Trial Outcomes & Findings for CRESTOR Athero Imaging Head to Head IVUS Study (NCT NCT00620542)
NCT ID: NCT00620542
Last Updated: 2012-07-16
Results Overview
Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: \[sum(EEMcsa-LUMENcsa)/sum EEMcsa\]\*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2333 participants
Primary outcome timeframe
End of study (Week 104)
Results posted on
2012-07-16
Participant Flow
2333 Coronary Artery Disease (CAD) patients with clinical indication for coronary angiography were randomized to Part A, the 2-week run-in period. Of these, 1578 patients were treated and 1385 completed Part A. The 1385 patients completing Part A were then randomized to Part B the core study period of 104 weeks of treatment.
Angiography was performed to determine if patients were qualified to continue in the study based on protocol-specified angiographic criteria. Patients who satisfied all inclusion and exclusion criteria had an Intravascular Ultrasound (IVUS) performed within 2 weeks of the qualifying angiography.
Participant milestones
| Measure |
Rosuvastatin 20 mg
2 week run-in period
|
Atorvastatin 40 mg
2 week run-in period
|
Rosuvastatin 40 mg
2 year core study
|
Atorvastatin 80 mg
2 year core study
|
|---|---|---|---|---|
|
Part A (Run-in - 2 Weeks)
STARTED
|
1167
|
1166
|
0
|
0
|
|
Part A (Run-in - 2 Weeks)
Received Treatment
|
783
|
795
|
0
|
0
|
|
Part A (Run-in - 2 Weeks)
COMPLETED
|
695
|
690
|
0
|
0
|
|
Part A (Run-in - 2 Weeks)
NOT COMPLETED
|
472
|
476
|
0
|
0
|
|
Part B (2 Year Core Study)
STARTED
|
0
|
0
|
694
|
691
|
|
Part B (2 Year Core Study)
Received Treatment
|
0
|
0
|
691
|
689
|
|
Part B (2 Year Core Study)
Intent-to-treat Population
|
0
|
0
|
520
|
519
|
|
Part B (2 Year Core Study)
COMPLETED
|
0
|
0
|
546
|
547
|
|
Part B (2 Year Core Study)
NOT COMPLETED
|
0
|
0
|
148
|
144
|
Reasons for withdrawal
| Measure |
Rosuvastatin 20 mg
2 week run-in period
|
Atorvastatin 40 mg
2 week run-in period
|
Rosuvastatin 40 mg
2 year core study
|
Atorvastatin 80 mg
2 year core study
|
|---|---|---|---|---|
|
Part A (Run-in - 2 Weeks)
Adverse Event
|
12
|
15
|
0
|
0
|
|
Part A (Run-in - 2 Weeks)
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Part A (Run-in - 2 Weeks)
Withdrawal by Subject
|
43
|
40
|
0
|
0
|
|
Part A (Run-in - 2 Weeks)
Lost to Follow-up
|
7
|
6
|
0
|
0
|
|
Part A (Run-in - 2 Weeks)
Safety reasons
|
0
|
1
|
0
|
0
|
|
Part A (Run-in - 2 Weeks)
IVUS not available
|
4
|
4
|
0
|
0
|
|
Part B (2 Year Core Study)
Adverse Event
|
0
|
0
|
46
|
49
|
|
Part B (2 Year Core Study)
Protocol Violation
|
0
|
0
|
13
|
16
|
|
Part B (2 Year Core Study)
Withdrawal by Subject
|
0
|
0
|
55
|
54
|
|
Part B (2 Year Core Study)
Lost to Follow-up
|
0
|
0
|
20
|
9
|
|
Part B (2 Year Core Study)
Safety reasons
|
0
|
0
|
2
|
3
|
|
Part B (2 Year Core Study)
Study specific discontinuation criteris
|
0
|
0
|
6
|
6
|
|
Part B (2 Year Core Study)
IVUS not available
|
0
|
0
|
3
|
2
|
Baseline Characteristics
CRESTOR Athero Imaging Head to Head IVUS Study
Baseline characteristics by cohort
| Measure |
Rosuvastatin 40 mg
n=520 Participants
2 years
|
Atorvastatin 80 mg
n=519 Participants
2 years
|
Total
n=1039 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
402 Participants
n=5 Participants
|
395 Participants
n=7 Participants
|
797 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
118 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Age Continuous
Age (yrs) at Week 0
|
57.4 years
STANDARD_DEVIATION 8.60 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 8.50 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
379 Participants
n=5 Participants
|
386 Participants
n=7 Participants
|
765 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of study (Week 104)Population: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: \[sum(EEMcsa-LUMENcsa)/sum EEMcsa\]\*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=520 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
|
-1.22 Percent change
Interval -1.52 to -0.9
|
-0.99 Percent change
Interval -1.19 to -0.63
|
SECONDARY outcome
Timeframe: End of study (Week 104)Population: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Regression defined as a change from baseline in PAV \< 0
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=520 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Numbers of Patients Showing Regression in PAV
|
356 Participants
|
328 Participants
|
SECONDARY outcome
Timeframe: End of study (Week 104)Population: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=520 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
|
-6.39 mm^3
Interval -7.52 to -5.12
|
-4.42 mm^3
Interval -5.98 to -3.26
|
SECONDARY outcome
Timeframe: End of study (Week 104)Population: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Regression defined as a change from baseline in TAV \< 0
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=520 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Numbers of Patients Showing Regression in TAV
|
371 Participants
|
336 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Total Cholesterol Blood Level
|
139.38 mg/dL
Standard Error 1.24
|
144.05 mg/dL
Standard Error 1.23
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
LDL-C Blood Level
|
62.64 mg/dL
Standard Error 1.00 • Interval 1.0 to
|
70.18 mg/dL
Standard Error 0.99 • Interval 0.99 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
HDL-C Blood Level
|
50.43 mg/dL
Standard Error 0.54 • Interval 0.54 to
|
48.64 mg/dL
Standard Error 0.53 • Interval 0.53 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Triglycerides Blood Level
|
132.50 mg/dL
Standard Error 2.44 • Interval 2.44 to
|
126.58 mg/dL
Standard Error 2.43 • Interval 2.43 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Non-HDL-C Blood Level
|
88.95 mg/dL
Standard Error 1.15 • Interval 1.15 to
|
95.41 mg/dL
Standard Error 1.14 • Interval 1.14 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
LDL-C/HDL-C Blood Level
|
1.30 Ratio
Standard Error 0.02 • Interval 0.02 to
|
1.50 Ratio
Standard Error 0.02 • Interval 0.02 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Total Cholesterol/HDL-C Blood Level
|
2.88 Ratio
Standard Error 0.03 • Interval 0.03 to
|
3.08 Ratio
Standard Error 0.03 • Interval 0.03 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Non-HDL-C/HDL-C Blood Level
|
1.88 Ratio
Standard Error 0.03 • Interval 0.03 to
|
2.08 Ratio
Standard Error 0.03 • Interval 0.03 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=518 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Apolipoprotein B Blood Level
|
72.55 mg/dL
Standard Error 0.85 • Interval 0.85 to
|
75.12 mg/dL
Standard Error 0.85 • Interval 0.85 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=518 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Apolipoprotein A-1 Blood Level
|
146.81 mg/dL
Standard Error 1.03 • Interval 1.03 to
|
137.68 mg/dL
Standard Error 1.02 • Interval 1.02 to
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=518 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
Apoliprotein B/Apolipoprotein A-1 Blood Level
|
0.51 Ratio
Standard Error 0.01
|
0.56 Ratio
Standard Error 0.01
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
Outcome measures
| Measure |
Rosuvastatin 40 mg
n=519 Participants
Part B: Rosuvastatin 40 mg for core study - 2 years
|
Atorvastatin 80 mg
n=519 Participants
Part B: Atorvastatin 80 mg for core study - 2 years
|
|---|---|---|
|
VLDL-C During the 104 Week Treatment Period
|
26.05 mg/dL
Standard Error 0.45
|
25.03 mg/dL
Standard Error 0.44
|
Adverse Events
Rosuvastatin 20 mg
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Atorvastatin 40 mg
Serious events: 25 serious events
Other events: 0 other events
Deaths: 0 deaths
Rosuvastatin 40 mg
Serious events: 194 serious events
Other events: 210 other events
Deaths: 0 deaths
Atorvastatin 80 mg
Serious events: 168 serious events
Other events: 213 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin 20 mg
n=783 participants at risk
2 week run-in period
|
Atorvastatin 40 mg
n=795 participants at risk
2 week run-in period
|
Rosuvastatin 40 mg
n=691 participants at risk
2 year core study
|
Atorvastatin 80 mg
n=689 participants at risk
2 year core study
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.29%
2/689
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Cardiac disorders
Angina Pectoris
|
0.64%
5/783
|
0.63%
5/795
|
3.6%
25/691
|
4.1%
28/689
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/783
|
0.25%
2/795
|
2.5%
17/691
|
1.6%
11/689
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.13%
1/783
|
0.00%
0/795
|
1.7%
12/691
|
1.3%
9/689
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/783
|
0.00%
0/795
|
1.4%
10/691
|
0.58%
4/689
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/783
|
0.13%
1/795
|
0.72%
5/691
|
0.87%
6/689
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/783
|
0.13%
1/795
|
0.43%
3/691
|
0.87%
6/689
|
|
Cardiac disorders
Myocardial Infarction
|
0.13%
1/783
|
0.00%
0/795
|
0.72%
5/691
|
0.44%
3/689
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/783
|
0.00%
0/795
|
0.43%
3/691
|
0.00%
0/689
|
|
Cardiac disorders
Palpitations
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.44%
3/689
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.13%
1/783
|
0.00%
0/795
|
0.29%
2/691
|
0.29%
2/689
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/783
|
0.25%
2/795
|
0.14%
1/691
|
0.29%
2/689
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.29%
2/689
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Cardiac disorders
Pericardial Rub
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Cardiac disorders
Pericarditis
|
0.13%
1/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Cardiac disorders
Sinus Arrest
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Cardiac disorders
Wolff-Parkinson-White Syndrome
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Congenital, familial and genetic disorders
Congenital Coronary Artery Malformation
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Congenital, familial and genetic disorders
Hip Dysplasia
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.29%
2/689
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Endocrine disorders
Basedow's Disease
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Eye disorders
Cataract
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/783
|
0.00%
0/795
|
0.58%
4/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.13%
1/783
|
0.00%
0/795
|
0.29%
2/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.29%
2/689
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.29%
2/689
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.29%
2/689
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Erosive Oesophagitis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
0.00%
0/783
|
0.13%
1/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Umbilical Hernia, Obstructive
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
General disorders
Non-Cardiac Chest Pain
|
0.13%
1/783
|
0.38%
3/795
|
2.0%
14/691
|
1.0%
7/689
|
|
General disorders
Chest Pain
|
0.00%
0/783
|
0.00%
0/795
|
1.0%
7/691
|
1.0%
7/689
|
|
General disorders
Chest Discomfort
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
General disorders
Device Malfunction
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
General disorders
Device Occlusion
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
General disorders
Device Stimulation Issue
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
General disorders
Hernia Pain
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
General disorders
Pyrexia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
General disorders
Sudden Death
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
General disorders
Thrombosis In Device
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/783
|
0.00%
0/795
|
0.58%
4/691
|
0.15%
1/689
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Infections and infestations
Pneumonia
|
0.00%
0/783
|
0.13%
1/795
|
0.58%
4/691
|
0.29%
2/689
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/783
|
0.00%
0/795
|
0.43%
3/691
|
0.29%
2/689
|
|
Infections and infestations
Gastroenteritis
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.29%
2/689
|
|
Infections and infestations
Urosepsis
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Infections and infestations
Appendicitis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Infections and infestations
Appendicitis Perforated
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Infections and infestations
Bronchitis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Infections and infestations
Cellulitis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Infections and infestations
Groin Infection
|
0.00%
0/783
|
0.13%
1/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Infections and infestations
Herpes Zoster Infection Neurological
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Infections and infestations
Pilonidal Cyst
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Infections and infestations
Puncture Site Infection
|
0.00%
0/783
|
0.13%
1/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Infections and infestations
Staphylococcal Abscess
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
In-Stent Coronary Artery Restenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.87%
6/691
|
0.44%
3/689
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Fractured Coccyx
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Heat Exhaustion
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
In-Stent Arterial Restenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/783
|
0.13%
1/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Post Procedural Myocardial Infarction
|
0.00%
0/783
|
0.13%
1/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Injury, poisoning and procedural complications
Traumatic Lung Injury
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.29%
2/689
|
|
Investigations
Cardiac Stress Test Abnormal
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Investigations
Heart Rate Irregular
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Investigations
Occult Blood Positive
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Investigations
Transaminases Increased
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.29%
2/689
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/783
|
0.00%
0/795
|
0.87%
6/691
|
0.29%
2/689
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.13%
1/783
|
0.00%
0/795
|
0.58%
4/691
|
0.00%
0/689
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.44%
3/689
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.29%
2/689
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Musculoskeletal and connective tissue disorders
Bone Loss
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Musculoskeletal and connective tissue disorders
Floating Patella
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/783
|
0.13%
1/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.29%
2/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid Tumour
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Prostate
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Cancer
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Nervous system disorders
Syncope
|
0.00%
0/783
|
0.00%
0/795
|
0.43%
3/691
|
0.87%
6/689
|
|
Nervous system disorders
Presyncope
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.44%
3/689
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.29%
2/689
|
|
Nervous system disorders
Dizziness
|
0.13%
1/783
|
0.00%
0/795
|
0.14%
1/691
|
0.29%
2/689
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/783
|
0.13%
1/795
|
0.29%
2/691
|
0.15%
1/689
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Nervous system disorders
Complicated Migraine
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Nervous system disorders
Convulsion
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Nervous system disorders
Intracranial Hypotension
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Nervous system disorders
Tremor
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Psychiatric disorders
Depression
|
0.00%
0/783
|
0.00%
0/795
|
0.43%
3/691
|
0.00%
0/689
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Psychiatric disorders
Dependence
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/783
|
0.00%
0/795
|
0.43%
3/691
|
0.00%
0/689
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.29%
2/689
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Renal and urinary disorders
Calculus Bladder
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Renal and urinary disorders
Ureteric Stenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/783
|
0.00%
0/795
|
0.43%
3/691
|
0.29%
2/689
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/783
|
0.00%
0/795
|
0.43%
3/691
|
0.44%
3/689
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.29%
2/689
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/783
|
0.13%
1/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Obstruction
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Polyps
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/783
|
0.13%
1/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Surgical and medical procedures
Coronary Arterial Stent Insertion
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.15%
1/689
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.29%
2/691
|
0.00%
0/689
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Vascular disorders
Arterial Stenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/783
|
0.13%
1/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Vascular disorders
Haematoma
|
0.00%
0/783
|
0.00%
0/795
|
0.14%
1/691
|
0.00%
0/689
|
|
Vascular disorders
Hypertension
|
0.13%
1/783
|
0.00%
0/795
|
0.14%
1/691
|
0.15%
1/689
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.13%
1/783
|
0.00%
0/795
|
0.00%
0/691
|
0.00%
0/689
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/783
|
0.00%
0/795
|
0.00%
0/691
|
0.15%
1/689
|
Other adverse events
| Measure |
Rosuvastatin 20 mg
n=783 participants at risk
2 week run-in period
|
Atorvastatin 40 mg
n=795 participants at risk
2 week run-in period
|
Rosuvastatin 40 mg
n=691 participants at risk
2 year core study
|
Atorvastatin 80 mg
n=689 participants at risk
2 year core study
|
|---|---|---|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/783
|
0.00%
0/795
|
8.8%
61/691
|
9.4%
65/689
|
|
General disorders
FATIGUE
|
0.00%
0/783
|
0.00%
0/795
|
4.6%
32/691
|
5.7%
39/689
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/783
|
0.00%
0/795
|
14.3%
99/691
|
13.2%
91/689
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/783
|
0.00%
0/795
|
7.2%
50/691
|
6.2%
43/689
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/783
|
0.00%
0/795
|
5.2%
36/691
|
5.8%
40/689
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60