Trial Outcomes & Findings for ABSORB EXTEND Clinical Investigation (NCT NCT01023789)
NCT ID: NCT01023789
Last Updated: 2018-02-14
Results Overview
The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
COMPLETED
NA
812 participants
≤ 7 days post index procedure (In hospital)
2018-02-14
Participant Flow
A total of 812 subjects (Intent-to-treat population) have been registered in 25 countries across the globe in compliance with the study Clinical Investigation Plan (CIP).
Out of the 812 subjects registered, a total of 43 subjects discontinued the study due to death (n=29) , withdrawal of consent (n=1) and lost-to-follow-up or missed the final 3 year follow-up visit (n=13).
Participant milestones
| Measure |
ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
30-day Follow-up Visit
STARTED
|
812
|
|
30-day Follow-up Visit
COMPLETED
|
812
|
|
30-day Follow-up Visit
NOT COMPLETED
|
0
|
|
180-day Clinical Follow-up
STARTED
|
812
|
|
180-day Clinical Follow-up
COMPLETED
|
812
|
|
180-day Clinical Follow-up
NOT COMPLETED
|
0
|
|
1 - Year Visit
STARTED
|
812
|
|
1 - Year Visit
COMPLETED
|
812
|
|
1 - Year Visit
NOT COMPLETED
|
0
|
|
2 - Year Visit
STARTED
|
812
|
|
2 - Year Visit
COMPLETED
|
812
|
|
2 - Year Visit
NOT COMPLETED
|
0
|
|
3 - Year Visit
STARTED
|
812
|
|
3 - Year Visit
COMPLETED
|
769
|
|
3 - Year Visit
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
3 - Year Visit
Death
|
29
|
|
3 - Year Visit
Withdrawal of consent
|
1
|
|
3 - Year Visit
Lost to Follow-up
|
13
|
Baseline Characteristics
ABSORB EXTEND Clinical Investigation
Baseline characteristics by cohort
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Age, Continuous
|
61.12 years
STANDARD_DEVIATION 10.75 • n=93 Participants
|
|
Sex: Female, Male
Female
|
209 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
603 Participants
n=93 Participants
|
|
Region of Enrollment
Singapore
|
20 participants
n=93 Participants
|
|
Region of Enrollment
Malaysia
|
23 participants
n=93 Participants
|
|
Region of Enrollment
Austria
|
24 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
67 participants
n=93 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=93 Participants
|
|
Region of Enrollment
Hong Kong
|
21 participants
n=93 Participants
|
|
Region of Enrollment
Brazil
|
97 participants
n=93 Participants
|
|
Region of Enrollment
Poland
|
13 participants
n=93 Participants
|
|
Region of Enrollment
France
|
57 participants
n=93 Participants
|
|
Region of Enrollment
Argentina
|
20 participants
n=93 Participants
|
|
Region of Enrollment
Japan
|
40 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=93 Participants
|
|
Region of Enrollment
Switzerland
|
13 participants
n=93 Participants
|
|
Region of Enrollment
India
|
100 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=93 Participants
|
|
Region of Enrollment
New Zealand
|
23 participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
27 participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
21 participants
n=93 Participants
|
|
Region of Enrollment
Taiwan
|
74 participants
n=93 Participants
|
|
Region of Enrollment
Denmark
|
15 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=93 Participants
|
|
Region of Enrollment
South Africa
|
4 participants
n=93 Participants
|
|
Region of Enrollment
Israel
|
13 participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
62 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: ≤ 7 days post index procedure (In hospital)Population: ITT population (per subject analysis).
The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
|
14 Participants
|
PRIMARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population (per subject analysis).
The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
|
21 Participants
|
PRIMARY outcome
Timeframe: 0 to 180 daysPopulation: ITT population (per subject analysis).
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
|
28 Participants
|
PRIMARY outcome
Timeframe: 0 to 1 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Outcome measures
| Measure |
ABSORB BVS
n=811 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
|
41 Participants
|
SECONDARY outcome
Timeframe: On day 0 (immediate post-index procedure)Population: ITT population (Per Lesion analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis \< 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.
Outcome measures
| Measure |
ABSORB BVS
n=871 Target Lesions
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Clinical Device Success
|
98.9 percentage of lesions
|
SECONDARY outcome
Timeframe: On day 0 (immediate post-index procedure)Population: ITT population (Per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of \< 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.
Outcome measures
| Measure |
ABSORB BVS
n=809 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Clinical Procedure Success
|
97.0 percentage of participants
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedure (In-hospital )Population: ITT population (per subject analysis).
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Cardiac Death
|
0 Participants
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedure (In-hospital )Population: ITT population (per subject analysis).
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Myocardial Infarction (MI) - Per Protocol
|
14 Participants
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedure (In-hospital )Population: ITT population (per subject analysis).
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
0 Participants
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedure (In-hospital )Population: ITT population (per subject analysis).
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
0 Participants
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedure (In-hospital )Population: ITT population (per subject analysis).
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population (per subject analysis).
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Cardiac Death
|
2 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population (per subject analysis).
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Myocardial Infarction (MI) - Per Protocol
|
20 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population (per subject analysis).
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population (per subject analysis).
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population (per subject analysis).
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: ITT population (per subject analysis).
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Cardiac Death
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: ITT population (per subject analysis).
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Myocardial Infarction (MI) - Per Protocol
|
24 Participants
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: ITT population (per subject analysis).
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
9 Participants
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: ITT population (per subject analysis).
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
11 Participants
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: ITT population (per subject analysis).
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 to 1 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Outcome measures
| Measure |
ABSORB BVS
n=811 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Cardiac Death
|
6 Participants
|
SECONDARY outcome
Timeframe: 0 to 1 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Outcome measures
| Measure |
ABSORB BVS
n=811 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Myocardial Infarction (MI) - Per Protocol
|
27 Participants
|
SECONDARY outcome
Timeframe: 0 to 1 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=811 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
19 Participants
|
SECONDARY outcome
Timeframe: 0 to 1 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=811 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
23 Participants
|
SECONDARY outcome
Timeframe: 0 to 1 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=811 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
|
10 Participants
|
SECONDARY outcome
Timeframe: 0 to 2 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Outcome measures
| Measure |
ABSORB BVS
n=807 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Cardiac Death
|
10 Participants
|
SECONDARY outcome
Timeframe: 0 to 2 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Outcome measures
| Measure |
ABSORB BVS
n=807 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Myocardial Infarction (MI) - Per Protocol
|
35 Participants
|
SECONDARY outcome
Timeframe: 0 to 2 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=807 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
34 Participants
|
SECONDARY outcome
Timeframe: 0 to 2 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=807 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
46 Participants
|
SECONDARY outcome
Timeframe: 0 to 2 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=807 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
|
20 Participants
|
SECONDARY outcome
Timeframe: 0 to 3 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Outcome measures
| Measure |
ABSORB BVS
n=801 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Cardiac Death
|
17 Participants
|
SECONDARY outcome
Timeframe: 0 to 3 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Outcome measures
| Measure |
ABSORB BVS
n=801 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Myocardial Infarction (MI) - Per Protocol
|
39 percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 3 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Revascularization at the target lesion associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=801 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
|
41 Participants
|
SECONDARY outcome
Timeframe: 0 to 3 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Revascularization in the target vessel associated with any of the following: * Positive functional ischemia study. * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA). * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Outcome measures
| Measure |
ABSORB BVS
n=801 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
41 Participants
|
SECONDARY outcome
Timeframe: 0 to 3 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=801 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
|
23 Participants
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedure (In hospital)Population: ITT population (per subject analysis).
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
|
14 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population (per subject analysis).
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
|
21 Participants
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: ITT population (per subject analysis).
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
|
30 Participants
|
SECONDARY outcome
Timeframe: 0 to 1 yearPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Outcome measures
| Measure |
ABSORB BVS
n=811 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
|
45 Participants
|
SECONDARY outcome
Timeframe: 0 to 2 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Outcome measures
| Measure |
ABSORB BVS
n=807 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
|
68 Participants
|
SECONDARY outcome
Timeframe: 0 to 3 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Outcome measures
| Measure |
ABSORB BVS
n=801 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
|
85 Participants
|
SECONDARY outcome
Timeframe: 0 to 2 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Outcome measures
| Measure |
ABSORB BVS
n=807 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
|
58 Participants
|
SECONDARY outcome
Timeframe: 0 to 3 yearsPopulation: ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Outcome measures
| Measure |
ABSORB BVS
n=801 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
|
74 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysPopulation: ITT population (Per Subject Analysis)
According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Outcome measures
| Measure |
ABSORB BVS
n=812 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Scaffold Thrombosis (Early)
Definite
|
4 Participants
|
|
Number of Participants With Scaffold Thrombosis (Early)
Possible
|
0 Participants
|
|
Number of Participants With Scaffold Thrombosis (Early)
Probable
|
1 Participants
|
SECONDARY outcome
Timeframe: 0 to 180 daysPopulation: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Outcome measures
| Measure |
ABSORB BVS
n=811 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Scaffold Thrombosis
Definite
|
6 Participants
|
|
Number of Participants With Scaffold Thrombosis
Probable
|
1 Participants
|
|
Number of Participants With Scaffold Thrombosis
Possible
|
2 Participants
|
SECONDARY outcome
Timeframe: 31 - 365 daysPopulation: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Outcome measures
| Measure |
ABSORB BVS
n=806 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Scaffold Thrombosis (Late)
Definite
|
3 Participants
|
|
Number of Participants With Scaffold Thrombosis (Late)
Possible
|
3 Participants
|
|
Number of Participants With Scaffold Thrombosis (Late)
Probable
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 1 yearPopulation: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Outcome measures
| Measure |
ABSORB BVS
n=808 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Scaffold Thrombosis
Definite
|
7 Participants
|
|
Number of Participants With Scaffold Thrombosis
Possible
|
3 Participants
|
|
Number of Participants With Scaffold Thrombosis
Probable
|
1 Participants
|
SECONDARY outcome
Timeframe: 366 days to 2 yearsPopulation: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Outcome measures
| Measure |
ABSORB BVS
n=794 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Scaffold Thrombosis (Very Late)
Definite
|
4 Participants
|
|
Number of Participants With Scaffold Thrombosis (Very Late)
Probable
|
0 Participants
|
|
Number of Participants With Scaffold Thrombosis (Very Late)
Possible
|
3 Participants
|
SECONDARY outcome
Timeframe: 0 to 2 yearsPopulation: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Outcome measures
| Measure |
ABSORB BVS
n=799 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Scaffold Thrombosis
Definite
|
11 Participants
|
|
Number of Participants With Scaffold Thrombosis
Probable
|
1 Participants
|
|
Number of Participants With Scaffold Thrombosis
Possible
|
6 Participants
|
SECONDARY outcome
Timeframe: 0 to 3 yearsPopulation: ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing: Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation \*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days). †Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Outcome measures
| Measure |
ABSORB BVS
n=788 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Number of Participants With Scaffold Thrombosis
Definite
|
13 Participants
|
|
Number of Participants With Scaffold Thrombosis
Probable
|
4 Participants
|
|
Number of Participants With Scaffold Thrombosis
Possible
|
11 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Area Stenosis (%)
|
24.71 Percentage
Standard Deviation 20.55
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Minimum Lumen Area
|
3.47 mm^2
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Mean Vessel Area
|
13.77 mm^2
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Minimum Vessel Area
|
9.9 mm^2
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Maximum Vessel Area
|
18.3 mm^2
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Mean Lumen Area
|
4.92 mm^2
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Maximum Lumen Area
|
6.59 mm^2
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Mean Plaque Area
|
8.85 mm^2
Standard Deviation 3.73
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Minimum Plaque Area
|
5.41 mm^2
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Maximum Plaque Area
|
13.18 mm^2
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Mean Reference Area
|
4.78 mm^2
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Calculated Minimum Lumen Diameter
|
2.08 mm
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.
The value calculated as 100 \* (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Outcome measures
| Measure |
ABSORB BVS
n=97 Participants
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Calculated Diameter Stenosis
|
14.05 Percent Diameter stenosis
Standard Deviation 11.96
|
Adverse Events
ABSORB BVS
Serious adverse events
| Measure |
ABSORB BVS
n=812 participants at risk
ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/812 • 3 years
|
|
Investigations
LOW DENSITY LIPOPROTEIN INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
RED BLOOD CELL SEDIMENTATION RATE INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
TROPONIN I INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
TROPONIN INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
TROPONIN T INCREASED
|
0.12%
1/812 • 3 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.25%
2/812 • 3 years
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
GLUCOSE TOLERANCE IMPAIRED
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/812 • 3 years
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
JAW CYST
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.62%
5/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.25%
2/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
POLYARTHRITIS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
SPONDYLITIS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BONE NEOPLASM
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.37%
3/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAIR FOLLICLE TUMOUR BENIGN
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARYNGEAL CANCER
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.49%
4/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDIASTINUM NEOPLASM
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MESOTHELIOMA
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.25%
2/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RETROPERITONEAL NEOPLASM
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SOFT TISSUE NEOPLASM
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VULVAL CANCER
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
BURNING SENSATION
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.49%
4/812 • 3 years
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.25%
2/812 • 3 years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.62%
5/812 • 3 years
|
|
Nervous system disorders
DEMENTIA
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
DIZZINESS
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
ENCEPHALITIS
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
EXERTIONAL HEADACHE
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
PARKINSONISM
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
PRESYNCOPE
|
0.37%
3/812 • 3 years
|
|
Nervous system disorders
SYNCOPE
|
0.49%
4/812 • 3 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.62%
5/812 • 3 years
|
|
Nervous system disorders
TREMOR
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
ABNORMAL BEHAVIOUR
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
DEPRESSION
|
0.25%
2/812 • 3 years
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
MANIA
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
MENTAL DISORDER
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
NERVOUSNESS
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
BLADDER DILATATION
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
BLADDER OBSTRUCTION
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
BACK INJURY
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
CARDIAC PROCEDURE COMPLICATION
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
CATHETER SITE HAEMATOMA
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
CORONARY ARTERY RESTENOSIS
|
0.25%
2/812 • 3 years
|
|
Injury, poisoning and procedural complications
ENDOTRACHEAL INTUBATION COMPLICATION
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
IN-STENT ARTERIAL RESTENOSIS
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.86%
7/812 • 3 years
|
|
Injury, poisoning and procedural complications
INJURY
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
LIMB CRUSHING INJURY
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
PERIORBITAL HAEMATOMA
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
PLAQUE SHIFT
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL MYOCARDIAL INFARCTION
|
1.2%
10/812 • 3 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL SWELLING
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HEADACHE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPERTENSION
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
RADIATION OESOPHAGITIS
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
URINARY RETENTION POSTOPERATIVE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.37%
3/812 • 3 years
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/812 • 3 years
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE MB INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
BLOOD PRESSURE ABNORMAL
|
0.00%
0/812 • 3 years
|
|
Investigations
BLOOD PRESSURE DECREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
CARCINOEMBRYONIC ANTIGEN INCREASED
|
0.12%
1/812 • 3 years
|
|
Investigations
CARDIAC ENZYMES INCREASED
|
0.25%
2/812 • 3 years
|
|
Investigations
CARDIAC STRESS TEST ABNORMAL
|
0.37%
3/812 • 3 years
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT ELEVATION
|
0.00%
0/812 • 3 years
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.62%
5/812 • 3 years
|
|
Blood and lymphatic system disorders
HEMORRHAGIC ANEMIA
|
0.12%
1/812 • 3 years
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANEMIA
|
0.12%
1/812 • 3 years
|
|
Blood and lymphatic system disorders
NEUTROPHILIA
|
0.00%
0/812 • 3 years
|
|
Blood and lymphatic system disorders
SPONTANEOUS HEMATOMA
|
0.00%
0/812 • 3 years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.74%
6/812 • 3 years
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
2.6%
21/812 • 3 years
|
|
Cardiac disorders
ANGINA PECTORIS
|
9.9%
80/812 • 3 years
|
|
Cardiac disorders
ANGINA UNSTABLE
|
1.5%
12/812 • 3 years
|
|
Cardiac disorders
ARRHYTHMIA
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.86%
7/812 • 3 years
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
BRADYCARDIA
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
CARDIAC ARREST
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.37%
3/812 • 3 years
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.25%
2/812 • 3 years
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.74%
6/812 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY DISSECTION
|
1.1%
9/812 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.25%
2/812 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.49%
4/812 • 3 years
|
|
Cardiac disorders
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.25%
2/812 • 3 years
|
|
Cardiac disorders
INTRACARDIAC THROMBUS
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.86%
7/812 • 3 years
|
|
Investigations
FEMORAL BRUIT
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
MYOCARDIAL ISCHEMIA
|
0.37%
3/812 • 3 years
|
|
Cardiac disorders
PALPITATIONS
|
0.25%
2/812 • 3 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
PERICARDITIS
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.25%
2/812 • 3 years
|
|
Cardiac disorders
SINUS ARREST
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
VENTRICULAR EXTRA SYSTOLES
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.25%
2/812 • 3 years
|
|
Congenital, familial and genetic disorders
THYROGLOSSAL CYST
|
0.12%
1/812 • 3 years
|
|
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY
|
0.00%
0/812 • 3 years
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/812 • 3 years
|
|
Ear and labyrinth disorders
VERTIGO
|
0.12%
1/812 • 3 years
|
|
Endocrine disorders
GOITER
|
0.12%
1/812 • 3 years
|
|
Endocrine disorders
PRIMARY HYPERALDOSTERONISM
|
0.12%
1/812 • 3 years
|
|
Eye disorders
CATARACT
|
0.25%
2/812 • 3 years
|
|
Eye disorders
CATARACT NUCLEAR
|
0.00%
0/812 • 3 years
|
|
Eye disorders
DRY EYE
|
0.00%
0/812 • 3 years
|
|
Eye disorders
UVEITIS
|
0.12%
1/812 • 3 years
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/812 • 3 years
|
|
Eye disorders
VITREOUS DEGENERATION
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.37%
3/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL WALL DISORDER
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
COLON CANCER
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.25%
2/812 • 3 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.25%
2/812 • 3 years
|
|
Gastrointestinal disorders
DIARRHEA
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
GASTRIC ULCER HEMORRHAGE
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HEMORRHAGE
|
0.49%
4/812 • 3 years
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
GINGIVITIS
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.25%
2/812 • 3 years
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
MELAENA
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
PERITONEAL HAEMORRHAGE
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
TOOTH SOCKET HAEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.49%
4/812 • 3 years
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/812 • 3 years
|
|
General disorders
ADVERSE DRUG REACTION
|
0.00%
0/812 • 3 years
|
|
General disorders
ASTHENIA
|
0.12%
1/812 • 3 years
|
|
General disorders
CATHETER SITE HAEMATOMA
|
0.00%
0/812 • 3 years
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
General disorders
CATHETER SITE PAIN
|
0.00%
0/812 • 3 years
|
|
General disorders
CATHETER SITE RELATED REACTION
|
0.00%
0/812 • 3 years
|
|
General disorders
CATHETER SITE SWELLING
|
0.00%
0/812 • 3 years
|
|
General disorders
CHEST DISCOMFORT
|
0.49%
4/812 • 3 years
|
|
General disorders
CHEST PAIN
|
0.62%
5/812 • 3 years
|
|
General disorders
CHILLS
|
0.00%
0/812 • 3 years
|
|
General disorders
DEATH
|
0.49%
4/812 • 3 years
|
|
General disorders
DEVICE DISLOCATION
|
0.00%
0/812 • 3 years
|
|
General disorders
DEVICE MALFUNCTION
|
0.25%
2/812 • 3 years
|
|
General disorders
DEVICE OCCLUSION
|
0.12%
1/812 • 3 years
|
|
General disorders
DROWNING
|
0.12%
1/812 • 3 years
|
|
General disorders
FATIGUE
|
0.00%
0/812 • 3 years
|
|
General disorders
GENERAL SYMPTOM
|
0.00%
0/812 • 3 years
|
|
General disorders
MALAISE
|
0.00%
0/812 • 3 years
|
|
General disorders
MASS
|
0.00%
0/812 • 3 years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
2.5%
20/812 • 3 years
|
|
General disorders
OEDEMA
|
0.00%
0/812 • 3 years
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/812 • 3 years
|
|
General disorders
PAIN
|
0.00%
0/812 • 3 years
|
|
General disorders
PYREXIA
|
0.37%
3/812 • 3 years
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.25%
2/812 • 3 years
|
|
General disorders
SUDDEN DEATH
|
0.12%
1/812 • 3 years
|
|
General disorders
THROMBOSIS IN DEVICE
|
0.74%
6/812 • 3 years
|
|
General disorders
VESSEL PUNCTURE SITE HAEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.25%
2/812 • 3 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.12%
1/812 • 3 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.12%
1/812 • 3 years
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.49%
4/812 • 3 years
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/812 • 3 years
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/812 • 3 years
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/812 • 3 years
|
|
Hepatobiliary disorders
NON-ALCOHOLIC STEATOHEPATITIS
|
0.00%
0/812 • 3 years
|
|
Immune system disorders
ALLERGY TO ARTHROPOD STING
|
0.12%
1/812 • 3 years
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.12%
1/812 • 3 years
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/812 • 3 years
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
ABSCESS LIMB
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
DIVERTICULITIS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
EMPYEMA
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
GASTROENTERITIS
|
0.37%
3/812 • 3 years
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
GROIN ABSCESS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
HERPES SIMPLEX
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
INFECTED BITES
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
LIVER ABSCESS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
LUNG INFECTION
|
0.37%
3/812 • 3 years
|
|
Infections and infestations
LYMPHANGITIS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
NOSOCOMIAL INFECTION
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
OSTEOMYELITIS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
OSTEOMYELITIS ACUTE
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
PNEUMONIA
|
0.74%
6/812 • 3 years
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.25%
2/812 • 3 years
|
|
Infections and infestations
SEPSIS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
SEPTIC SHOCK
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
TUBERCULOSIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.37%
3/812 • 3 years
|
|
Infections and infestations
VARICELLA
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
WOUND INFECTION
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/812 • 3 years
|
|
Investigations
GLYCOSYLATED HAEMOGLOBIN INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
HEART RATE INCREASED
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
RENAL ARTERY STENOSIS
|
0.25%
2/812 • 3 years
|
|
Renal and urinary disorders
RENAL COLIC
|
0.25%
2/812 • 3 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.25%
2/812 • 3 years
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
RENAL MASS
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.12%
1/812 • 3 years
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/812 • 3 years
|
|
Reproductive system and breast disorders
BREAST CALCIFICATIONS
|
0.00%
0/812 • 3 years
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
0.00%
0/812 • 3 years
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/812 • 3 years
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/812 • 3 years
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.25%
2/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.25%
2/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS CHRONIC
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.37%
3/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.86%
7/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.37%
3/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
NOCTURNAL DYSPNOEA
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.25%
2/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.25%
2/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
IDIOPATHIC URTICARIA
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
INCREASED TENDENCY TO BRUISE
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/812 • 3 years
|
|
Social circumstances
OCCUPATIONAL EXPOSURE TO AIR CONTAMINANTS
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
CARDIAC ABLATION
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
CARDIAC PACEMAKER INSERTION
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
FLUID REPLACEMENT
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
PERIPHERAL ARTERY ANGIOPLASTY
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
PROSTATECTOMY
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
URETHRAL STENT REMOVAL
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
VASECTOMY
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
BLOOD PRESSURE INADEQUATELY CONTROLLED
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
HYPERTENSIVE EMERGENCY
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
HYPOTENSION
|
0.25%
2/812 • 3 years
|
|
Vascular disorders
ILIAC ARTERY OCCLUSION
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.25%
2/812 • 3 years
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.25%
2/812 • 3 years
|
|
Vascular disorders
SUBCLAVIAN ARTERY STENOSIS
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.00%
0/812 • 3 years
|
Other adverse events
| Measure |
ABSORB BVS
n=812 participants at risk
ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
0.49%
4/812 • 3 years
|
|
Blood and lymphatic system disorders
HEMORRHAGIC ANEMIA
|
0.00%
0/812 • 3 years
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANEMIA
|
0.00%
0/812 • 3 years
|
|
Blood and lymphatic system disorders
NEUTROPHILIA
|
0.12%
1/812 • 3 years
|
|
Blood and lymphatic system disorders
SPONTANEOUS HEMATOMA
|
0.12%
1/812 • 3 years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
ANGINA PECTORIS
|
8.1%
66/812 • 3 years
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.49%
4/812 • 3 years
|
|
Cardiac disorders
ARRHYTHMIA
|
0.37%
3/812 • 3 years
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.1%
9/812 • 3 years
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.25%
2/812 • 3 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
BRADYCARDIA
|
0.62%
5/812 • 3 years
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.25%
2/812 • 3 years
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY DISSECTION
|
2.0%
16/812 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
INTRACARDIAC THROMBUS
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
MYOCARDIAL ISCHEMIA
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
PALPITATIONS
|
0.99%
8/812 • 3 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
SINUS ARREST
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.00%
0/812 • 3 years
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
TACHYCARDIA
|
0.25%
2/812 • 3 years
|
|
Cardiac disorders
VENTRICULAR EXTRA SYSTOLES
|
0.37%
3/812 • 3 years
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.12%
1/812 • 3 years
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.12%
1/812 • 3 years
|
|
Congenital, familial and genetic disorders
THYROGLOSSAL CYST
|
0.00%
0/812 • 3 years
|
|
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY
|
0.12%
1/812 • 3 years
|
|
Ear and labyrinth disorders
TINNITUS
|
0.12%
1/812 • 3 years
|
|
Ear and labyrinth disorders
VERTIGO
|
0.25%
2/812 • 3 years
|
|
Endocrine disorders
GOITER
|
0.12%
1/812 • 3 years
|
|
Endocrine disorders
PRIMARY HYPERALDOSTERONISM
|
0.00%
0/812 • 3 years
|
|
Eye disorders
CATARACT
|
0.12%
1/812 • 3 years
|
|
Eye disorders
CATARACT NUCLEAR
|
0.12%
1/812 • 3 years
|
|
Eye disorders
DRY EYE
|
0.25%
2/812 • 3 years
|
|
Eye disorders
UVEITIS
|
0.00%
0/812 • 3 years
|
|
Eye disorders
VISION BLURRED
|
0.12%
1/812 • 3 years
|
|
Eye disorders
VITREOUS DEGENERATION
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.49%
4/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.74%
6/812 • 3 years
|
|
Gastrointestinal disorders
ABDOMINAL WALL DISORDER
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
COLON CANCER
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.37%
3/812 • 3 years
|
|
Gastrointestinal disorders
DIARRHEA
|
1.4%
11/812 • 3 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.62%
5/812 • 3 years
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
GASTRIC ULCER HEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
GASTRITIS
|
0.62%
5/812 • 3 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
GINGIVITIS
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
HEMATOCHEZIA
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.49%
4/812 • 3 years
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.25%
2/812 • 3 years
|
|
Gastrointestinal disorders
MELENA
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
MOUTH HEMORRHAGE
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
NAUSEA
|
0.74%
6/812 • 3 years
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
PERITONEAL HEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL HEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
TOOTH SOCKET HEMORRHAGE
|
0.12%
1/812 • 3 years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/812 • 3 years
|
|
Gastrointestinal disorders
VOMITING
|
0.12%
1/812 • 3 years
|
|
General disorders
ADVERSE DRUG REACTION
|
3.3%
27/812 • 3 years
|
|
General disorders
ASTHENIA
|
0.74%
6/812 • 3 years
|
|
General disorders
CATHETER SITE HAEMATOMA
|
4.9%
40/812 • 3 years
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
2.1%
17/812 • 3 years
|
|
General disorders
CATHETER SITE PAIN
|
1.5%
12/812 • 3 years
|
|
General disorders
CATHETER SITE RELATED REACTION
|
0.25%
2/812 • 3 years
|
|
General disorders
CATHETER SITE SWELLING
|
0.12%
1/812 • 3 years
|
|
General disorders
CHEST DISCOMFORT
|
1.6%
13/812 • 3 years
|
|
General disorders
CHEST PAIN
|
0.86%
7/812 • 3 years
|
|
General disorders
CHILLS
|
0.12%
1/812 • 3 years
|
|
General disorders
DEVICE DISLOCATION
|
0.25%
2/812 • 3 years
|
|
General disorders
DEVICE MALFUNCTION
|
0.00%
0/812 • 3 years
|
|
General disorders
DEVICE OCCLUSION
|
0.00%
0/812 • 3 years
|
|
General disorders
DROWNING
|
0.00%
0/812 • 3 years
|
|
General disorders
FATIGUE
|
2.0%
16/812 • 3 years
|
|
General disorders
GENERAL SYMPTOM
|
0.12%
1/812 • 3 years
|
|
General disorders
MALAISE
|
0.12%
1/812 • 3 years
|
|
General disorders
MASS
|
0.12%
1/812 • 3 years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
7.8%
63/812 • 3 years
|
|
General disorders
OEDEMA
|
0.12%
1/812 • 3 years
|
|
General disorders
OEDEMA PERIPHERAL
|
0.86%
7/812 • 3 years
|
|
General disorders
PAIN
|
0.12%
1/812 • 3 years
|
|
General disorders
PYREXIA
|
0.74%
6/812 • 3 years
|
|
General disorders
THROMBOSIS IN DEVICE
|
0.00%
0/812 • 3 years
|
|
General disorders
VESSEL PUNCTURE SITE HAEMORRHAGE
|
0.12%
1/812 • 3 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/812 • 3 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/812 • 3 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/812 • 3 years
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/812 • 3 years
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.12%
1/812 • 3 years
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.12%
1/812 • 3 years
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.12%
1/812 • 3 years
|
|
Hepatobiliary disorders
NON-ALCOHOLIC STEATOHEPATITIS
|
0.12%
1/812 • 3 years
|
|
Immune system disorders
ALLERGY TO ARTHROPOD STING
|
0.00%
0/812 • 3 years
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.12%
1/812 • 3 years
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.49%
4/812 • 3 years
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.49%
4/812 • 3 years
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
BRONCHITIS
|
0.37%
3/812 • 3 years
|
|
Infections and infestations
CAMPYLOBACTER GASTROENTERITIS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
EMPYEMA
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
GASTROENTERITIS
|
0.25%
2/812 • 3 years
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.25%
2/812 • 3 years
|
|
Infections and infestations
GROIN ABSCESS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
HERPES SIMPLEX
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
HERPES ZOSTER
|
0.37%
3/812 • 3 years
|
|
Infections and infestations
INFECTED BITES
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
INFLUENZA
|
0.25%
2/812 • 3 years
|
|
Infections and infestations
KIDNEY INFECTION
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
LIVER ABSCESS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.25%
2/812 • 3 years
|
|
Infections and infestations
LUNG INFECTION
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
LYMPHANGITIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.49%
4/812 • 3 years
|
|
Infections and infestations
NOSOCOMIAL INFECTION
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
OSTEOMYELITIS ACUTE
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
PNEUMONIA
|
0.37%
3/812 • 3 years
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
RASH PUSTULAR
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
SEPSIS
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/812 • 3 years
|
|
Infections and infestations
TOOTH INFECTION
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
TUBERCULOSIS
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.25%
2/812 • 3 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.49%
4/812 • 3 years
|
|
Infections and infestations
VARICELLA
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
VIRAL INFECTION
|
0.12%
1/812 • 3 years
|
|
Infections and infestations
WOUND INFECTION
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
BACK INJURY
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
CARDIAC PROCEDURE COMPLICATION
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
CATHETER SITE HAEMATOMA
|
0.37%
3/812 • 3 years
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
CORONARY ARTERY RESTENOSIS
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
ENDOTRACHEAL INTUBATION COMPLICATION
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
FALL
|
0.37%
3/812 • 3 years
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
IN-STENT ARTERIAL RESTENOSIS
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.37%
3/812 • 3 years
|
|
Injury, poisoning and procedural complications
INJURY
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.25%
2/812 • 3 years
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.25%
2/812 • 3 years
|
|
Injury, poisoning and procedural complications
LIMB CRUSHING INJURY
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
PERIORBITAL HAEMATOMA
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
PLAQUE SHIFT
|
0.12%
1/812 • 3 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL MYOCARDIAL INFARCTION
|
1.6%
13/812 • 3 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL SWELLING
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HEADACHE
|
0.25%
2/812 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPERTENSION
|
0.49%
4/812 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
0.49%
4/812 • 3 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
0.86%
7/812 • 3 years
|
|
Injury, poisoning and procedural complications
RADIATION OESOPHAGITIS
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
URINARY RETENTION POSTOPERATIVE
|
0.00%
0/812 • 3 years
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.25%
2/812 • 3 years
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.12%
1/812 • 3 years
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
2.2%
18/812 • 3 years
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE MB INCREASED
|
4.8%
39/812 • 3 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.25%
2/812 • 3 years
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.37%
3/812 • 3 years
|
|
Investigations
BLOOD PRESSURE ABNORMAL
|
0.12%
1/812 • 3 years
|
|
Investigations
BLOOD PRESSURE DECREASED
|
0.12%
1/812 • 3 years
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.12%
1/812 • 3 years
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
0.37%
3/812 • 3 years
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.25%
2/812 • 3 years
|
|
Investigations
CARCINOEMBRYONIC ANTIGEN INCREASED
|
0.00%
0/812 • 3 years
|
|
Investigations
CARDIAC ENZYMES INCREASED
|
6.2%
50/812 • 3 years
|
|
Investigations
CARDIAC STRESS TEST ABNORMAL
|
0.00%
0/812 • 3 years
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT ELEVATION
|
0.25%
2/812 • 3 years
|
|
Investigations
FEMORAL BRUIT
|
0.12%
1/812 • 3 years
|
|
Investigations
GLYCOSYLATED HAEMOGLOBIN INCREASED
|
0.25%
2/812 • 3 years
|
|
Investigations
HEART RATE INCREASED
|
0.12%
1/812 • 3 years
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.37%
3/812 • 3 years
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.12%
1/812 • 3 years
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.25%
2/812 • 3 years
|
|
Investigations
LOW DENSITY LIPOPROTEIN INCREASED
|
0.12%
1/812 • 3 years
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.25%
2/812 • 3 years
|
|
Investigations
RED BLOOD CELL SEDIMENTATION RATE INCREASED
|
0.12%
1/812 • 3 years
|
|
Investigations
TROPONIN I INCREASED
|
5.3%
43/812 • 3 years
|
|
Investigations
TROPONIN INCREASED
|
8.7%
71/812 • 3 years
|
|
Investigations
TROPONIN T INCREASED
|
3.8%
31/812 • 3 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.1%
9/812 • 3 years
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.12%
1/812 • 3 years
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.12%
1/812 • 3 years
|
|
Metabolism and nutrition disorders
GLUCOSE TOLERANCE IMPAIRED
|
0.12%
1/812 • 3 years
|
|
Metabolism and nutrition disorders
GOUT
|
0.25%
2/812 • 3 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.12%
1/812 • 3 years
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.12%
1/812 • 3 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.12%
1/812 • 3 years
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.12%
1/812 • 3 years
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.25%
2/812 • 3 years
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.74%
6/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.1%
17/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
JAW CYST
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.37%
3/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.49%
4/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.37%
3/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.25%
2/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.86%
7/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
POLYARTHRITIS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.00%
0/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
SPONDYLITIS
|
0.12%
1/812 • 3 years
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BONE NEOPLASM
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAIR FOLLICLE TUMOUR BENIGN
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARYNGEAL CANCER
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDIASTINUM NEOPLASM
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MESOTHELIOMA
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RETROPERITONEAL NEOPLASM
|
0.00%
0/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SOFT TISSUE NEOPLASM
|
0.12%
1/812 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VULVAL CANCER
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
BALANCE DISORDER
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
BURNING SENSATION
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.25%
2/812 • 3 years
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
DEMENTIA
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
DIZZINESS
|
1.5%
12/812 • 3 years
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.37%
3/812 • 3 years
|
|
Nervous system disorders
ENCEPHALITIS
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
EXERTIONAL HEADACHE
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
HEADACHE
|
2.2%
18/812 • 3 years
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.37%
3/812 • 3 years
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
LETHARGY
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
MIGRAINE
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
PARAESTHESIA
|
0.37%
3/812 • 3 years
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
0.12%
1/812 • 3 years
|
|
Nervous system disorders
PARKINSONISM
|
0.00%
0/812 • 3 years
|
|
Nervous system disorders
PRESYNCOPE
|
1.6%
13/812 • 3 years
|
|
Nervous system disorders
SYNCOPE
|
0.74%
6/812 • 3 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.37%
3/812 • 3 years
|
|
Nervous system disorders
TREMOR
|
0.25%
2/812 • 3 years
|
|
Psychiatric disorders
ABNORMAL BEHAVIOUR
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
ANXIETY
|
0.49%
4/812 • 3 years
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
DELIRIUM
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
DEPRESSION
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
INSOMNIA
|
0.37%
3/812 • 3 years
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
MANIA
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
MENTAL DISORDER
|
0.00%
0/812 • 3 years
|
|
Psychiatric disorders
MOOD SWINGS
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
NERVOUSNESS
|
0.25%
2/812 • 3 years
|
|
Psychiatric disorders
PANIC ATTACK
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
RESTLESSNESS
|
0.12%
1/812 • 3 years
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
BLADDER DILATATION
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
BLADDER OBSTRUCTION
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
DYSURIA
|
0.25%
2/812 • 3 years
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
RENAL ARTERY STENOSIS
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
RENAL COLIC
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.25%
2/812 • 3 years
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
RENAL MASS
|
0.00%
0/812 • 3 years
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
0.12%
1/812 • 3 years
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/812 • 3 years
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.25%
2/812 • 3 years
|
|
Reproductive system and breast disorders
BREAST CALCIFICATIONS
|
0.12%
1/812 • 3 years
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
0.12%
1/812 • 3 years
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.12%
1/812 • 3 years
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.12%
1/812 • 3 years
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS CHRONIC
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.37%
3/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.7%
14/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.1%
17/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
1.2%
10/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.37%
3/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.25%
2/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
NOCTURNAL DYSPNOEA
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
0.12%
1/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/812 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.25%
2/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.25%
2/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.37%
3/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.37%
3/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
IDIOPATHIC URTICARIA
|
0.12%
1/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
INCREASED TENDENCY TO BRUISE
|
0.25%
2/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.12%
1/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.25%
2/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.25%
2/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.12%
1/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.99%
8/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.12%
1/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.25%
2/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.12%
1/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.12%
1/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.12%
1/812 • 3 years
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.25%
2/812 • 3 years
|
|
Social circumstances
OCCUPATIONAL EXPOSURE TO AIR CONTAMINANTS
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
CARDIAC ABLATION
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
CARDIAC PACEMAKER INSERTION
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
FLUID REPLACEMENT
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
PERIPHERAL ARTERY ANGIOPLASTY
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
PROSTATECTOMY
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.12%
1/812 • 3 years
|
|
Surgical and medical procedures
URETHRAL STENT REMOVAL
|
0.00%
0/812 • 3 years
|
|
Surgical and medical procedures
VASECTOMY
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
BLOOD PRESSURE INADEQUATELY CONTROLLED
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
HAEMATOMA
|
0.37%
3/812 • 3 years
|
|
Vascular disorders
HAEMORRHAGE
|
0.25%
2/812 • 3 years
|
|
Vascular disorders
HYPERTENSION
|
2.2%
18/812 • 3 years
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.37%
3/812 • 3 years
|
|
Vascular disorders
HYPERTENSIVE EMERGENCY
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
HYPOTENSION
|
2.1%
17/812 • 3 years
|
|
Vascular disorders
ILIAC ARTERY OCCLUSION
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
0.12%
1/812 • 3 years
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
SUBCLAVIAN ARTERY STENOSIS
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
0.00%
0/812 • 3 years
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.12%
1/812 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60