Trial Outcomes & Findings for Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) (NCT NCT00094575)
NCT ID: NCT00094575
Last Updated: 2016-03-07
Results Overview
Participants vital status was assessed from randomization to end of study follow-up \[10/15/2011\] or death \[whichever occurred first\].
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
881 participants
Primary outcome timeframe
Participants were followed for the duration of the study, up to 9 years
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
Endovascular Repair
Endovascular Repair
|
Open Repair
Standard Open Repair
|
|---|---|---|
|
Overall Study
STARTED
|
444
|
437
|
|
Overall Study
COMPLETED
|
298
|
291
|
|
Overall Study
NOT COMPLETED
|
146
|
146
|
Reasons for withdrawal
| Measure |
Endovascular Repair
Endovascular Repair
|
Open Repair
Standard Open Repair
|
|---|---|---|
|
Overall Study
Death
|
146
|
146
|
Baseline Characteristics
Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)
Baseline characteristics by cohort
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
Total
n=881 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
70.5 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
70.1 years
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
441 Participants
n=99 Participants
|
435 Participants
n=107 Participants
|
876 Participants
n=206 Participants
|
|
Weight in kilograms
|
89.9 Kilogram
STANDARD_DEVIATION 16.8 • n=99 Participants
|
89.7 Kilogram
STANDARD_DEVIATION 17.8 • n=107 Participants
|
89.8 Kilogram
STANDARD_DEVIATION 17.3 • n=206 Participants
|
|
Body Mass Index [BMI]
|
28.6 Kg/m^2
STANDARD_DEVIATION 5.2 • n=99 Participants
|
28.7 Kg/m^2
STANDARD_DEVIATION 5.6 • n=107 Participants
|
28.6 Kg/m^2
STANDARD_DEVIATION 5.4 • n=206 Participants
|
|
Smoking Status
Ever Smoked
|
428 Participants
n=99 Participants
|
413 Participants
n=107 Participants
|
841 Participants
n=206 Participants
|
|
Smoking Status
Never Smoked
|
16 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Currently Smoking
Yes
|
170 Participants
n=99 Participants
|
193 Participants
n=107 Participants
|
363 Participants
n=206 Participants
|
|
Currently Smoking
No
|
274 Participants
n=99 Participants
|
244 Participants
n=107 Participants
|
518 Participants
n=206 Participants
|
|
Surgical Risk [RAND Score]
Low
|
240 Participants
n=99 Participants
|
228 Participants
n=107 Participants
|
468 Participants
n=206 Participants
|
|
Surgical Risk [RAND Score]
Intermediate
|
169 Participants
n=99 Participants
|
175 Participants
n=107 Participants
|
344 Participants
n=206 Participants
|
|
Surgical Risk [RAND Score]
High
|
31 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Surgical Risk [RAND Score]
Not Assessed
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Maximum Aneurysm Diameter
|
5.7 Centimeter
STANDARD_DEVIATION .8 • n=99 Participants
|
5.7 Centimeter
STANDARD_DEVIATION 1.0 • n=107 Participants
|
5.7 Centimeter
STANDARD_DEVIATION 0.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of the study, up to 9 yearsParticipants vital status was assessed from randomization to end of study follow-up \[10/15/2011\] or death \[whichever occurred first\].
Outcome measures
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
|---|---|---|
|
All-cause Mortality
|
146 participants
|
146 participants
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of the study, up to 9 yearsThis outcome includes any procedure that resulted directly or indirectly from the initial procedure and that required a separate trip to the procedure suite (with each trip to the procedure suite counting as one secondary procedure), including any unplanned surgical procedures within 30 days after the initial procedure and any additional aortoiliac procedures at any time.
Outcome measures
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
|---|---|---|
|
Secondary Therapeutic Procedures
|
98 participants
|
78 participants
|
SECONDARY outcome
Timeframe: Outcome was assessed at 6 months and then yearly, up to 9 yearsChange (over time) since baseline in Mental Component Score of SF-36. The MCS Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates. Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome measures
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
|---|---|---|
|
SF-36 Mental Component Score (MCS)
|
-0.77 units on a scale
Interval -1.42 to -0.12
|
-0.66 units on a scale
Interval -1.32 to 0.002
|
SECONDARY outcome
Timeframe: Outcome was assessed at 6 months and yearly thereafter, up to 9 yearsChange (over time) since baseline in Physical Component Score of SF-36. The PCS Score ranges from 0-100 with higher scores indicating better health Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates. Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome measures
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
|---|---|---|
|
SF-36 Physical Component Score (PCS)
|
-3.18 units on a scale
Interval -3.91 to -2.45
|
-3.05 units on a scale
Interval -3.79 to -2.31
|
SECONDARY outcome
Timeframe: Outcome was assessed at 6 months and yearly thereafter, up to 9 yearsChange (over time) since baseline in Physical Component Deaths included Score of SF-36. The PCTD Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates. Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome measures
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
|---|---|---|
|
SF-36 Physical Component Deaths Included Score (PCTD)
|
-7.30 units on a scale
Interval -8.94 to -5.67
|
-6.98 units on a scale
Interval -8.64 to -5.32
|
SECONDARY outcome
Timeframe: Outcome was assessed at 6 months and yearly thereafter, up to 9 yearsChange (over time) since baseline in EQ-5D. The EQ-5D Index Score ('thermometer scale') ranges from 0 (worst health status) to 100 (best health status). Since this outcome captures change since baseline, values could be below 0. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates. Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome measures
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
|---|---|---|
|
European Quality of Life-5 Dimension (EQ-5D) Index Score
|
-3.67 units on a scale
Interval -4.91 to -2.43
|
-3.17 units on a scale
Interval -4.43 to -1.91
|
SECONDARY outcome
Timeframe: Outcome was assessed at 6 months and yearly thereafter, up to 9 yearsChange (over time) since baseline in EQ-5D Visual Analog Scale. The EQ-5D Visual Analog Scale ranges from 0 (death) to 1 (perfect health). Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates. Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome measures
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
|---|---|---|
|
European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale
|
-0.04 units on a scale
Interval -0.05 to -0.03
|
-0.03 units on a scale
Interval -0.05 to -0.02
|
SECONDARY outcome
Timeframe: Outcome was assessed at 6 months and yearly thereafter, up to 9 yearsChange (over time) since baseline in IIEF-5. The IIEF-5 Score ranges from 5-25 with higher scores indicating better erectile function. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates. Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome measures
| Measure |
Endovascular Repair
n=444 Participants
Endovascular Repair
|
Open Repair
n=437 Participants
Standard Open Repair
|
|---|---|---|
|
International Index of Erectile Function (IIEF-5)
|
-3.54 units on a scale
Interval -4.18 to -2.89
|
-3.73 units on a scale
Interval -4.38 to -3.08
|
Adverse Events
Endovascular Repair
Serious events: 336 serious events
Other events: 127 other events
Deaths: 0 deaths
Open Repair
Serious events: 329 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Endovascular Repair
n=444 participants at risk
Endovascular Repair
|
Open Repair
n=437 participants at risk
Standard Open Repair
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
6/444 • Number of events 6
|
1.8%
8/437 • Number of events 8
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
5/444 • Number of events 5
|
2.1%
9/437 • Number of events 10
|
|
Cardiac disorders
Angina pectoris
|
0.45%
2/444 • Number of events 2
|
0.69%
3/437 • Number of events 3
|
|
Cardiac disorders
Angina unstable
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 2
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/444
|
0.69%
3/437 • Number of events 4
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.90%
4/444 • Number of events 4
|
0.46%
2/437 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
16/444 • Number of events 17
|
3.4%
15/437 • Number of events 19
|
|
Cardiac disorders
Atrial flutter
|
0.90%
4/444 • Number of events 4
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.23%
1/444 • Number of events 1
|
0.69%
3/437 • Number of events 3
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.45%
2/444 • Number of events 2
|
1.1%
5/437 • Number of events 6
|
|
Cardiac disorders
Cardiac arrest
|
0.90%
4/444 • Number of events 4
|
2.5%
11/437 • Number of events 11
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.68%
3/444 • Number of events 3
|
0.92%
4/437 • Number of events 4
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Cardiac failure chronic
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Cardiac disorders
Cardiac failure congestive
|
5.2%
23/444 • Number of events 31
|
6.4%
28/437 • Number of events 44
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 2
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Cardiomyopathy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
2.5%
11/444 • Number of events 14
|
2.1%
9/437 • Number of events 10
|
|
Cardiac disorders
Coronary artery occlusion
|
1.4%
6/444 • Number of events 6
|
1.1%
5/437 • Number of events 5
|
|
Cardiac disorders
Coronary artery stenosis
|
0.45%
2/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
3.6%
16/444 • Number of events 18
|
5.3%
23/437 • Number of events 26
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Sick sinus syndrome
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/444
|
1.6%
7/437 • Number of events 13
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Eye disorders
Corneal degeneration
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/444
|
1.1%
5/437 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/444
|
2.1%
9/437 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
5/444 • Number of events 5
|
0.69%
3/437 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 2
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 3
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Colonic polyp
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Diarrhoea
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Gastrointestinal disorders
Diverticulum
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Duodenitis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.45%
2/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Gastritis
|
0.45%
2/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.90%
4/444 • Number of events 4
|
1.4%
6/437 • Number of events 7
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.68%
3/444 • Number of events 3
|
0.92%
4/437 • Number of events 4
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/444
|
0.69%
3/437 • Number of events 5
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.45%
2/444 • Number of events 3
|
0.00%
0/437
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.23%
1/444 • Number of events 1
|
1.1%
5/437 • Number of events 6
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/444
|
1.1%
5/437 • Number of events 5
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Large intestinal ulcer haemorrhage
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.68%
3/444 • Number of events 3
|
0.46%
2/437 • Number of events 2
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.68%
3/444 • Number of events 3
|
1.6%
7/437 • Number of events 8
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Gastrointestinal disorders
Vomiting
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 2
|
|
General disorders
Adverse drug reaction
|
0.68%
3/444 • Number of events 4
|
0.69%
3/437 • Number of events 3
|
|
General disorders
Asthenia
|
0.45%
2/444 • Number of events 2
|
0.92%
4/437 • Number of events 4
|
|
General disorders
Cardiac death
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
General disorders
Chest pain
|
3.8%
17/444 • Number of events 20
|
1.8%
8/437 • Number of events 11
|
|
General disorders
Death
|
5.4%
24/444 • Number of events 24
|
3.2%
14/437 • Number of events 14
|
|
General disorders
Device dislocation
|
0.90%
4/444 • Number of events 5
|
0.00%
0/437
|
|
General disorders
Device malfunction
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
General disorders
Device occlusion
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
General disorders
Gait disturbance
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Hernia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Hernia obstructive
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Influenza like illness
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Medical device complication
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
General disorders
Multi-organ failure
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
0.90%
4/444 • Number of events 4
|
0.46%
2/437 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Pyrexia
|
0.90%
4/444 • Number of events 4
|
0.46%
2/437 • Number of events 2
|
|
General disorders
Sudden cardiac death
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Unevaluable event
|
0.45%
2/444 • Number of events 2
|
0.69%
3/437 • Number of events 3
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Hepatobiliary disorders
Bile duct stone
|
0.45%
2/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/444 • Number of events 1
|
0.92%
4/437 • Number of events 4
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/444 • Number of events 1
|
1.4%
6/437 • Number of events 7
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
5/444 • Number of events 5
|
0.92%
4/437 • Number of events 4
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Abscess limb
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Anal abscess
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Appendicitis perforated
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Infections and infestations
Babesiosis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Infections and infestations
Bacterial infection
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Bronchitis
|
1.1%
5/444 • Number of events 7
|
1.1%
5/437 • Number of events 5
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Cardiac valve vegetation
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
2.0%
9/444 • Number of events 9
|
2.1%
9/437 • Number of events 14
|
|
Infections and infestations
Cellulitis orbital
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Clostridial infection
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Clostridium difficile colitis
|
0.90%
4/444 • Number of events 4
|
1.4%
6/437 • Number of events 6
|
|
Infections and infestations
Device related infection
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Infections and infestations
Diverticulitis
|
1.1%
5/444 • Number of events 6
|
1.1%
5/437 • Number of events 6
|
|
Infections and infestations
Empyema
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Fungal sepsis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Gangrene
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Gastroenteritis
|
0.68%
3/444 • Number of events 3
|
0.46%
2/437 • Number of events 2
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Graft infection
|
1.1%
5/444 • Number of events 6
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Groin infection
|
2.3%
10/444 • Number of events 10
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
HIV infection
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Infections and infestations
Hepatitis C
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Infected skin ulcer
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Infection
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Intervertebral discitis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Klebsiella sepsis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Liver abscess
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Infections and infestations
Lobar pneumonia
|
0.45%
2/444 • Number of events 2
|
0.69%
3/437 • Number of events 3
|
|
Infections and infestations
Localised infection
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Lung infection pseudomonal
|
0.45%
2/444 • Number of events 3
|
0.00%
0/437
|
|
Infections and infestations
Meningitis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Oral candidiasis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Orchitis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 2
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
10.8%
48/444 • Number of events 61
|
8.5%
37/437 • Number of events 55
|
|
Infections and infestations
Pneumonia bacterial
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Pneumonia klebsiella
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
0.68%
3/444 • Number of events 3
|
1.1%
5/437 • Number of events 6
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Pseudomonas infection
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Rectal abscess
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Respiratory tract infection viral
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Sepsis
|
0.68%
3/444 • Number of events 3
|
0.69%
3/437 • Number of events 5
|
|
Infections and infestations
Sinusitis
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
0.23%
1/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Tinea pedis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
3.8%
17/444 • Number of events 19
|
4.1%
18/437 • Number of events 20
|
|
Infections and infestations
Urosepsis
|
0.68%
3/444 • Number of events 3
|
0.46%
2/437 • Number of events 2
|
|
Infections and infestations
Vestibular neuronitis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Viral labyrinthitis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Wound infection
|
0.23%
1/444 • Number of events 1
|
0.92%
4/437 • Number of events 5
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/444
|
0.23%
1/437 • Number of events 3
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haematoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
27/444 • Number of events 32
|
7.1%
31/437 • Number of events 38
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.90%
4/444 • Number of events 4
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
4.7%
21/444 • Number of events 25
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
1.1%
5/444 • Number of events 7
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Head injury
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.45%
2/444 • Number of events 3
|
2.1%
9/437 • Number of events 9
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Injury, poisoning and procedural complications
Overdose
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.68%
3/444 • Number of events 3
|
0.69%
3/437 • Number of events 3
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/444
|
0.92%
4/437 • Number of events 4
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.23%
1/444 • Number of events 2
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Procedural complication
|
1.4%
6/444 • Number of events 6
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.68%
3/444 • Number of events 3
|
0.92%
4/437 • Number of events 4
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Seroma
|
0.68%
3/444 • Number of events 3
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Splenic haematoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.45%
2/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Injury, poisoning and procedural complications
Urinary bladder rupture
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
1.4%
6/444 • Number of events 7
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Arteriogram normal
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Blood creatinine increased
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Investigations
Blood culture positive
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Bronchoscopy
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Cardiac enzymes increased
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Cardiac enzymes normal
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Cardiac stress test abnormal
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Colonoscopy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Computerised tomogram thorax abnormal
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Diagnostic procedure
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Investigations
Heart rate irregular
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Vitamin B12 decreased
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
8/444 • Number of events 9
|
1.8%
8/437 • Number of events 8
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.90%
4/444 • Number of events 4
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Metabolism and nutrition disorders
Gout
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.23%
1/444 • Number of events 1
|
0.92%
4/437 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
6/444 • Number of events 6
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/444 • Number of events 2
|
0.00%
0/437
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer metastatic
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.23%
1/444 • Number of events 2
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma metastatic
|
0.23%
1/444 • Number of events 3
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.45%
2/444 • Number of events 3
|
0.46%
2/437 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.23%
1/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/444
|
0.23%
1/437 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage IV
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.23%
1/444 • Number of events 2
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.90%
4/444 • Number of events 5
|
1.6%
7/437 • Number of events 8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
2.3%
10/444 • Number of events 10
|
1.1%
5/437 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.45%
2/444 • Number of events 2
|
0.69%
3/437 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mediastinal neoplasm
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.45%
2/444 • Number of events 3
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.45%
2/444 • Number of events 3
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIB
|
0.23%
1/444 • Number of events 3
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma metastatic
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.68%
3/444 • Number of events 3
|
0.46%
2/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/444
|
0.69%
3/437 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.23%
1/444 • Number of events 1
|
0.92%
4/437 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer extensive stage
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.23%
1/444 • Number of events 2
|
0.69%
3/437 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Ataxia
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Nervous system disorders
Central nervous system lesion
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Nervous system disorders
Cerebral infarction
|
0.45%
2/444 • Number of events 2
|
0.69%
3/437 • Number of events 3
|
|
Nervous system disorders
Cerebrovascular accident
|
4.1%
18/444 • Number of events 22
|
2.5%
11/437 • Number of events 12
|
|
Nervous system disorders
Cognitive disorder
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.68%
3/444 • Number of events 5
|
0.69%
3/437 • Number of events 3
|
|
Nervous system disorders
Dementia
|
0.23%
1/444 • Number of events 1
|
0.69%
3/437 • Number of events 3
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Embolic stroke
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Hemiparesis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Hypoaesthesia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/444
|
0.23%
1/437 • Number of events 2
|
|
Nervous system disorders
Lacunar infarction
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Nervous system disorders
Neuralgia
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Nervous system disorders
Presyncope
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.3%
10/444 • Number of events 10
|
1.4%
6/437 • Number of events 7
|
|
Nervous system disorders
Syringomyelia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.68%
3/444 • Number of events 3
|
0.69%
3/437 • Number of events 4
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Completed suicide
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Psychiatric disorders
Confusional state
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 2
|
|
Psychiatric disorders
Delirium
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Psychiatric disorders
Impaired self-care
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Intentional drug misuse
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Psychiatric disorders
Mania
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Psychiatric disorders
Schizophrenia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Psychiatric disorders
Suicidal ideation
|
0.23%
1/444 • Number of events 1
|
0.69%
3/437 • Number of events 3
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Hydronephrosis
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Nephrogenic diabetes insipidus
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.90%
4/444 • Number of events 4
|
0.46%
2/437 • Number of events 2
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Renal and urinary disorders
Renal artery occlusion
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.23%
1/444 • Number of events 1
|
0.92%
4/437 • Number of events 4
|
|
Renal and urinary disorders
Renal failure acute
|
2.3%
10/444 • Number of events 10
|
2.3%
10/437 • Number of events 10
|
|
Renal and urinary disorders
Renal failure chronic
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Renal and urinary disorders
Renal injury
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Renal and urinary disorders
Renal ischaemia
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
0.23%
1/444 • Number of events 2
|
0.00%
0/437
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/444
|
0.23%
1/437 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/444
|
0.23%
1/437 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.2%
23/444 • Number of events 34
|
8.7%
38/437 • Number of events 62
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.90%
4/444 • Number of events 5
|
1.1%
5/437 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.90%
4/444 • Number of events 4
|
1.4%
6/437 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.90%
4/444 • Number of events 4
|
0.92%
4/437 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.45%
2/444 • Number of events 2
|
0.69%
3/437 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.45%
2/444 • Number of events 3
|
2.7%
12/437 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.45%
2/444 • Number of events 3
|
0.00%
0/437
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/444
|
1.1%
5/437 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.68%
3/444 • Number of events 3
|
1.1%
5/437 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Social circumstances
Homicide
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Social circumstances
Physical disability
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Social circumstances
Treatment noncompliance
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 2
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.00%
0/444
|
1.1%
5/437 • Number of events 5
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Surgical and medical procedures
Anticoagulant therapy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Blood product transfusion
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 3
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.45%
2/444 • Number of events 2
|
0.92%
4/437 • Number of events 4
|
|
Surgical and medical procedures
Diabetes mellitus management
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Endotracheal intubation
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Surgical and medical procedures
Enteral nutrition
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Extubation
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Fluid replacement
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Gastrostomy tube insertion
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Haematoma evacuation
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Hospitalisation
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Ileostomy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Incisional drainage
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Leg amputation
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Lung lobectomy
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Surgical and medical procedures
Removal of foreign body
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Self-medication
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Strangulated hernia repair
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Tracheostomy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Transurethral bladder resection
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Surgical and medical procedures
Vascular stent insertion
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Aneurysm
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Aortic aneurysm
|
0.45%
2/444 • Number of events 3
|
0.46%
2/437 • Number of events 2
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.90%
4/444 • Number of events 4
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Aortic dissection
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Aortic stenosis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Aortic thrombosis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Arterial haemorrhage
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Arterial stenosis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Arteriosclerosis
|
0.90%
4/444 • Number of events 4
|
1.6%
7/437 • Number of events 7
|
|
Vascular disorders
Bloody discharge
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
5/444 • Number of events 6
|
1.6%
7/437 • Number of events 8
|
|
Vascular disorders
Femoral artery occlusion
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Vascular disorders
Haematoma
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.23%
1/444 • Number of events 1
|
0.69%
3/437 • Number of events 4
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.68%
3/444 • Number of events 3
|
0.69%
3/437 • Number of events 3
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Iliac artery occlusion
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Vascular disorders
Intermittent claudication
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Vascular disorders
Ischaemia
|
0.68%
3/444 • Number of events 3
|
0.92%
4/437 • Number of events 5
|
|
Vascular disorders
Ischaemic limb pain
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Lymphocele
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Microangiopathy
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Orthostatic hypotension
|
0.68%
3/444 • Number of events 3
|
0.46%
2/437 • Number of events 2
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.23%
1/444 • Number of events 1
|
0.69%
3/437 • Number of events 5
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.68%
3/444 • Number of events 4
|
0.69%
3/437 • Number of events 4
|
|
Vascular disorders
Peripheral embolism
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/444
|
0.69%
3/437 • Number of events 3
|
|
Vascular disorders
Peripheral vascular disorder
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.45%
2/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Vasculitis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
Other adverse events
| Measure |
Endovascular Repair
n=444 participants at risk
Endovascular Repair
|
Open Repair
n=437 participants at risk
Standard Open Repair
|
|---|---|---|
|
Gastrointestinal disorders
Adynamic ileus
|
1.4%
6/444 • Number of events 6
|
2.1%
9/437 • Number of events 10
|
|
Psychiatric disorders
Agitation/anxiety
|
0.68%
3/444 • Number of events 3
|
0.92%
4/437 • Number of events 4
|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
5/444 • Number of events 5
|
1.4%
6/437 • Number of events 6
|
|
Cardiac disorders
Angina
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Cardiac disorders
Arrhythmia
|
1.6%
7/444 • Number of events 8
|
2.3%
10/437 • Number of events 11
|
|
Vascular disorders
Arteriovenous fistula
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Bleeding complications
|
0.90%
4/444 • Number of events 4
|
1.4%
6/437 • Number of events 7
|
|
Gastrointestinal disorders
Bowel ischemia
|
0.45%
2/444 • Number of events 2
|
0.92%
4/437 • Number of events 5
|
|
Vascular disorders
Branch vessel occlusion
|
0.45%
2/444 • Number of events 2
|
0.46%
2/437 • Number of events 3
|
|
General disorders
Chest Pain
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Claudication
|
1.8%
8/444 • Number of events 8
|
0.92%
4/437 • Number of events 4
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/444
|
0.46%
2/437 • Number of events 2
|
|
Injury, poisoning and procedural complications
Dehiscence
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.6%
7/444 • Number of events 7
|
3.7%
16/437 • Number of events 19
|
|
Vascular disorders
Embolism
|
0.45%
2/444 • Number of events 2
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Endoprosthesis migration or reallignment
|
2.5%
11/444 • Number of events 15
|
0.00%
0/437
|
|
General disorders
Endoprosthesis thrombosis
|
1.8%
8/444 • Number of events 10
|
0.23%
1/437 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.23%
1/444 • Number of events 1
|
1.8%
8/437 • Number of events 9
|
|
General disorders
Fever
|
1.1%
5/444 • Number of events 7
|
1.4%
6/437 • Number of events 6
|
|
Vascular disorders
Hematoma
|
2.3%
10/444 • Number of events 11
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.1%
5/444 • Number of events 5
|
0.69%
3/437 • Number of events 4
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.1%
5/444 • Number of events 6
|
11.4%
50/437 • Number of events 69
|
|
General disorders
Leg edema
|
1.1%
5/444 • Number of events 6
|
1.8%
8/437 • Number of events 8
|
|
Vascular disorders
Lumen obstruction
|
1.6%
7/444 • Number of events 8
|
0.69%
3/437 • Number of events 3
|
|
Vascular disorders
Lymphocele
|
1.1%
5/444 • Number of events 6
|
0.69%
3/437 • Number of events 3
|
|
Cardiac disorders
Myocardial Infarction
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Injury, poisoning and procedural complications
Nerve injury
|
1.1%
5/444 • Number of events 7
|
0.46%
2/437 • Number of events 2
|
|
General disorders
Pain
|
4.5%
20/444 • Number of events 25
|
5.3%
23/437 • Number of events 31
|
|
Nervous system disorders
Paraplegia/paraparesis
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Investigations
Positive blood cultures
|
0.00%
0/444
|
0.46%
2/437 • Number of events 5
|
|
Injury, poisoning and procedural complications
Post operative nausea and vomiting
|
2.9%
13/444 • Number of events 13
|
4.3%
19/437 • Number of events 19
|
|
Injury, poisoning and procedural complications
Post-Implant syndrome
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 1
|
|
Infections and infestations
Pseudomembranous colitis
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Renal and urinary disorders
Renal failure or other renal complications
|
4.5%
20/444 • Number of events 27
|
2.5%
11/437 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory complications
|
2.3%
10/444 • Number of events 12
|
4.8%
21/437 • Number of events 29
|
|
Reproductive system and breast disorders
Scrotal edema
|
0.45%
2/444 • Number of events 2
|
1.1%
5/437 • Number of events 6
|
|
Investigations
Troponin increase
|
0.23%
1/444 • Number of events 1
|
1.1%
5/437 • Number of events 6
|
|
Injury, poisoning and procedural complications
Vascular trauma
|
0.00%
0/444
|
0.23%
1/437 • Number of events 2
|
|
Vascular disorders
Venous thrombosis
|
0.23%
1/444 • Number of events 1
|
0.69%
3/437 • Number of events 3
|
|
Infections and infestations
Wound infection
|
3.4%
15/444 • Number of events 18
|
3.0%
13/437 • Number of events 14
|
|
General disorders
Other with no matching Adverse Event co
|
7.4%
33/444 • Number of events 43
|
10.1%
44/437 • Number of events 99
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
1/444 • Number of events 1
|
0.23%
1/437 • Number of events 2
|
|
Nervous system disorders
Spinal neurological deficit
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
Injury, poisoning and procedural complications
Access failure
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Surgical and medical procedures
Amputation
|
0.23%
1/444 • Number of events 1
|
0.46%
2/437 • Number of events 5
|
|
Vascular disorders
Aneurysm enlargement
|
2.3%
10/444 • Number of events 15
|
0.23%
1/437 • Number of events 1
|
|
Vascular disorders
Aneurysm rupture
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/444
|
1.8%
8/437 • Number of events 9
|
|
Gastrointestinal disorders
Chylous Ascites
|
0.00%
0/444
|
0.23%
1/437 • Number of events 1
|
|
General disorders
Deployment failure
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
|
Infections and infestations
Endoprosthesis infection
|
0.90%
4/444 • Number of events 7
|
0.00%
0/437
|
|
General disorders
Endoprosthesis material failure or dilation
|
0.45%
2/444 • Number of events 2
|
0.00%
0/437
|
|
General disorders
Post operative nausea and vomiting
|
0.90%
4/444 • Number of events 4
|
0.92%
4/437 • Number of events 5
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.23%
1/444 • Number of events 1
|
0.00%
0/437
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place