Trial Outcomes & Findings for JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events (NCT NCT00239681)
NCT ID: NCT00239681
Last Updated: 2014-03-24
Results Overview
Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
17802 participants
Primary outcome timeframe
up to 5 years
Results posted on
2014-03-24
Participant Flow
The first subject was enrolled on 05 February 2003. The last subject completed on 20 August 2008. Study subjects were randomized at 1348 centers in 26 countries. Enrolled subjects participated in an initial 4-week, run-in phase and received placebo therapy.
If found eligible for the main study on the basis of appropriate levels of baseline Low Density Lipoprotein (LDL), High-sensitivity C-Reactive Protein (hsCRP), and run-in phase compliance (\>80% of pills taken), subjects were randomized to either rosuvastatin 20 mg or placebo once daily
Participant milestones
| Measure |
Rosuvastatin
Rosuvastatin 20 mg once daily
|
Placebo
Placebo once daily
|
|---|---|---|
|
Overall Study
STARTED
|
8901
|
8901
|
|
Overall Study
Randomized and Treated (Safety Pop)
|
8869
|
8864
|
|
Overall Study
COMPLETED
|
8208
|
8186
|
|
Overall Study
NOT COMPLETED
|
693
|
715
|
Reasons for withdrawal
| Measure |
Rosuvastatin
Rosuvastatin 20 mg once daily
|
Placebo
Placebo once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
100
|
99
|
|
Overall Study
Withdrawal by Subject
|
458
|
489
|
|
Overall Study
Lost to Follow-up
|
28
|
22
|
|
Overall Study
Protocol Violation
|
4
|
4
|
|
Overall Study
Physician Decision
|
13
|
17
|
|
Overall Study
No information chacked on CaseReportForm
|
90
|
84
|
Baseline Characteristics
JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events
Baseline characteristics by cohort
| Measure |
Rosuvastatin
n=8901 Participants
Rosuvastatin 20 mg once daily
|
Placebo
n=8901 Participants
Placebo once daily
|
Total
n=17802 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3426 Participants
n=5 Participants
|
3375 Participants
n=7 Participants
|
6801 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5475 Participants
n=5 Participants
|
5526 Participants
n=7 Participants
|
11001 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 yearsPopulation: Intention to treat population
Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
Outcome measures
| Measure |
Rosuvastatin
n=8901 Participants
Rosuvastatin 20 mg once daily
|
Placebo
n=8901 Participants
Placebo once daily
|
|---|---|---|
|
Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)
|
1646.4 Days
Standard Error 2.76
|
1578.3 Days
Standard Error 3.49
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Intention to treat population
Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean
Outcome measures
| Measure |
Rosuvastatin
n=8901 Participants
Rosuvastatin 20 mg once daily
|
Placebo
n=8901 Participants
Placebo once daily
|
|---|---|---|
|
Time to Death Due to Any Cause
|
1543.3 days
Standard Error 2.48
|
1619.1 days
Standard Error 3.10
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Intention to treat population
Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
Outcome measures
| Measure |
Rosuvastatin
n=8901 Participants
Rosuvastatin 20 mg once daily
|
Placebo
n=8901 Participants
Placebo once daily
|
|---|---|---|
|
Time to Non-cardiovascular Death
|
1558.5 Days
Standard Error 1.90
|
1640.5 Days
Standard Error 2.44
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Intention to treat population
Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean
Outcome measures
| Measure |
Rosuvastatin
n=8901 Participants
Rosuvastatin 20 mg once daily
|
Placebo
n=8901 Participants
Placebo once daily
|
|---|---|---|
|
Time to Development of Diabetes Mellitus
|
1687.0 Days
Standard Error 3.92
|
1517.0 Days
Standard Error 2.46
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Intention to treat population
Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
Outcome measures
| Measure |
Rosuvastatin
n=8901 Participants
Rosuvastatin 20 mg once daily
|
Placebo
n=8901 Participants
Placebo once daily
|
|---|---|---|
|
Time to Venous Thromboembolic Event
|
1147.4 Days
Standard Error 0.54
|
1377.2 Days
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Intention to treat population
Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean
Outcome measures
| Measure |
Rosuvastatin
n=8901 Participants
Rosuvastatin 20 mg once daily
|
Placebo
n=8901 Participants
Placebo once daily
|
|---|---|---|
|
Time to Bone Fracture
|
1662.7 Days
Standard Error 3.35
|
1546.9 Days
Standard Error 2.78
|
Adverse Events
PLACEBO
Serious events: 1216 serious events
Other events: 3170 other events
Deaths: 0 deaths
ROSUVASTATIN 20 MG
Serious events: 1205 serious events
Other events: 3228 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLACEBO
n=8864 participants at risk
|
ROSUVASTATIN 20 MG
n=8869 participants at risk
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia chronic
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8864
|
0.05%
4/8869 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Foreign body aspiration
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal leukoplakia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.08%
7/8864 • Number of events 7
|
0.05%
4/8869 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
7/8864 • Number of events 7
|
0.05%
4/8869 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
14/8864 • Number of events 14
|
0.12%
11/8869 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.05%
4/8864 • Number of events 4
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.14%
12/8864 • Number of events 12
|
0.14%
12/8869 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Facial hemiatrophy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Surgical and medical procedures
Pancreatectomy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm
|
0.06%
5/8864 • Number of events 5
|
0.03%
3/8869 • Number of events 3
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Aortic dissection
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Aortic stenosis
|
0.02%
2/8864 • Number of events 2
|
0.05%
4/8869 • Number of events 4
|
|
Vascular disorders
Arterial occlusive disease
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Arterial thrombosis limb
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Arteriosclerosis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Vascular disorders
Circulatory collapse
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
0.15%
13/8864 • Number of events 13
|
0.08%
7/8869 • Number of events 7
|
|
Vascular disorders
Embolism
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.08%
7/8864 • Number of events 7
|
0.10%
9/8869 • Number of events 9
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Vascular disorders
Hypertensive emergency
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Hypotension
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Vascular disorders
Hypovolaemic shock
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Vascular disorders
Intermittent claudication
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Vascular disorders
Lymphoedema
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Orthostatic hypotension
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Vascular disorders
Peripheral embolism
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Peripheral ischaemia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Phlebitis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Vascular disorders
Varicose vein
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Vascular disorders
Venous thrombosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Blood and lymphatic system disorders
Anaemia
|
0.12%
11/8864 • Number of events 11
|
0.17%
15/8869 • Number of events 15
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
2/8864 • Number of events 2
|
0.05%
4/8869 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
AV dissociation
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
Acute coronary syndrome
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Cardiac disorders
Angina pectoris
|
0.11%
10/8864 • Number of events 10
|
0.11%
10/8869 • Number of events 10
|
|
Cardiac disorders
Angina unstable
|
0.07%
6/8864 • Number of events 6
|
0.03%
3/8869 • Number of events 3
|
|
Cardiac disorders
Aortic valve incompetence
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/8864
|
0.05%
4/8869 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
0.73%
65/8864 • Number of events 65
|
0.63%
56/8869 • Number of events 56
|
|
Cardiac disorders
Atrial flutter
|
0.10%
9/8864 • Number of events 9
|
0.06%
5/8869 • Number of events 5
|
|
Cardiac disorders
Atrial tachycardia
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/8864
|
0.06%
5/8869 • Number of events 5
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.07%
6/8864 • Number of events 6
|
0.11%
10/8869 • Number of events 10
|
|
Cardiac disorders
Bundle branch block left
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
Cardiac arrest
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.06%
5/8864 • Number of events 5
|
0.07%
6/8869 • Number of events 6
|
|
Cardiac disorders
Cardiac failure congestive
|
0.21%
19/8864 • Number of events 19
|
0.18%
16/8869 • Number of events 16
|
|
Cardiac disorders
Cardiac valve sclerosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Cardiomyopathy
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Cardiac disorders
Coronary artery disease
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Cardiac disorders
Coronary artery occlusion
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Extrasystoles
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Intracardiac thrombus
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Mitral valve incompetence
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
7/8864 • Number of events 7
|
0.03%
3/8869 • Number of events 3
|
|
Cardiac disorders
Myocardial ischaemia
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Cardiac disorders
Pericardial effusion
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Cardiac disorders
Sick sinus syndrome
|
0.07%
6/8864 • Number of events 6
|
0.06%
5/8869 • Number of events 5
|
|
Cardiac disorders
Sinus bradycardia
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Cardiac disorders
Tachycardia
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Cardiac disorders
Ventricular flutter
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Congenital, familial and genetic disorders
Congenital intestinal malformation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Congenital, familial and genetic disorders
Duchenne muscular dystrophy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Congenital, familial and genetic disorders
Hereditary haemorrhagic telangiectasia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Congenital, familial and genetic disorders
Lymphangioma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Ear and labyrinth disorders
Auricular swelling
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
3/8864 • Number of events 3
|
0.05%
4/8869 • Number of events 4
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Endocrine disorders
Hyperparathyroidism
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
2/8864 • Number of events 2
|
0.05%
4/8869 • Number of events 4
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Endocrine disorders
Pituitary cyst
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Endocrine disorders
Thyroid mass
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Eye disorders
Amaurosis fugax
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Eye disorders
Blindness
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Eye disorders
Cataract
|
0.09%
8/8864 • Number of events 8
|
0.03%
3/8869 • Number of events 3
|
|
Eye disorders
Diplopia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Eye disorders
Ectropion
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Eye disorders
Lacrimal disorder
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Eye disorders
Macular degeneration
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Eye disorders
Retinal detachment
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Eye disorders
Retinal tear
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Eye disorders
Visual disturbance
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Eye disorders
Vitreous detachment
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.08%
7/8864 • Number of events 7
|
0.10%
9/8869 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
5/8864 • Number of events 5
|
0.05%
4/8869 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal wall disorder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Colitis
|
0.05%
4/8864 • Number of events 4
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Colonic polyp
|
0.03%
3/8864 • Number of events 3
|
0.05%
4/8869 • Number of events 4
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Crohn's disease
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
8/8864 • Number of events 8
|
0.06%
5/8869 • Number of events 5
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
2/8864 • Number of events 2
|
0.05%
4/8869 • Number of events 4
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Duodenitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Dyspepsia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Dysphagia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Faecaloma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.07%
6/8864 • Number of events 6
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
2/8864 • Number of events 2
|
0.03%
3/8869 • Number of events 3
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.05%
4/8864 • Number of events 4
|
0.03%
3/8869 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.15%
13/8864 • Number of events 13
|
0.23%
20/8869 • Number of events 20
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.05%
4/8864 • Number of events 4
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
2/8864 • Number of events 2
|
0.03%
3/8869 • Number of events 3
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.02%
2/8864 • Number of events 2
|
0.05%
4/8869 • Number of events 4
|
|
Gastrointestinal disorders
Ileus
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.17%
15/8864 • Number of events 15
|
0.19%
17/8869 • Number of events 17
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.08%
7/8864 • Number of events 7
|
0.12%
11/8869 • Number of events 11
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Odynophagia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Oesophagitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.07%
6/8864 • Number of events 6
|
0.03%
3/8869 • Number of events 3
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
6/8864 • Number of events 6
|
0.10%
9/8869 • Number of events 9
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Peritonitis
|
0.03%
3/8864 • Number of events 3
|
0.05%
4/8869 • Number of events 4
|
|
Gastrointestinal disorders
Proctalgia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.05%
4/8864 • Number of events 4
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Salivary gland cyst
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.08%
7/8864 • Number of events 7
|
0.06%
5/8869 • Number of events 5
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.06%
5/8864 • Number of events 5
|
0.09%
8/8869 • Number of events 8
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Volvulus
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
General disorders
Adhesion
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Adverse drug reaction
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
General disorders
Asthenia
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
General disorders
Calcinosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
General disorders
Chest pain
|
0.08%
7/8864 • Number of events 7
|
0.10%
9/8869 • Number of events 9
|
|
General disorders
Death
|
0.38%
34/8864 • Number of events 34
|
0.34%
30/8869 • Number of events 30
|
|
General disorders
Deformity
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Dysplasia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Fatigue
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
General physical health deterioration
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Hernia
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
General disorders
Hernia obstructive
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Malaise
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Mucosal inflammation
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Multi-organ failure
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
0.25%
22/8864 • Number of events 22
|
0.33%
29/8869 • Number of events 29
|
|
General disorders
Oedema peripheral
|
0.06%
5/8864 • Number of events 5
|
0.01%
1/8869 • Number of events 1
|
|
General disorders
Pyrexia
|
0.01%
1/8864 • Number of events 1
|
0.05%
4/8869 • Number of events 4
|
|
General disorders
Sudden death
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Systemic inflammatory response syndrome
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Ulcer
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stone
|
0.06%
5/8864 • Number of events 5
|
0.05%
4/8869 • Number of events 4
|
|
Hepatobiliary disorders
Biliary colic
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
9/8864 • Number of events 9
|
0.11%
10/8869 • Number of events 10
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.06%
5/8864 • Number of events 5
|
0.05%
4/8869 • Number of events 4
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.05%
4/8864 • Number of events 4
|
0.00%
0/8869
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
23/8864 • Number of events 23
|
0.25%
22/8869 • Number of events 22
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cyst ruptured
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic mass
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Immune system disorders
Allergy to arthropod sting
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/8864
|
0.05%
4/8869 • Number of events 4
|
|
Immune system disorders
Sarcoidosis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Abdominal sepsis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Abdominal wall abscess
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Abscess
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Abscess limb
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Abscess rupture
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Appendicitis
|
0.08%
7/8864 • Number of events 7
|
0.06%
5/8869 • Number of events 5
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Arthritis infective
|
0.03%
3/8864 • Number of events 3
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Aspergillosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Bacteraemia
|
0.03%
3/8864 • Number of events 3
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Bacterial infection
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Bronchiectasis
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.06%
5/8864 • Number of events 5
|
0.08%
7/8869 • Number of events 7
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Cellulitis
|
0.23%
20/8864 • Number of events 20
|
0.15%
13/8869 • Number of events 13
|
|
Infections and infestations
Cholecystitis infective
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Clostridial infection
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Clostridium difficile colitis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Corneal abscess
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Device related infection
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.18%
16/8864 • Number of events 16
|
0.15%
13/8869 • Number of events 13
|
|
Infections and infestations
Empyema
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Endocarditis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Epiglottitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Erysipelas
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Gangrene
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Gastroenteritis
|
0.12%
11/8864 • Number of events 11
|
0.09%
8/8869 • Number of events 8
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
HIV infection
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Hepatitis A
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Infected cyst
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Infection
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Infections and infestations
Labyrinthitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Liver abscess
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.10%
9/8864 • Number of events 9
|
0.05%
4/8869 • Number of events 4
|
|
Infections and infestations
Lung abscess
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Infections and infestations
Lung infection
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Meningitis pneumococcal
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Meningococcal sepsis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Orchitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Osteomyelitis
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Infections and infestations
Otitis media
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Parotid abscess
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Perianal abscess
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.64%
57/8864 • Number of events 57
|
0.63%
56/8869 • Number of events 56
|
|
Infections and infestations
Pneumonia bacterial
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Pneumonia chlamydial
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Pneumonia viral
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Postoperative wound infection
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Prostate infection
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Pyelonephritis
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Pyelonephritis acute
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Rash pustular
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Rectal abscess
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Scrotal infection
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Sepsis
|
0.06%
5/8864 • Number of events 5
|
0.12%
11/8869 • Number of events 11
|
|
Infections and infestations
Septic shock
|
0.02%
2/8864 • Number of events 2
|
0.05%
4/8869 • Number of events 4
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Staphylococcal infection
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Subacute endocarditis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Subcutaneous abscess
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Infections and infestations
Tooth abscess
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Tracheitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Upper respiratory tract infection
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Urinary tract infection
|
0.07%
6/8864 • Number of events 6
|
0.17%
15/8869 • Number of events 15
|
|
Infections and infestations
Urosepsis
|
0.05%
4/8864 • Number of events 4
|
0.00%
0/8869
|
|
Infections and infestations
Viral infection
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Infections and infestations
Viral pericarditis
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Infections and infestations
Vulvitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.05%
4/8864 • Number of events 4
|
0.01%
1/8869 • Number of events 1
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
9/8864 • Number of events 9
|
0.16%
14/8869 • Number of events 14
|
|
Injury, poisoning and procedural complications
Back injury
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.03%
3/8864 • Number of events 3
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Contusion
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.02%
2/8864 • Number of events 2
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.07%
6/8864 • Number of events 6
|
0.09%
8/8869 • Number of events 8
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.05%
4/8864 • Number of events 4
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Head injury
|
0.06%
5/8864 • Number of events 5
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.16%
14/8864 • Number of events 14
|
0.17%
15/8869 • Number of events 15
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
3/8864 • Number of events 3
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Injury
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.06%
5/8864 • Number of events 5
|
0.06%
5/8869 • Number of events 5
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.03%
3/8864 • Number of events 3
|
0.05%
4/8869 • Number of events 4
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.05%
4/8864 • Number of events 4
|
0.06%
5/8869 • Number of events 5
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/8864
|
0.05%
4/8869 • Number of events 4
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
3/8864 • Number of events 3
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.02%
2/8864 • Number of events 2
|
0.05%
4/8869 • Number of events 4
|
|
Injury, poisoning and procedural complications
Retinal injury
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.09%
8/8864 • Number of events 8
|
0.05%
4/8869 • Number of events 4
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.05%
4/8864 • Number of events 4
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.02%
2/8864 • Number of events 2
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.02%
2/8864 • Number of events 2
|
0.05%
4/8869 • Number of events 4
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.06%
5/8864 • Number of events 5
|
0.03%
3/8869 • Number of events 3
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.03%
3/8864 • Number of events 3
|
0.05%
4/8869 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Investigations
Anticonvulsant drug level increased
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Investigations
Electrocardiogram T wave inversion
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Investigations
Heart rate increased
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Investigations
Heart rate irregular
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Investigations
Prostatic specific antigen increased
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Investigations
Weight decreased
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
8/8864 • Number of events 8
|
0.06%
5/8869 • Number of events 5
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.15%
13/8864 • Number of events 13
|
0.16%
14/8869 • Number of events 14
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Metabolism and nutrition disorders
Gout
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8864
|
0.06%
5/8869 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
4/8864 • Number of events 4
|
0.03%
3/8869 • Number of events 3
|
|
Metabolism and nutrition disorders
Lipomatosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8864
|
0.08%
7/8869 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.60%
53/8864 • Number of events 53
|
0.54%
48/8869 • Number of events 48
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
6/8864 • Number of events 6
|
0.09%
8/8869 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.03%
3/8864 • Number of events 3
|
0.07%
6/8869 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.14%
12/8864 • Number of events 12
|
0.10%
9/8869 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.05%
4/8864 • Number of events 4
|
0.07%
6/8869 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.03%
3/8864 • Number of events 3
|
0.07%
6/8869 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.01%
1/8864 • Number of events 1
|
0.06%
5/8869 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.17%
15/8864 • Number of events 15
|
0.19%
17/8869 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.07%
6/8864 • Number of events 6
|
0.07%
6/8869 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.05%
4/8864 • Number of events 4
|
0.02%
2/8869 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.01%
1/8864 • Number of events 1
|
0.05%
4/8869 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myelomonocytic leukaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma malignant
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.06%
5/8864 • Number of events 5
|
0.12%
11/8869 • Number of events 11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer recurrent
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.09%
8/8864 • Number of events 8
|
0.06%
5/8869 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.08%
7/8864 • Number of events 7
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.25%
22/8864 • Number of events 22
|
0.23%
20/8869 • Number of events 20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/8864
|
0.06%
5/8869 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial neoplasm
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of bladder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage III
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix neoplasm
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
20/8864 • Number of events 20
|
0.18%
16/8869 • Number of events 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage I
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/8864
|
0.06%
5/8869 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ganglioneuroma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.05%
4/8864 • Number of events 4
|
0.05%
4/8869 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.06%
5/8864 • Number of events 5
|
0.05%
4/8869 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell carcinoma of the respiratory tract stage unspecified
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.01%
1/8864 • Number of events 1
|
0.05%
4/8869 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.08%
7/8864 • Number of events 7
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.15%
13/8864 • Number of events 13
|
0.11%
10/8869 • Number of events 10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
3/8864 • Number of events 3
|
0.05%
4/8869 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoplasmacytoid lymphoma/immunocytoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.05%
4/8864 • Number of events 4
|
0.05%
4/8869 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.02%
2/8864 • Number of events 2
|
0.03%
3/8869 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
2/8864 • Number of events 2
|
0.08%
7/8869 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.02%
2/8864 • Number of events 2
|
0.07%
6/8869 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.07%
6/8864 • Number of events 6
|
0.03%
3/8869 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.05%
4/8864 • Number of events 4
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.07%
6/8864 • Number of events 6
|
0.05%
4/8869 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage unspecified
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.43%
38/8864 • Number of events 38
|
0.38%
34/8869 • Number of events 34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pseudomyxoma peritonei
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
6/8864 • Number of events 6
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.06%
5/8864 • Number of events 5
|
0.06%
5/8869 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Signet-ring cell carcinoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/8864
|
0.05%
4/8869 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer metastatic
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/8864
|
0.05%
4/8869 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Anticholinergic syndrome
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Carotid artery stenosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Cerebellar atrophy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Cerebral ischaemia
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
5/8864 • Number of events 5
|
0.10%
9/8869 • Number of events 9
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Cognitive disorder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Convulsion
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.08%
7/8864 • Number of events 7
|
0.03%
3/8869 • Number of events 3
|
|
Nervous system disorders
Drop attacks
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Encephalitis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Encephalopathy
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Epilepsy
|
0.02%
2/8864 • Number of events 2
|
0.03%
3/8869 • Number of events 3
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Facial palsy
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.03%
3/8864 • Number of events 3
|
0.03%
3/8869 • Number of events 3
|
|
Nervous system disorders
Hemicephalalgia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Hydrocephalus
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Hypertonia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Intracranial aneurysm
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Intracranial pressure increased
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Ischaemic stroke
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Lacunar infarction
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Migraine
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Myxoedema coma
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Nerve compression
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Nerve root compression
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Paralysis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Peripheral paralysis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Pneumocephalus
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8864
|
0.06%
5/8869 • Number of events 5
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Radiculopathy
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Sciatica
|
0.03%
3/8864 • Number of events 3
|
0.02%
2/8869 • Number of events 2
|
|
Nervous system disorders
Senile dementia
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Sensory loss
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.17%
15/8864 • Number of events 15
|
0.12%
11/8869 • Number of events 11
|
|
Nervous system disorders
Transient ischaemic attack
|
0.11%
10/8864 • Number of events 10
|
0.10%
9/8869 • Number of events 9
|
|
Nervous system disorders
Tremor
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Psychiatric disorders
Aggression
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Psychiatric disorders
Alcohol abuse
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Psychiatric disorders
Alcoholism
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Psychiatric disorders
Anxiety
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Psychiatric disorders
Completed suicide
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.01%
1/8864 • Number of events 1
|
0.08%
7/8869 • Number of events 7
|
|
Psychiatric disorders
Delirium
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.02%
2/8864 • Number of events 2
|
0.08%
7/8869 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Psychiatric disorders
Major depression
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Psychiatric disorders
Mental status changes
|
0.01%
1/8864 • Number of events 1
|
0.02%
2/8869 • Number of events 2
|
|
Psychiatric disorders
Panic attack
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Psychiatric disorders
Psychotic disorder
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Bladder obstruction
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Bladder prolapse
|
0.06%
5/8864 • Number of events 5
|
0.00%
0/8869
|
|
Renal and urinary disorders
Bladder stenosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Calculus bladder
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Calculus urinary
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Dysuria
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Haematuria
|
0.07%
6/8864 • Number of events 6
|
0.12%
11/8869 • Number of events 11
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
12/8864 • Number of events 12
|
0.08%
7/8869 • Number of events 7
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Renal colic
|
0.05%
4/8864 • Number of events 4
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.08%
7/8864 • Number of events 7
|
0.07%
6/8869 • Number of events 6
|
|
Renal and urinary disorders
Renal failure acute
|
0.07%
6/8864 • Number of events 6
|
0.07%
6/8869 • Number of events 6
|
|
Renal and urinary disorders
Renal failure chronic
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Renal mass
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Urethral obstruction
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Renal and urinary disorders
Urethral polyp
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.06%
5/8864 • Number of events 5
|
0.08%
7/8869 • Number of events 7
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Renal and urinary disorders
Vesical fistula
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.19%
17/8864 • Number of events 17
|
0.14%
12/8869 • Number of events 12
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Reproductive system and breast disorders
Cystocele
|
0.03%
3/8864 • Number of events 3
|
0.00%
0/8869
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/8864
|
0.02%
2/8869 • Number of events 2
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Genital cyst
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.01%
1/8864 • Number of events 1
|
0.03%
3/8869 • Number of events 3
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatism
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Reproductive system and breast disorders
Prostatitis
|
0.02%
2/8864 • Number of events 2
|
0.02%
2/8869 • Number of events 2
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.06%
5/8864 • Number of events 5
|
0.03%
3/8869 • Number of events 3
|
|
Reproductive system and breast disorders
Rectocele
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine cervical erosion
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.05%
4/8864 • Number of events 4
|
0.08%
7/8869 • Number of events 7
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.01%
1/8864 • Number of events 1
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
3/8864 • Number of events 3
|
0.07%
6/8869 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.01%
1/8864 • Number of events 1
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.02%
2/8864 • Number of events 2
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/8864
|
0.03%
3/8869 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
33/8864 • Number of events 33
|
0.28%
25/8869 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
2/8864 • Number of events 2
|
0.00%
0/8869
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8864
|
0.01%
1/8869 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
6/8864 • Number of events 6
|
0.09%
8/8869 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.06%
5/8864 • Number of events 5
|
0.00%
0/8869
|
Other adverse events
| Measure |
PLACEBO
n=8864 participants at risk
|
ROSUVASTATIN 20 MG
n=8869 participants at risk
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
6.4%
571/8864 • Number of events 571
|
6.7%
596/8869 • Number of events 596
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
607/8864 • Number of events 607
|
7.1%
632/8869 • Number of events 632
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
637/8864 • Number of events 637
|
6.5%
580/8869 • Number of events 580
|
|
Infections and infestations
Urinary tract infection
|
7.7%
686/8864 • Number of events 686
|
7.9%
699/8869 • Number of events 699
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
576/8864 • Number of events 576
|
7.1%
631/8869 • Number of events 631
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.3%
559/8864 • Number of events 559
|
7.4%
653/8869 • Number of events 653
|
|
Vascular disorders
Hypertension
|
7.1%
628/8864 • Number of events 628
|
6.3%
557/8869 • Number of events 557
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place