Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)

This study has been terminated.

(The trial was terminated at the request of the Data and Safety Monitoring Board.)

Sponsor:

Collaborator:

Duke Clinical Research Institute

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00527943

First received: September 7, 2007

Last updated: March 31, 2017

Last verified: March 2017

History of Changes

Results First Received: May 9, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Investigator, Outcomes Assessor; Primary Purpose: Prevention
Conditions:	Atherosclerosis Myocardial Ischemia Myocardial Infarction
Interventions:	Drug: Vorapaxar Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Prior to the planned study completion, the Data Safety Monitoring Board recommended that all participants stop treatment and that the study be closed-out. The protocol-defined target number of primary efficacy endpoints had been reached by this time. However, follow-up in the study was terminated earlier than planned.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Intent to Treat (ITT) Population, defined as all enrolled participants who were randomly assigned to a treatment group.

Reporting Groups

	Description
Placebo	Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Vorapaxar	Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.

Participant Flow: Overall Study

	Placebo	Vorapaxar
STARTED	6471	6473
Received Treatment	6441	6446
COMPLETED	6311	6327
NOT COMPLETED	160	146

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Placebo	Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Vorapaxar	Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Vorapaxar	Total
Overall Participants Analyzed [Units: Participants]	6471	6473	12944

Age, Customized [Units: Participants]
<65 years	3369	3390	6759
65 to <75 years	2006	1973	3979
>= 75 years	1096	1110	2206

Sex: Female, Male [Units: Participants] Count of Participants
Female	1822 28.2%	1810 28.0%	3632 28.1%
Male	4649 71.8%	4663 72.0%	9312 71.9%

Outcome Measures

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1. Primary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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2. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization [ Time Frame: up to 2 years ]

Show Outcome Measure 2

3. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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4. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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5. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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6. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or MI Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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7. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

Show Outcome Measure 7

8. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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9. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

Show Outcome Measure 9

10. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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11. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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12. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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13. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

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14. Secondary:

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization [ Time Frame: Up to 2 years ]

Show Outcome Measure 14

Serious Adverse Events

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Time Frame	No text entered.
Additional Description	Adverse events are reported using the As Treated Population, which included all participants who received at least 1 dose of study medication and are reported according to treatment received.

Reporting Groups

	Description
Placebo	Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Vorapaxar	Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.

Serious Adverse Events

	Placebo	Vorapaxar
Total, Serious Adverse Events
# participants affected / at risk	1718/6441 (26.67%)	1866/6446 (28.95%)
Blood and lymphatic system disorders
ANAEMIA ^† 1
# participants affected / at risk	28/6441 (0.43%)	55/6446 (0.85%)
# events	29	59
COAGULOPATHY ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
DISSEMINATED INTRAVASCULAR COAGULATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
EOSINOPHILIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
FEBRILE NEUTROPENIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GRANULOCYTOPENIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	2	0
HAEMORRHAGIC ANAEMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
HAEMORRHAGIC DIATHESIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	10/6446 (0.16%)
# events	1	10
HEPARIN-INDUCED THROMBOCYTOPENIA ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
HYPOCHROMIC ANAEMIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	3
IDIOPATHIC THROMBOCYTOPENIC PURPURA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
IRON DEFICIENCY ANAEMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	8/6446 (0.12%)
# events	1	8
LEUKOCYTOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
LYMPHADENOPATHY ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
LYMPHADENOPATHY MEDIASTINAL ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
MICROCYTIC ANAEMIA ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
NORMOCHROMIC NORMOCYTIC ANAEMIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SPLENIC INFARCTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SPONTANEOUS HAEMATOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
THROMBOCYTOPENIA ^† 1
# participants affected / at risk	34/6441 (0.53%)	30/6446 (0.47%)
# events	34	30
THROMBOCYTOSIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	2
Cardiac disorders
ANGINA PECTORIS ^† 1
# participants affected / at risk	3/6441 (0.05%)	6/6446 (0.09%)
# events	3	6
ANGINA UNSTABLE ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
AORTIC VALVE DISEASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
AORTIC VALVE INCOMPETENCE ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
AORTIC VALVE STENOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
ARRHYTHMIA ^† 1
# participants affected / at risk	5/6441 (0.08%)	6/6446 (0.09%)
# events	5	6
ARRHYTHMIA SUPRAVENTRICULAR ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	5
ARTERIOSCLEROSIS CORONARY ARTERY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ARTERIOSPASM CORONARY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ATRIAL FIBRILLATION ^† 1
# participants affected / at risk	93/6441 (1.44%)	96/6446 (1.49%)
# events	100	113
ATRIAL FLUTTER ^† 1
# participants affected / at risk	17/6441 (0.26%)	17/6446 (0.26%)
# events	17	18
ATRIAL RUPTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ATRIAL THROMBOSIS ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
ATRIOVENTRICULAR BLOCK ^† 1
# participants affected / at risk	1/6441 (0.02%)	4/6446 (0.06%)
# events	1	4
ATRIOVENTRICULAR BLOCK COMPLETE ^† 1
# participants affected / at risk	9/6441 (0.14%)	9/6446 (0.14%)
# events	9	9
ATRIOVENTRICULAR BLOCK SECOND DEGREE ^† 1
# participants affected / at risk	6/6441 (0.09%)	7/6446 (0.11%)
# events	6	7
ATRIOVENTRICULAR DISSOCIATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BIFASCICULAR BLOCK ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BRADYARRHYTHMIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BRADYCARDIA ^† 1
# participants affected / at risk	26/6441 (0.40%)	14/6446 (0.22%)
# events	26	14
BUNDLE BRANCH BLOCK LEFT ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CARDIAC ARREST ^† 1
# participants affected / at risk	12/6441 (0.19%)	9/6446 (0.14%)
# events	12	9
CARDIAC ASTHMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
CARDIAC FAILURE ^† 1
# participants affected / at risk	146/6441 (2.27%)	142/6446 (2.20%)
# events	191	191
CARDIAC FAILURE ACUTE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
CARDIAC FAILURE CHRONIC ^† 1
# participants affected / at risk	4/6441 (0.06%)	1/6446 (0.02%)
# events	5	1
CARDIAC FAILURE CONGESTIVE ^† 1
# participants affected / at risk	35/6441 (0.54%)	45/6446 (0.70%)
# events	46	53
CARDIAC HYPERTROPHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CARDIAC PERFORATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CARDIAC TAMPONADE ^† 1
# participants affected / at risk	5/6441 (0.08%)	4/6446 (0.06%)
# events	5	4
CARDIAC VALVE DISEASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CARDIO-RESPIRATORY ARREST ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
CARDIOGENIC SHOCK ^† 1
# participants affected / at risk	39/6441 (0.61%)	24/6446 (0.37%)
# events	41	24
CARDIOMEGALY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CARDIOMYOPATHY ^† 1
# participants affected / at risk	4/6441 (0.06%)	1/6446 (0.02%)
# events	4	1
CARDIOPULMONARY FAILURE ^† 1
# participants affected / at risk	3/6441 (0.05%)	3/6446 (0.05%)
# events	3	3
CARDIOVASCULAR INSUFFICIENCY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CHORDAE TENDINAE RUPTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CONGESTIVE CARDIOMYOPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COR PULMONALE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CORONARY ARTERY DISEASE ^† 1
# participants affected / at risk	6/6441 (0.09%)	5/6446 (0.08%)
# events	6	5
CORONARY ARTERY DISSECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
CORONARY ARTERY INSUFFICIENCY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CORONARY ARTERY OCCLUSION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DRESSLER'S SYNDROME ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
EXTRASYSTOLES ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
GASTROCARDIAC SYNDROME ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HEART VALVE CALCIFICATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INTRACARDIAC THROMBUS ^† 1
# participants affected / at risk	4/6441 (0.06%)	2/6446 (0.03%)
# events	4	2
ISCHAEMIC CARDIOMYOPATHY ^† 1
# participants affected / at risk	4/6441 (0.06%)	2/6446 (0.03%)
# events	4	2
LEFT VENTRICULAR DYSFUNCTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
LEFT VENTRICULAR FAILURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	3
MITRAL VALVE INCOMPETENCE ^† 1
# participants affected / at risk	6/6441 (0.09%)	5/6446 (0.08%)
# events	6	5
MYOCARDIAL RUPTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
MYOCARDITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MYOPERICARDITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
NODAL ARRHYTHMIA ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
NODAL RHYTHM ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
PALPITATIONS ^† 1
# participants affected / at risk	6/6441 (0.09%)	8/6446 (0.12%)
# events	6	8
PAPILLARY MUSCLE RUPTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PERICARDIAL EFFUSION ^† 1
# participants affected / at risk	7/6441 (0.11%)	7/6446 (0.11%)
# events	7	7
PERICARDIAL HAEMORRHAGE ^† 1
# participants affected / at risk	8/6441 (0.12%)	18/6446 (0.28%)
# events	8	19
PERICARDITIS ^† 1
# participants affected / at risk	5/6441 (0.08%)	3/6446 (0.05%)
# events	5	3
PERICARDITIS CONSTRICTIVE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PLEUROPERICARDITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PRINZMETAL ANGINA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PULSELESS ELECTRICAL ACTIVITY ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	2
RESTRICTIVE CARDIOMYOPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	2
RIGHT VENTRICULAR DYSFUNCTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RIGHT VENTRICULAR FAILURE ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
SICK SINUS SYNDROME ^† 1
# participants affected / at risk	8/6441 (0.12%)	7/6446 (0.11%)
# events	8	8
SINOATRIAL BLOCK ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
SINUS ARREST ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SINUS ARRHYTHMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
SINUS BRADYCARDIA ^† 1
# participants affected / at risk	3/6441 (0.05%)	3/6446 (0.05%)
# events	3	3
SINUS TACHYCARDIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
STRESS CARDIOMYOPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
SUPRAVENTRICULAR TACHYARRHYTHMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SUPRAVENTRICULAR TACHYCARDIA ^† 1
# participants affected / at risk	15/6441 (0.23%)	9/6446 (0.14%)
# events	15	11
TACHYCARDIA ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	3
TORSADE DE POINTES ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
TRICUSPID VALVE INCOMPETENCE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
TRIFASCICULAR BLOCK ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VENTRICLE RUPTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
VENTRICULAR ARRHYTHMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
VENTRICULAR DYSFUNCTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VENTRICULAR EXTRASYSTOLES ^† 1
# participants affected / at risk	1/6441 (0.02%)	4/6446 (0.06%)
# events	1	4
VENTRICULAR FIBRILLATION ^† 1
# participants affected / at risk	28/6441 (0.43%)	30/6446 (0.47%)
# events	33	32
VENTRICULAR TACHYARRHYTHMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VENTRICULAR TACHYCARDIA ^† 1
# participants affected / at risk	36/6441 (0.56%)	23/6446 (0.36%)
# events	41	29
Congenital, familial and genetic disorders
ARTERIOVENOUS MALFORMATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ATRIAL SEPTAL DEFECT ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GASTROINTESTINAL ANGIODYSPLASIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTROINTESTINAL ARTERIOVENOUS MALFORMATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HYDROCELE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
PHIMOSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
Ear and labyrinth disorders
DEAFNESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DEAFNESS NEUROSENSORY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
EAR HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SUDDEN HEARING LOSS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
TINNITUS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
VERTIGO ^† 1
# participants affected / at risk	10/6441 (0.16%)	9/6446 (0.14%)
# events	10	9
VERTIGO POSITIONAL ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
VESTIBULAR DISORDER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
Endocrine disorders
ADRENAL INSUFFICIENCY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GOITRE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HYPERTHYROIDISM ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
HYPOTHYROIDISM ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TOXIC NODULAR GOITRE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
Eye disorders
ABNORMAL SENSATION IN EYE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CATARACT ^† 1
# participants affected / at risk	6/6441 (0.09%)	4/6446 (0.06%)
# events	7	5
CONJUNCTIVITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DIPLOPIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
EYE HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GLAUCOMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	3	0
MACULAR HOLE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
OPTIC ISCHAEMIC NEUROPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
RETINAL ARTERY OCCLUSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
RETINAL DETACHMENT ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
RETINAL VASCULAR THROMBOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
STRABISMUS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ULCERATIVE KERATITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
VISUAL IMPAIRMENT ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
Gastrointestinal disorders
ABDOMINAL DISCOMFORT ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ABDOMINAL HERNIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ABDOMINAL PAIN ^† 1
# participants affected / at risk	11/6441 (0.17%)	11/6446 (0.17%)
# events	15	12
ABDOMINAL PAIN UPPER ^† 1
# participants affected / at risk	4/6441 (0.06%)	9/6446 (0.14%)
# events	4	9
ABDOMINAL STRANGULATED HERNIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ABDOMINAL WALL HAEMATOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ACUTE ABDOMEN ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ANAL FISTULA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ANAL HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ASCITES ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
COELIAC DISEASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	3	0
COLITIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
COLITIS ISCHAEMIC ^† 1
# participants affected / at risk	5/6441 (0.08%)	1/6446 (0.02%)
# events	7	1
COLITIS ULCERATIVE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COLONIC POLYP ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
CONSTIPATION ^† 1
# participants affected / at risk	7/6441 (0.11%)	6/6446 (0.09%)
# events	9	6
CROHN'S DISEASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	3	2
DIABETIC GASTROPARESIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DIARRHOEA ^† 1
# participants affected / at risk	5/6441 (0.08%)	8/6446 (0.12%)
# events	6	9
DIARRHOEA HAEMORRHAGIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DIVERTICULAR PERFORATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DIVERTICULUM ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
DIVERTICULUM INTESTINAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DIVERTICULUM INTESTINAL HAEMORRHAGIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DUODENAL ULCER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DUODENAL ULCER HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
DUODENITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DYSPEPSIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
DYSPHAGIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
ENTERITIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
ENTEROVESICAL FISTULA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
EROSIVE OESOPHAGITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
FAECALOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
FOOD POISONING ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
GASTRIC HAEMORRHAGE ^† 1
# participants affected / at risk	4/6441 (0.06%)	3/6446 (0.05%)
# events	4	4
GASTRIC POLYPS ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
GASTRIC ULCER ^† 1
# participants affected / at risk	7/6441 (0.11%)	7/6446 (0.11%)
# events	8	7
GASTRIC ULCER HAEMORRHAGE ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
GASTRIC ULCER PERFORATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GASTRIC VARICES HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTRITIS ^† 1
# participants affected / at risk	5/6441 (0.08%)	14/6446 (0.22%)
# events	6	14
GASTRITIS EROSIVE ^† 1
# participants affected / at risk	3/6441 (0.05%)	5/6446 (0.08%)
# events	3	5
GASTRITIS HAEMORRHAGIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
GASTRODUODENITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
GASTROINTESTINAL DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
GASTROINTESTINAL EROSION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTROINTESTINAL HAEMORRHAGE ^† 1
# participants affected / at risk	13/6441 (0.20%)	26/6446 (0.40%)
# events	13	28
GASTROINTESTINAL NECROSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
GASTROINTESTINAL PERFORATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GASTROINTESTINAL ULCER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTROOESOPHAGEAL REFLUX DISEASE ^† 1
# participants affected / at risk	10/6441 (0.16%)	7/6446 (0.11%)
# events	10	7
GINGIVAL BLEEDING ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HAEMATEMESIS ^† 1
# participants affected / at risk	10/6441 (0.16%)	12/6446 (0.19%)
# events	10	12
HAEMATOCHEZIA ^† 1
# participants affected / at risk	5/6441 (0.08%)	10/6446 (0.16%)
# events	5	10
HAEMORRHAGIC EROSIVE GASTRITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HAEMORRHOIDAL HAEMORRHAGE ^† 1
# participants affected / at risk	3/6441 (0.05%)	4/6446 (0.06%)
# events	3	4
HAEMORRHOIDS ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
HYPERCHLORHYDRIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ILEUS ^† 1
# participants affected / at risk	3/6441 (0.05%)	4/6446 (0.06%)
# events	3	4
ILEUS PARALYTIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INGUINAL HERNIA ^† 1
# participants affected / at risk	6/6441 (0.09%)	16/6446 (0.25%)
# events	6	16
INGUINAL HERNIA, OBSTRUCTIVE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INTESTINAL HAEMATOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INTESTINAL HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INTESTINAL ISCHAEMIA ^† 1
# participants affected / at risk	3/6441 (0.05%)	5/6446 (0.08%)
# events	3	5
INTESTINAL OBSTRUCTION ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	4	4
INTESTINAL PERFORATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LARGE INTESTINAL HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LARGE INTESTINAL OBSTRUCTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LOCALISED INTRAABDOMINAL FLUID COLLECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LOWER GASTROINTESTINAL HAEMORRHAGE ^† 1
# participants affected / at risk	4/6441 (0.06%)	3/6446 (0.05%)
# events	4	3
MECHANICAL ILEUS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MELAENA ^† 1
# participants affected / at risk	26/6441 (0.40%)	38/6446 (0.59%)
# events	28	40
MESENTERIC VEIN THROMBOSIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
NAUSEA ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
OESOPHAGEAL PERFORATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
OESOPHAGEAL STENOSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
OESOPHAGEAL ULCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
OESOPHAGEAL ULCER HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
OESOPHAGITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	5/6446 (0.08%)
# events	0	5
OESOPHAGITIS HAEMORRHAGIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PANCREATIC CYST ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PANCREATITIS ^† 1
# participants affected / at risk	6/6441 (0.09%)	10/6446 (0.16%)
# events	6	10
PANCREATITIS ACUTE ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	4	4
PEPTIC ULCER ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
PERIODONTITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PERITONEAL HAEMATOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PERITONITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PHARYNGOESOPHAGEAL DIVERTICULUM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RECTAL HAEMORRHAGE ^† 1
# participants affected / at risk	22/6441 (0.34%)	26/6446 (0.40%)
# events	22	29
REFLUX OESOPHAGITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
RETROPERITONEAL FIBROSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RETROPERITONEAL HAEMATOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RETROPERITONEAL HAEMORRHAGE ^† 1
# participants affected / at risk	6/6441 (0.09%)	7/6446 (0.11%)
# events	6	7
SMALL INTESTINAL HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SMALL INTESTINAL OBSTRUCTION ^† 1
# participants affected / at risk	5/6441 (0.08%)	1/6446 (0.02%)
# events	5	1
SUBILEUS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
TONGUE DISORDER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TOOTHACHE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
UMBILICAL HERNIA ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
UMBILICAL HERNIA, OBSTRUCTIVE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
UPPER GASTROINTESTINAL HAEMORRHAGE ^† 1
# participants affected / at risk	6/6441 (0.09%)	10/6446 (0.16%)
# events	7	10
VOMITING ^† 1
# participants affected / at risk	8/6441 (0.12%)	3/6446 (0.05%)
# events	8	3
General disorders
ASTHENIA ^† 1
# participants affected / at risk	3/6441 (0.05%)	4/6446 (0.06%)
# events	3	4
BLOODY DISCHARGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CATHETER SITE HAEMATOMA ^† 1
# participants affected / at risk	16/6441 (0.25%)	13/6446 (0.20%)
# events	16	13
CATHETER SITE HAEMORRHAGE ^† 1
# participants affected / at risk	17/6441 (0.26%)	23/6446 (0.36%)
# events	17	23
CHEST DISCOMFORT ^† 1
# participants affected / at risk	5/6441 (0.08%)	6/6446 (0.09%)
# events	5	6
CHEST PAIN ^† 1
# participants affected / at risk	33/6441 (0.51%)	29/6446 (0.45%)
# events	42	30
CYST ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DEVICE BREAKAGE ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
DEVICE DISLOCATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
DEVICE MALFUNCTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
DRUG INTOLERANCE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
EXERCISE TOLERANCE DECREASED ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
FATIGUE ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
GAIT DISTURBANCE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GENERAL PHYSICAL HEALTH DETERIORATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
GENERALISED OEDEMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HERNIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HERNIA OBSTRUCTIVE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
HYPOTHERMIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
IMPAIRED HEALING ^† 1
# participants affected / at risk	1/6441 (0.02%)	6/6446 (0.09%)
# events	1	6
INFLAMMATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INFLUENZA LIKE ILLNESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INJECTION SITE HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
LOCAL SWELLING ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MALAISE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MEDICAL DEVICE COMPLICATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MUCOSAL INFLAMMATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MULTI-ORGAN DISORDER ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	2	4
MULTI-ORGAN FAILURE ^† 1
# participants affected / at risk	11/6441 (0.17%)	7/6446 (0.11%)
# events	11	7
NECROSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
NON-CARDIAC CHEST PAIN ^† 1
# participants affected / at risk	112/6441 (1.74%)	141/6446 (2.19%)
# events	127	158
OEDEMA PERIPHERAL ^† 1
# participants affected / at risk	3/6441 (0.05%)	4/6446 (0.06%)
# events	3	4
PAIN ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
POLYP ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PUNCTURE SITE REACTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PYREXIA ^† 1
# participants affected / at risk	6/6441 (0.09%)	4/6446 (0.06%)
# events	6	4
SECRETION DISCHARGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SENSATION OF PRESSURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SUDDEN CARDIAC DEATH ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
THROMBOSIS IN DEVICE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ULCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
Hepatobiliary disorders
ACUTE HEPATIC FAILURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BILE DUCT OBSTRUCTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BILE DUCT STONE ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	2	4
BILIARY COLIC ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
BILIARY DYSKINESIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CHOLANGITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CHOLANGITIS ACUTE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CHOLECYSTITIS ^† 1
# participants affected / at risk	18/6441 (0.28%)	9/6446 (0.14%)
# events	18	9
CHOLECYSTITIS ACUTE ^† 1
# participants affected / at risk	10/6441 (0.16%)	10/6446 (0.16%)
# events	10	10
CHOLELITHIASIS ^† 1
# participants affected / at risk	15/6441 (0.23%)	13/6446 (0.20%)
# events	15	13
GALLBLADDER DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
HEPATIC CIRRHOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HEPATIC FAILURE ^† 1
# participants affected / at risk	4/6441 (0.06%)	2/6446 (0.03%)
# events	4	2
HEPATIC STEATOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HEPATITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
HEPATITIS ACUTE ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
HEPATITIS TOXIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
JAUNDICE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LIVER DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
Immune system disorders
ALLERGY TO CHEMICALS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
AMYLOIDOSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ANAPHYLACTIC REACTION ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
ANAPHYLACTIC SHOCK ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ANTIPHOSPHOLIPID SYNDROME ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CONTRAST MEDIA ALLERGY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DRUG HYPERSENSITIVITY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
HYPERSENSITIVITY ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
SARCOIDOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
Infections and infestations
ABDOMINAL ABSCESS ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
ABDOMINAL INFECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
ABDOMINAL SEPSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ABSCESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ABSCESS LIMB ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ABSCESS ORAL ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ANAL ABSCESS ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	3	4
APPENDICITIS ^† 1
# participants affected / at risk	4/6441 (0.06%)	9/6446 (0.14%)
# events	4	9
APPENDICITIS PERFORATED ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
ARTERIOVENOUS GRAFT SITE INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ARTERITIS INFECTIVE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ARTHRITIS INFECTIVE ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
BACTERAEMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
BACTERIAL INFECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BACTERIAL SEPSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
BORRELIA INFECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
BRONCHITIS ^† 1
# participants affected / at risk	11/6441 (0.17%)	18/6446 (0.28%)
# events	12	18
BRONCHITIS VIRAL ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BRONCHOPNEUMONIA ^† 1
# participants affected / at risk	4/6441 (0.06%)	2/6446 (0.03%)
# events	4	2
CELLULITIS ^† 1
# participants affected / at risk	16/6441 (0.25%)	25/6446 (0.39%)
# events	16	26
CHEST WALL ABSCESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CHOLECYSTITIS INFECTIVE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CLOSTRIDIAL INFECTION ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
CLOSTRIDIUM DIFFICILE COLITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CYSTITIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	2
CYTOMEGALOVIRUS INFECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DEVICE RELATED INFECTION ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
DIABETIC FOOT INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DIVERTICULITIS ^† 1
# participants affected / at risk	8/6441 (0.12%)	13/6446 (0.20%)
# events	9	14
ENDOCARDITIS ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
ENTEROCOCCAL INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ENTEROCOCCAL SEPSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ERYSIPELAS ^† 1
# participants affected / at risk	5/6441 (0.08%)	3/6446 (0.05%)
# events	5	4
ESCHERICHIA SEPSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ESCHERICHIA URINARY TRACT INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
EYE INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GANGRENE ^† 1
# participants affected / at risk	4/6441 (0.06%)	0/6446 (0.00%)
# events	5	0
GASTROENTERITIS ^† 1
# participants affected / at risk	8/6441 (0.12%)	12/6446 (0.19%)
# events	9	13
GASTROENTERITIS NOROVIRUS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GASTROENTERITIS SALMONELLA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTROENTERITIS VIRAL ^† 1
# participants affected / at risk	3/6441 (0.05%)	4/6446 (0.06%)
# events	3	4
GRAFT INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
GROIN ABSCESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GROIN INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
H1N1 INFLUENZA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HAEMATOMA INFECTION ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
HEPATITIS B ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HEPATITIS C ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HERPES SIMPLEX ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HERPES ZOSTER ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
HIV INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
IMPLANT SITE INFECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INCISION SITE INFECTION ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
INFECTED CYST ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INFECTED SEBACEOUS CYST ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INFECTED SKIN ULCER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INFECTION ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	2
INFLUENZA ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
INJECTION SITE ABSCESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INTERVERTEBRAL DISCITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
KIDNEY INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LEISHMANIASIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LEPROSY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LIP INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LOBAR PNEUMONIA ^† 1
# participants affected / at risk	5/6441 (0.08%)	6/6446 (0.09%)
# events	5	6
LOCALISED INFECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	4/6446 (0.06%)
# events	1	4
LOWER RESPIRATORY TRACT INFECTION ^† 1
# participants affected / at risk	3/6441 (0.05%)	3/6446 (0.05%)
# events	3	3
LUNG INFECTION ^† 1
# participants affected / at risk	6/6441 (0.09%)	1/6446 (0.02%)
# events	6	1
LUNG INFECTION PSEUDOMONAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LYMPH NODE ABSCESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
MEDIASTINITIS ^† 1
# participants affected / at risk	4/6441 (0.06%)	5/6446 (0.08%)
# events	4	5
MENINGITIS ASEPTIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
METAPNEUMOVIRUS INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
NECROTISING FASCIITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
NOCARDIOSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ORCHITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
OSTEOMYELITIS ^† 1
# participants affected / at risk	7/6441 (0.11%)	6/6446 (0.09%)
# events	7	6
OSTEOMYELITIS CHRONIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
OTITIS MEDIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
OTITIS MEDIA CHRONIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PELVIC ABSCESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PERICARDITIS TUBERCULOUS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PERIDIVERTICULAR ABSCESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PERIRECTAL ABSCESS ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
PERITONEAL ABSCESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
PNEUMONIA ^† 1
# participants affected / at risk	83/6441 (1.29%)	100/6446 (1.55%)
# events	93	111
PNEUMONIA BACTERIAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PNEUMONIA HAEMOPHILUS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PNEUMONIA INFLUENZAL ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PNEUMONIA KLEBSIELLA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PNEUMONIA PNEUMOCOCCAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PNEUMONIA PRIMARY ATYPICAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
POST PROCEDURAL INFECTION ^† 1
# participants affected / at risk	3/6441 (0.05%)	3/6446 (0.05%)
# events	4	3
POSTOPERATIVE WOUND INFECTION ^† 1
# participants affected / at risk	6/6441 (0.09%)	9/6446 (0.14%)
# events	6	9
PSEUDOMEMBRANOUS COLITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	2
PSEUDOMONAS BRONCHITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PSOAS ABSCESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PYELONEPHRITIS ^† 1
# participants affected / at risk	5/6441 (0.08%)	1/6446 (0.02%)
# events	5	1
PYOTHORAX ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
RESPIRATORY TRACT INFECTION ^† 1
# participants affected / at risk	7/6441 (0.11%)	4/6446 (0.06%)
# events	7	4
RESPIRATORY TRACT INFECTION VIRAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SCROTAL ABSCESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SEPSIS ^† 1
# participants affected / at risk	23/6441 (0.36%)	24/6446 (0.37%)
# events	23	25
SEPTIC SHOCK ^† 1
# participants affected / at risk	18/6441 (0.28%)	11/6446 (0.17%)
# events	18	11
SERRATIA INFECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SHUNT INFECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SIALOADENITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SINUSITIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
SKIN INFECTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
SMALL INTESTINE GANGRENE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
STAPHYLOCOCCAL ABSCESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
STAPHYLOCOCCAL BACTERAEMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
STAPHYLOCOCCAL INFECTION ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
STAPHYLOCOCCAL MEDIASTINITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
STAPHYLOCOCCAL SEPSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
STERNITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
STITCH ABSCESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
STREPTOCOCCAL SEPSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
UPPER RESPIRATORY TRACT INFECTION ^† 1
# participants affected / at risk	6/6441 (0.09%)	3/6446 (0.05%)
# events	6	3
URINARY TRACT INFECTION ^† 1
# participants affected / at risk	26/6441 (0.40%)	23/6446 (0.36%)
# events	27	25
UROSEPSIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	8/6446 (0.12%)
# events	2	8
VESTIBULAR NEURONITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
VIRAL INFECTION ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
VIRAL UPPER RESPIRATORY TRACT INFECTION ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
WOUND INFECTION ^† 1
# participants affected / at risk	12/6441 (0.19%)	7/6446 (0.11%)
# events	12	7
WOUND INFECTION STAPHYLOCOCCAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	2	0
WOUND SEPSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
Injury, poisoning and procedural complications
ABDOMINAL INJURY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ABDOMINAL WOUND DEHISCENCE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ACCIDENTAL OVERDOSE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ALCOHOL POISONING ^† 1
# participants affected / at risk	4/6441 (0.06%)	2/6446 (0.03%)
# events	4	2
ANAEMIA POSTOPERATIVE ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
ANKLE FRACTURE ^† 1
# participants affected / at risk	3/6441 (0.05%)	3/6446 (0.05%)
# events	3	3
ARTERIAL INJURY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ARTERIOVENOUS FISTULA SITE HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BACK INJURY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CARDIAC PROCEDURE COMPLICATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CARDIAC VALVE RUPTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CEREBRAL HAEMORRHAGE TRAUMATIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CLAVICLE FRACTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COLLAPSE OF LUNG ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
COMMINUTED FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CONCUSSION ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
CONFUSION POSTOPERATIVE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CONTUSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	6/6446 (0.09%)
# events	1	8
CRUSH INJURY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
EXTRADURAL HAEMATOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
FACE INJURY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
FACIAL BONES FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
FALL ^† 1
# participants affected / at risk	16/6441 (0.25%)	22/6446 (0.34%)
# events	16	22
FEMORAL NECK FRACTURE ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	2	4
FEMUR FRACTURE ^† 1
# participants affected / at risk	4/6441 (0.06%)	9/6446 (0.14%)
# events	4	9
FIBULA FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
FOOT FRACTURE ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
FOREARM FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTROINTESTINAL STOMA COMPLICATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GUN SHOT WOUND ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HEAD INJURY ^† 1
# participants affected / at risk	3/6441 (0.05%)	4/6446 (0.06%)
# events	3	4
HEPATIC HAEMATOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HEPATIC RUPTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HIP FRACTURE ^† 1
# participants affected / at risk	5/6441 (0.08%)	7/6446 (0.11%)
# events	5	7
HUMERUS FRACTURE ^† 1
# participants affected / at risk	3/6441 (0.05%)	4/6446 (0.06%)
# events	3	4
INCISION SITE COMPLICATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INCISION SITE HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INCISIONAL HERNIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INFLAMMATION OF WOUND ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
JOINT DISLOCATION ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
LACERATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
LIMB INJURY ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
LIMB TRAUMATIC AMPUTATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LUMBAR VERTEBRAL FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
MENISCUS LESION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
MULTIPLE FRACTURES ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
MUSCLE STRAIN ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
OPEN FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
OPERATIVE HAEMORRHAGE ^† 1
# participants affected / at risk	11/6441 (0.17%)	10/6446 (0.16%)
# events	12	10
OVERDOSE ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	2	4
PATELLA FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
PELVIC FRACTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
PERIPROSTHETIC FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
POST PROCEDURAL COMPLICATION ^† 1
# participants affected / at risk	6/6441 (0.09%)	3/6446 (0.05%)
# events	6	3
POST PROCEDURAL DISCHARGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
POST PROCEDURAL HAEMATOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
POST PROCEDURAL HAEMORRHAGE ^† 1
# participants affected / at risk	91/6441 (1.41%)	112/6446 (1.74%)
# events	91	114
POSTOPERATIVE HERNIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
POSTOPERATIVE ILEUS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
POSTOPERATIVE THORACIC PROCEDURE COMPLICATION ^† 1
# participants affected / at risk	5/6441 (0.08%)	4/6446 (0.06%)
# events	5	4
POSTOPERATIVE WOUND COMPLICATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
POSTPERICARDIOTOMY SYNDROME ^† 1
# participants affected / at risk	4/6441 (0.06%)	3/6446 (0.05%)
# events	4	3
PROCEDURAL PAIN ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
PUBIS FRACTURE ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
RADIUS FRACTURE ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
RIB FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
ROAD TRAFFIC ACCIDENT ^† 1
# participants affected / at risk	2/6441 (0.03%)	7/6446 (0.11%)
# events	2	8
SHUNT MALFUNCTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SKULL FRACTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
SKULL FRACTURED BASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SOFT TISSUE INJURY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SPINAL COMPRESSION FRACTURE ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	3
SPINAL FRACTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SPLENIC RUPTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
STAB WOUND ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
STERNAL FRACTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SUBDURAL HAEMATOMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	9/6446 (0.14%)
# events	2	9
SUBDURAL HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
TENDON INJURY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TENDON RUPTURE ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
THERMAL BURN ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TIBIA FRACTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
TOXICITY TO VARIOUS AGENTS ^† 1
# participants affected / at risk	5/6441 (0.08%)	0/6446 (0.00%)
# events	5	0
TRANSPLANT FAILURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TRAUMATIC LIVER INJURY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
TRAUMATIC LUNG INJURY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
UPPER LIMB FRACTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	4/6446 (0.06%)
# events	1	4
URINARY RETENTION POSTOPERATIVE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
VASCULAR PROCEDURE COMPLICATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
VASCULAR PSEUDOANEURYSM ^† 1
# participants affected / at risk	5/6441 (0.08%)	17/6446 (0.26%)
# events	5	17
VASOPLEGIA SYNDROME ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VENA CAVA INJURY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
WOUND ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
WOUND COMPLICATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
WOUND DEHISCENCE ^† 1
# participants affected / at risk	4/6441 (0.06%)	0/6446 (0.00%)
# events	4	0
WOUND HAEMORRHAGE ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
WOUND SECRETION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
WRIST FRACTURE ^† 1
# participants affected / at risk	6/6441 (0.09%)	0/6446 (0.00%)
# events	6	0
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ALANINE AMINOTRANSFERASE INCREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BLEEDING TIME PROLONGED ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
BLOOD ALKALINE PHOSPHATASE INCREASED ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BLOOD BILIRUBIN INCREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BLOOD CREATINE PHOSPHOKINASE INCREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BLOOD CREATINE PHOSPHOKINASE MB INCREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BLOOD CREATININE INCREASED ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
BLOOD CULTURE POSITIVE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BLOOD GLUCOSE ABNORMAL ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BLOOD GLUCOSE INCREASED ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	2
BLOOD POTASSIUM DECREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BLOOD PRESSURE INCREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
C-REACTIVE PROTEIN INCREASED ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
CARDIAC MONITORING ABNORMAL ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CAROTID BRUIT ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
EJECTION FRACTION DECREASED ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
GAMMA-GLUTAMYLTRANSFERASE INCREASED ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
HAEMOGLOBIN DECREASED ^† 1
# participants affected / at risk	11/6441 (0.17%)	12/6446 (0.19%)
# events	11	12
HEART RATE IRREGULAR ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HEPATIC ENZYME INCREASED ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	4	4
LIPOPROTEIN (A) INCREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LIVER FUNCTION TEST ABNORMAL ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
OCCULT BLOOD POSITIVE ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
PLATELET COUNT DECREASED ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	5	4
TRANSAMINASES INCREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TROPONIN INCREASED ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
URINE OUTPUT DECREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
WEIGHT DECREASED ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
WEIGHT INCREASED ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
Metabolism and nutrition disorders
CACHEXIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DEHYDRATION ^† 1
# participants affected / at risk	10/6441 (0.16%)	7/6446 (0.11%)
# events	10	9
DIABETES MELLITUS ^† 1
# participants affected / at risk	11/6441 (0.17%)	6/6446 (0.09%)
# events	13	6
DIABETES MELLITUS INADEQUATE CONTROL ^† 1
# participants affected / at risk	5/6441 (0.08%)	9/6446 (0.14%)
# events	5	9
DIABETIC FOOT ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
DIABETIC KETOACIDOSIS ^† 1
# participants affected / at risk	4/6441 (0.06%)	3/6446 (0.05%)
# events	4	8
ELECTROLYTE IMBALANCE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
FAILURE TO THRIVE ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
FLUID OVERLOAD ^† 1
# participants affected / at risk	6/6441 (0.09%)	2/6446 (0.03%)
# events	7	2
FLUID RETENTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GOUT ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	2
HYPERGLYCAEMIA ^† 1
# participants affected / at risk	8/6441 (0.12%)	7/6446 (0.11%)
# events	8	7
HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HYPERKALAEMIA ^† 1
# participants affected / at risk	9/6441 (0.14%)	5/6446 (0.08%)
# events	10	5
HYPOCALCAEMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
HYPOGLYCAEMIA ^† 1
# participants affected / at risk	11/6441 (0.17%)	10/6446 (0.16%)
# events	11	12
HYPOGLYCAEMIC UNCONSCIOUSNESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HYPOKALAEMIA ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	2
HYPONATRAEMIA ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	4	4
IRON DEFICIENCY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LACTIC ACIDOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
OBESITY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TYPE 2 DIABETES MELLITUS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1
# participants affected / at risk	5/6441 (0.08%)	4/6446 (0.06%)
# events	5	4
ARTHRITIS ^† 1
# participants affected / at risk	4/6441 (0.06%)	5/6446 (0.08%)
# events	4	5
ARTHRITIS REACTIVE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ARTHROPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
ARTICULAR CALCIFICATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BACK PAIN ^† 1
# participants affected / at risk	8/6441 (0.12%)	8/6446 (0.12%)
# events	8	8
BONE PAIN ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BURSITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CERVICAL SPINAL STENOSIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
CHONDRITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
COMPARTMENT SYNDROME ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CRYSTAL ARTHROPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GROIN PAIN ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HAEMARTHROSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INTERVERTEBRAL DISC PROTRUSION ^† 1
# participants affected / at risk	9/6441 (0.14%)	3/6446 (0.05%)
# events	9	3
JOINT EFFUSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
KYPHOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LUMBAR SPINAL STENOSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	4/6446 (0.06%)
# events	0	4
MUSCLE HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
MUSCLE TIGHTNESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MUSCULAR WEAKNESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MUSCULOSKELETAL CHEST PAIN ^† 1
# participants affected / at risk	19/6441 (0.29%)	14/6446 (0.22%)
# events	19	16
MUSCULOSKELETAL PAIN ^† 1
# participants affected / at risk	5/6441 (0.08%)	10/6446 (0.16%)
# events	5	10
MYALGIA ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	4	6
MYALGIA INTERCOSTAL ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
MYOPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
MYOSCLEROSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
NECK PAIN ^† 1
# participants affected / at risk	5/6441 (0.08%)	2/6446 (0.03%)
# events	5	2
OSTEOARTHRITIS ^† 1
# participants affected / at risk	22/6441 (0.34%)	16/6446 (0.25%)
# events	22	16
OSTEONECROSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PAIN IN EXTREMITY ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	3	5
POLYARTHRITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
RHABDOMYOLYSIS ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
RHEUMATOID ARTHRITIS ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
ROTATOR CUFF SYNDROME ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
SCOLIOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SPINAL COLUMN STENOSIS ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
SPINAL DISORDER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SPONDYLOLISTHESIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
SYMPATHETIC POSTERIOR CERVICAL SYNDROME ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SYNOVIAL CYST ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
TENDONITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TRIGGER FINGER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ABDOMINAL NEOPLASM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ADENOCARCINOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ADRENAL ADENOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ADRENAL NEOPLASM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
B-CELL LYMPHOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
BASAL CELL CARCINOMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	3	3
BENIGN LUNG NEOPLASM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BENIGN NEOPLASM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BENIGN NEOPLASM OF BLADDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BENIGN OESOPHAGEAL NEOPLASM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BILE DUCT CANCER ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
BLADDER CANCER ^† 1
# participants affected / at risk	5/6441 (0.08%)	9/6446 (0.14%)
# events	5	9
BLADDER NEOPLASM ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	2	5
BLADDER TRANSITIONAL CELL CARCINOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BRAIN NEOPLASM BENIGN ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BREAST CANCER ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
BREAST NEOPLASM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BRONCHIAL CARCINOMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
CANCER PAIN ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CARDIAC VALVE FIBROELASTOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CEREBRAL HAEMANGIOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CHRONIC LYMPHOCYTIC LEUKAEMIA ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
CHRONIC MYELOMONOCYTIC LEUKAEMIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COLON ADENOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COLON CANCER ^† 1
# participants affected / at risk	10/6441 (0.16%)	20/6446 (0.31%)
# events	10	20
COLON CANCER STAGE II ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COLON CANCER STAGE III ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
COLON NEOPLASM ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
COLORECTAL CANCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ENDOMETRIAL CANCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
ENDOMETRIAL CANCER STAGE I ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
ENDOMETRIAL NEOPLASM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
FIBROMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTRIC CANCER ^† 1
# participants affected / at risk	7/6441 (0.11%)	4/6446 (0.06%)
# events	7	4
GASTRIC CANCER STAGE 0 ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTRIC NEOPLASM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
GASTROINTESTINAL CANCER METASTATIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
GASTROINTESTINAL TRACT ADENOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
GASTROOESOPHAGEAL CANCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HEPATIC NEOPLASM MALIGNANT ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
HODGKIN'S DISEASE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HODGKIN'S DISEASE MIXED CELLULARITY STAGE UNSPECIFIED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INTESTINAL ADENOCARCINOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
INTRAOCULAR MELANOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
IRITIC MELANOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LARYNGEAL CANCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
LIPOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LUNG ADENOCARCINOMA ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
LUNG ADENOCARCINOMA METASTATIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LUNG CANCER METASTATIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LUNG NEOPLASM ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	2	4
LUNG NEOPLASM MALIGNANT ^† 1
# participants affected / at risk	2/6441 (0.03%)	8/6446 (0.12%)
# events	2	8
LUNG SQUAMOUS CELL CARCINOMA STAGE III ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LYMPHOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MALIGNANT GLIOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MALIGNANT MELANOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	4
MEDIASTINUM NEOPLASM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
METASTASES TO BONE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
METASTASES TO CENTRAL NERVOUS SYSTEM ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
METASTASES TO LARYNX ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
METASTASES TO LIVER ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
METASTASES TO LUNG ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
METASTASES TO LYMPH NODES ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
METASTATIC MALIGNANT MELANOMA ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
METASTATIC NEOPLASM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
METASTATIC RENAL CELL CARCINOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
METASTATIC SQUAMOUS CELL CARCINOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
MYELODYSPLASTIC SYNDROME ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
NASAL CAVITY CANCER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
NEOPLASM MALIGNANT ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
NEUROENDOCRINE CARCINOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
NON-SMALL CELL LUNG CANCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
OESOPHAGEAL CARCINOMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
OESOPHAGEAL CARCINOMA RECURRENT ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
OVARIAN CANCER ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
OVARIAN CANCER METASTATIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
OVARIAN NEOPLASM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PAGET'S DISEASE OF SKIN ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PANCREATIC CARCINOMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
PAPILLOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PHAEOCHROMOCYTOMA ^† 1
# participants affected / at risk	4/6441 (0.06%)	0/6446 (0.00%)
# events	4	0
PITUITARY TUMOUR BENIGN ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PROSTATE CANCER ^† 1
# participants affected / at risk	6/6441 (0.09%)	7/6446 (0.11%)
# events	6	8
PROSTATE CANCER METASTATIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
PROSTATE CANCER RECURRENT ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PROSTATIC ADENOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RECTAL ADENOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
RECTAL CANCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
RECTAL NEOPLASM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RENAL CANCER ^† 1
# participants affected / at risk	4/6441 (0.06%)	0/6446 (0.00%)
# events	4	0
RENAL CANCER RECURRENT ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RENAL CELL CARCINOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	3/6446 (0.05%)
# events	0	3
RENAL CELL CARCINOMA RECURRENT ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
RENAL NEOPLASM ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
RENAL ONCOCYTOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SARCOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SMALL CELL LUNG CANCER STAGE UNSPECIFIED ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SMALL INTESTINE CARCINOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SQUAMOUS CELL CARCINOMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	2
SQUAMOUS CELL CARCINOMA OF SKIN ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
T-CELL LYMPHOMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
TESTIS CANCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
THYROID NEOPLASM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
TRANSITIONAL CELL CARCINOMA ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
UTERINE CANCER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
Nervous system disorders
ALCOHOLIC SEIZURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ATAXIA ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
BRACHIAL PLEXOPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BRAIN MASS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
BRAIN OEDEMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CAROTID ARTERY DISEASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
CAROTID ARTERY OCCLUSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
CAROTID ARTERY STENOSIS ^† 1
# participants affected / at risk	11/6441 (0.17%)	17/6446 (0.26%)
# events	12	18
CARPAL TUNNEL SYNDROME ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
CEREBELLAR HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CEREBRAL HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	4/6446 (0.06%)
# events	1	4
CEREBRAL HYPOPERFUSION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CERVICOBRACHIAL SYNDROME ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
CLUSTER HEADACHE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CONVULSION ^† 1
# participants affected / at risk	9/6441 (0.14%)	6/6446 (0.09%)
# events	9	7
CRANIAL NERVE PARALYSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CRITICAL ILLNESS POLYNEUROPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DEMENTIA ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
DEMENTIA ALZHEIMER'S TYPE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DEMENTIA WITH LEWY BODIES ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DEPRESSED LEVEL OF CONSCIOUSNESS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DIABETIC NEUROPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
DIZZINESS ^† 1
# participants affected / at risk	10/6441 (0.16%)	5/6446 (0.08%)
# events	12	5
DYSAESTHESIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DYSARTHRIA ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
ENCEPHALOPATHY ^† 1
# participants affected / at risk	4/6441 (0.06%)	2/6446 (0.03%)
# events	4	2
EPILEPSY ^† 1
# participants affected / at risk	4/6441 (0.06%)	1/6446 (0.02%)
# events	4	1
GRAND MAL CONVULSION ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	2
HAEMORRHAGE INTRACRANIAL ^† 1
# participants affected / at risk	12/6441 (0.19%)	33/6446 (0.51%)
# events	13	35
HAEMORRHAGIC STROKE ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
HAEMORRHAGIC TRANSFORMATION STROKE ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
HEADACHE ^† 1
# participants affected / at risk	12/6441 (0.19%)	2/6446 (0.03%)
# events	12	2
HEMIPARESIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
HEPATIC ENCEPHALOPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HYPERTENSIVE ENCEPHALOPATHY ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
HYPOAESTHESIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HYPOKINESIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HYPOTONIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
INTERCOSTAL NEURALGIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INTRACRANIAL ANEURYSM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LETHARGY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
LOSS OF CONSCIOUSNESS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
MENTAL IMPAIRMENT ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
MIGRAINE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MYASTHENIA GRAVIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
MYELOPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
NERVE COMPRESSION ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
NERVE DEGENERATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
NERVE ROOT COMPRESSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
NERVOUS SYSTEM DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
NEURITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
NEUROMYOPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
NEUROPATHY PERIPHERAL ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
NORMAL PRESSURE HYDROCEPHALUS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PARAESTHESIA ^† 1
# participants affected / at risk	5/6441 (0.08%)	0/6446 (0.00%)
# events	5	0
PARAPARESIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PARKINSON'S DISEASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
PARTIAL SEIZURES ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PERONEAL NERVE PALSY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PHRENIC NERVE PARALYSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PRESYNCOPE ^† 1
# participants affected / at risk	7/6441 (0.11%)	4/6446 (0.06%)
# events	7	4
PSYCHOMOTOR HYPERACTIVITY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SCIATICA ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	4	1
SEDATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
SENSORIMOTOR DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SENSORY LOSS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SPINAL CORD COMPRESSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SPONDYLITIC MYELOPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SUBARACHNOID HAEMORRHAGE ^† 1
# participants affected / at risk	3/6441 (0.05%)	3/6446 (0.05%)
# events	3	3
SUBDURAL HYGROMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SYNCOPE ^† 1
# participants affected / at risk	48/6441 (0.75%)	44/6446 (0.68%)
# events	48	48
SYRINGOMYELIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	2	0
TREMOR ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VASCULAR ENCEPHALOPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
VERTEBRAL ARTERY STENOSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
VIITH NERVE PARALYSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
Psychiatric disorders
ABNORMAL BEHAVIOUR ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
AGITATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ALCOHOL ABUSE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ALCOHOL WITHDRAWAL SYNDROME ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
ALCOHOLISM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ANXIETY ^† 1
# participants affected / at risk	7/6441 (0.11%)	3/6446 (0.05%)
# events	7	3
ANXIETY DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BIPOLAR I DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COMPLETED SUICIDE ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
CONFUSIONAL STATE ^† 1
# participants affected / at risk	4/6441 (0.06%)	5/6446 (0.08%)
# events	4	5
DELIRIUM ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
DEPRESSION ^† 1
# participants affected / at risk	8/6441 (0.12%)	11/6446 (0.17%)
# events	10	15
HALLUCINATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HALLUCINATION, VISUAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
MAJOR DEPRESSION ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	2
MENTAL STATUS CHANGES ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
PANIC ATTACK ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PSYCHOTIC DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SUBSTANCE ABUSE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SUICIDAL IDEATION ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
SUICIDE ATTEMPT ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
TOBACCO WITHDRAWAL SYMPTOMS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
Renal and urinary disorders
BLADDER DYSFUNCTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CALCULUS BLADDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
CALCULUS URETERIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	4/6446 (0.06%)
# events	1	4
CALCULUS URINARY ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	2
HAEMATURIA ^† 1
# participants affected / at risk	15/6441 (0.23%)	31/6446 (0.48%)
# events	16	37
HAEMORRHAGE URINARY TRACT ^† 1
# participants affected / at risk	2/6441 (0.03%)	5/6446 (0.08%)
# events	2	6
HYDRONEPHROSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
NEPHROLITHIASIS ^† 1
# participants affected / at risk	6/6441 (0.09%)	7/6446 (0.11%)
# events	6	7
NEPHROPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
NEPHROPATHY TOXIC ^† 1
# participants affected / at risk	3/6441 (0.05%)	1/6446 (0.02%)
# events	3	1
NEPHROTIC SYNDROME ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
NEUROGENIC BLADDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	2	0
OBSTRUCTIVE UROPATHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
POLYURIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RENAL ANEURYSM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RENAL ARTERY OCCLUSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RENAL ARTERY STENOSIS ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	4	2
RENAL COLIC ^† 1
# participants affected / at risk	4/6441 (0.06%)	6/6446 (0.09%)
# events	5	6
RENAL CYST ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RENAL DISORDER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
RENAL FAILURE ^† 1
# participants affected / at risk	50/6441 (0.78%)	56/6446 (0.87%)
# events	55	61
RENAL FAILURE ACUTE ^† 1
# participants affected / at risk	36/6441 (0.56%)	38/6446 (0.59%)
# events	38	39
RENAL FAILURE CHRONIC ^† 1
# participants affected / at risk	5/6441 (0.08%)	8/6446 (0.12%)
# events	5	9
RENAL IMPAIRMENT ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
RENAL MASS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RENAL TUBULAR NECROSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
STRESS URINARY INCONTINENCE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
TUBULOINTERSTITIAL NEPHRITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
URINARY RETENTION ^† 1
# participants affected / at risk	4/6441 (0.06%)	6/6446 (0.09%)
# events	4	6
URINARY TRACT OBSTRUCTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA ^† 1
# participants affected / at risk	4/6441 (0.06%)	9/6446 (0.14%)
# events	4	9
BREAST INFLAMMATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
CYSTOCELE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
EPIDIDYMITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
GENITAL HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
OVARIAN CYST ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PELVIC FLUID COLLECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
POSTMENOPAUSAL HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
PROSTATITIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	3
PROSTATOMEGALY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
RECTOCELE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
UTERINE ENLARGEMENT ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
UTERINE PROLAPSE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VAGINAL PROLAPSE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA ^† 1
# participants affected / at risk	9/6441 (0.14%)	14/6446 (0.22%)
# events	9	14
ACUTE RESPIRATORY DISTRESS SYNDROME ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	4	4
ACUTE RESPIRATORY FAILURE ^† 1
# participants affected / at risk	16/6441 (0.25%)	15/6446 (0.23%)
# events	16	16
ALLERGIC GRANULOMATOUS ANGIITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ALVEOLITIS ALLERGIC ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
APNOEA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ASPIRATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
ASTHMA ^† 1
# participants affected / at risk	5/6441 (0.08%)	3/6446 (0.05%)
# events	6	3
ATELECTASIS ^† 1
# participants affected / at risk	6/6441 (0.09%)	2/6446 (0.03%)
# events	6	2
BRONCHIAL HYPERREACTIVITY ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
BRONCHIAL OBSTRUCTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
BRONCHITIS CHRONIC ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
BRONCHOSPASM ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
CHRONIC OBSTRUCTIVE PULMONARY DISEASE ^† 1
# participants affected / at risk	51/6441 (0.79%)	44/6446 (0.68%)
# events	71	68
CHYLOTHORAX ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
COUGH ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
DIAPHRAGMATIC HERNIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DIAPHRAGMATIC PARALYSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
DYSPNOEA ^† 1
# participants affected / at risk	20/6441 (0.31%)	20/6446 (0.31%)
# events	20	22
DYSPNOEA EXERTIONAL ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
DYSPNOEA PAROXYSMAL NOCTURNAL ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
EPISTAXIS ^† 1
# participants affected / at risk	9/6441 (0.14%)	21/6446 (0.33%)
# events	9	22
HAEMOPTYSIS ^† 1
# participants affected / at risk	7/6441 (0.11%)	7/6446 (0.11%)
# events	8	7
HAEMOTHORAX ^† 1
# participants affected / at risk	7/6441 (0.11%)	3/6446 (0.05%)
# events	7	3
HICCUPS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
HYDROTHORAX ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HYPERVENTILATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
INTERSTITIAL LUNG DISEASE ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	3	0
LARYNGEAL OEDEMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LARYNGEAL STENOSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LUNG DISORDER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LUNG INFILTRATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
NASAL POLYPS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
OBSTRUCTIVE AIRWAYS DISORDER ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
OROPHARYNGEAL SWELLING ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PHARYNGEAL HAEMORRHAGE ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
PLEURAL EFFUSION ^† 1
# participants affected / at risk	30/6441 (0.47%)	32/6446 (0.50%)
# events	31	38
PLEURAL HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PLEURISY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PLEURITIC PAIN ^† 1
# participants affected / at risk	1/6441 (0.02%)	2/6446 (0.03%)
# events	1	2
PNEUMONIA ASPIRATION ^† 1
# participants affected / at risk	6/6441 (0.09%)	4/6446 (0.06%)
# events	7	4
PNEUMONITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
PNEUMOTHORAX ^† 1
# participants affected / at risk	3/6441 (0.05%)	4/6446 (0.06%)
# events	3	4
PULMONARY ALVEOLAR HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
PULMONARY CONGESTION ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	4	4
PULMONARY EMBOLISM ^† 1
# participants affected / at risk	34/6441 (0.53%)	20/6446 (0.31%)
# events	34	20
PULMONARY EOSINOPHILIA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PULMONARY FIBROSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
PULMONARY HAEMORRHAGE ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
PULMONARY HYPERTENSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PULMONARY MASS ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
PULMONARY OEDEMA ^† 1
# participants affected / at risk	12/6441 (0.19%)	19/6446 (0.29%)
# events	13	23
RESPIRATORY ARREST ^† 1
# participants affected / at risk	2/6441 (0.03%)	4/6446 (0.06%)
# events	2	4
RESPIRATORY DISTRESS ^† 1
# participants affected / at risk	2/6441 (0.03%)	5/6446 (0.08%)
# events	2	5
RESPIRATORY FAILURE ^† 1
# participants affected / at risk	26/6441 (0.40%)	30/6446 (0.47%)
# events	27	30
RESPIRATORY TRACT INFLAMMATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
RESTRICTIVE PULMONARY DISEASE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SLEEP APNOEA SYNDROME ^† 1
# participants affected / at risk	2/6441 (0.03%)	2/6446 (0.03%)
# events	2	2
TONSILLAR HYPERTROPHY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
VOCAL CORD POLYP ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	2
Skin and subcutaneous tissue disorders
ANGIOEDEMA ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
DECUBITUS ULCER ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DERMATITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
DERMATITIS EXFOLIATIVE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DIABETIC ULCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DRUG ERUPTION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
DYSHIDROSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
HYPERHIDROSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
NEUROPATHIC ULCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PEMPHIGOID ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PEMPHIGUS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PSORIASIS ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
PURPURA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
RASH ^† 1
# participants affected / at risk	3/6441 (0.05%)	2/6446 (0.03%)
# events	3	2
RASH MACULO-PAPULAR ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SKIN EXFOLIATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SKIN HAEMORRHAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SKIN LESION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SKIN NECROSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
SKIN ULCER ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
STASIS DERMATITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SUBCUTANEOUS EMPHYSEMA ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
URTICARIA ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
Surgical and medical procedures
CARDIAC OPERATION ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
CATARACT OPERATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
DIABETES MELLITUS MANAGEMENT ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
WOUND DRAINAGE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
Vascular disorders
ACCELERATED HYPERTENSION ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
ANEURYSM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
AORTIC ANEURYSM ^† 1
# participants affected / at risk	5/6441 (0.08%)	6/6446 (0.09%)
# events	5	7
AORTIC ANEURYSM RUPTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
AORTIC DISSECTION ^† 1
# participants affected / at risk	6/6441 (0.09%)	2/6446 (0.03%)
# events	6	2
AORTIC DISSECTION RUPTURE ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
AORTIC RUPTURE ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
AORTIC STENOSIS ^† 1
# participants affected / at risk	4/6441 (0.06%)	4/6446 (0.06%)
# events	4	4
AORTIC THROMBOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ARTERIAL OCCLUSIVE DISEASE ^† 1
# participants affected / at risk	4/6441 (0.06%)	0/6446 (0.00%)
# events	4	0
ARTERIAL STENOSIS LIMB ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ARTERIAL THROMBOSIS LIMB ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	3
ARTERIOSCLEROSIS OBLITERANS ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
ARTERIOVENOUS FISTULA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
CIRCULATORY COLLAPSE ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
COELIAC ARTERY OCCLUSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
DEEP VEIN THROMBOSIS ^† 1
# participants affected / at risk	10/6441 (0.16%)	13/6446 (0.20%)
# events	10	13
DIABETIC MACROANGIOPATHY ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
EMBOLISM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ESSENTIAL HYPERTENSION ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
FEMORAL ARTERIAL STENOSIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
FEMORAL ARTERY ANEURYSM ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
FEMORAL ARTERY DISSECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
FEMORAL ARTERY OCCLUSION ^† 1
# participants affected / at risk	3/6441 (0.05%)	0/6446 (0.00%)
# events	3	0
HAEMATOMA ^† 1
# participants affected / at risk	7/6441 (0.11%)	20/6446 (0.31%)
# events	7	26
HAEMODYNAMIC INSTABILITY ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
HAEMORRHAGE ^† 1
# participants affected / at risk	12/6441 (0.19%)	13/6446 (0.20%)
# events	12	13
HYPERTENSION ^† 1
# participants affected / at risk	23/6441 (0.36%)	22/6446 (0.34%)
# events	25	24
HYPERTENSIVE CRISIS ^† 1
# participants affected / at risk	13/6441 (0.20%)	20/6446 (0.31%)
# events	13	21
HYPERTENSIVE EMERGENCY ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
HYPOTENSION ^† 1
# participants affected / at risk	28/6441 (0.43%)	29/6446 (0.45%)
# events	29	29
HYPOVOLAEMIC SHOCK ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
ILIAC ARTERY STENOSIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	3/6446 (0.05%)
# events	2	3
INTERMITTENT CLAUDICATION ^† 1
# participants affected / at risk	14/6441 (0.22%)	9/6446 (0.14%)
# events	16	9
INTRA-ABDOMINAL HAEMATOMA ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
JUGULAR VEIN THROMBOSIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
LABILE HYPERTENSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
LERICHE SYNDROME ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
MALIGNANT HYPERTENSION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
ORTHOSTATIC HYPOTENSION ^† 1
# participants affected / at risk	10/6441 (0.16%)	6/6446 (0.09%)
# events	10	6
PELVIC VENOUS THROMBOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE ^† 1
# participants affected / at risk	11/6441 (0.17%)	13/6446 (0.20%)
# events	12	14
PERIPHERAL ARTERY ANEURYSM ^† 1
# participants affected / at risk	2/6441 (0.03%)	0/6446 (0.00%)
# events	2	0
PERIPHERAL ARTERY DISSECTION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PERIPHERAL EMBOLISM ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
PERIPHERAL ISCHAEMIA ^† 1
# participants affected / at risk	9/6441 (0.14%)	7/6446 (0.11%)
# events	10	7
PERIPHERAL VASCULAR DISORDER ^† 1
# participants affected / at risk	5/6441 (0.08%)	8/6446 (0.12%)
# events	7	9
PHLEBITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
POOR PERIPHERAL CIRCULATION ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
SHOCK ^† 1
# participants affected / at risk	1/6441 (0.02%)	3/6446 (0.05%)
# events	1	3
SHOCK HAEMORRHAGIC ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
SUBCLAVIAN ARTERY STENOSIS ^† 1
# participants affected / at risk	2/6441 (0.03%)	1/6446 (0.02%)
# events	2	1
SUBCLAVIAN STEAL SYNDROME ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
TEMPORAL ARTERITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	2
THROMBOANGIITIS OBLITERANS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
THROMBOPHLEBITIS ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
THROMBOPHLEBITIS SUPERFICIAL ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VARICOSE VEIN ^† 1
# participants affected / at risk	0/6441 (0.00%)	2/6446 (0.03%)
# events	0	2
VASCULAR INSUFFICIENCY ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
VASCULAR STENOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VASCULITIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VASODILATATION ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1
VENA CAVA THROMBOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	0/6446 (0.00%)
# events	1	0
VENOUS THROMBOSIS ^† 1
# participants affected / at risk	1/6441 (0.02%)	1/6446 (0.02%)
# events	1	1
VENOUS THROMBOSIS LIMB ^† 1
# participants affected / at risk	0/6441 (0.00%)	1/6446 (0.02%)
# events	0	1

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 14.0

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Prior to the planned study completion, the Data Safety Monitoring Board recommended that all participants stop treatment and that the study be closed-out. The protocol-defined target number of primary efficacy endpoints had been reached by this time.

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All draft publications will be submitted to the Publication Committee for review. Full-length papers will be submitted at least 45 days prior to submission to a journal. Abstracts or public presentations (eg, poster) will be submitted at least 14 days in advance.

Results Point of Contact:

Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

Publications of Results:

Storey RF, Kotha J, Smyth SS, Moliterno DJ, Rorick TL, Moccetti T, Valgimigli M, Dery JP, Cornel JH, Thomas GS, Huber K, Harrington RA, Hord E, Judge HM, Chen E, Strony J, Mahaffey KW, Tricoci P, Becker RC, Jennings LK. Effects of vorapaxar on platelet reactivity and biomarker expression in non-ST-elevation acute coronary syndromes. The TRACER Pharmacodynamic Substudy. Thromb Haemost. 2014 May 5;111(5):883-91. doi: 10.1160/TH13-07-0624. Epub 2014 Jan 9.

Valgimigli M, Tricoci P, Huang Z, Aylward PE, Armstrong PW, Van de Werf F, Leonardi S, White HD, Widimsky P, Harrington RA, Cequier A, Chen E, Lokhnygina Y, Wallentin L, Strony J, Mahaffey KW, Moliterno DJ. Usefulness and safety of vorapaxar in patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention (from the TRACER Trial). Am J Cardiol. 2014 Sep 1;114(5):665-73. doi: 10.1016/j.amjcard.2014.05.054. Epub 2014 Jun 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Popma CJ, Sheng S, Korjian S, Daaboul Y, Chi G, Tricoci P, Huang Z, Moliterno DJ, White HD, Van de Werf F, Harrington RA, Wallentin L, Held C, Armstrong PW, Aylward PE, Strony J, Mahaffey KW, Gibson CM. Lack of Concordance Between Local Investigators, Angiographic Core Laboratory, and Clinical Event Committee in the Assessment of Stent Thrombosis: Results From the TRACER Angiographic Substudy. Circ Cardiovasc Interv. 2016 May;9(5):e003114. doi: 10.1161/CIRCINTERVENTIONS.115.003114.

Vranckx P, White HD, Huang Z, Mahaffey KW, Armstrong PW, Van de Werf F, Moliterno DJ, Wallentin L, Held C, Aylward PE, Cornel JH, Bode C, Huber K, Nicolau JC, Ruzyllo W, Harrington RA, Tricoci P. Validation of BARC Bleeding Criteria in Patients With Acute Coronary Syndromes: The TRACER Trial. J Am Coll Cardiol. 2016 May 10;67(18):2135-44. doi: 10.1016/j.jacc.2016.02.056.

Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

Bagai A, Huang Z, Lokhnygina Y, Harrington RA, Armstrong PW, Strony J, White HD, Leonardi S, Held C, Van de Werf F, Wallentin L, Tricoci P, Mahaffey KW. Magnitude of troponin elevation and long-term clinical outcomes in acute coronary syndrome patients treated with and without revascularization. Circ Cardiovasc Interv. 2015 Jun;8(6):e002314. doi: 10.1161/CIRCINTERVENTIONS.115.002314.

White HD, Huang Z, Tricoci P, Van de Werf F, Wallentin L, Lokhnygina Y, Moliterno DJ, Aylward PE, Mahaffey KW, Armstrong PW. Reduction in overall occurrences of ischemic events with vorapaxar: results from TRACER. J Am Heart Assoc. 2014 Jul 10;3(4). pii: e001032. doi: 10.1161/JAHA.114.001032.

Whellan DJ, Tricoci P, Chen E, Huang Z, Leibowitz D, Vranckx P, Marhefka GD, Held C, Nicolau JC, Storey RF, Ruzyllo W, Huber K, Sinnaeve P, Weiss AT, Dery JP, Moliterno DJ, Van de Werf F, Aylward PE, White HD, Armstrong PW, Wallentin L, Strony J, Harrington RA, Mahaffey KW. Vorapaxar in acute coronary syndrome patients undergoing coronary artery bypass graft surgery: subgroup analysis from the TRACER trial (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome). J Am Coll Cardiol. 2014 Mar 25;63(11):1048-57. doi: 10.1016/j.jacc.2013.10.048. Epub 2013 Nov 21.

Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW; TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012 Jan 5;366(1):20-33. doi: 10.1056/NEJMoa1109719. Epub 2011 Nov 13.

TRA*CER Executive and Steering Committees. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale. Am Heart J. 2009 Sep;158(3):327-334.e4. doi: 10.1016/j.ahj.2009.07.001. Erratum in: Am Heart J. 2010 May;159(5):932.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00527943 History of Changes
Other Study ID Numbers:	P04736 TRA•CER 2006-002809-31 MK-5348-014 ( Other Identifier: Merck Study Number )
Study First Received:	September 7, 2007
Results First Received:	May 9, 2014
Last Updated:	March 31, 2017

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