Trial Outcomes & Findings for VA NEPHRON-D: Diabetes iN Nephropathy Study (NCT NCT00555217)

NCT ID: NCT00555217

Last Updated: 2015-05-29

Results Overview

Time to the first event of reduction in estimated GFR of 30ml/min/1.73m\*m in individuals w/a baseline estimated GFR \>= 60 ml/min/1.73m\*m, reduction in estimated GFR \>50% in individuals w/ baseline estimated GFR \<60ml/min/1.73m\*m; ESRD or death.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1448 participants

Primary outcome timeframe

From enrollemnt to time of first primary event, up to 4.5 years

Results posted on

2015-05-29

Participant Flow

Participant milestones

Participant milestones
Measure
Combination of ARB and ACEI
Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB) losartan: 50 or 100mg/day lisinopril: 10, 20 or 40 mg/day
Monotherapy ARB
Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB) losartan: 50 or 100mg/day
Overall Study
STARTED
724
724
Overall Study
COMPLETED
649
656
Overall Study
NOT COMPLETED
75
68

Reasons for withdrawal

Reasons for withdrawal
Measure
Combination of ARB and ACEI
Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB) losartan: 50 or 100mg/day lisinopril: 10, 20 or 40 mg/day
Monotherapy ARB
Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB) losartan: 50 or 100mg/day
Overall Study
Withdrawal by Subject
35
31
Overall Study
Lost to Follow-up
19
20
Overall Study
close out sites
21
17

Baseline Characteristics

VA NEPHRON-D: Diabetes iN Nephropathy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Combination of ARB and ACEI
n=724 Participants
Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB) losartan: 50 or 100mg/day lisinopril: 10, 20 or 40 mg/day
Monotherapy ARB
n=724 Participants
Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB) losartan: 50 or 100mg/day
Total
n=1448 Participants
Total of all reporting groups
Age, Continuous
64.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
64.7 years
STANDARD_DEVIATION 7.7 • n=7 Participants
64.6 years
STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
3 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
715 Participants
n=5 Participants
721 Participants
n=7 Participants
1436 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
71 Participants
n=5 Participants
75 Participants
n=7 Participants
146 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
653 Participants
n=5 Participants
649 Participants
n=7 Participants
1302 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
16 Participants
n=5 Participants
25 Participants
n=7 Participants
41 Participants
n=5 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
8 Participants
n=5 Participants
5 Participants
n=7 Participants
13 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
172 Participants
n=5 Participants
160 Participants
n=7 Participants
332 Participants
n=5 Participants
Race (NIH/OMB)
White
523 Participants
n=5 Participants
514 Participants
n=7 Participants
1037 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
14 Participants
n=7 Participants
14 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
724 participants
n=5 Participants
724 participants
n=7 Participants
1448 participants
n=5 Participants
Body Mass Index
34.9 kg/m^2
STANDARD_DEVIATION 6.7 • n=5 Participants
34.3 kg/m^2
STANDARD_DEVIATION 6.9 • n=7 Participants
34.6 kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
Coronary Artery Disease
Yes
159 participants
n=5 Participants
167 participants
n=7 Participants
326 participants
n=5 Participants
Coronary Artery Disease
No
565 participants
n=5 Participants
557 participants
n=7 Participants
1122 participants
n=5 Participants
Congestive Heart Failure
Yes
116 participants
n=5 Participants
110 participants
n=7 Participants
226 participants
n=5 Participants
Congestive Heart Failure
No
608 participants
n=5 Participants
614 participants
n=7 Participants
1222 participants
n=5 Participants
Retinopathy
Yes
309 participants
n=5 Participants
310 participants
n=7 Participants
619 participants
n=5 Participants
Retinopathy
No
415 participants
n=5 Participants
414 participants
n=7 Participants
829 participants
n=5 Participants
SBP
136.9 mmHg
STANDARD_DEVIATION 16.5 • n=5 Participants
137.0 mmHg
STANDARD_DEVIATION 16.0 • n=7 Participants
136.9 mmHg
STANDARD_DEVIATION 16.3 • n=5 Participants
DBP
72.5 mmHg
STANDARD_DEVIATION 10.6 • n=5 Participants
72.8 mmHg
STANDARD_DEVIATION 9.9 • n=7 Participants
72.7 mmHg
STANDARD_DEVIATION 10.2 • n=5 Participants
Total Cholesterol
157.9 mg/dl
STANDARD_DEVIATION 43.6 • n=5 Participants
159.0 mg/dl
STANDARD_DEVIATION 40.5 • n=7 Participants
158.4 mg/dl
STANDARD_DEVIATION 42.1 • n=5 Participants
LDL cholesterol
81.6 mg/dl
STANDARD_DEVIATION 32.4 • n=5 Participants
84.3 mg/dl
STANDARD_DEVIATION 35.0 • n=7 Participants
82.9 mg/dl
STANDARD_DEVIATION 33.7 • n=5 Participants
HDL cholesterol
37.7 mg/dl
STANDARD_DEVIATION 11.0 • n=5 Participants
38.7 mg/dl
STANDARD_DEVIATION 11.3 • n=7 Participants
38.2 mg/dl
STANDARD_DEVIATION 11.2 • n=5 Participants
Triglycerides
165 mg/dl
n=5 Participants
162 mg/dl
n=7 Participants
163 mg/dl
n=5 Participants
HbA1c
7.8 %
STANDARD_DEVIATION 1.2 • n=5 Participants
7.8 %
STANDARD_DEVIATION 1.3 • n=7 Participants
7.8 %
STANDARD_DEVIATION 1.3 • n=5 Participants
serum Creatinine at enrollment
1.5 mg/dl
STANDARD_DEVIATION 0.4 • n=5 Participants
1.5 mg/dl
STANDARD_DEVIATION 0.4 • n=7 Participants
1.5 mg/dl
STANDARD_DEVIATION 0.4 • n=5 Participants
Potassium
4.3 meq/L
STANDARD_DEVIATION 0.5 • n=5 Participants
4.3 meq/L
STANDARD_DEVIATION 0.5 • n=7 Participants
4.3 meq/L
STANDARD_DEVIATION 0.5 • n=5 Participants
eGFR at enrollment
53.6 ml/min/1.73m^2
STANDARD_DEVIATION 15.5 • n=5 Participants
53.7 ml/min/1.73m^2
STANDARD_DEVIATION 16.2 • n=7 Participants
53.7 ml/min/1.73m^2
STANDARD_DEVIATION 15.9 • n=5 Participants
urine albumin/creatinine at enrollment
841.5 mg/g
n=5 Participants
861.5 mg/g
n=7 Participants
851.0 mg/g
n=5 Participants

PRIMARY outcome

Timeframe: From enrollemnt to time of first primary event, up to 4.5 years

Time to the first event of reduction in estimated GFR of 30ml/min/1.73m\*m in individuals w/a baseline estimated GFR \>= 60 ml/min/1.73m\*m, reduction in estimated GFR \>50% in individuals w/ baseline estimated GFR \<60ml/min/1.73m\*m; ESRD or death.

Outcome measures

Outcome measures
Measure
Combination of ARB and ACEI
n=724 Participants
Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
Monotherapy ARB
n=724 Participants
Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death
132 participants
152 participants

SECONDARY outcome

Timeframe: From enrollment to time of first event, up to 4.5 years

Time to the first event of reduction in estimated GFR of \>50% (for individuals with baseline GFR \<60) or reduction in GFR of \>30 (for individuals with baseline GFR \>= GFR 60) or ESRD.

Outcome measures

Outcome measures
Measure
Combination of ARB and ACEI
n=724 Participants
Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
Monotherapy ARB
n=724 Participants
Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD.
77 participants
101 participants

Adverse Events

Combination of ARB and ACEI

Serious events: 416 serious events
Other events: 0 other events
Deaths: 0 deaths

Monotherapy ARB

Serious events: 380 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Combination of ARB and ACEI
n=724 participants at risk
Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
Monotherapy ARB
n=724 participants at risk
Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
Blood and lymphatic system disorders
Anaemia of chronic disease
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
Blood and lymphatic system disorders
Anaemia of malignant disease
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Blood and lymphatic system disorders
Anemia
2.1%
15/724 • Number of events 23 • July 2008 - January 2013
1.7%
12/724 • Number of events 13 • July 2008 - January 2013
Blood and lymphatic system disorders
Coagulopathy
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Blood and lymphatic system disorders
Idiopathic thrombocytopenic pu
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 3 • July 2008 - January 2013
Blood and lymphatic system disorders
Iron deficiency anaemia
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Blood and lymphatic system disorders
Leukocytosis
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Blood and lymphatic system disorders
Normochromic normocytic anaemi
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Blood and lymphatic system disorders
Pancytopenia
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Blood and lymphatic system disorders
Thrombocytopenia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Acute coronary syndrome
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.97%
7/724 • Number of events 8 • July 2008 - January 2013
Cardiac disorders
Acute myocardial infarction
3.7%
27/724 • Number of events 31 • July 2008 - January 2013
3.3%
24/724 • Number of events 25 • July 2008 - January 2013
Cardiac disorders
Angina pectoris
0.97%
7/724 • Number of events 8 • July 2008 - January 2013
1.2%
9/724 • Number of events 11 • July 2008 - January 2013
Cardiac disorders
Angina unstable
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Cardiac disorders
Arrhythmia
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Atrial fibrillation
1.8%
13/724 • Number of events 18 • July 2008 - January 2013
1.9%
14/724 • Number of events 19 • July 2008 - January 2013
Cardiac disorders
Atrial flutter
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Cardiac disorders
Atrioventricular block
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Atrioventricular block complet
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Cardiac disorders
Atrioventricular block first d
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Atrioventricular block second
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Bradycardia
1.1%
8/724 • Number of events 8 • July 2008 - January 2013
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
Cardiac disorders
Bundle branch block right
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Cardiac arrest
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Cardiac failure
0.97%
7/724 • Number of events 8 • July 2008 - January 2013
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
Cardiac disorders
Cardiac failure acute
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.41%
3/724 • Number of events 4 • July 2008 - January 2013
Cardiac disorders
Cardiac failure chronic
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Cardiac failure congestive
11.0%
80/724 • Number of events 143 • July 2008 - January 2013
13.1%
95/724 • Number of events 155 • July 2008 - January 2013
Cardiac disorders
Cardiac tamponade
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Cardio-respiratory arrest
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Cardiogenic shock
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Cardiomyopathy
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Cardiac disorders
Cardiorenal syndrome
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Cardiovascular disorder
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Coronary artery disease
4.4%
32/724 • Number of events 35 • July 2008 - January 2013
3.2%
23/724 • Number of events 26 • July 2008 - January 2013
Cardiac disorders
Coronary artery occlusion
0.83%
6/724 • Number of events 7 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Cardiac disorders
Coronary artery stenosis
0.97%
7/724 • Number of events 7 • July 2008 - January 2013
0.97%
7/724 • Number of events 7 • July 2008 - January 2013
Cardiac disorders
Coronary artery thrombosis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Diastolic dysfunction
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Hypertensive heart disease
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Intracardiac thrombus
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Ischaemic cardiomyopathy
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Mitral valve incompetence
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Myocardial infarction
2.5%
18/724 • Number of events 18 • July 2008 - January 2013
2.1%
15/724 • Number of events 17 • July 2008 - January 2013
Cardiac disorders
Myocardial ischaemia
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Nodal arrhythmia
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Nodal rhythm
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Pericardial effusion
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Cardiac disorders
Pericarditis
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
Cardiac disorders
Rhythm idioventricular
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Right ventricular failure
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Sick sinus syndrome
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Sinus bradycardia
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Supraventricular tachycardia
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Tachycardia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Trifascicular block
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Cardiac disorders
Ventricular tachycardia
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous mal
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Ear and labyrinth disorders
Cerumen impaction
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Ear and labyrinth disorders
Meniere's disease
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Ear and labyrinth disorders
Vertigo
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Ear and labyrinth disorders
Vertigo positional
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Endocrine disorders
Adrenal mass
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Endocrine disorders
Goitre
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Endocrine disorders
Hyperparathyroidism
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Eye disorders
Amaurosis fugax
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Eye disorders
Cataract
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Eye disorders
Conjunctivitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Eye disorders
Diplopia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Eye disorders
Glaucoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Eye disorders
Iridocyclitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Eye disorders
Retinal detachment
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Eye disorders
Visual acuity reduced
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Abdominal pain
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Gastrointestinal disorders
Abdominal pain upper
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Abdominal wall haematoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Abdominal wall haemorrhage
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Ascites
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Colitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Colonic polyp
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Colonic pseudo-obstruction
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Constipation
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Diarrhoea
1.4%
10/724 • Number of events 11 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Gastrointestinal disorders
Diverticulum intestinal
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Diverticulum intestinal haemor
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Duodenal ulcer
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Dyspepsia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Enterocolitis haemorrhagic
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Flatulence
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Gastric ulcer
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Gastric varices haemorrhage
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Gastritis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Gastritis haemorrhagic
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Gastrointestinal haemorrhage
1.9%
14/724 • Number of events 17 • July 2008 - January 2013
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
Gastrointestinal disorders
Gastrointestinal oedema
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Gastrointestinal ulcer haemorr
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Gastrooesophageal reflux disea
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Gastrointestinal disorders
Haemorrhoids
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Ileus
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Impaired gastric emptying
0.28%
2/724 • Number of events 5 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Intestinal mass
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Intestinal obstruction
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Intestinal perforation
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Intestinal polyp haemorrhage
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Large intestinal ulcer
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Lower gastrointestinal haemorr
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Gastrointestinal disorders
Oesophageal spasm
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Oesophagitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Pancreatitis
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.28%
2/724 • Number of events 4 • July 2008 - January 2013
Gastrointestinal disorders
Pancreatitis acute
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Gastrointestinal disorders
Pancreatitis chronic
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Peritoneal perforation
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Pneumatosis intestinalis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/724 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Gastrointestinal disorders
Retroperitoneal haematoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Retroperitoneal haemorrhage
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Small intestinal obstruction
0.97%
7/724 • Number of events 7 • July 2008 - January 2013
0.28%
2/724 • Number of events 4 • July 2008 - January 2013
Gastrointestinal disorders
Small intestinal perforation
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Swollen tongue
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Gastrointestinal disorders
Umbilical hernia
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Upper gastrointestinal haemorr
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Gastrointestinal disorders
Vomiting
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
General disorders
Adverse drug reaction
0.55%
4/724 • Number of events 5 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
General disorders
Asthenia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
General disorders
Chest discomfort
0.00%
0/724 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
General disorders
Chest pain
3.3%
24/724 • Number of events 27 • July 2008 - January 2013
2.9%
21/724 • Number of events 26 • July 2008 - January 2013
General disorders
Death
3.5%
25/724 • Number of events 25 • July 2008 - January 2013
1.8%
13/724 • Number of events 13 • July 2008 - January 2013
General disorders
Device malfunction
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
General disorders
Disease progression
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
General disorders
Hernia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
General disorders
Hernia obstructive
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
General disorders
Hypothermia
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
General disorders
Impaired healing
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
General disorders
Medical device complication
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
General disorders
Non-cardiac chest pain
0.97%
7/724 • Number of events 7 • July 2008 - January 2013
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
General disorders
Oedema
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
General disorders
Oedema peripheral
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
General disorders
Pain
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
General disorders
Pyrexia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
General disorders
Sudden cardiac death
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
General disorders
Swelling
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
General disorders
Systemic inflammatory response
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Hepatobiliary disorders
Bile duct stone
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Hepatobiliary disorders
Cholecystitis
0.00%
0/724 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Hepatobiliary disorders
Cholecystitis acute
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Hepatobiliary disorders
Cholelithiasis
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Hepatobiliary disorders
Gallbladder disorder
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Hepatobiliary disorders
Hepatic congestion
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Hepatobiliary disorders
Portal vein thrombosis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Immune system disorders
Amyloidosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
Immune system disorders
Drug hypersensitivity
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Abscess limb
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Appendicitis
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Appendicitis perforated
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Arthritis bacterial
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Bacteraemia
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Bacterial infection
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Bacterial pyelonephritis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Bronchitis
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Infections and infestations
Bronchitis bacterial
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Candidiasis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Cellulitis
4.6%
33/724 • Number of events 46 • July 2008 - January 2013
4.3%
31/724 • Number of events 39 • July 2008 - January 2013
Infections and infestations
Cellulitis staphylococcal
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Clostridial infection
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Clostridium difficile colitis
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Infections and infestations
Device related infection
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Diverticulitis
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Infections and infestations
Ear infection
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Emphysematous pyelonephritis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Enterobacter bacteraemia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Epiglottitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Escherichia bacteraemia
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Escherichia infection
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
External ear cellulitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Gangrene
0.83%
6/724 • Number of events 7 • July 2008 - January 2013
0.55%
4/724 • Number of events 5 • July 2008 - January 2013
Infections and infestations
Gastroenteritis
1.2%
9/724 • Number of events 10 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Infections and infestations
Gastroenteritis clostridial
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Gastroenteritis viral
0.00%
0/724 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Infections and infestations
Graft infection
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Groin abscess
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Haemophilus infection
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Herpes zoster
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Infected bites
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Infected skin ulcer
0.41%
3/724 • Number of events 4 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Infection
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Influenza
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Infections and infestations
Intervertebral discitis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Labyrinthitis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Lobar pneumonia
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
Infections and infestations
Localised infection
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Lymphangitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Nosocomial infection
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Oesophageal candidiasis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Orchitis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Osteomyelitis
1.8%
13/724 • Number of events 17 • July 2008 - January 2013
1.8%
13/724 • Number of events 15 • July 2008 - January 2013
Infections and infestations
Osteomyelitis acute
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Osteomyelitis chronic
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Otitis media
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Peptostreptococcus infection
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Perirectal abscess
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Pertussis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Pneumonia
5.9%
43/724 • Number of events 50 • July 2008 - January 2013
5.7%
41/724 • Number of events 43 • July 2008 - January 2013
Infections and infestations
Pneumonia bacterial
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Pneumonia influenzal
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Pneumonia klebsiella
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Pneumonia legionella
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Pneumonia staphylococcal
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Pneumonia streptococcal
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Post procedural infection
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Postoperative wound infection
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Pseudomonas infection
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Pyelonephritis
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Respiratory tract infection
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Scrotal abscess
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Sepsis
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Infections and infestations
Sepsis syndrome
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Septic shock
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Infections and infestations
Staphylococcal infection
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Infections and infestations
Staphylococcal sepsis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Streptococcal bacteraemia
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Subcutaneous abscess
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Subdural empyema
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Tinea pedis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Infections and infestations
Upper respiratory tract infect
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Infections and infestations
Urinary tract infection
1.9%
14/724 • Number of events 16 • July 2008 - January 2013
1.2%
9/724 • Number of events 10 • July 2008 - January 2013
Infections and infestations
Urosepsis
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Infections and infestations
Viral cardiomyopathy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
West Nile viral infection
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Wound infection
0.55%
4/724 • Number of events 5 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Infections and infestations
Wound infection staphylococcal
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Injury, poisoning and procedural complications
Accident at home
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Accident at work
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Accidental overdose
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Animal bite
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Ankle fracture
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Arteriovenous fistula site com
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Arteriovenous fistula thrombos
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Arthropod bite
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Cardiac procedure complication
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Contrast media reaction
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Coronary artery restenosis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Fall
2.3%
17/724 • Number of events 18 • July 2008 - January 2013
2.8%
20/724 • Number of events 22 • July 2008 - January 2013
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Foreign body
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Gastroenteritis radiation
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Head injury
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Heat stroke
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
In-stent coronary artery reste
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Incorrect dose administered
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Injury
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Limb injury
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Lower limb fracture
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Medication error
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Overdose
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Patella fracture
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Post procedural complication
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
Injury, poisoning and procedural complications
Post procedural haematoma
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Postoperative fever
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Postoperative wound complicati
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Procedural complication
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Procedural hypertension
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Procedural vomiting
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Radiation dysphagia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Radiation pneumonitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Road traffic accident
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
1.2%
9/724 • Number of events 11 • July 2008 - January 2013
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Subdural haemorrhage
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Toxicity to various agents
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Injury, poisoning and procedural complications
Vascular graft complication
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Vascular graft occlusion
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Injury, poisoning and procedural complications
Wound dehiscence
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Investigations
Antibiotic resistant Staphyloc
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Investigations
Anticoagulation drug level abo
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Investigations
Anticoagulation drug level bel
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Investigations
Biopsy kidney
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Investigations
Biopsy lung
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Investigations
Blood bicarbonate decreased
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Investigations
Blood creatine phosphokinase i
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Investigations
Blood creatinine increased
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Investigations
Blood glucose decreased
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Investigations
Blood glucose increased
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Investigations
Blood potassium increased
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Investigations
Electrocardiogram change
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Investigations
Fistulogram
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Investigations
Heart rate irregular
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Investigations
International normalised ratio
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Metabolism and nutrition disorders
Dehydration
0.97%
7/724 • Number of events 7 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Metabolism and nutrition disorders
Diabetes mellitus inadequate c
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.14%
1/724 • Number of events 3 • July 2008 - January 2013
Metabolism and nutrition disorders
Fluid overload
0.97%
7/724 • Number of events 12 • July 2008 - January 2013
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
Metabolism and nutrition disorders
Gout
0.69%
5/724 • Number of events 6 • July 2008 - January 2013
0.83%
6/724 • Number of events 7 • July 2008 - January 2013
Metabolism and nutrition disorders
Hypercalcaemia
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Metabolism and nutrition disorders
Hyperglycaemia
0.97%
7/724 • Number of events 10 • July 2008 - January 2013
2.2%
16/724 • Number of events 16 • July 2008 - January 2013
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar no
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Metabolism and nutrition disorders
Hyperkalaemia
5.4%
39/724 • Number of events 45 • July 2008 - January 2013
2.2%
16/724 • Number of events 16 • July 2008 - January 2013
Metabolism and nutrition disorders
Hypermagnesaemia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Metabolism and nutrition disorders
Hypoglycaemia
2.6%
19/724 • Number of events 21 • July 2008 - January 2013
2.8%
20/724 • Number of events 27 • July 2008 - January 2013
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Metabolism and nutrition disorders
Hyponatraemia
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.69%
5/724 • Number of events 6 • July 2008 - January 2013
Metabolism and nutrition disorders
Hypovolaemia
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Metabolism and nutrition disorders
Metabolic acidosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Metabolism and nutrition disorders
Obesity
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Arthritis
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Back pain
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Foot deformity
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Intervertebral disc degenerati
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Muscular weakness
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Neck mass
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Pain in extremity
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.41%
3/724 • Number of events 4 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
0.00%
0/724 • July 2008 - January 2013
0.41%
3/724 • Number of events 8 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.41%
3/724 • Number of events 6 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
0.28%
2/724 • Number of events 8 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma s
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 4 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer stage IV
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of th
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastati
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.41%
3/724 • Number of events 5 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
0.14%
1/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage u
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
0.14%
1/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Altered state of consciousness
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Amnesia
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Autonomic nervous system imbal
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Brain stem infarction
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Carotid artery disease
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Carotid artery stenosis
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Nervous system disorders
Central nervous system mass
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Cerebellar artery thrombosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Cerebral infarction
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Cerebral ischaemia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Cerebral ventricle dilatation
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Cerebrovascular accident
1.7%
12/724 • Number of events 12 • July 2008 - January 2013
1.4%
10/724 • Number of events 12 • July 2008 - January 2013
Nervous system disorders
Cognitive disorder
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Convulsion
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Dizziness
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Dizziness postural
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Dysarthria
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Encephalopathy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Facial paresis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Grand mal convulsion
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Haemorrhage intracranial
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Headache
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Hepatic encephalopathy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Hypersomnia
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Hypoaesthesia
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Hypoglycaemic seizure
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Hypoglycaemic unconsciousness
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Intracranial aneurysm
0.14%
1/724 • Number of events 3 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Ischaemic cerebral infarction
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Ischaemic stroke
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Lacunar infarction
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Loss of consciousness
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Metabolic encephalopathy
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Nerve root compression
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Neuritis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Nervous system disorders
Parkinson's disease
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Polyneuropathy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Presyncope
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Radiculopathy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Sciatica
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Spondylitic myelopathy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Syncope
1.4%
10/724 • Number of events 10 • July 2008 - January 2013
1.2%
9/724 • Number of events 10 • July 2008 - January 2013
Nervous system disorders
Thalamic infarction
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Toxic encephalopathy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Nervous system disorders
Transient ischaemic attack
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
1.4%
10/724 • Number of events 12 • July 2008 - January 2013
Nervous system disorders
Tremor
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Psychiatric disorders
Adjustment disorder
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Psychiatric disorders
Alcohol abuse
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Psychiatric disorders
Alcoholism
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Psychiatric disorders
Anxiety
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Psychiatric disorders
Delirium
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Psychiatric disorders
Depression
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Psychiatric disorders
Drug abuse
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Psychiatric disorders
Major depression
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Psychiatric disorders
Mania
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Psychiatric disorders
Mental status changes
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
Psychiatric disorders
Psychotic disorder
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Psychiatric disorders
Suicidal ideation
1.2%
9/724 • Number of events 10 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Psychiatric disorders
Suicide attempt
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
Renal and urinary disorders
Azotaemia
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Renal and urinary disorders
Bladder mass
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Renal and urinary disorders
Calculus ureteric
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Calculus urinary
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Diabetic end stage renal disea
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Haematuria
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
0.28%
2/724 • Number of events 4 • July 2008 - January 2013
Renal and urinary disorders
Hydronephrosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Nephrolithiasis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Nephropathy toxic
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Renal and urinary disorders
Nephrotic syndrome
0.00%
0/724 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Renal and urinary disorders
Obstructive uropathy
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Polyuria
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Renal disorder
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Renal and urinary disorders
Renal failure
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.69%
5/724 • Number of events 6 • July 2008 - January 2013
Renal and urinary disorders
Renal failure acute
18.0%
130/724 • Number of events 190 • July 2008 - January 2013
11.0%
80/724 • Number of events 105 • July 2008 - January 2013
Renal and urinary disorders
Renal failure chronic
0.55%
4/724 • Number of events 5 • July 2008 - January 2013
0.97%
7/724 • Number of events 7 • July 2008 - January 2013
Renal and urinary disorders
Renal impairment
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Renal mass
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Renal tubular necrosis
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Renal and urinary disorders
Tubulointerstitial nephritis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Renal and urinary disorders
Urinary retention
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Reproductive system and breast disorders
Erectile dysfunction
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Reproductive system and breast disorders
Prostatitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
1.9%
14/724 • Number of events 20 • July 2008 - January 2013
3.0%
22/724 • Number of events 39 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Cough
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.97%
7/724 • Number of events 9 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/724 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Hypoventilation
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pleural disorder
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pleural effusion
1.4%
10/724 • Number of events 13 • July 2008 - January 2013
0.55%
4/724 • Number of events 5 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
1.1%
8/724 • Number of events 8 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.69%
5/724 • Number of events 6 • July 2008 - January 2013
0.83%
6/724 • Number of events 7 • July 2008 - January 2013
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Skin and subcutaneous tissue disorders
Diabetic foot
0.97%
7/724 • Number of events 8 • July 2008 - January 2013
1.4%
10/724 • Number of events 12 • July 2008 - January 2013
Skin and subcutaneous tissue disorders
Diabetic ulcer
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Skin and subcutaneous tissue disorders
Dry gangrene
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Skin and subcutaneous tissue disorders
Skin ulcer
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
Skin and subcutaneous tissue disorders
Stasis dermatitis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Social circumstances
Treatment noncompliance
0.69%
5/724 • Number of events 5 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Surgical and medical procedures
Amputation
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Appendicectomy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Surgical and medical procedures
Arteriovenous fistula operatio
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 3 • July 2008 - January 2013
Surgical and medical procedures
Arthrotomy
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Brachytherapy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Surgical and medical procedures
Carotid endarterectomy
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Surgical and medical procedures
Chemotherapy
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Coronary arterial stent insert
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Surgical and medical procedures
Coronary artery bypass
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Drug rehabilitation
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Elective surgery
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Ethmoid sinus surgery
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Extubation
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Surgical and medical procedures
Foot amputation
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Gastric banding
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Surgical and medical procedures
Gastric bypass
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Gastrointestinal tube insertio
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Haemodialysis
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Hip arthroplasty
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Knee arthroplasty
0.00%
0/724 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Surgical and medical procedures
Leg amputation
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Penile prosthesis insertion
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Surgical and medical procedures
Rehabilitation therapy
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Surgical and medical procedures
Therapy regimen changed
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Surgical and medical procedures
Toe amputation
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Surgical and medical procedures
Tooth extraction
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Accelerated hypertension
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Aneurysm
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Angiodysplasia
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Aortic aneurysm
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Aortic aneurysm rupture
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Aortic arteriosclerosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Aortic stenosis
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Arteriosclerosis
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Arteriovenous fistula
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Deep vein thrombosis
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Embolism
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Femoral arterial stenosis
0.28%
2/724 • Number of events 3 • July 2008 - January 2013
0.28%
2/724 • Number of events 2 • July 2008 - January 2013
Vascular disorders
Haematoma
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Haemorrhage
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Hypertension
0.55%
4/724 • Number of events 5 • July 2008 - January 2013
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
Vascular disorders
Hypertensive crisis
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
0.55%
4/724 • Number of events 4 • July 2008 - January 2013
Vascular disorders
Hypertensive emergency
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.41%
3/724 • Number of events 4 • July 2008 - January 2013
Vascular disorders
Hypotension
1.5%
11/724 • Number of events 13 • July 2008 - January 2013
1.1%
8/724 • Number of events 8 • July 2008 - January 2013
Vascular disorders
Iliac artery stenosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Intermittent claudication
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Lymphoedema
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Orthostatic hypotension
0.14%
1/724 • Number of events 3 • July 2008 - January 2013
0.83%
6/724 • Number of events 6 • July 2008 - January 2013
Vascular disorders
Peripheral arterial occlusive
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Peripheral artery aneurysm
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Peripheral embolism
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Peripheral ischaemia
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Peripheral vascular disorder
0.55%
4/724 • Number of events 6 • July 2008 - January 2013
0.41%
3/724 • Number of events 3 • July 2008 - January 2013
Vascular disorders
Shock
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Shock haemorrhagic
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Thrombosed varicose vein
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
0.00%
0/724 • July 2008 - January 2013
Vascular disorders
Thrombosis
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Vascular occlusion
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013
Vascular disorders
Venous insufficiency
0.00%
0/724 • July 2008 - January 2013
0.14%
1/724 • Number of events 1 • July 2008 - January 2013

Other adverse events

Adverse event data not reported

Additional Information

Linda Fried, MD, MPH

VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh, PA

Phone: 412-360-3930

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place