Trial Outcomes & Findings for PROMUS Element Plus US Post-Approval Study (NCT NCT01589978)

NCT ID: NCT01589978

Last Updated: 2018-07-26

Results Overview

Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and \<2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 2681 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2018-07-26

Participant Flow

Participant milestones

Measure	PROMUS Element Overall Population Subjects who receive the PROMUS Element everolimus-eluting coronary stent. Subgroups within the Overall Population Group: PLATINUM-Like Patients N=776 (at time of Primary endpoint) Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and \<2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm. Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent.
Overall Study STARTED	2681
Overall Study COMPLETED	2681
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PROMUS Element Plus US Post-Approval Study

Baseline characteristics by cohort

Measure	PROMUS Element n=2681 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Age, Continuous	63.7 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	807 Participants n=5 Participants
Sex: Female, Male Male	1874 Participants n=5 Participants
Region of Enrollment United States	2681 participants n=5 Participants
Cardiac History History of CAD	1625 participants n=5 Participants
Cardiac History History of MI	1409 participants n=5 Participants
Cardiac History History of CHF	275 participants n=5 Participants
Cardiac History Stable Angina	620 participants n=5 Participants
Cardiac History Unstable Angina	1347 participants n=5 Participants
Cardiac History Silent Ischemia	149 participants n=5 Participants
Cardiac History History of PCI	1159 participants n=5 Participants
Cardiac History History of CABG	457 participants n=5 Participants
Cardiac Risk Factors Smoking, Ever	1600 participants n=5 Participants
Cardiac Risk Factors Current Diabetic Mellitus	989 participants n=5 Participants
Cardiac Risk Factors Hyperlipidemia Requiring Medication	2016 participants n=5 Participants
Cardiac Risk Factors History of Hypertension Requiring Medication	2077 participants n=5 Participants
Cardiac Risk Factors Family History of CAD	1625 participants n=5 Participants
Lesion Characteristics: Target Lesion Vessel Left Anterior Descending Artery	1339 lesions n=5 Participants
Lesion Characteristics: Target Lesion Vessel Circumflex Artery	848 lesions n=5 Participants
Lesion Characteristics: Target Lesion Vessel Right Coronary Artery	1165 lesions n=5 Participants
Lesion Characteristics: Target Lesion Vessel Left Main	54 lesions n=5 Participants
Lesion Characteristics: Target Lesion Vessel Graft	199 lesions n=5 Participants
Lesion Characteristics: Lesion Length	17.0 mm STANDARD_DEVIATION 10.3 • n=5 Participants
Lesion Characteristics: Reference Vessel Diameter	2.94 mm STANDARD_DEVIATION 0.51 • n=5 Participants
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Invarction (TIMI) Flow 0	359 lesions n=5 Participants
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Invarction (TIMI) Flow 1	157 lesions n=5 Participants
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Invarction (TIMI) Flow 2	487 lesions n=5 Participants
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Invarction (TIMI) Flow 3	2539 lesions n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.

Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)

Outcome measures

Measure	PROMUS Element n=1907 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients	1.78 percentage of patients

SECONDARY outcome

Timeframe: 12 months

Population: PROMUS Element PLATINUM-Like patients (a subgroup of the overall population as described in the Participant Flow Module), N=776.

ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)

Outcome measures

Measure	PROMUS Element n=776 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients	0.3 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)

Outcome measures

Measure	PROMUS Element n=2681 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients	0.7 percentage of patients

SECONDARY outcome

Timeframe: Index Procedure

Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.

Outcome measures

Measure	PROMUS Element n=2681 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Rate of Longitudinal Stent Deformation	2 stents

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Composite of cardiac death, myocardial infarction, and target vessel revascularization

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Major Adverse Cardiac Event Rate (MACE)	6.9 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent	4.7 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Myocardial Infarction (MI) Rate	1.1 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent	0.7 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Cardiac Death Rate	1.4 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Rate of Cardiac Death Events Related to the PROMUS Element Stent	1.3 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Target Vessel Revascularization (TVR) Rate	5.6 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent	3.5 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

See individual descriptions of events.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Cardiac Death or Myocardial Infarction (MI) Rate	2.3 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

See individual descriptions of events.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent	1.8 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.

For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Target Vessel Failure (TVF) Rate	6.7 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.

For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent	4.7 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

All death includes cardiac death and non-cardiac death.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
All Death Rate	2.3 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

Non-cardiac death is defined as death not due to cardiac causes.

Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Non-cardiac Death Rate	0.9 percentage of patients

SECONDARY outcome

Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years

See description of individual events.

Outcome measures

Measure	PROMUS Element n=2554 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
All Death or Myocardial Infarction Rate	3.2 percentage of patients

SECONDARY outcome

Timeframe: 12 Months

Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)

Outcome measures

Measure	PROMUS Element n=276 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients	3.26 percentage of patients

SECONDARY outcome

Timeframe: Annually through 5 years

Population: Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.

Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).

Outcome measures

Measure	PROMUS Element n=1907 Participants Subjects who receive the PROMUS Element everolimus-eluting coronary stent
ARC ST Rate in PLATINUM-like Population.	0.0023 percentage of participants

Adverse Events

PROMUS Element

Serious events: 780 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	PROMUS Element n=2681 participants at risk Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Vascular disorders ISCHAEMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders ISCHAEMIC LIMB PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders LYMPHOEDEMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders ORTHOSTATIC HYPOTENSION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ANGINA PECTORIS	4.5% 120/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ANGINA UNSTABLE	3.5% 93/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CORONARY ARTERY DISEASE	1.8% 49/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	1.7% 46/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	1.2% 33/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders MYOCARDIAL INFARCTION	0.82% 22/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ATRIAL FIBRILLATION	0.86% 23/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CORONARY ARTERY DISSECTION	0.71% 19/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CORONARY ARTERY THROMBOSIS	0.56% 15/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ACUTE CORONARY SYNDROME	0.37% 10/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	0.37% 10/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders VENTRICULAR TACHYCARDIA	0.30% 8/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.26% 7/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CORONARY ARTERY STENOSIS	0.26% 7/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CARDIOMYOPATHY	0.22% 6/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CARDIAC ARREST	0.19% 5/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CARDIAC FAILURE CHRONIC	0.19% 5/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CARDIOGENIC SHOCK	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ATRIAL FLUTTER	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CORONARY ARTERY OCCLUSION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders VENTRICULAR FIBRILLATION	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CARDIAC FAILURE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders POSTINFARCTION ANGINA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders SINUS BRADYCARDIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders TACHYCARDIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders AORTIC VALVE STENOSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ARRHYTHMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders BRADYCARDIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders BUNDLE BRANCH BLOCK LEFT	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders CORONARY ARTERY EMBOLISM	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders HYPERTROPHIC CARDIOMYOPATHY	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders PALPITATIONS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders SICK SINUS SYNDROME	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders SINUS ARRHYTHMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Cardiac disorders TACHYARRHYTHMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders NON-CARDIAC CHEST PAIN	2.9% 78/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders DEATH	0.34% 9/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders CHEST PAIN	0.30% 8/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders ASTHENIA	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders CHEST DISCOMFORT	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders INFLUENZA LIKE ILLNESS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders ULCER HAEMORRHAGE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders ADVERSE EVENT	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders BLOODY DISCHARGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders CATHETER SITE HAEMATOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders HERNIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders IMPAIRED HEALING	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders MALAISE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders OEDEMA PERIPHERAL	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
General disorders PYREXIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations PNEUMONIA	1.3% 36/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations CELLULITIS	0.34% 9/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations SEPSIS	0.30% 8/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations URINARY TRACT INFECTION	0.30% 8/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations OSTEOMYELITIS	0.22% 6/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations BRONCHITIS	0.19% 5/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations UROSEPSIS	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations APPENDICITIS	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations BACTERAEMIA	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations DIVERTICULITIS	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations INFLUENZA	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations STAPHYLOCOCCAL INFECTION	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations ABSCESS LIMB	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations BRONCHIECTASIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations GANGRENE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations GASTROENTERITIS VIRAL	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations INFECTION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations LOBAR PNEUMONIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations WOUND INFECTION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations ABDOMINAL ABSCESS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations ANOGENITAL WARTS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations BRONCHITIS VIRAL	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations CLOSTRIDIAL INFECTION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations ENDOCARDITIS BACTERIAL	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations GASTROENTERITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations MYCOBACTERIAL INFECTION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations OSTEOMYELITIS ACUTE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations OSTEOMYELITIS CHRONIC	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations PNEUMONIA BACTERIAL	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations PNEUMONIA STAPHYLOCOCCAL	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations PURULENT DISCHARGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations PYELONEPHRITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations RESPIRATORY TRACT INFECTION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations SEPTIC SHOCK	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Infections and infestations STREPTOCOCCAL BACTERAEMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.90% 24/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.71% 19/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.48% 13/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.26% 7/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.22% 6/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders ASTHMA	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders COUGH	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders ALLERGIC BRONCHITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders CHRONIC RESPIRATORY FAILURE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders MEDIASTINAL MASS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.56% 15/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.30% 8/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders ABDOMINAL PAIN	0.19% 5/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders DYSPHAGIA	0.19% 5/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders RETROPERITONEAL HAEMORRHAGE	0.19% 5/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders COLITIS	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders DIARRHOEA	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTRIC ULCER	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders MELAENA	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders PANCREATITIS	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders ABDOMINAL HERNIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Respiratory, thoracic and mediastinal disorders ABDOMINAL PAIN UPPER	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders COLITIS ISCHAEMIC	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders DIABETIC GASTROPARESIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTRITIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTRITIS EROSIVE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders INGUINAL HERNIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders PANCREATITIS ACUTE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders RETROPERITONEAL HAEMATOMA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders ANAL FISTULA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders DUODENAL ULCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTRIC DISORDER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTRIC POLYPS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders HAEMATOCHEZIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders HAEMORRHOIDS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders IMPAIRED GASTRIC EMPTYING	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders INTESTINAL HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders INTESTINAL POLYP	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders NAUSEA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders ODYNOPHAGIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders OESOPHAGEAL ULCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Gastrointestinal disorders VOMITING	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders SYNCOPE	0.63% 17/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.48% 13/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders CAROTID ARTERY STENOSIS	0.41% 11/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.26% 7/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders ENCEPHALOPATHY	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders PRESYNCOPE	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders CEREBRAL INFARCTION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders DYSARTHRIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders HEADACHE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders BASAL GANGLIA INFARCTION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders BRAIN STEM STROKE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders CAROTID ARTERY DISEASE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders CARPAL TUNNEL SYNDROME	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders CEREBRAL HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders CONVULSION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders ENCEPHALITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders HYPOAESTHESIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders LETHARGY	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders LOSS OF CONSCIOUSNESS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders PARAESTHESIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders RADICULAR PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Nervous system disorders SCIATICA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders INTERMITTENT CLAUDICATION	0.34% 9/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders DEEP VEIN THROMBOSIS	0.30% 8/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders HYPERTENSION	0.26% 7/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders HYPOTENSION	0.26% 7/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders AORTIC STENOSIS	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders ARTERIOSCLEROSIS	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders FEMORAL ARTERY OCCLUSION	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders HAEMATOMA	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders PERIPHERAL ISCHAEMIA	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders PERIPHERAL VASCULAR DISORDER	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders HYPERTENSIVE CRISIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders MALIGNANT HYPERTENSION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders ACCELERATED HYPERTENSION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders AORTIC ANEURYSM	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders ARTERIAL THROMBOSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders ARTERIAL THROMBOSIS LIMB	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders FEMORAL ARTERY ANEURYSM	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders HOT FLUSH	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders PERIPHERAL COLDNESS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders SHOCK	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders TAKAYASU'S ARTERITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders THROMBOPHLEBITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Vascular disorders VENOUS THROMBOSIS LIMB	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.19% 5/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications HIP FRACTURE	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications ANKLE FRACTURE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications CONTRAST MEDIA REACTION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications DRUG TOXICITY	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications FALL	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications GRAFT THROMBOSIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications PELVIC FRACTURE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications POST PROCEDURAL COMPLICATION	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications RIB FRACTURE	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications ALCOHOL POISONING	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications ANASTOMOTIC ULCER HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications CONCUSSION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications DISLOCATION OF JOINT PROSTHESIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications FEMUR FRACTURE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications GASTROINTESTINAL STOMA COMPLICATION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications GUN SHOT WOUND	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications POSTOPERATIVE WOUND COMPLICATION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications PROCEDURAL HYPERTENSION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications PUBIC RAMI FRACTURE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications SEROMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications TIBIA FRACTURE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications TRAUMATIC BRAIN INJURY	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications VASCULAR GRAFT COMPLICATION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications WOUND	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders RENAL FAILURE ACUTE	0.48% 13/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders RENAL FAILURE CHRONIC	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders NEPHROLITHIASIS	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders RENAL ARTERY STENOSIS	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders RENAL FAILURE	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders URINARY RETENTION	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders HAEMATURIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders RENAL TUBULAR NECROSIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders BLADDER OBSTRUCTION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders CALCULUS URETERIC	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders RENAL COLIC	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders RENAL DISORDER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders URETHRAL MEATUS STENOSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Renal and urinary disorders URETHRAL STENOSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER STAGE IV	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA PANCREAS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN NEOPLASM	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL CARCINOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIP AND/OR ORAL CAVITY CANCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC GASTRIC CANCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER METASTATIC	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SARCOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SARCOMA METASTATIC	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders ANAEMIA	0.41% 11/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders HAEMORRHAGIC ANAEMIA	0.22% 6/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders LEUKOCYTOSIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders BONE MARROW FAILURE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders MICROCYTIC ANAEMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders PANCYTOPENIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Blood and lymphatic system disorders SPONTANEOUS HAEMATOMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders ARTHRITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders BACK PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders BONE PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders COSTOCHONDRITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders FLANK PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL DISCOMFORT	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders PAIN IN JAW	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders POLYMYALGIA RHEUMATICA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Musculoskeletal and connective tissue disorders SYNOVIAL CYST	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders FLUID OVERLOAD	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders HYPOKALAEMIA	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders HYPERKALAEMIA	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders DEHYDRATION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders DIABETES MELLITUS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders DIABETIC FOOT	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders DYSLIPIDAEMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders HYPONATRAEMIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Metabolism and nutrition disorders OBESITY	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders CHOLELITHIASIS	0.15% 4/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders CHOLECYSTITIS	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders GALLBLADDER DISORDER	0.07% 2/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders BILIARY DYSKINESIA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders CHOLANGITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders CHOLECYSTITIS CHRONIC	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Hepatobiliary disorders ISCHAEMIC HEPATITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Investigations BLOOD CREATININE INCREASED	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Investigations BLOOD GLUCOSE DECREASED	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Investigations BLOOD URINE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Investigations CATHETERISATION CARDIAC	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Psychiatric disorders ANXIETY	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Psychiatric disorders BIPOLAR DISORDER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Psychiatric disorders CONVERSION DISORDER	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Psychiatric disorders DELIRIUM	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Psychiatric disorders DEPRESSION	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Ear and labyrinth disorders VERTIGO	0.11% 3/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Immune system disorders DRUG HYPERSENSITIVITY	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Immune system disorders HYPERSENSITIVITY	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Reproductive system and breast disorders POSTMENOPAUSAL HAEMORRHAGE	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Reproductive system and breast disorders PROSTATITIS	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Congenital, familial and genetic disorders DIVERTICULITIS MECKEL'S	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Eye disorders CATARACT	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Surgical and medical procedures CAROTID ENDARTERECTOMY	0.04% 1/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).

Other adverse events

Measure	PROMUS Element n=2681 participants at risk Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Cardiac disorders Myocardial Infarction	0.19% 5/2681 • Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).

Additional Information

Peter Maurer, Director Clinical Trials

Boston Scientific

Phone: 508-683-6678

Email: Peter.Maurer@bsci.com

Results disclosure agreements

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

Restriction type: LTE60