Cardiac disorders
Aortic valve stenosis
|
14.7%
139/943
|
19.1%
177/929
|
|
Cardiac disorders
Atrial fibrillation
|
9.3%
88/943
|
12.2%
113/929
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.4%
23/943
|
1.2%
11/929
|
|
Cardiac disorders
Cardiac failure
|
2.0%
19/943
|
2.6%
24/929
|
|
Cardiac disorders
Coronary artery disease
|
2.7%
25/943
|
3.6%
33/929
|
|
Cardiac disorders
Palpitations
|
2.0%
19/943
|
1.8%
17/929
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
27/943
|
3.0%
28/929
|
|
Eye disorders
Cataract
|
2.3%
22/943
|
3.6%
33/929
|
|
Gastrointestinal disorders
Constipation
|
3.2%
30/943
|
4.1%
38/929
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
39/943
|
4.2%
39/929
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
23/943
|
1.7%
16/929
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
22/943
|
2.0%
19/929
|
|
Gastrointestinal disorders
Nausea
|
4.1%
39/943
|
2.3%
21/929
|
|
General disorders
Alanine aminotransferase increased
|
3.6%
34/943
|
1.8%
17/929
|
|
General disorders
Aspartate aminotransferase increased
|
4.0%
38/943
|
1.6%
15/929
|
|
General disorders
Blood creatine phosphokinase increased
|
3.4%
32/943
|
2.9%
27/929
|
|
General disorders
Blood glucose increased
|
1.6%
15/943
|
2.4%
22/929
|
|
General disorders
C-reactive protein increased
|
0.64%
6/943
|
2.3%
21/929
|
|
General disorders
Gamma-glutamyltransferase increased
|
3.0%
28/943
|
2.2%
20/929
|
|
General disorders
Haemoglobin decreased
|
2.4%
23/943
|
2.5%
23/929
|
|
General disorders
Weight decreased
|
2.3%
22/943
|
2.5%
23/929
|
|
General disorders
Chest pain
|
4.8%
45/943
|
5.6%
52/929
|
|
General disorders
Fatigue
|
4.6%
43/943
|
4.4%
41/929
|
|
General disorders
Oedema peripheral
|
6.3%
59/943
|
5.5%
51/929
|
|
Infections and infestations
Bronchitis
|
4.1%
39/943
|
4.8%
45/929
|
|
Infections and infestations
Cystitis
|
1.5%
14/943
|
2.6%
24/929
|
|
Infections and infestations
Influenza
|
2.2%
21/943
|
2.4%
22/929
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
57/943
|
5.9%
55/929
|
|
Infections and infestations
Pneumonia
|
4.8%
45/943
|
4.4%
41/929
|
|
Infections and infestations
Urinary tract infection
|
5.4%
51/943
|
5.5%
51/929
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.2%
21/943
|
1.8%
17/929
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/943
|
2.0%
19/929
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
61/943
|
4.8%
45/929
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
56/943
|
5.2%
48/929
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
19/943
|
4.2%
39/929
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
41/943
|
5.5%
51/929
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.1%
29/943
|
4.2%
39/929
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
32/943
|
3.7%
34/929
|
|
Nervous system disorders
Dizziness
|
7.7%
73/943
|
8.3%
77/929
|
|
Nervous system disorders
Headache
|
2.8%
26/943
|
3.4%
32/929
|
|
Nervous system disorders
Syncope
|
2.1%
20/943
|
2.0%
19/929
|
|
Psychiatric disorders
Depression
|
4.0%
38/943
|
3.7%
34/929
|
|
Psychiatric disorders
Insomnia
|
2.7%
25/943
|
2.5%
23/929
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.8%
26/943
|
2.2%
20/929
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.85%
8/943
|
2.2%
20/929
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
38/943
|
3.8%
35/929
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
81/943
|
12.5%
116/929
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.7%
25/943
|
2.2%
20/929
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
18/943
|
2.0%
19/929
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
26/943
|
2.7%
25/929
|
|
Vascular disorders
Hypertension
|
14.1%
133/943
|
15.9%
148/929
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER