Trial Outcomes & Findings for Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT NCT01107886)
NCT ID: NCT01107886
Last Updated: 2014-07-17
Results Overview
Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18206 participants
Primary outcome timeframe
Randomization (day 0) up to 2.9 years
Results posted on
2014-07-17
Participant Flow
The first participant was enrolled on 10 May 2010 and the last participant completed the study on 16 May 2013. A total of 18206 subjects were enrolled in the study of which 16492 were randomised. Study participants were randomized from 790 centers in 26 countries.
Subjects meeting all inclusion criteria and with no exclusion criteria were randomised in a 1:1 ratio to receive either saxagliptin or matching placebo (Day 0).
Participant milestones
| Measure |
Saxagliptin
5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR \>50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
|
Placebo
Matching Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
8280
|
8212
|
|
Overall Study
COMPLETED
|
8078
|
7998
|
|
Overall Study
NOT COMPLETED
|
202
|
214
|
Reasons for withdrawal
| Measure |
Saxagliptin
5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR \>50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
|
Placebo
Matching Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
13
|
|
Overall Study
Withdrawal by Subject
|
180
|
196
|
|
Overall Study
Administrative withdrawal of consent
|
7
|
5
|
Baseline Characteristics
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
Baseline characteristics by cohort
| Measure |
Saxagliptin
n=8280 Participants
5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR \>50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
|
Placebo
n=8212 Participants
Matching Placebo
|
Total
n=16492 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 Years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
65.0 Years
STANDARD_DEVIATION 8.58 • n=7 Participants
|
65.0 Years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2768 Participants
n=5 Participants
|
2687 Participants
n=7 Participants
|
5455 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5512 Participants
n=5 Participants
|
5525 Participants
n=7 Participants
|
11037 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1778 Participants
n=5 Participants
|
1763 Participants
n=7 Participants
|
3541 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6502 Participants
n=5 Participants
|
6449 Participants
n=7 Participants
|
12951 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
896 Participants
n=5 Participants
|
884 Participants
n=7 Participants
|
1780 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
278 Participants
n=5 Participants
|
290 Participants
n=7 Participants
|
568 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6241 Participants
n=5 Participants
|
6166 Participants
n=7 Participants
|
12407 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
768 Participants
n=5 Participants
|
758 Participants
n=7 Participants
|
1526 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
68 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Cardiovascular Risk Category: Cardiovascular disease/Multiple risk factors (CVD/MRF)
CVD
|
6494 Participants
n=5 Participants
|
6465 Participants
n=7 Participants
|
12959 Participants
n=5 Participants
|
|
Cardiovascular Risk Category: Cardiovascular disease/Multiple risk factors (CVD/MRF)
MRF
|
1786 Participants
n=5 Participants
|
1747 Participants
n=7 Participants
|
3533 Participants
n=5 Participants
|
|
Renal Functione Categor: Normal or Mild impairment/Moderate impairment/Severe impairment
Normal or Mild impairment
|
6986 Participants
n=5 Participants
|
6930 Participants
n=7 Participants
|
13916 Participants
n=5 Participants
|
|
Renal Functione Categor: Normal or Mild impairment/Moderate impairment/Severe impairment
Moderate impairment
|
1122 Participants
n=5 Participants
|
1118 Participants
n=7 Participants
|
2240 Participants
n=5 Participants
|
|
Renal Functione Categor: Normal or Mild impairment/Moderate impairment/Severe impairment
Severe impairment
|
172 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization (day 0) up to 2.9 yearsPopulation: Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.
Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Outcome measures
| Measure |
Saxagliptin
n=8280 Participants
5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR \>50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
|
Placebo
n=8212 Participants
Matching Placebo
|
|---|---|---|
|
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
|
613 participants
|
609 participants
|
SECONDARY outcome
Timeframe: Randomization (day 0) up to 2.9 yearsPopulation: Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.
Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Outcome measures
| Measure |
Saxagliptin
n=8280 Participants
5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR \>50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
|
Placebo
n=8212 Participants
Matching Placebo
|
|---|---|---|
|
Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation
|
1059 participants
|
1034 participants
|
SECONDARY outcome
Timeframe: Randomization (day 0) up to 2.9 yearsPopulation: Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.
Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.
Outcome measures
| Measure |
Saxagliptin
n=8280 Participants
5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR \>50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
|
Placebo
n=8212 Participants
Matching Placebo
|
|---|---|---|
|
Participants With Event of Death
|
420 participants
|
378 participants
|
Adverse Events
Placebo
Serious events: 2075 serious events
Other events: 3641 other events
Deaths: 0 deaths
Saxagliptin
Serious events: 2114 serious events
Other events: 3504 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=8212 participants at risk
Matching Placebo
|
Saxagliptin
n=8280 participants at risk
5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR \>50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
26/8212 • Number of events 27
|
0.21%
17/8280 • Number of events 19
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Blood and lymphatic system disorders
Hypereosinophilic syndrome
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.09%
7/8212 • Number of events 7
|
0.06%
5/8280 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/8212
|
0.05%
4/8280 • Number of events 4
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.04%
3/8212 • Number of events 3
|
0.06%
5/8280 • Number of events 5
|
|
Cardiac disorders
Acute coronary syndrome
|
0.09%
7/8212 • Number of events 7
|
0.06%
5/8280 • Number of events 5
|
|
Cardiac disorders
Acute left ventricular failure
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Acute myocardial infarction
|
0.02%
2/8212 • Number of events 2
|
0.07%
6/8280 • Number of events 6
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
1.3%
106/8212 • Number of events 116
|
1.1%
89/8280 • Number of events 98
|
|
Cardiac disorders
Angina unstable
|
0.77%
63/8212 • Number of events 79
|
0.53%
44/8280 • Number of events 48
|
|
Cardiac disorders
Aortic valve stenosis
|
0.06%
5/8212 • Number of events 5
|
0.07%
6/8280 • Number of events 6
|
|
Cardiac disorders
Arrhythmia
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Arteriospasm coronary
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Atrial fibrillation
|
0.93%
76/8212 • Number of events 90
|
0.94%
78/8280 • Number of events 85
|
|
Cardiac disorders
Atrial flutter
|
0.13%
11/8212 • Number of events 13
|
0.27%
22/8280 • Number of events 25
|
|
Cardiac disorders
Atrial septal defect acquired
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Atrial tachycardia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Atrial thrombosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Atrioventricular block
|
0.04%
3/8212 • Number of events 3
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Atrioventricular block complete
|
0.16%
13/8212 • Number of events 13
|
0.07%
6/8280 • Number of events 6
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.06%
5/8212 • Number of events 6
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Bradyarrhythmia
|
0.05%
4/8212 • Number of events 4
|
0.00%
0/8280
|
|
Cardiac disorders
Bradycardia
|
0.13%
11/8212 • Number of events 11
|
0.17%
14/8280 • Number of events 15
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Bundle branch block left
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.05%
4/8212 • Number of events 4
|
0.06%
5/8280 • Number of events 5
|
|
Cardiac disorders
Cardiac failure
|
0.29%
24/8212 • Number of events 24
|
0.25%
21/8280 • Number of events 22
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Cardiac failure chronic
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
21/8212 • Number of events 22
|
0.36%
30/8280 • Number of events 30
|
|
Cardiac disorders
Cardiac fibrillation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Cardiac tamponade
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Cardiac valve disease
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Cardiogenic shock
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Cardiomyopathy
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Cor pulmonale
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
18/8212 • Number of events 19
|
0.21%
17/8280 • Number of events 17
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Cardiac disorders
Coronary artery occlusion
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Hypertensive heart disease
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Intracardiac thrombus
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.07%
6/8212 • Number of events 7
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 3
|
|
Cardiac disorders
Mitral valve incompetence
|
0.04%
3/8212 • Number of events 3
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Myocardial infarction
|
0.06%
5/8212 • Number of events 5
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Myocardial ischaemia
|
0.13%
11/8212 • Number of events 11
|
0.08%
7/8280 • Number of events 7
|
|
Cardiac disorders
Nodal arrhythmia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Palpitations
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Pericardial effusion
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Pericarditis
|
0.04%
3/8212 • Number of events 4
|
0.00%
0/8280
|
|
Cardiac disorders
Pulseless electrical activity
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Sick sinus syndrome
|
0.17%
14/8212 • Number of events 14
|
0.12%
10/8280 • Number of events 10
|
|
Cardiac disorders
Sinoatrial block
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Sinus arrhythmia
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.07%
6/8212 • Number of events 6
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.05%
4/8212 • Number of events 4
|
0.11%
9/8280 • Number of events 10
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Tachyarrhythmia
|
0.01%
1/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.02%
2/8212 • Number of events 3
|
0.10%
8/8280 • Number of events 8
|
|
Cardiac disorders
Torsade de pointes
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Trifascicular block
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.05%
4/8212 • Number of events 4
|
0.01%
1/8280 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.06%
5/8212 • Number of events 5
|
0.04%
3/8280 • Number of events 3
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Cardiac disorders
Ventricular tachycardia
|
0.13%
11/8212 • Number of events 16
|
0.19%
16/8280 • Number of events 17
|
|
Ear and labyrinth disorders
Deafness
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 2
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 2
|
|
Ear and labyrinth disorders
Vertigo
|
0.12%
10/8212 • Number of events 10
|
0.19%
16/8280 • Number of events 16
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Endocrine disorders
Adrenal insufficiency
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Endocrine disorders
Goitre
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Endocrine disorders
Hypercorticoidism
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
2/8212 • Number of events 2
|
0.07%
6/8280 • Number of events 6
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Angle closure glaucoma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Eye disorders
Cataract
|
0.16%
13/8212 • Number of events 15
|
0.08%
7/8280 • Number of events 9
|
|
Eye disorders
Cataract cortical
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.01%
1/8212 • Number of events 1
|
0.07%
6/8280 • Number of events 7
|
|
Eye disorders
Diplopia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Eye haemorrhage
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Eye disorders
Glaucoma
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Eye disorders
Macular oedema
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Eye disorders
Retinal artery occlusion
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Retinal ischaemia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Eye disorders
Vitreous haemorrhage
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.06%
5/8212 • Number of events 5
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
13/8212 • Number of events 14
|
0.21%
17/8280 • Number of events 17
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.02%
2/8212 • Number of events 2
|
0.05%
4/8280 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
2/8212 • Number of events 3
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Colitis
|
0.06%
5/8212 • Number of events 5
|
0.05%
4/8280 • Number of events 4
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.01%
1/8212 • Number of events 1
|
0.07%
6/8280 • Number of events 6
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Colonic polyp
|
0.05%
4/8212 • Number of events 4
|
0.07%
6/8280 • Number of events 6
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.06%
5/8212 • Number of events 5
|
0.05%
4/8280 • Number of events 4
|
|
Gastrointestinal disorders
Crohn's disease
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.02%
2/8212 • Number of events 5
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
15/8212 • Number of events 15
|
0.14%
12/8280 • Number of events 13
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.09%
7/8212 • Number of events 7
|
0.05%
4/8280 • Number of events 4
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Dyskinesia oesophageal
|
0.01%
1/8212 • Number of events 3
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Dyspepsia
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.05%
4/8212 • Number of events 4
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
7/8212 • Number of events 7
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
11/8212 • Number of events 12
|
0.18%
15/8280 • Number of events 15
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.22%
18/8212 • Number of events 25
|
0.18%
15/8280 • Number of events 15
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal telangiectasia
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
8/8212 • Number of events 8
|
0.08%
7/8280 • Number of events 7
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Haematochezia
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.05%
4/8212 • Number of events 4
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.04%
3/8212 • Number of events 3
|
0.06%
5/8280 • Number of events 5
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.05%
4/8212 • Number of events 4
|
0.07%
6/8280 • Number of events 6
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.02%
2/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
3/8212 • Number of events 3
|
0.06%
5/8280 • Number of events 5
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Intestinal polyp haemorrhage
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.05%
4/8212 • Number of events 4
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Megacolon
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Mesenteric vascular insufficiency
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8212
|
0.05%
4/8280 • Number of events 4
|
|
Gastrointestinal disorders
Oesophageal fibrosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/8212
|
0.05%
4/8280 • Number of events 4
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Omental infarction
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Pancreatic duct dilatation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.15%
12/8212 • Number of events 14
|
0.22%
18/8280 • Number of events 19
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
6/8212 • Number of events 6
|
0.05%
4/8280 • Number of events 5
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Rectal polyp
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
4/8212 • Number of events 6
|
0.05%
4/8280 • Number of events 4
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.05%
4/8212 • Number of events 4
|
0.06%
5/8280 • Number of events 5
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.11%
9/8212 • Number of events 10
|
0.06%
5/8280 • Number of events 5
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Gastrointestinal disorders
Vomiting
|
0.01%
1/8212 • Number of events 1
|
0.07%
6/8280 • Number of events 6
|
|
General disorders
Adverse drug reaction
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Application site pain
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Asthenia
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.02%
2/8212 • Number of events 3
|
0.00%
0/8280
|
|
General disorders
Chest pain
|
0.12%
10/8212 • Number of events 10
|
0.17%
14/8280 • Number of events 14
|
|
General disorders
Cyst
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
General disorders
Death
|
0.01%
1/8212 • Number of events 1
|
0.06%
5/8280 • Number of events 5
|
|
General disorders
Device battery issue
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
General disorders
Device breakage
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
General disorders
Device damage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Device dislocation
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Device failure
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Device lead damage
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Device malfunction
|
0.00%
0/8212
|
0.05%
4/8280 • Number of events 4
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Fatigue
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
General disorders
Feeling cold
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Foaming at mouth
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
General disorders
Gait disturbance
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
General physical health deterioration
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
General symptom
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Generalised oedema
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Hernia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Hernia obstructive
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Hypothermia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
General disorders
Impaired healing
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
General disorders
Implant site haematoma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
General disorders
Inflammation
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
General disorders
Ischaemic ulcer
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
|
General disorders
Lipogranuloma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Malaise
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
General disorders
Medical device complication
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Multi-organ disorder
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.06%
5/8212 • Number of events 5
|
0.08%
7/8280 • Number of events 7
|
|
General disorders
Necrobiosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Necrosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
1.3%
109/8212 • Number of events 131
|
1.3%
108/8280 • Number of events 125
|
|
General disorders
Oedema peripheral
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
General disorders
Organ failure
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
General disorders
Polyp
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
General disorders
Pyrexia
|
0.09%
7/8212 • Number of events 7
|
0.08%
7/8280 • Number of events 7
|
|
General disorders
Spinal pain
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
General disorders
Systemic inflammatory response syndrome
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Bile duct stone
|
0.06%
5/8212 • Number of events 5
|
0.04%
3/8280 • Number of events 3
|
|
Hepatobiliary disorders
Biliary colic
|
0.05%
4/8212 • Number of events 4
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Hepatobiliary disorders
Biliary polyp
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.12%
10/8212 • Number of events 12
|
0.16%
13/8280 • Number of events 13
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.17%
14/8212 • Number of events 14
|
0.27%
22/8280 • Number of events 22
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.05%
4/8212 • Number of events 4
|
0.01%
1/8280 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.33%
27/8212 • Number of events 28
|
0.31%
26/8280 • Number of events 27
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.07%
6/8212 • Number of events 6
|
0.02%
2/8280 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic failure
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Hepatitis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Jaundice
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Liver disorder
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Immune system disorders
Allergy to venom
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Immune system disorders
Anaphylactic reaction
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Immune system disorders
Cryoglobulinaemia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity
|
0.05%
4/8212 • Number of events 4
|
0.05%
4/8280 • Number of events 4
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Immune system disorders
Sarcoidosis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Abdominal abscess
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Abdominal wall abscess
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Abscess
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Infections and infestations
Abscess limb
|
0.05%
4/8212 • Number of events 4
|
0.06%
5/8280 • Number of events 5
|
|
Infections and infestations
Abscess soft tissue
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Acute sinusitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Anal abscess
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
|
Infections and infestations
Appendicitis
|
0.11%
9/8212 • Number of events 9
|
0.08%
7/8280 • Number of events 7
|
|
Infections and infestations
Appendicitis perforated
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Arthritis bacterial
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Infections and infestations
Arthritis infective
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Bacteraemia
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Infections and infestations
Bacterial infection
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Bacterial sepsis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Bone abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Breast cellulitis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Breast infection
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.43%
35/8212 • Number of events 35
|
0.28%
23/8280 • Number of events 23
|
|
Infections and infestations
Bronchitis viral
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Bronchopneumonia
|
0.10%
8/8212 • Number of events 9
|
0.12%
10/8280 • Number of events 10
|
|
Infections and infestations
Bursitis infective
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Carbuncle
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Cellulitis
|
0.79%
65/8212 • Number of events 70
|
0.70%
58/8280 • Number of events 70
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Cervicitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Chest wall abscess
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Cholangitis suppurative
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Cholecystitis infective
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Infections and infestations
Clostridium difficile colitis
|
0.07%
6/8212 • Number of events 6
|
0.02%
2/8280 • Number of events 2
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Creutzfeldt-Jakob disease
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 4
|
|
Infections and infestations
Dengue fever
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Device related infection
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Infections and infestations
Diabetic foot infection
|
0.04%
3/8212 • Number of events 3
|
0.12%
10/8280 • Number of events 11
|
|
Infections and infestations
Diabetic gangrene
|
0.05%
4/8212 • Number of events 4
|
0.11%
9/8280 • Number of events 9
|
|
Infections and infestations
Diarrhoea infectious
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Diverticulitis
|
0.12%
10/8212 • Number of events 13
|
0.12%
10/8280 • Number of events 11
|
|
Infections and infestations
Ear infection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Emphysematous cystitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Empyema
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Endocarditis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Endophthalmitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Enterobacter infection
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Enterobacter pneumonia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Enterococcal sepsis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Infections and infestations
Erysipelas
|
0.07%
6/8212 • Number of events 6
|
0.07%
6/8280 • Number of events 6
|
|
Infections and infestations
Escherichia bacteraemia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Escherichia infection
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Febrile infection
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Furuncle
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Gangrene
|
0.19%
16/8212 • Number of events 17
|
0.27%
22/8280 • Number of events 23
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Gastroenteritis
|
0.21%
17/8212 • Number of events 17
|
0.34%
28/8280 • Number of events 29
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Gastroenteritis shigella
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Gastroenteritis viral
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Infections and infestations
Graft infection
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Infections and infestations
Groin abscess
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Groin infection
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
H1N1 influenza
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
HIV infection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Helicobacter infection
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Implant site cellulitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Incision site infection
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Infected dermal cyst
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Infected fistula
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Infected skin ulcer
|
0.10%
8/8212 • Number of events 9
|
0.05%
4/8280 • Number of events 4
|
|
Infections and infestations
Infection
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Infections and infestations
Infectious peritonitis
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Infections and infestations
Infectious thyroiditis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Infections and infestations
Influenza
|
0.02%
2/8212 • Number of events 2
|
0.07%
6/8280 • Number of events 6
|
|
Infections and infestations
Intestinal gangrene
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Labyrinthitis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Liver abscess
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.10%
8/8212 • Number of events 8
|
0.19%
16/8280 • Number of events 16
|
|
Infections and infestations
Localised infection
|
0.13%
11/8212 • Number of events 11
|
0.10%
8/8280 • Number of events 8
|
|
Infections and infestations
Lower respiratory tract infection
|
0.02%
2/8212 • Number of events 2
|
0.05%
4/8280 • Number of events 6
|
|
Infections and infestations
Ludwig angina
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Lung infection pseudomonal
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Lyme disease
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Mastoiditis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Mediastinitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Meningitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Necrotising fasciitis
|
0.05%
4/8212 • Number of events 4
|
0.00%
0/8280
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Orchitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Osteomyelitis
|
0.29%
24/8212 • Number of events 25
|
0.22%
18/8280 • Number of events 23
|
|
Infections and infestations
Osteomyelitis chronic
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Infections and infestations
Otitis externa
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Infections and infestations
Parametritis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pelvic abscess
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Peridiverticular abscess
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Perihepatic abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Perineal abscess
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Perinephric abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Perirectal abscess
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Peritonitis
|
0.05%
4/8212 • Number of events 4
|
0.06%
5/8280 • Number of events 5
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pilonidal cyst
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pneumocystis jiroveci infection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.4%
118/8212 • Number of events 127
|
1.8%
151/8280 • Number of events 168
|
|
Infections and infestations
Pneumonia bacterial
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Infections and infestations
Pneumonia chlamydial
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pneumonia fungal
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Pneumonia legionella
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Infections and infestations
Pneumonia viral
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Post procedural infection
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Postoperative abscess
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Infections and infestations
Postoperative wound infection
|
0.11%
9/8212 • Number of events 10
|
0.10%
8/8280 • Number of events 9
|
|
Infections and infestations
Prostatic abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Pulmonary sepsis
|
0.05%
4/8212 • Number of events 4
|
0.07%
6/8280 • Number of events 6
|
|
Infections and infestations
Pyelonephritis
|
0.09%
7/8212 • Number of events 7
|
0.13%
11/8280 • Number of events 11
|
|
Infections and infestations
Pyelonephritis acute
|
0.01%
1/8212 • Number of events 1
|
0.06%
5/8280 • Number of events 6
|
|
Infections and infestations
Rectal abscess
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Renal abscess
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Infections and infestations
Respiratory tract infection
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection viral
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Retroperitoneal abscess
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.24%
20/8212 • Number of events 22
|
0.25%
21/8280 • Number of events 21
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.11%
9/8212 • Number of events 9
|
0.13%
11/8280 • Number of events 11
|
|
Infections and infestations
Sinusitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Skin bacterial infection
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Infections and infestations
Skin infection
|
0.01%
1/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Staphylococcal infection
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 5
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Staphylococcal skin infection
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
0.04%
3/8212 • Number of events 3
|
0.05%
4/8280 • Number of events 4
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Syphilis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Testicular abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Tracheobronchitis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Typhoid fever
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Upper respiratory tract infection
|
0.09%
7/8212 • Number of events 7
|
0.08%
7/8280 • Number of events 8
|
|
Infections and infestations
Urinary tract infection
|
0.60%
49/8212 • Number of events 50
|
0.48%
40/8280 • Number of events 42
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
0.10%
8/8212 • Number of events 8
|
0.12%
10/8280 • Number of events 10
|
|
Infections and infestations
Vaginal abscess
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Viral infection
|
0.05%
4/8212 • Number of events 4
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.09%
7/8212 • Number of events 7
|
0.08%
7/8280 • Number of events 7
|
|
Infections and infestations
Wound infection staphylococcal
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Infections and infestations
Wound sepsis
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
8/8212 • Number of events 8
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haematoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Brachial plexus injury
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
2/8212 • Number of events 2
|
0.06%
5/8280 • Number of events 5
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Contusion
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
8/8212 • Number of events 8
|
0.07%
6/8280 • Number of events 6
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.06%
5/8212 • Number of events 5
|
0.12%
10/8280 • Number of events 10
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
10/8212 • Number of events 10
|
0.16%
13/8280 • Number of events 15
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.05%
4/8212 • Number of events 4
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Head injury
|
0.05%
4/8212 • Number of events 4
|
0.06%
5/8280 • Number of events 5
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.12%
10/8212 • Number of events 10
|
0.10%
8/8280 • Number of events 9
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.06%
5/8212 • Number of events 5
|
0.11%
9/8280 • Number of events 9
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.06%
5/8212 • Number of events 5
|
0.07%
6/8280 • Number of events 6
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Injury, poisoning and procedural complications
Laceration
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.02%
2/8212 • Number of events 2
|
0.08%
7/8280 • Number of events 7
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Multiple drug overdose intentional
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.01%
1/8212 • Number of events 1
|
0.06%
5/8280 • Number of events 5
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post embolisation syndrome
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.06%
5/8212 • Number of events 6
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.01%
1/8212 • Number of events 1
|
0.06%
5/8280 • Number of events 5
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.06%
5/8212 • Number of events 5
|
0.06%
5/8280 • Number of events 5
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
7/8212 • Number of events 7
|
0.05%
4/8280 • Number of events 4
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
7/8212 • Number of events 7
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Splenic haematoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.10%
8/8212 • Number of events 8
|
0.11%
9/8280 • Number of events 9
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.04%
3/8212 • Number of events 3
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.06%
5/8212 • Number of events 5
|
0.06%
5/8280 • Number of events 5
|
|
Injury, poisoning and procedural complications
Tracheal injury
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.02%
2/8212 • Number of events 2
|
0.05%
4/8280 • Number of events 4
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.04%
3/8212 • Number of events 3
|
0.07%
6/8280 • Number of events 6
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Arteriogram coronary
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Investigations
Aspartate aminotransferase increased
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Investigations
Blood creatinine increased
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Investigations
Blood potassium increased
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Investigations
Blood pressure abnormal
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Cardiac stress test abnormal
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Chest X-ray abnormal
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Investigations
Clostridium test positive
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Coagulation factor VIII level increased
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Investigations
Coagulation test abnormal
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Investigations
Ejection fraction decreased
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Heart rate increased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.07%
6/8212 • Number of events 6
|
0.06%
5/8280 • Number of events 5
|
|
Investigations
International normalised ratio increased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Transaminases increased
|
0.00%
0/8212
|
0.05%
4/8280 • Number of events 4
|
|
Investigations
Troponin increased
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Investigations
Weight decreased
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
17/8212 • Number of events 18
|
0.16%
13/8280 • Number of events 13
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.16%
13/8212 • Number of events 14
|
0.14%
12/8280 • Number of events 14
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.13%
11/8212 • Number of events 13
|
0.12%
10/8280 • Number of events 12
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
5/8212 • Number of events 6
|
0.10%
8/8280 • Number of events 10
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.06%
5/8212 • Number of events 5
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.02%
2/8212 • Number of events 2
|
0.10%
8/8280 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.71%
58/8212 • Number of events 62
|
0.62%
51/8280 • Number of events 55
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.16%
13/8212 • Number of events 15
|
0.21%
17/8280 • Number of events 17
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
7/8212 • Number of events 8
|
0.04%
3/8280 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Metabolism and nutrition disorders
Obesity
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
4/8212 • Number of events 4
|
0.10%
8/8280 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.06%
5/8212 • Number of events 5
|
0.04%
3/8280 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Articular calcification
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
10/8212 • Number of events 10
|
0.11%
9/8280 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.01%
1/8212 • Number of events 1
|
0.06%
5/8280 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Carpal collapse
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Diabetic amyotrophy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Extraskeletal ossification
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Hip deformity
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.04%
3/8212 • Number of events 3
|
0.05%
4/8280 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.16%
13/8212 • Number of events 14
|
0.11%
9/8280 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.04%
3/8212 • Number of events 3
|
0.07%
6/8280 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8212
|
0.05%
4/8280 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.39%
32/8212 • Number of events 35
|
0.28%
23/8280 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.49%
40/8212 • Number of events 42
|
0.59%
49/8280 • Number of events 51
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.06%
5/8212 • Number of events 5
|
0.10%
8/8280 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
4/8212 • Number of events 4
|
0.02%
2/8280 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.07%
6/8212 • Number of events 6
|
0.08%
7/8280 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Musculoskeletal and connective tissue disorders
Vertebral column mass
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.02%
2/8212 • Number of events 4
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiocentric lymphoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.51%
42/8212 • Number of events 57
|
0.63%
52/8280 • Number of events 58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of choroid
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.11%
9/8212 • Number of events 9
|
0.14%
12/8280 • Number of events 13
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.06%
5/8212 • Number of events 5
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage II
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.05%
4/8212 • Number of events 4
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage II
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blast crisis in myelogenous leukaemia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.15%
12/8212 • Number of events 12
|
0.12%
10/8280 • Number of events 10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.22%
18/8212 • Number of events 18
|
0.16%
13/8280 • Number of events 13
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.05%
4/8212 • Number of events 4
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage IV
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer metastatic
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.11%
9/8212 • Number of events 11
|
0.07%
6/8280 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.05%
4/8212 • Number of events 4
|
0.08%
7/8280 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant recurrent
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease nodular sclerosis stage unspecified
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage I
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.06%
5/8212 • Number of events 5
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.05%
4/8212 • Number of events 4
|
0.07%
6/8280 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage 0
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.01%
1/8212 • Number of events 1
|
0.07%
6/8280 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.18%
15/8212 • Number of events 16
|
0.23%
19/8280 • Number of events 20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage II
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.02%
2/8212 • Number of events 2
|
0.05%
4/8280 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.04%
3/8212 • Number of events 3
|
0.06%
5/8280 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.11%
9/8212 • Number of events 9
|
0.13%
11/8280 • Number of events 11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant urinary tract neoplasm
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal gammopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.10%
8/8212 • Number of events 8
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neuroendocrine tumour metastatic
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.41%
34/8212 • Number of events 34
|
0.50%
41/8280 • Number of events 43
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.05%
4/8212 • Number of events 4
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
6/8212 • Number of events 6
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.05%
4/8212 • Number of events 4
|
0.05%
4/8280 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.10%
8/8212 • Number of events 8
|
0.05%
4/8280 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage IV
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma metastatic
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.02%
2/8212 • Number of events 2
|
0.06%
5/8280 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.04%
3/8212 • Number of events 4
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.05%
4/8212 • Number of events 4
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.37%
30/8212 • Number of events 32
|
0.22%
18/8280 • Number of events 19
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.07%
6/8212 • Number of events 6
|
0.08%
7/8280 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.07%
6/8212 • Number of events 7
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vascular neoplasm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Aphasia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Brain injury
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Brain mass
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 4
|
|
Nervous system disorders
Carotid artery occlusion
|
0.01%
1/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Nervous system disorders
Carotid artery stenosis
|
0.13%
11/8212 • Number of events 11
|
0.35%
29/8280 • Number of events 29
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 2
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Nervous system disorders
Cerebral infarction
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.17%
14/8212 • Number of events 14
|
0.14%
12/8280 • Number of events 12
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Cervical myelopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Cervical root pain
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Cognitive disorder
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Coma
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Nervous system disorders
Convulsion
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Nervous system disorders
Dementia
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 3
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Diabetic encephalopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Diabetic neuropathy
|
0.07%
6/8212 • Number of events 6
|
0.08%
7/8280 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
0.12%
10/8212 • Number of events 11
|
0.19%
16/8280 • Number of events 16
|
|
Nervous system disorders
Dysarthria
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Encephalitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Encephalomalacia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
0.09%
7/8212 • Number of events 8
|
0.02%
2/8280 • Number of events 2
|
|
Nervous system disorders
Fahr's disease
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Nervous system disorders
Headache
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Nervous system disorders
Hemiparesis
|
0.02%
2/8212 • Number of events 2
|
0.05%
4/8280 • Number of events 4
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Hemisensory neglect
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
IVth nerve paralysis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Ischaemic neuropathy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Nervous system disorders
Lacunar infarction
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Movement disorder
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Myasthenia gravis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
|
Nervous system disorders
Neurological symptom
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Orthostatic intolerance
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Paraesthesia
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Nervous system disorders
Parkinson's disease
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Polyneuropathy
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Nervous system disorders
Presyncope
|
0.05%
4/8212 • Number of events 4
|
0.06%
5/8280 • Number of events 5
|
|
Nervous system disorders
Radicular pain
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Sensory disturbance
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Speech disorder
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Spinal cord infarction
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.02%
2/8212 • Number of events 2
|
0.05%
4/8280 • Number of events 4
|
|
Nervous system disorders
Syncope
|
0.39%
32/8212 • Number of events 33
|
0.45%
37/8280 • Number of events 39
|
|
Nervous system disorders
Tension headache
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.73%
60/8212 • Number of events 64
|
0.58%
48/8280 • Number of events 49
|
|
Nervous system disorders
Ulnar nerve palsy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.05%
4/8212 • Number of events 4
|
0.10%
8/8280 • Number of events 8
|
|
Nervous system disorders
Vascular dementia
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.04%
3/8212 • Number of events 3
|
0.04%
3/8280 • Number of events 3
|
|
Nervous system disorders
Vocal cord paralysis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Nervous system disorders
White matter lesion
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Psychiatric disorders
Agitation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Psychiatric disorders
Alcoholism
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Psychiatric disorders
Bipolar disorder
|
0.01%
1/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Psychiatric disorders
Completed suicide
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.02%
2/8212 • Number of events 2
|
0.08%
7/8280 • Number of events 8
|
|
Psychiatric disorders
Delirium
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.07%
6/8212 • Number of events 8
|
0.06%
5/8280 • Number of events 5
|
|
Psychiatric disorders
Drug abuse
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Psychiatric disorders
Hallucination
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Psychiatric disorders
Insomnia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Psychiatric disorders
Major depression
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
|
Psychiatric disorders
Mental status changes
|
0.06%
5/8212 • Number of events 5
|
0.08%
7/8280 • Number of events 8
|
|
Psychiatric disorders
Psychosomatic disease
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Psychiatric disorders
Stress
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Psychiatric disorders
Suicide attempt
|
0.05%
4/8212 • Number of events 4
|
0.04%
3/8280 • Number of events 3
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Renal and urinary disorders
Azotaemia
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 3
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Renal and urinary disorders
Calculus bladder
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Renal and urinary disorders
Calculus ureteric
|
0.09%
7/8212 • Number of events 8
|
0.06%
5/8280 • Number of events 7
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Renal and urinary disorders
Glomerulonephritis membranoproliferative
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Haematuria
|
0.09%
7/8212 • Number of events 7
|
0.06%
5/8280 • Number of events 6
|
|
Renal and urinary disorders
Hydronephrosis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Renal and urinary disorders
Lupus nephritis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
11/8212 • Number of events 11
|
0.16%
13/8280 • Number of events 16
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Renal and urinary disorders
Renal cyst
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Renal failure
|
0.24%
20/8212 • Number of events 20
|
0.28%
23/8280 • Number of events 23
|
|
Renal and urinary disorders
Renal failure acute
|
0.79%
65/8212 • Number of events 71
|
0.97%
80/8280 • Number of events 89
|
|
Renal and urinary disorders
Renal failure chronic
|
0.21%
17/8212 • Number of events 18
|
0.22%
18/8280 • Number of events 19
|
|
Renal and urinary disorders
Renal impairment
|
0.29%
24/8212 • Number of events 25
|
0.27%
22/8280 • Number of events 25
|
|
Renal and urinary disorders
Renal infarct
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Renal mass
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Renal and urinary disorders
Urethral stenosis
|
0.02%
2/8212 • Number of events 2
|
0.06%
5/8280 • Number of events 6
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.05%
4/8212 • Number of events 4
|
0.10%
8/8280 • Number of events 8
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.05%
4/8212 • Number of events 4
|
0.00%
0/8280
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Balanitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.16%
13/8212 • Number of events 13
|
0.16%
13/8280 • Number of events 13
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Reproductive system and breast disorders
Colpocele
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
0.05%
4/8212 • Number of events 4
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 2
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.01%
1/8212 • Number of events 1
|
0.05%
4/8280 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.04%
3/8212 • Number of events 3
|
0.14%
12/8280 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
6/8212 • Number of events 7
|
0.18%
15/8280 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
53/8212 • Number of events 79
|
0.86%
71/8280 • Number of events 88
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.29%
24/8212 • Number of events 24
|
0.22%
18/8280 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.05%
4/8212 • Number of events 4
|
0.02%
2/8280 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.04%
3/8212 • Number of events 3
|
0.10%
8/8280 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.04%
3/8212 • Number of events 3
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.05%
4/8212 • Number of events 5
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypertrophy
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
8/8212 • Number of events 9
|
0.06%
5/8280 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.01%
1/8212 • Number of events 1
|
0.12%
10/8280 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
10/8212 • Number of events 10
|
0.13%
11/8280 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.02%
2/8212 • Number of events 2
|
0.04%
3/8280 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.06%
5/8212 • Number of events 5
|
0.05%
4/8280 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
7/8212 • Number of events 8
|
0.10%
8/8280 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.13%
11/8212 • Number of events 13
|
0.11%
9/8280 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.07%
6/8212 • Number of events 6
|
0.02%
2/8280 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.01%
1/8212 • Number of events 1
|
0.06%
5/8280 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/8212
|
0.05%
4/8280 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.28%
23/8212 • Number of events 25
|
0.27%
22/8280 • Number of events 24
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin fibrosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.27%
22/8212 • Number of events 24
|
0.25%
21/8280 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Vascular disorders
Accelerated hypertension
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
8/8212 • Number of events 8
|
0.05%
4/8280 • Number of events 4
|
|
Vascular disorders
Aortic calcification
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/8212
|
0.02%
2/8280 • Number of events 2
|
|
Vascular disorders
Aortic stenosis
|
0.09%
7/8212 • Number of events 7
|
0.05%
4/8280 • Number of events 4
|
|
Vascular disorders
Arterial insufficiency
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis
|
0.06%
5/8212 • Number of events 5
|
0.02%
2/8280 • Number of events 2
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Circulatory collapse
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.11%
9/8212 • Number of events 9
|
0.10%
8/8280 • Number of events 8
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Vascular disorders
Embolism venous
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Vascular disorders
Extremity necrosis
|
0.04%
3/8212 • Number of events 3
|
0.07%
6/8280 • Number of events 6
|
|
Vascular disorders
Femoral artery embolism
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Vascular disorders
Femoral artery occlusion
|
0.09%
7/8212 • Number of events 8
|
0.02%
2/8280 • Number of events 2
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.04%
3/8212 • Number of events 3
|
0.06%
5/8280 • Number of events 5
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Vascular disorders
Haemorrhagic infarction
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Vascular disorders
Hypertension
|
0.37%
30/8212 • Number of events 33
|
0.35%
29/8280 • Number of events 32
|
|
Vascular disorders
Hypertensive crisis
|
0.19%
16/8212 • Number of events 17
|
0.21%
17/8280 • Number of events 18
|
|
Vascular disorders
Hypertensive emergency
|
0.04%
3/8212 • Number of events 3
|
0.02%
2/8280 • Number of events 2
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.21%
17/8212 • Number of events 18
|
0.23%
19/8280 • Number of events 22
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/8212
|
0.04%
3/8280 • Number of events 3
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
2/8212 • Number of events 2
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Intermittent claudication
|
0.12%
10/8212 • Number of events 11
|
0.12%
10/8280 • Number of events 11
|
|
Vascular disorders
Necrosis ischaemic
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
|
Vascular disorders
Orthostatic hypotension
|
0.06%
5/8212 • Number of events 6
|
0.07%
6/8280 • Number of events 6
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.52%
43/8212 • Number of events 49
|
0.29%
24/8280 • Number of events 25
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.04%
3/8212 • Number of events 3
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Peripheral artery dissection
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Peripheral artery stenosis
|
0.10%
8/8212 • Number of events 9
|
0.22%
18/8280 • Number of events 20
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.02%
2/8212 • Number of events 2
|
0.02%
2/8280 • Number of events 2
|
|
Vascular disorders
Peripheral embolism
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Vascular disorders
Peripheral ischaemia
|
0.47%
39/8212 • Number of events 46
|
0.29%
24/8280 • Number of events 35
|
|
Vascular disorders
Peripheral vascular disorder
|
0.24%
20/8212 • Number of events 22
|
0.25%
21/8280 • Number of events 24
|
|
Vascular disorders
Shock
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Shock haemorrhagic
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Subclavian artery occlusion
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Vascular disorders
Subclavian artery stenosis
|
0.02%
2/8212 • Number of events 2
|
0.00%
0/8280
|
|
Vascular disorders
Thrombophlebitis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.01%
1/8212 • Number of events 1
|
0.04%
3/8280 • Number of events 3
|
|
Vascular disorders
Varicose vein
|
0.01%
1/8212 • Number of events 1
|
0.02%
2/8280 • Number of events 2
|
|
Vascular disorders
Vascular occlusion
|
0.01%
1/8212 • Number of events 1
|
0.00%
0/8280
|
|
Vascular disorders
Vascular stenosis
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Vasculitis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Venous insufficiency
|
0.01%
1/8212 • Number of events 1
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/8212
|
0.01%
1/8280 • Number of events 1
|
|
Vascular disorders
Venous thrombosis limb
|
0.01%
1/8212 • Number of events 2
|
0.00%
0/8280
|
Other adverse events
| Measure |
Placebo
n=8212 participants at risk
Matching Placebo
|
Saxagliptin
n=8280 participants at risk
5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR \>50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
198/8212 • Number of events 208
|
2.4%
197/8280 • Number of events 204
|
|
Cardiac disorders
Angina pectoris
|
2.4%
197/8212 • Number of events 217
|
2.1%
171/8280 • Number of events 188
|
|
Gastrointestinal disorders
Constipation
|
2.0%
164/8212 • Number of events 175
|
2.1%
170/8280 • Number of events 183
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
314/8212 • Number of events 369
|
3.9%
321/8280 • Number of events 379
|
|
Gastrointestinal disorders
Nausea
|
2.2%
182/8212 • Number of events 215
|
2.4%
200/8280 • Number of events 218
|
|
General disorders
Fatigue
|
2.3%
192/8212 • Number of events 215
|
2.0%
167/8280 • Number of events 179
|
|
General disorders
Oedema peripheral
|
4.3%
352/8212 • Number of events 375
|
4.1%
343/8280 • Number of events 380
|
|
Infections and infestations
Bronchitis
|
4.6%
375/8212 • Number of events 453
|
4.0%
331/8280 • Number of events 414
|
|
Infections and infestations
Influenza
|
2.4%
195/8212 • Number of events 232
|
2.4%
199/8280 • Number of events 230
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
280/8212 • Number of events 334
|
3.5%
293/8280 • Number of events 341
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
324/8212 • Number of events 398
|
4.0%
330/8280 • Number of events 408
|
|
Infections and infestations
Urinary tract infection
|
3.9%
323/8212 • Number of events 431
|
3.7%
307/8280 • Number of events 389
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.1%
666/8212 • Number of events 834
|
6.5%
538/8280 • Number of events 666
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
278/8212 • Number of events 327
|
2.6%
215/8280 • Number of events 271
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
306/8212 • Number of events 332
|
3.8%
313/8280 • Number of events 354
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
319/8212 • Number of events 350
|
4.0%
330/8280 • Number of events 358
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
165/8212 • Number of events 179
|
2.0%
168/8280 • Number of events 185
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
321/8212 • Number of events 342
|
3.2%
264/8280 • Number of events 298
|
|
Nervous system disorders
Dizziness
|
4.2%
344/8212 • Number of events 393
|
4.5%
374/8280 • Number of events 485
|
|
Nervous system disorders
Headache
|
2.9%
241/8212 • Number of events 255
|
2.5%
208/8280 • Number of events 240
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
302/8212 • Number of events 337
|
3.1%
258/8280 • Number of events 282
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
199/8212 • Number of events 217
|
2.2%
182/8280 • Number of events 196
|
|
Vascular disorders
Hypertension
|
3.9%
321/8212 • Number of events 352
|
4.2%
349/8280 • Number of events 379
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AstraZeneca's Publication Policy, data disclosure and transparency are available at the website: http://www.astrazeneca.com/responsibility/code-and-policies/policies?itemId=4861823\&nav=yes. All papers or abstracts must be submitted to the Steering Committee and the SPONSOR, through BRIGHAM, for review of its appropriateness and scientific merit at least six weeks prior to submission to any publication.
- Publication restrictions are in place
Restriction type: OTHER