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Trial record 48 of 464 for:    ASPIRIN AND clopidogrel AND ischemic

Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00249873
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : March 26, 2010
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Atrial Fibrillation
Vascular Risk
Interventions Drug: clopidogrel (SR25990C)
Drug: placebo
Enrollment 7554
Recruitment Details Patients were enrolled from June 2003 until May 2006. The study was conducted at 580 centers in 33 countries. The planned final follow-up visit date ensuring a median follow-up of three years was November 2008. The follow-up of the study was actually completed on March 2009 corresponding to an actual median follow-up of 3.5 years.
Pre-assignment Details  
Arm/Group Title Clopidogrel + ASA Placebo + ASA
Hide Arm/Group Description Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
Period Title: Overall Study
Started 3772 [1] 3782 [1]
Completed 2442 [2] 2528 [2]
Not Completed 1330 1254
Reason Not Completed
Not treated             7             8
Significant thrombocytopenia             9             8
Severe allergic reaction             8             1
Serious haemorrhagic Adverse Event             74             30
Other Serious Adverse Event             86             97
Qualifying condition not present             20             23
Contraindication to oral anticoagulant             4             8
Withdrawal by Subject             504             466
Lost to Follow-up             4             7
Minor bleeding             99             37
Non-compliance             41             46
Other non serious Adverse Event             112             108
Other contraindicated medication             1             0
Patient not wish to continue after May08             3             4
Physician withdrew consent             59             60
Open label clopidogrel required             31             42
Angiotensin II receptor blocker required             1             0
Oral anticoagulant required             159             157
Study drug intolerance             5             0
Surgery/ procedure             9             9
Event related to cardiac condition             12             21
Thromboembolic/outcome event             82             122
[1]
randomized patients: patients remained in the study whether treated or not until planned study end
[2]
started and completed study drug
Arm/Group Title Clopidogrel + ASA Placebo + ASA Total
Hide Arm/Group Description Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion) Total of all reporting groups
Overall Number of Baseline Participants 3772 3782 7554
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3772 participants 3782 participants 7554 participants
18 to <65 years 931 935 1866
65 to <75 years 1291 1258 2549
>= 75 years 1550 1589 3139
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3772 participants 3782 participants 7554 participants
70.9  (10.2) 71.1  (10.2) 71.0  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3772 participants 3782 participants 7554 participants
Female
1560
  41.4%
1597
  42.2%
3157
  41.8%
Male
2212
  58.6%
2185
  57.8%
4397
  58.2%
CHADS2 Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3772 participants 3782 participants 7554 participants
0 105 101 206
1 1360 1338 2698
2 1263 1315 2578
>2 1040 1028 2068
Missing 4 0 4
[1]
Measure Description: CHADS2 score is the Congestive heart failure, High blood pressure, Age, Diabetes, Stroke 2 score. It is a validated clinical prediction rule for determining the risk of stroke. It assigns points (0-6) depending on the presence or absence of co-morbidities such as history of Congestive heart failure, hypertension, Age, history of Diabetes, previous Stroke. A high score means higher risk of stroke.
Sitting Systolic Blood Pressure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3772 participants 3782 participants 7554 participants
<120 mmHg 603 620 1223
>=120 mmHg 3166 3159 6325
Missing 3 3 6
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 3772 participants 3782 participants 7554 participants
28.370  (5.575) 28.459  (6.022) 28.415  (5.803)
1.Primary Outcome
Title First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication
Hide Description

The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :

  • stroke (nonfatal or fatal)
  • myocardial infarction (nonfatal or fatal)
  • non-CNS systemic embolism
  • vascular death

The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group.

Time Frame expected median follow-up of approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient’s compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.
Arm/Group Title Clopidogrel + ASA Placebo + ASA
Hide Arm/Group Description:
Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
Overall Number of Participants Analyzed 3772 3782
Measure Type: Number
Unit of Measure: participants
All components 832 924
- Myocardial Infarction (fatal or not) 84 105
- Stroke (fatal or not) 285 391
- Non-CNS systemic embolism 50 48
- Vascular death 413 380
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel + ASA, Placebo + ASA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval 95%
0.81 to 0.98
Estimation Comments The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of any component of the primary event for the clopidogrel group compared with the Placebo group.
2.Secondary Outcome
Title Occurrence of Stroke
Time Frame expected median follow-up of approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was used for this analysis.
Arm/Group Title Clopidogrel + ASA Placebo + ASA
Hide Arm/Group Description:
Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
Overall Number of Participants Analyzed 3772 3782
Measure Type: Number
Unit of Measure: participants
296 408
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel + ASA, Placebo + ASA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval 95%
0.62 to 0.83
Estimation Comments The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of stroke for the clopidogrel group compared with the Placebo group.
3.Secondary Outcome
Title Death From Any Cause (Cardiovascular and Noncardiovascular)
Hide Description The considered event is death from any cause. The analysis is performed on the time from randomization to this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.
Time Frame expected median follow-up of approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was used for the analysis.
Arm/Group Title Clopidogrel + ASA Placebo + ASA
Hide Arm/Group Description:
Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
Overall Number of Participants Analyzed 3772 3782
Measure Type: Number
Unit of Measure: participants
825 841
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel + ASA, Placebo + ASA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.696
Comments Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval 95%
0.89 to 1.08
Estimation Comments The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the clopidogrel group compared with the Placebo group.
4.Secondary Outcome
Title Adjudicated Major Bleedings
Hide Description The number of participants with at least one major bleeding, validated by the Event Adjudication Committee are counted over the duration of the follow-up (including after permanent discontinuation of the study drug).
Time Frame expected median follow-up of approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population was used for the analysis.
Arm/Group Title Clopidogrel + ASA Placebo + ASA
Hide Arm/Group Description:
Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
Overall Number of Participants Analyzed 3772 3782
Measure Type: Number
Unit of Measure: participants
251 162
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clopidogrel + ASA, Placebo + ASA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame From randomization through 28 days after the end of study drug treatment or the final follow-up visit. In both treatment groups, median duration of exposure was approximately 36 months, with a maximum of 62 months.
Adverse Event Reporting Description The intent to treat population was also used for safety analyses.
 
Arm/Group Title Clopidogrel + ASA Placebo + ASA
Hide Arm/Group Description Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
All-Cause Mortality
Clopidogrel + ASA Placebo + ASA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clopidogrel + ASA Placebo + ASA
Affected / at Risk (%) Affected / at Risk (%)
Total   1154/3772 (30.59%)   1069/3782 (28.27%) 
Blood and lymphatic system disorders     
Anaemia * 1  18/3772 (0.48%)  19/3782 (0.50%) 
Anaemia megaloblastic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Anaemia of chronic disease * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Anaemia of malignant disease * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Haemorrhagic anaemia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Haemorrhagic disorder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Hypochromic anaemia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Iron deficiency anaemia * 1  4/3772 (0.11%)  2/3782 (0.05%) 
Nephrogenic anaemia * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Pancytopenia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Thrombocytopenia * 1  6/3772 (0.16%)  2/3782 (0.05%) 
Cardiac disorders     
Angina pectoris * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Atrial fibrillation * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Atrioventricular block complete * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Bradycardia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Cardiac amyloidosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Cardiopulmonary failure * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Congestive cardiomyopathy * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Intracardiac thrombus * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Pericardial haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pericarditis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Sinoatrial block * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Tricuspid valve disease * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Congenital, familial and genetic disorders     
Adenomatous polyposis coli * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Dermoid cyst * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gastrointestinal angiodysplasia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gastrointestinal angiodysplasia haemorrhagic * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Hydrocele * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Muscular dystrophy * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Phimosis * 1  0/3772 (0.00%)  4/3782 (0.11%) 
Ear and labyrinth disorders     
Deafness neurosensory * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hearing impaired * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Sudden hearing loss * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Vertigo * 1  2/3772 (0.05%)  7/3782 (0.19%) 
Vertigo positional * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Vestibular disorder * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Endocrine disorders     
Autoimmune thyroiditis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Diabetes insipidus * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Ectopic hyperthyroidism * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Goitre * 1  3/3772 (0.08%)  1/3782 (0.03%) 
Hyperparathyroidism * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hyperparathyroidism secondary * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Hyperthyroidism * 1  2/3772 (0.05%)  9/3782 (0.24%) 
Hypothyroidism * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Thyroiditis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Toxic nodular goitre * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Eye disorders     
Angle closure glaucoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Cataract * 1  20/3772 (0.53%)  18/3782 (0.48%) 
Corneal degeneration * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Diplopia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Eye haemorrhage * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Eyelid oedema * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Glaucoma * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Maculopathy * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pupils unequal * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Retinal artery occlusion * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Retinal degeneration * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Retinal detachment * 1  1/3772 (0.03%)  3/3782 (0.08%) 
Retinal haemorrhage * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Retinal vein thrombosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Visual impairment * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gastrointestinal disorders     
Abdominal hernia * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Abdominal pain * 1  4/3772 (0.11%)  8/3782 (0.21%) 
Abdominal pain upper * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Abdominal strangulated hernia * 1  3/3772 (0.08%)  0/3782 (0.00%) 
Acute abdomen * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Anal fissure * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Anal haemorrhage * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Appendicitis perforated * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Barrett's oesophagus * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Coeliac disease * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Colitis * 1  0/3772 (0.00%)  3/3782 (0.08%) 
Colitis ischaemic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Colitis ulcerative * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Colonic polyp * 1  4/3772 (0.11%)  6/3782 (0.16%) 
Colonic stenosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Constipation * 1  4/3772 (0.11%)  5/3782 (0.13%) 
Diarrhoea * 1  11/3772 (0.29%)  10/3782 (0.26%) 
Diarrhoea haemorrhagic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Diverticular perforation * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Diverticulitis intestinal haemorrhagic * 1  3/3772 (0.08%)  1/3782 (0.03%) 
Diverticulum * 1  4/3772 (0.11%)  2/3782 (0.05%) 
Diverticulum intestinal * 1  2/3772 (0.05%)  3/3782 (0.08%) 
Diverticulum intestinal haemorrhagic * 1  5/3772 (0.13%)  0/3782 (0.00%) 
Duodenal ulcer * 1  1/3772 (0.03%)  3/3782 (0.08%) 
Duodenal ulcer haemorrhage * 1  6/3772 (0.16%)  7/3782 (0.19%) 
Duodenal ulcer perforation * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Duodenitis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Dyspepsia * 1  3/3772 (0.08%)  3/3782 (0.08%) 
Dysphagia * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Enterocolitis * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Enterocolitis haemorrhagic * 1  3/3772 (0.08%)  1/3782 (0.03%) 
Faecaloma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Femoral hernia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Femoral hernia, obstructive * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Food poisoning * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gallstone ileus * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gastric antral vascular ectasia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gastric haemorrhage * 1  4/3772 (0.11%)  1/3782 (0.03%) 
Gastric mucosal lesion * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Gastric polyps * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gastric ulcer * 1  8/3772 (0.21%)  3/3782 (0.08%) 
Gastric ulcer haemorrhage * 1  21/3772 (0.56%)  6/3782 (0.16%) 
Gastritis * 1  8/3772 (0.21%)  7/3782 (0.19%) 
Gastritis erosive * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Gastritis haemorrhagic * 1  9/3772 (0.24%)  3/3782 (0.08%) 
Gastroduodenal ulcer * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gastroduodenitis * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Gastrointestinal haemorrhage * 1  26/3772 (0.69%)  9/3782 (0.24%) 
Gastrointestinal necrosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gastrointestinal ulcer haemorrhage * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Gastrooesophageal reflux disease * 1  5/3772 (0.13%)  1/3782 (0.03%) 
Gastrooesophagitis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Haematochezia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Haemorrhoidal haemorrhage * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Haemorrhoids * 1  3/3772 (0.08%)  3/3782 (0.08%) 
Hiatus hernia * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Ileus * 1  6/3772 (0.16%)  4/3782 (0.11%) 
Inguinal hernia * 1  18/3772 (0.48%)  17/3782 (0.45%) 
Inguinal hernia, obstructive * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Intestinal dilatation * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Intestinal functional disorder * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Intestinal haemorrhage * 1  3/3772 (0.08%)  1/3782 (0.03%) 
Intestinal infarction * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Intestinal ischaemia * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Intestinal obstruction * 1  7/3772 (0.19%)  5/3782 (0.13%) 
Intestinal perforation * 1  4/3772 (0.11%)  0/3782 (0.00%) 
Intestinal polyp * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Intestinal strangulation * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Intra-abdominal haematoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Intra-abdominal haemorrhage * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Irritable bowel syndrome * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Large intestinal haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Large intestine perforation * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Lower gastrointestinal haemorrhage * 1  13/3772 (0.34%)  3/3782 (0.08%) 
Mallory-weiss syndrome * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Mechanical ileus * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Melaena * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Mesenteric occlusion * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Nausea * 1  0/3772 (0.00%)  3/3782 (0.08%) 
Oesophageal perforation * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Oesophageal ulcer * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Oesophageal ulcer haemorrhage * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Oesophageal varices haemorrhage * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Oesophagitis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Oesophagitis haemorrhagic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pancreatitis * 1  4/3772 (0.11%)  8/3782 (0.21%) 
Pancreatitis acute * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Pancreatitis chronic * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Peptic ulcer * 1  2/3772 (0.05%)  3/3782 (0.08%) 
Peptic ulcer haemorrhage * 1  5/3772 (0.13%)  1/3782 (0.03%) 
Periodontitis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Peritoneal adhesions * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Peritonitis * 1  4/3772 (0.11%)  3/3782 (0.08%) 
Rectal haemorrhage * 1  10/3772 (0.27%)  1/3782 (0.03%) 
Rectal polyp * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Rectal prolapse * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Reflux oesophagitis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Retroperitoneal haematoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Retroperitoneal haemorrhage * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Salivary gland calculus * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Small intestinal obstruction * 1  4/3772 (0.11%)  1/3782 (0.03%) 
Stomatitis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Subileus * 1  6/3772 (0.16%)  1/3782 (0.03%) 
Tooth disorder * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Umbilical hernia * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Umbilical hernia, obstructive * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Upper gastrointestinal haemorrhage * 1  28/3772 (0.74%)  7/3782 (0.19%) 
Volvulus * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Vomiting * 1  6/3772 (0.16%)  4/3782 (0.11%) 
General disorders     
Asthenia * 1  2/3772 (0.05%)  3/3782 (0.08%) 
Chest pain * 1  7/3772 (0.19%)  8/3782 (0.21%) 
Cyst * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Death * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Dysplasia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Fatigue * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Gait disturbance * 1  2/3772 (0.05%)  0/3782 (0.00%) 
General physical health deterioration * 1  7/3772 (0.19%)  4/3782 (0.11%) 
Generalised oedema * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Hernia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Malaise * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Multi-organ failure * 1  8/3772 (0.21%)  8/3782 (0.21%) 
Non-cardiac chest pain * 1  3/3772 (0.08%)  8/3782 (0.21%) 
Oedema peripheral * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Pelvic mass * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Perforated ulcer * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Performance status decreased * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Puncture site haemorrhage * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Pyrexia * 1  4/3772 (0.11%)  4/3782 (0.11%) 
Submandibular mass * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Swelling * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hepatobiliary disorders     
Alcoholic liver disease * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bile duct obstruction * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bile duct stenosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bile duct stone * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Biliary cirrhosis primary * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Biliary colic * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Cholangitis * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Cholangitis acute * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Cholecystitis * 1  16/3772 (0.42%)  12/3782 (0.32%) 
Cholecystitis acute * 1  5/3772 (0.13%)  9/3782 (0.24%) 
Cholecystitis chronic * 1  3/3772 (0.08%)  0/3782 (0.00%) 
Cholelithiasis * 1  16/3772 (0.42%)  18/3782 (0.48%) 
Cholestasis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Cirrhosis alcoholic * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Hepatic cirrhosis * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Hepatic congestion * 1  0/3772 (0.00%)  3/3782 (0.08%) 
Hepatic cyst * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Hepatic failure * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hepatic function abnormal * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hepatic mass * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hepatitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hepatitis acute * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Hepatitis alcoholic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hepatitis toxic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hepatocellular injury * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hyperbilirubinaemia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Jaundice * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Jaundice cholestatic * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Post cholecystectomy syndrome * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Immune system disorders     
Drug hypersensitivity * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hypersensitivity * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Infections and infestations     
Abdominal sepsis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Abscess * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Abscess neck * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Acarodermatitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
American trypanosomiasis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Anogenital warts * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Appendiceal abscess * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Appendicitis * 1  7/3772 (0.19%)  3/3782 (0.08%) 
Arthritis bacterial * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Arthritis infective * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bacteraemia * 1  3/3772 (0.08%)  3/3782 (0.08%) 
Bacterial infection * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Biliary tract infection * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Breast abscess * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Bronchiectasis * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Bronchitis * 1  20/3772 (0.53%)  13/3782 (0.34%) 
Bronchitis viral * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bronchopneumonia * 1  10/3772 (0.27%)  15/3782 (0.40%) 
Cellulitis * 1  9/3772 (0.24%)  7/3782 (0.19%) 
Central line infection * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Chronic sinusitis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Clostridial infection * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Clostridium difficile colitis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Corneal abscess * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Cryptosporidiosis infection * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Cystitis * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Dengue fever * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Dermo-hypodermitis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Device related infection * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Diverticulitis * 1  11/3772 (0.29%)  7/3782 (0.19%) 
Emphysematous cholecystitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Empyema * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Endocarditis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Endocarditis bacterial * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Enterocolitis infectious * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Erysipelas * 1  5/3772 (0.13%)  10/3782 (0.26%) 
Escherichia infection * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gallbladder empyema * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Gangrene * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Gastroenteritis * 1  13/3772 (0.34%)  10/3782 (0.26%) 
Gastroenteritis norovirus * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gastroenteritis salmonella * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gastroenteritis viral * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gastrointestinal infection * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Groin abscess * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Haematoma infection * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Hepatitis e * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Herpes zoster * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Herpes zoster ophthalmic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Implant site infection * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Infected skin ulcer * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Infection * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Infective exacerbation of chronic obstructive airways disease * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Influenza * 1  3/3772 (0.08%)  4/3782 (0.11%) 
Intervertebral discitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Keratitis fungal * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Labyrinthitis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Lobar pneumonia * 1  7/3772 (0.19%)  10/3782 (0.26%) 
Localised infection * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Lower respiratory tract infection * 1  5/3772 (0.13%)  7/3782 (0.19%) 
Lower respiratory tract infection viral * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Lung infection * 1  5/3772 (0.13%)  4/3782 (0.11%) 
Meningitis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Nasopharyngitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Necrotising fasciitis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Orchitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Osteomyelitis * 1  0/3772 (0.00%)  3/3782 (0.08%) 
Otitis externa * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Otitis media * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Parotitis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Perirectal abscess * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Peritoneal infection * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Pharyngitis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Pilonidal cyst * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Pneumococcal infection * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pneumonia * 1  139/3772 (3.69%)  128/3782 (3.38%) 
Pneumonia klebsiella * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Pneumonia primary atypical * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Pneumonia staphylococcal * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Pneumonia streptococcal * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Portal pyaemia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Post procedural infection * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Post procedural sepsis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Postoperative wound infection * 1  3/3772 (0.08%)  2/3782 (0.05%) 
Pseudomonas infection * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pulmonary sepsis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pulmonary tuberculosis * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Pyelonephritis * 1  5/3772 (0.13%)  10/3782 (0.26%) 
Pyelonephritis acute * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Renal abscess * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Respiratory tract infection * 1  8/3772 (0.21%)  6/3782 (0.16%) 
Sepsis * 1  27/3772 (0.72%)  19/3782 (0.50%) 
Sepsis syndrome * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Septic shock * 1  6/3772 (0.16%)  10/3782 (0.26%) 
Sinusitis * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Skin bacterial infection * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Staphylococcal infection * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Staphylococcal sepsis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Staphylococcal toxaemia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Streptococcal sepsis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Subcutaneous abscess * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Tetanus * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Thrombophlebitis septic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Tooth abscess * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Toxic shock syndrome * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Tracheobronchitis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Tuberculosis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Upper respiratory tract infection * 1  5/3772 (0.13%)  6/3782 (0.16%) 
Urethritis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Urinary tract infection * 1  23/3772 (0.61%)  28/3782 (0.74%) 
Urosepsis * 1  7/3772 (0.19%)  7/3782 (0.19%) 
Viral infection * 1  3/3772 (0.08%)  3/3782 (0.08%) 
Viral pericarditis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Vulval abscess * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Wound infection * 1  4/3772 (0.11%)  4/3782 (0.11%) 
Wound infection staphylococcal * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Accidental overdose * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Alcohol poisoning * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Anaemia postoperative * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Anastomotic leak * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Anastomotic stenosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Anastomotic ulcer haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Ankle fracture * 1  3/3772 (0.08%)  4/3782 (0.11%) 
Asbestosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Brain contusion * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Concussion * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Contusion * 1  6/3772 (0.16%)  4/3782 (0.11%) 
Dislocation of joint prosthesis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Drug toxicity * 1  1/3772 (0.03%)  7/3782 (0.19%) 
Ear injury * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Epiphyseal fracture * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Extradural haematoma * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Facial bones fracture * 1  2/3772 (0.05%)  3/3782 (0.08%) 
Fall * 1  24/3772 (0.64%)  19/3782 (0.50%) 
Femoral neck fracture * 1  9/3772 (0.24%)  6/3782 (0.16%) 
Femur fracture * 1  15/3772 (0.40%)  19/3782 (0.50%) 
Foot fracture * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Fracture * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Fracture displacement * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Fractured coccyx * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Fractured sacrum * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Graft complication * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Haematuria traumatic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Head injury * 1  7/3772 (0.19%)  1/3782 (0.03%) 
Heat exhaustion * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hip fracture * 1  12/3772 (0.32%)  18/3782 (0.48%) 
Humerus fracture * 1  3/3772 (0.08%)  1/3782 (0.03%) 
Implantable defibrillator malfunction * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Injury * 1  6/3772 (0.16%)  3/3782 (0.08%) 
Joint dislocation * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Joint injury * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Joint sprain * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Limb injury * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Lower limb fracture * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Lumbar vertebral fracture * 1  1/3772 (0.03%)  3/3782 (0.08%) 
Multiple fractures * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Muscle rupture * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Open fracture * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Open wound * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Operative haemorrhage * 1  3/3772 (0.08%)  2/3782 (0.05%) 
Overdose * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Pacemaker complication * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Patella fracture * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pelvic fracture * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Pharyngeal injury * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Poisoning * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Post procedural complication * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Post procedural haematoma * 1  3/3772 (0.08%)  2/3782 (0.05%) 
Post procedural haematuria * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Post procedural haemorrhage * 1  10/3772 (0.27%)  10/3782 (0.26%) 
Post-traumatic pain * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Postoperative adhesion * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Postoperative ileus * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Postoperative renal failure * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Procedural pain * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Pubic rami fracture * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Radiation mucositis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Radius fracture * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Rib fracture * 1  9/3772 (0.24%)  3/3782 (0.08%) 
Road traffic accident * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Scapula fracture * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Skin laceration * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Skull fracture * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Spinal compression fracture * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Spinal fracture * 1  4/3772 (0.11%)  6/3782 (0.16%) 
Subcutaneous haematoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Subdural haematoma * 1  14/3772 (0.37%)  3/3782 (0.08%) 
Subdural haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Tendon injury * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Tendon rupture * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Therapeutic agent toxicity * 1  9/3772 (0.24%)  8/3782 (0.21%) 
Thermal burn * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Thoracic vertebral fracture * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Tibia fracture * 1  4/3772 (0.11%)  1/3782 (0.03%) 
Traumatic brain injury * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Traumatic haematoma * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Traumatic haemorrhage * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Traumatic intracranial haemorrhage * 1  3/3772 (0.08%)  1/3782 (0.03%) 
Upper limb fracture * 1  7/3772 (0.19%)  4/3782 (0.11%) 
Wound * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Wound complication * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Wrist fracture * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Investigations     
Aspiration bronchial * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Carbohydrate tolerance decreased * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Haemoglobin decreased * 1  1/3772 (0.03%)  1/3782 (0.03%) 
International normalised ratio increased * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Prostatic specific antigen increased * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Weight decreased * 1  3/3772 (0.08%)  0/3782 (0.00%) 
Metabolism and nutrition disorders     
Cachexia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Dehydration * 1  19/3772 (0.50%)  13/3782 (0.34%) 
Diabetes mellitus * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Diabetes mellitus inadequate control * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Electrolyte imbalance * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Failure to thrive * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gout * 1  4/3772 (0.11%)  3/3782 (0.08%) 
Haemosiderosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hypercalcaemia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Hyperkalaemia * 1  5/3772 (0.13%)  1/3782 (0.03%) 
Hypoalbuminaemia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hypoglycaemia * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Hypokalaemia * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Hyponatraemia * 1  4/3772 (0.11%)  9/3782 (0.24%) 
Hypovolaemia * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Iron deficiency * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Malnutrition * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Metabolic disorder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Obesity * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Starvation * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Underweight * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/3772 (0.00%)  3/3782 (0.08%) 
Arthritis * 1  3/3772 (0.08%)  3/3782 (0.08%) 
Back pain * 1  2/3772 (0.05%)  9/3782 (0.24%) 
Bunion * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bursitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Chondrocalcinosis pyrophosphate * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Dupuytren's contracture * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Finger deformity * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Foot deformity * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gouty arthritis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Intervertebral disc degeneration * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Intervertebral disc disorder * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Intervertebral disc protrusion * 1  5/3772 (0.13%)  3/3782 (0.08%) 
Lumbar spinal stenosis * 1  2/3772 (0.05%)  3/3782 (0.08%) 
Mobility decreased * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Muscular weakness * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Musculoskeletal chest pain * 1  6/3772 (0.16%)  3/3782 (0.08%) 
Musculoskeletal pain * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Myalgia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Osteoarthritis * 1  28/3772 (0.74%)  36/3782 (0.95%) 
Osteochondrosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Osteoporosis * 1  3/3772 (0.08%)  2/3782 (0.05%) 
Osteoporotic fracture * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Pain in extremity * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Pathological fracture * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Periarthritis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Periostitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Polymyalgia rheumatica * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Rhabdomyolysis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Rheumatoid arthritis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Senile osteoporosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Spinal column stenosis * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Spinal osteoarthritis * 1  2/3772 (0.05%)  7/3782 (0.19%) 
Spondylolisthesis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Abdominal neoplasm * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Acute leukaemia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Acute myeloid leukaemia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Adenocarcinoma * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Adenocarcinoma pancreas * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Adrenal neoplasm * 1  1/3772 (0.03%)  1/3782 (0.03%) 
B-cell lymphoma * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Basal cell carcinoma * 1  4/3772 (0.11%)  3/3782 (0.08%) 
Basosquamous carcinoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Benign anorectal neoplasm * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Benign lung neoplasm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Benign neoplasm of bladder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Benign ovarian tumour * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bile duct cancer * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Biliary cancer metastatic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Biliary neoplasm * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Bladder cancer * 1  3/3772 (0.08%)  3/3782 (0.08%) 
Bladder cancer recurrent * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Bladder neoplasm * 1  5/3772 (0.13%)  2/3782 (0.05%) 
Bladder papilloma * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Bladder transitional cell carcinoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Bone sarcoma * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Brain neoplasm * 1  2/3772 (0.05%)  3/3782 (0.08%) 
Brain neoplasm malignant * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Breast cancer * 1  9/3772 (0.24%)  13/3782 (0.34%) 
Breast cancer female * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Breast cancer recurrent * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Breast neoplasm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bronchial carcinoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bronchioloalveolar carcinoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Cancer pain * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Carcinoid tumour of the stomach * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Cervix carcinoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Cholesteatoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Chronic lymphocytic leukaemia * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Colon adenoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Colon cancer * 1  13/3772 (0.34%)  11/3782 (0.29%) 
Colon cancer metastatic * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Colon cancer stage iv * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Colon neoplasm * 1  0/3772 (0.00%)  5/3782 (0.13%) 
Colorectal cancer * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Colorectal cancer metastatic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Cystosarcoma phyllodes * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Diffuse large b-cell lymphoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Duodenal neoplasm * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Endometrial cancer * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Endometrial cancer metastatic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Gallbladder cancer * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Gastric cancer * 1  10/3772 (0.27%)  5/3782 (0.13%) 
Gastric neoplasm * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Gastrointestinal carcinoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gastrointestinal stromal tumour * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Glioblastoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Glioblastoma multiforme * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Glioma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Haemangioma of liver * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hepatic neoplasm malignant * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Intestinal adenocarcinoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Large cell carcinoma of the respiratory tract stage unspecified * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Large granular lymphocytosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Large intestine carcinoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Laryngeal cancer * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Leiomyoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Leiomyosarcoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Lipoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Lung adenocarcinoma * 1  5/3772 (0.13%)  3/3782 (0.08%) 
Lung neoplasm * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Lung neoplasm malignant * 1  8/3772 (0.21%)  11/3782 (0.29%) 
Lung squamous cell carcinoma stage unspecified * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Lymph node cancer metastatic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Lymphocytic leukaemia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Lymphoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Malignant melanoma * 1  3/3772 (0.08%)  4/3782 (0.11%) 
Malignant melanoma in situ * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Malignant soft tissue neoplasm * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Mediastinum neoplasm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Meningioma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Metastases to adrenals * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Metastases to bone * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Metastases to central nervous system * 1  1/3772 (0.03%)  3/3782 (0.08%) 
Metastases to liver * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Metastases to lung * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Metastatic gastric cancer * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Metastatic neoplasm * 1  3/3772 (0.08%)  2/3782 (0.05%) 
Metastatic squamous cell carcinoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Multiple myeloma * 1  1/3772 (0.03%)  5/3782 (0.13%) 
Myelodysplastic syndrome * 1  7/3772 (0.19%)  2/3782 (0.05%) 
Myelofibrosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Nasal neoplasm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Neoplasm malignant * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Neoplasm skin * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Neurilemmoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Neuroendocrine carcinoma * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Neuroendocrine carcinoma of the skin * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Neuroma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Non-Hodgkin's lymphoma * 1  3/3772 (0.08%)  4/3782 (0.11%) 
Non-small cell lung cancer * 1  1/3772 (0.03%)  3/3782 (0.08%) 
Non-small cell lung cancer stage IV * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Oesophageal adenocarcinoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Oesophageal carcinoma * 1  4/3772 (0.11%)  2/3782 (0.05%) 
Oral neoplasm * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Ovarian cancer * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Pancreatic carcinoma * 1  1/3772 (0.03%)  8/3782 (0.21%) 
Pancreatic carcinoma metastatic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Pancreatic neoplasm * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Pancreatic neuroendocrine tumour * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Papilloma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Pelvic neoplasm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Penis carcinoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Peritoneal carcinoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Pharyngeal cancer stage unspecified * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pituitary tumour benign * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Plasmacytoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pleural mesothelioma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Prostate cancer * 1  24/3772 (0.64%)  16/3782 (0.42%) 
Prostate cancer metastatic * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Prostatic adenoma * 1  5/3772 (0.13%)  6/3782 (0.16%) 
Rectal cancer * 1  3/3772 (0.08%)  8/3782 (0.21%) 
Rectal cancer metastatic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Rectosigmoid cancer * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Renal cancer * 1  1/3772 (0.03%)  3/3782 (0.08%) 
Renal cancer metastatic * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Renal cell carcinoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Renal neoplasm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Salivary gland adenoma * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Salivary gland neoplasm * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Sarcoma uterus * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Skin cancer * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Small intestine carcinoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Squamous cell carcinoma * 1  4/3772 (0.11%)  6/3782 (0.16%) 
Squamous cell carcinoma of skin * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Thyroid adenoma * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Thyroid cancer * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Thyroid neoplasm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Tongue neoplasm malignant stage unspecified * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Transitional cell carcinoma * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Tumour haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Uterine cancer * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Uterine leiomyoma * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Vulval cancer * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Nervous system disorders     
Amyotrophic lateral sclerosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Ataxia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Balance disorder * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Carpal tunnel syndrome * 1  4/3772 (0.11%)  0/3782 (0.00%) 
Cauda equina syndrome * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Cerebral artery occlusion * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Cerebral disorder * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Cerebral haematoma * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Cerebral haemorrhage * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Cerebrovascular accident * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Cerebrovascular disorder * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Cervical root pain * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Cognitive disorder * 1  3/3772 (0.08%)  0/3782 (0.00%) 
Convulsion * 1  3/3772 (0.08%)  4/3782 (0.11%) 
Dementia * 1  4/3772 (0.11%)  3/3782 (0.08%) 
Dementia Alzheimer's type * 1  4/3772 (0.11%)  1/3782 (0.03%) 
Dizziness * 1  5/3772 (0.13%)  8/3782 (0.21%) 
Dizziness postural * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Encephalitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Encephalopathy * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Epilepsy * 1  5/3772 (0.13%)  4/3782 (0.11%) 
Extrapyramidal disorder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Facial paresis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Grand mal convulsion * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Guillain-barre syndrome * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Haemorrhage intracranial * 1  2/3772 (0.05%)  3/3782 (0.08%) 
Haemorrhagic stroke * 1  17/3772 (0.45%)  10/3782 (0.26%) 
Haemorrhagic transformation stroke * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Headache * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Hydrocephalus * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hypokinesia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Intercostal neuralgia * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Intracranial haematoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Ivth nerve paralysis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Loss of consciousness * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Lumbar radiculopathy * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Mental impairment * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Mononeuropathy * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Nervous system disorder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Neuralgia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Neurological decompensation * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Optic neuritis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Paraesthesia * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Parkinson's disease * 1  1/3772 (0.03%)  3/3782 (0.08%) 
Polyneuropathy * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Post herpetic neuralgia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Presyncope * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Radicular syndrome * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Ruptured cerebral aneurysm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Sciatica * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Simple partial seizures * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Somnolence * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Spinal cord compression * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Status epilepticus * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Subarachnoid haemorrhage * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Syncope * 1  12/3772 (0.32%)  9/3782 (0.24%) 
Syncope vasovagal * 1  1/3772 (0.03%)  4/3782 (0.11%) 
Thalamus haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Thrombotic stroke * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Vascular dementia * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Vascular encephalopathy * 1  4/3772 (0.11%)  1/3782 (0.03%) 
Vertebrobasilar insufficiency * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Psychiatric disorders     
Abnormal behaviour * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Alcohol abuse * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Alcohol withdrawal syndrome * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Alcoholism * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bipolar i disorder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Completed suicide * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Confusional state * 1  6/3772 (0.16%)  5/3782 (0.13%) 
Delirium * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Delusion * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Delusional disorder, persecutory type * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Depression * 1  11/3772 (0.29%)  5/3782 (0.13%) 
Hallucination * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Major depression * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Mental disorder * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Mental status changes * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Neurosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Panic disorder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Psychotic disorder * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Schizophrenia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Schizophrenia, paranoid type * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Renal and urinary disorders     
Anuria * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Bladder neck sclerosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bladder obstruction * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bladder stenosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Calculus bladder * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Calculus ureteric * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Calculus urinary * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Cystitis haemorrhagic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Cystitis noninfective * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Cystitis ulcerative * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Dysuria * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Enuresis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Glomerulonephritis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Glomerulonephritis chronic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Haematuria * 1  10/3772 (0.27%)  4/3782 (0.11%) 
Haemorrhage urinary tract * 1  4/3772 (0.11%)  1/3782 (0.03%) 
Hydronephrosis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Nephrolithiasis * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Nephropathy * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Obstructive uropathy * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Polyuria * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Proteinuria * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Renal artery stenosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Renal colic * 1  4/3772 (0.11%)  1/3782 (0.03%) 
Renal cyst * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Renal disorder * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Renal failure * 1  16/3772 (0.42%)  14/3782 (0.37%) 
Renal failure acute * 1  22/3772 (0.58%)  23/3782 (0.61%) 
Renal failure chronic * 1  3/3772 (0.08%)  5/3782 (0.13%) 
Renal haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Renal impairment * 1  3/3772 (0.08%)  4/3782 (0.11%) 
Ureteric obstruction * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Urethral fistula * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Urethral meatus stenosis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Urethral stenosis * 1  4/3772 (0.11%)  6/3782 (0.16%) 
Urinary bladder haemorrhage * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Urinary bladder polyp * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Urinary incontinence * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Urinary retention * 1  11/3772 (0.29%)  2/3782 (0.05%) 
Urinary tract disorder * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  12/3772 (0.32%)  13/3782 (0.34%) 
Breast mass * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Cervical dysplasia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Colpocele * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Endometrial atrophy * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Endometrial hyperplasia * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Endometrial hypertrophy * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Fibrocystic breast disease * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Gynaecomastia * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Ovarian cyst * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Prostatic disorder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Prostatic haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Prostatism * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Prostatitis * 1  4/3772 (0.11%)  3/3782 (0.08%) 
Prostatomegaly * 1  0/3772 (0.00%)  3/3782 (0.08%) 
Rectocele * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Uterine enlargement * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Uterine haemorrhage * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Uterine polyp * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Uterine prolapse * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Vaginal cyst * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Vaginal haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Acute respiratory distress syndrome * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Acute respiratory failure * 1  2/3772 (0.05%)  4/3782 (0.11%) 
Alveolitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Asthma * 1  5/3772 (0.13%)  4/3782 (0.11%) 
Atelectasis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Bronchial disorder * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Bronchitis chronic * 1  7/3772 (0.19%)  7/3782 (0.19%) 
Bronchopneumopathy * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Bronchospasm * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Chronic obstructive pulmonary disease * 1  28/3772 (0.74%)  27/3782 (0.71%) 
Cough * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Dyspnoea * 1  0/3772 (0.00%)  3/3782 (0.08%) 
Dyspnoea exertional * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Epistaxis * 1  17/3772 (0.45%)  7/3782 (0.19%) 
Haemoptysis * 1  2/3772 (0.05%)  2/3782 (0.05%) 
Haemothorax * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Interstitial lung disease * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Lung disorder * 1  3/3772 (0.08%)  2/3782 (0.05%) 
Nasal polyps * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pleural adhesion * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pleural effusion * 1  8/3772 (0.21%)  8/3782 (0.21%) 
Pleurisy * 1  5/3772 (0.13%)  1/3782 (0.03%) 
Pneumonia aspiration * 1  4/3772 (0.11%)  4/3782 (0.11%) 
Pneumonitis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Pneumothorax * 1  4/3772 (0.11%)  2/3782 (0.05%) 
Pulmonary congestion * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Pulmonary embolism * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Pulmonary fibrosis * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Pulmonary haemorrhage * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Pulmonary hilum mass * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pulmonary mass * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pulmonary oedema * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Respiratory acidosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Respiratory arrest * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Respiratory distress * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Respiratory failure * 1  5/3772 (0.13%)  6/3782 (0.16%) 
Sleep apnoea syndrome * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Status asthmaticus * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Thoracic haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Tonsillar disorder * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Dermatitis allergic * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Dermatitis atopic * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Ecchymosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Haemorrhage subcutaneous * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Pemphigoid * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Psoriasis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Pustular psoriasis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Rash * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Skin induration * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Skin lesion * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Skin necrosis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Skin ulcer * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Skin ulcer haemorrhage * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Stasis dermatitis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Toxic skin eruption * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Urticaria * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Social circumstances     
Bedridden * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Disability * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Elderly * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Joint prosthesis user * 1  2/3772 (0.05%)  0/3782 (0.00%) 
Social problem * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Social stay hospitalisation * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Surgical and medical procedures     
Circumcision * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Haemorrhoid operation * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Hip arthroplasty * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Intestinal stoma * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Intraocular lens implant * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Obesity surgery * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Wound drainage * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Vascular disorders     
Aneurysm * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Angiodysplasia * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Aortic aneurysm * 1  2/3772 (0.05%)  6/3782 (0.16%) 
Aortic aneurysm rupture * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Aortic dissection * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Aortic rupture * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Arteriosclerosis * 1  1/3772 (0.03%)  1/3782 (0.03%) 
Arteriosclerosis obliterans * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Bleeding varicose vein * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Cardiovascular insufficiency * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Circulatory collapse * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Deep vein thrombosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Femoral artery aneurysm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Haematoma * 1  1/3772 (0.03%)  3/3782 (0.08%) 
Haemorrhage * 1  6/3772 (0.16%)  3/3782 (0.08%) 
Hypertension * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Hypertensive crisis * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Hypotension * 1  5/3772 (0.13%)  3/3782 (0.08%) 
Orthostatic hypotension * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Peripheral arterial occlusive disease * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Peripheral artery aneurysm * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Peripheral embolism * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Peripheral ischaemia * 1  0/3772 (0.00%)  2/3782 (0.05%) 
Peripheral vascular disorder * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Thrombophlebitis * 1  2/3772 (0.05%)  1/3782 (0.03%) 
Thrombosis * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Varicose ulceration * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Varicose vein * 1  0/3772 (0.00%)  1/3782 (0.03%) 
Vasculitis * 1  1/3772 (0.03%)  2/3782 (0.05%) 
Venous insufficiency * 1  1/3772 (0.03%)  0/3782 (0.00%) 
Venous thrombosis * 1  0/3772 (0.00%)  1/3782 (0.03%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clopidogrel + ASA Placebo + ASA
Affected / at Risk (%) Affected / at Risk (%)
Total   2542/3772 (67.39%)   2502/3782 (66.16%) 
Cardiac disorders     
Any Cardiac disorders * 1  301/3772 (7.98%)  314/3782 (8.30%) 
Eye disorders     
Any Eye disorders * 1  190/3772 (5.04%)  198/3782 (5.24%) 
Gastrointestinal disorders     
Any Gastrointestinal disorders * 1  806/3772 (21.37%)  763/3782 (20.17%) 
General disorders     
Any General disorders and administration site conditions * 1  582/3772 (15.43%)  541/3782 (14.30%) 
Infections and infestations     
Any Infections and infestations * 1  994/3772 (26.35%)  961/3782 (25.41%) 
Injury, poisoning and procedural complications     
Any Injury, poisoning and procedural complications * 1  433/3772 (11.48%)  353/3782 (9.33%) 
Investigations     
Any Investigations * 1  185/3772 (4.90%)  201/3782 (5.31%) 
Metabolism and nutrition disorders     
Any Metabolism and nutrition disorders * 1  239/3772 (6.34%)  257/3782 (6.80%) 
Musculoskeletal and connective tissue disorders     
Any Musculoskeletal and connective tissue disorders * 1  532/3772 (14.10%)  623/3782 (16.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Any Neoplasms benign, malignant and unspecified (incl cysts and polyps) * 1  220/3772 (5.83%)  208/3782 (5.50%) 
Nervous system disorders     
Any Nervous system disorders * 1  661/3772 (17.52%)  682/3782 (18.03%) 
Dizziness * 1  300/3772 (7.95%)  312/3782 (8.25%) 
Renal and urinary disorders     
Any Renal and urinary disorders * 1  184/3772 (4.88%)  196/3782 (5.18%) 
Respiratory, thoracic and mediastinal disorders     
Any Respiratory, thoracic and mediastinal disorders * 1  538/3772 (14.26%)  510/3782 (13.48%) 
Dyspnoea * 1  231/3772 (6.12%)  215/3782 (5.68%) 
Skin and subcutaneous tissue disorders     
Any Skin and subcutaneous tissue disorders * 1  337/3772 (8.93%)  289/3782 (7.64%) 
Vascular disorders     
Any Vascular disorders * 1  440/3772 (11.66%)  414/3782 (10.95%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of the study will be made jointly in the name of all wholehearted collaborators. Other papers will be authored based on the contributions of the individuals to the overall study. Substudies with scientific merit which have received prior approval from the Steering Committee (SC) may be published in the names of the contributing investigators. A copy of all manuscripts will be provided to the sponsors for their review. The final decision to publish articles will be made by the SC.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: International Clinical Development, Clinical Study Director
Organization: sanofi-aventis
EMail: GV-Contact-us@sanofi-aventis.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00249873     History of Changes
Other Study ID Numbers: EFC4912 A
First Submitted: November 4, 2005
First Posted: November 7, 2005
Results First Submitted: March 8, 2010
Results First Posted: March 26, 2010
Last Update Posted: June 15, 2015