Trial Outcomes & Findings for RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial (NCT NCT00808067)
NCT ID: NCT00808067
Last Updated: 2014-06-09
Results Overview
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: * Bleeding associated with a reduction in hemoglobin of at least 20 g/L * Required transfusion of at least 2 units of blood or packed cells * Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal Major bleed were classified as life-threatening if they met one or more of the following criteria: * Reduction in hemoglobin of at least 50 g/L * Transfusion of at least 4 units of blood or packed cells * Symptomatic intracranial bleeding, either subdural or intracerebral * Associated with hypotension requiring use of intravenous inotropic agents * Required surgical intervention to stop bleeding * Resulted in death
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5897 participants
Primary outcome timeframe
up to 43 months
Results posted on
2014-06-09
Participant Flow
A total of 5897 subjects were enrolled (rolled over from RE-LY trial), and 5891 were entered in this study. There were 8 subjects not treated; therefore 5883 subjects comprise the 'started' treatment group.
Participant milestones
| Measure |
Dabigatran 110 mg
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
2927
|
2956
|
|
Overall Study
COMPLETED
|
2446
|
2438
|
|
Overall Study
NOT COMPLETED
|
481
|
518
|
Reasons for withdrawal
| Measure |
Dabigatran 110 mg
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Overall Study
Major/minor bleed
|
30
|
44
|
|
Overall Study
Outcome event - other
|
33
|
25
|
|
Overall Study
Adverse Event
|
111
|
121
|
|
Overall Study
Hospitalization (not including surgery)
|
18
|
17
|
|
Overall Study
Hospitalization due to surgery
|
37
|
40
|
|
Overall Study
Reduced creatinine clearance
|
53
|
55
|
|
Overall Study
Elevated LFT results
|
7
|
3
|
|
Overall Study
Patient refused to take study medication
|
65
|
76
|
|
Overall Study
Missing
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Procedure
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
21
|
25
|
|
Overall Study
Site closed
|
4
|
3
|
|
Overall Study
Physician Decision
|
47
|
38
|
|
Overall Study
Protocol Violation
|
3
|
11
|
|
Overall Study
Patient elected
|
7
|
9
|
|
Overall Study
Site closed for cause
|
19
|
19
|
|
Overall Study
Other reason not defined above
|
5
|
5
|
|
Overall Study
Excluded from analysis
|
13
|
19
|
Baseline Characteristics
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
Baseline characteristics by cohort
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
Total
n=5851 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
73.1 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
73.1 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1000 Participants
n=5 Participants
|
1026 Participants
n=7 Participants
|
2026 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1914 Participants
n=5 Participants
|
1911 Participants
n=7 Participants
|
3825 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: * Bleeding associated with a reduction in hemoglobin of at least 20 g/L * Required transfusion of at least 2 units of blood or packed cells * Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal Major bleed were classified as life-threatening if they met one or more of the following criteria: * Reduction in hemoglobin of at least 50 g/L * Transfusion of at least 4 units of blood or packed cells * Symptomatic intracranial bleeding, either subdural or intracerebral * Associated with hypotension requiring use of intravenous inotropic agents * Required surgical intervention to stop bleeding * Resulted in death
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Major Bleeding, Annualized Rate of Subjects With Major Bleeds
|
2.79 percentage of subject-years
|
3.59 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Stroke, Annualized Rate of Subjects With Stroke
|
1.39 percentage of subject-years
|
1.26 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE
|
0.25 percentage of subject-years
|
0.23 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Pulmonary Embolism was generally documented by one of the following: 1. an intraluminal filling defect in segmental or more proximal branches on spiral CT scan 2. an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram 3. a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS) 4. inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Pulmonary Embolism (PE), Annualized Rate of Subjects With PE
|
0.10 percentage of subject-years
|
0.12 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI
|
0.72 percentage of subject-years
|
0.66 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deep Vein Thrombosis (DVT) was generally documented by one of the following: 1. abnormal compression ultrasound (CUS), 2. an intraluminal filling defect on venography.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Deep Vein Thrombosis, Annualized Rate of Subjects With DVT
|
0.06 percentage of subject-years
|
0.11 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Death, Annualized Rate of Subject Death
|
3.18 percentage of subject-years
|
2.99 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)
|
1.60 percentage of subject-years
|
1.47 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death
|
4.40 percentage of subject-years
|
4.02 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death
|
3.51 percentage of subject-years
|
3.32 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed
|
6.65 percentage of subject-years
|
7.14 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Annualized Rate of Subjects With Minor Bleeds
|
7.49 percentage of subject-years
|
8.98 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)
|
9.44 percentage of subject-years
|
11.20 percentage of subject-years
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: SAF-FAS interval
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Outcome measures
| Measure |
Dabigatran 110 mg
n=2914 Participants
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 Participants
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)
|
0.28 percentage of subject-years
|
0.33 percentage of subject-years
|
Adverse Events
Dabigatran 110 mg
Serious events: 1028 serious events
Other events: 0 other events
Deaths: 0 deaths
Dabigatran 150 mg
Serious events: 1106 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dabigatran 110 mg
n=2914 participants at risk
Dabigatran etexilate 110 mg twice daily
|
Dabigatran 150 mg
n=2937 participants at risk
Dabigatran etexilate 150 mg twice daily
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.14%
4/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell histiocytosis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell carcinoma of the respiratory tract stage unspecified
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer recurrent
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.10%
3/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.55%
16/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.79%
23/2914 • Up to 43 months
|
1.2%
36/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.03%
1/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.14%
4/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.17%
5/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.07%
2/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Angina pectoris
|
1.2%
34/2914 • Up to 43 months
|
1.2%
36/2937 • Up to 43 months
|
|
Cardiac disorders
Angina unstable
|
0.07%
2/2914 • Up to 43 months
|
0.44%
13/2937 • Up to 43 months
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Arrhythmia
|
0.17%
5/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
84/2914 • Up to 43 months
|
3.2%
95/2937 • Up to 43 months
|
|
Cardiac disorders
Atrial flutter
|
0.14%
4/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Cardiac disorders
Atrial tachycardia
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Atrial thrombosis
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Cardiac disorders
Atrioventricular block
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.07%
2/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Cardiac disorders
Bradyarrhythmia
|
0.10%
3/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Cardiac disorders
Bradycardia
|
0.65%
19/2914 • Up to 43 months
|
0.78%
23/2937 • Up to 43 months
|
|
Cardiac disorders
Cardiac arrest
|
0.24%
7/2914 • Up to 43 months
|
0.31%
9/2937 • Up to 43 months
|
|
Cardiac disorders
Cardiac failure
|
2.4%
70/2914 • Up to 43 months
|
3.0%
87/2937 • Up to 43 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Cardiac failure chronic
|
0.10%
3/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
68/2914 • Up to 43 months
|
2.4%
71/2937 • Up to 43 months
|
|
Cardiac disorders
Cardiac valve disease
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Cardiac disorders
Chronotropic incompetence
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Coronary artery disease
|
0.48%
14/2914 • Up to 43 months
|
0.41%
12/2937 • Up to 43 months
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Cardiac disorders
Left ventricular failure
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Mitral valve incompetence
|
0.24%
7/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Cardiac disorders
Mitral valve stenosis
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
3/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Palpitations
|
0.14%
4/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Cardiac disorders
Pericardial effusion
|
0.10%
3/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Right ventricular failure
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Cardiac disorders
Sick sinus syndrome
|
0.45%
13/2914 • Up to 43 months
|
0.34%
10/2937 • Up to 43 months
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Cardiac disorders
Tachycardia
|
0.07%
2/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.24%
7/2914 • Up to 43 months
|
0.27%
8/2937 • Up to 43 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.14%
4/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.24%
7/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.21%
6/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Endocrine disorders
Goitre
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Eye disorders
Amaurosis fugax
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Eye disorders
Blepharochalasis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Eye disorders
Blindness
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Eye disorders
Cataract
|
0.27%
8/2914 • Up to 43 months
|
0.34%
10/2937 • Up to 43 months
|
|
Eye disorders
Diplopia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Eye disorders
Glaucoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Eye disorders
Macular pseudohole
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Eye disorders
Retinal detachment
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Eye disorders
Retinal vein occlusion
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Eye disorders
Scotoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Abdominal mass
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.00%
29/2914 • Up to 43 months
|
0.92%
27/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Anal fistula
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Ascites
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Colitis
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Colonic polyp
|
0.38%
11/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Constipation
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.27%
8/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.14%
4/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.24%
7/2914 • Up to 43 months
|
0.41%
12/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.27%
8/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gastritis
|
0.27%
8/2914 • Up to 43 months
|
0.24%
7/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.69%
20/2914 • Up to 43 months
|
0.68%
20/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gastrointestinal mucosal disorder
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Ileus
|
0.21%
6/2914 • Up to 43 months
|
0.24%
7/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.45%
13/2914 • Up to 43 months
|
0.24%
7/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.07%
2/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.27%
8/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
1/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Melaena
|
0.21%
6/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Nausea
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.03%
1/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.17%
5/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.17%
5/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Subileus
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.14%
4/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
6/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
General disorders
Adverse drug reaction
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Asthenia
|
0.24%
7/2914 • Up to 43 months
|
0.34%
10/2937 • Up to 43 months
|
|
General disorders
Chest discomfort
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Chest pain
|
1.2%
35/2914 • Up to 43 months
|
1.6%
47/2937 • Up to 43 months
|
|
General disorders
Death
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Device breakage
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
General disorders
Device dislocation
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Device malfunction
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Drug ineffective
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
General disorders
Fatigue
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
General disorders
Gait disturbance
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
General disorders
General physical health deterioration
|
0.03%
1/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
General disorders
Generalised oedema
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Hernia
|
0.21%
6/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
General disorders
Hernia obstructive
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
General disorders
Impaired healing
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Malaise
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Medical device complication
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Multi-organ disorder
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
General disorders
Multi-organ failure
|
0.10%
3/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
General disorders
Necrosis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Non-cardiac chest pain
|
0.17%
5/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
General disorders
Oedema
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
General disorders
Oedema peripheral
|
0.17%
5/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
General disorders
Pain
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Pyrexia
|
0.10%
3/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
General disorders
Stent-graft endoleak
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
General disorders
Sudden cardiac death
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
General disorders
Sudden death
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.14%
4/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Biliary colic
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.14%
4/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.34%
10/2914 • Up to 43 months
|
0.24%
7/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.14%
4/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
10/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Immune system disorders
Anaphylactic shock
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Abscess
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Abscess limb
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Abscess neck
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Anal abscess
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Appendicitis
|
0.10%
3/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Infections and infestations
Arthritis bacterial
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Atypical pneumonia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Bacteraemia
|
0.14%
4/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Brain abscess
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Bronchitis
|
0.38%
11/2914 • Up to 43 months
|
0.27%
8/2937 • Up to 43 months
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Cellulitis
|
0.86%
25/2914 • Up to 43 months
|
0.85%
25/2937 • Up to 43 months
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Cholecystitis infective
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Chronic sinusitis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Clostridial infection
|
0.10%
3/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Corneal abscess
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Cystitis
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Dengue fever
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Infections and infestations
Diabetic foot infection
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Diverticulitis
|
0.03%
1/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Infections and infestations
Ear infection
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Endocarditis
|
0.17%
5/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Erysipelas
|
0.24%
7/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Fungal infection
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Gangrene
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Gastroenteritis
|
0.10%
3/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Gastrointestinal infection
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Groin abscess
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Groin infection
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Implant site infection
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Infected bites
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Infected cyst
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Infection
|
0.17%
5/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Influenza
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Klebsiella sepsis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Labyrinthitis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Liver abscess
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Lobar pneumonia
|
0.10%
3/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Infections and infestations
Localised infection
|
0.14%
4/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Neuroborreliosis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Oesophageal candidiasis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Oesophageal infection
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Osteomyelitis
|
0.07%
2/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Infections and infestations
Otitis externa
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Pancreatic abscess
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Parotitis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Peritonitis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Peritonitis bacterial
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Pharyngeal abscess
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Pharyngolaryngeal abscess
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Pneumonia
|
3.1%
91/2914 • Up to 43 months
|
3.4%
99/2937 • Up to 43 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Post procedural infection
|
0.10%
3/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Pyelonephritis
|
0.03%
1/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Respiratory tract infection
|
0.17%
5/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Infections and infestations
Sepsis
|
0.65%
19/2914 • Up to 43 months
|
0.78%
23/2937 • Up to 43 months
|
|
Infections and infestations
Septic shock
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Sinusitis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Skin infection
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Staphylococcal sepsis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.17%
5/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Infections and infestations
Urethritis chlamydial
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Urinary tract infection
|
0.72%
21/2914 • Up to 43 months
|
0.99%
29/2937 • Up to 43 months
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Infections and infestations
Urosepsis
|
0.10%
3/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Infections and infestations
Viral infection
|
0.03%
1/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
3/2914 • Up to 43 months
|
0.27%
8/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.10%
3/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Deafness traumatic
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.89%
26/2914 • Up to 43 months
|
1.1%
31/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.14%
4/2914 • Up to 43 months
|
0.31%
9/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
10/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.38%
11/2914 • Up to 43 months
|
0.37%
11/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.10%
3/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Open wound
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.14%
4/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.03%
1/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
1/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.10%
3/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.07%
2/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.17%
5/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.17%
5/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.07%
2/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.17%
5/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.10%
3/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Investigations
Blood glucagon abnormal
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Investigations
Creatinine renal clearance decreased
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Investigations
Haemoglobin decreased
|
0.17%
5/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Investigations
Heart rate decreased
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Investigations
Heart rate irregular
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Investigations
Hepatic enzyme increased
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Investigations
International normalised ratio increased
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Investigations
Liver function test abnormal
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Investigations
Troponin I increased
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Investigations
Weight decreased
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.38%
11/2914 • Up to 43 months
|
0.68%
20/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.10%
3/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Gout
|
0.14%
4/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.14%
4/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.14%
4/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.27%
8/2914 • Up to 43 months
|
0.27%
8/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.31%
9/2914 • Up to 43 months
|
0.24%
7/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.24%
7/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.31%
9/2914 • Up to 43 months
|
0.51%
15/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Crystal arthropathy
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.07%
2/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/2914 • Up to 43 months
|
0.27%
8/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.07%
2/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.96%
28/2914 • Up to 43 months
|
1.2%
36/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.14%
4/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.03%
1/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.10%
3/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.27%
8/2914 • Up to 43 months
|
0.31%
9/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone sarcoma
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.27%
8/2914 • Up to 43 months
|
0.31%
9/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.45%
13/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pelvis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.21%
6/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.03%
1/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.10%
3/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.45%
13/2914 • Up to 43 months
|
0.48%
14/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer recurrent
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.07%
2/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.10%
3/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.14%
4/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Amnesia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Aphasia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Brachial plexopathy
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Brain stem stroke
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Carotid artery insufficiency
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Carotid artery occlusion
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Carotid artery stenosis
|
0.14%
4/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.27%
8/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Nervous system disorders
Cervical root pain
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Cognitive disorder
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Coma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Convulsion
|
0.17%
5/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Nervous system disorders
Dementia
|
0.07%
2/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Nervous system disorders
Dizziness
|
0.14%
4/2914 • Up to 43 months
|
0.24%
7/2937 • Up to 43 months
|
|
Nervous system disorders
Embolic stroke
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Encephalopathy
|
0.14%
4/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Nervous system disorders
Epilepsy
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Headache
|
0.07%
2/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Nervous system disorders
Hemiparesis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Hydrocephalus
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.17%
5/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Migraine
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Myasthenia gravis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Paraesthesia
|
0.10%
3/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Paresis cranial nerve
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Parkinson's disease
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Parkinsonism
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Partial seizures
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Presyncope
|
0.03%
1/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Nervous system disorders
Sciatic nerve palsy
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Sciatica
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Syncope
|
0.82%
24/2914 • Up to 43 months
|
0.82%
24/2937 • Up to 43 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.21%
6/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Psychiatric disorders
Abnormal behaviour
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Psychiatric disorders
Alcohol abuse
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Psychiatric disorders
Anxiety
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Psychiatric disorders
Confusional state
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Psychiatric disorders
Delirium
|
0.10%
3/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Psychiatric disorders
Depression
|
0.03%
1/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Psychiatric disorders
Mental status changes
|
0.17%
5/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Psychiatric disorders
Panic attack
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Psychiatric disorders
Panic disorder
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Psychiatric disorders
Suicide attempt
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Renal and urinary disorders
Bladder obstruction
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Renal and urinary disorders
Bladder prolapse
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Renal and urinary disorders
Dysuria
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Renal and urinary disorders
Haematuria
|
0.07%
2/2914 • Up to 43 months
|
0.24%
7/2937 • Up to 43 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
4/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal cyst
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal disorder
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal embolism
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal failure
|
0.65%
19/2914 • Up to 43 months
|
0.31%
9/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.79%
23/2914 • Up to 43 months
|
0.78%
23/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal failure chronic
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.41%
12/2914 • Up to 43 months
|
0.44%
13/2937 • Up to 43 months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Reproductive system and breast disorders
Spermatocele
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.03%
1/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.14%
4/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
4/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.07%
2/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.93%
27/2914 • Up to 43 months
|
1.0%
30/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
34/2914 • Up to 43 months
|
1.1%
32/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
1/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.07%
2/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.38%
11/2914 • Up to 43 months
|
0.24%
7/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.10%
3/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.07%
2/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.10%
3/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.21%
6/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
3/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Social circumstances
Activities of daily living impaired
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Surgical and medical procedures
Lesion excision
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Aneurysm
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Aortic aneurysm
|
0.38%
11/2914 • Up to 43 months
|
0.27%
8/2937 • Up to 43 months
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Aortic dissection
|
0.17%
5/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Aortic intramural haematoma
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Aortic stenosis
|
0.21%
6/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Vascular disorders
Arteritis
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Circulatory collapse
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
2/2914 • Up to 43 months
|
0.20%
6/2937 • Up to 43 months
|
|
Vascular disorders
Femoral artery aneurysm
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Femoral artery occlusion
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Haematoma
|
0.07%
2/2914 • Up to 43 months
|
0.10%
3/2937 • Up to 43 months
|
|
Vascular disorders
Haemorrhage
|
0.14%
4/2914 • Up to 43 months
|
0.17%
5/2937 • Up to 43 months
|
|
Vascular disorders
Hypertension
|
0.38%
11/2914 • Up to 43 months
|
0.34%
10/2937 • Up to 43 months
|
|
Vascular disorders
Hypertensive crisis
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Hypotension
|
0.27%
8/2914 • Up to 43 months
|
0.31%
9/2937 • Up to 43 months
|
|
Vascular disorders
Intermittent claudication
|
0.03%
1/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Vascular disorders
Ischaemia
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Leriche syndrome
|
0.03%
1/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Malignant hypertension
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.07%
2/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.14%
4/2914 • Up to 43 months
|
0.07%
2/2937 • Up to 43 months
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Peripheral artery stenosis
|
0.07%
2/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Peripheral embolism
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Peripheral ischaemia
|
0.07%
2/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Peripheral vascular disorder
|
0.07%
2/2914 • Up to 43 months
|
0.14%
4/2937 • Up to 43 months
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/2914 • Up to 43 months
|
0.03%
1/2937 • Up to 43 months
|
|
Vascular disorders
Temporal arteritis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Thrombosis
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
|
Vascular disorders
Venous occlusion
|
0.03%
1/2914 • Up to 43 months
|
0.00%
0/2937 • Up to 43 months
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER