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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12610000131055 | Registry Identifier | Australian New Zealand Clinical Trials Registry | |
| REFCTRI000460, 03-05-2010 | Registry Identifier | Clinical Trials Registry - India |
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The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System
ABSORB BVS is currently in development at Abbott Vascular.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABSORB BVS | Experimental | Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABSORB BVS | Device | Absorb Bioresorbable Vascular Scaffold (BVS) System implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | The composite endpoint composed of
| ≤ 7 days post index procedure (In hospital) |
| Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | The composite endpoint composed of
| 0 to 30 days |
| Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). | 0 to 180 days |
| Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). | 0 to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Device Success | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Abizaid, MD | Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia | Principal Investigator |
| Patrick Serruys, MD | Thoraxcenter-Erasmus University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Cardiovascular de Buenos Aires-ICBA | Buenos Aires | 1428 | Argentina | |||
| Eastern Heart Clinic, The Prince of Wales Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30286520 | Derived | Costa JR Jr, Abizaid A, Whitbourn R, Serruys PW, Jepson N, Steinwender C, Stuteville M, Ediebah D, Sudhir K, Bartorelli AL; ABSORB EXTEND investigators. Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4. | |
| 29699614 |
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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).
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | ABSORB BVS | Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 30-day Follow-up Visit |
|
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| On day 0 (immediate post-index procedure) |
| Clinical Procedure Success | 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. | On day 0 (immediate post-index procedure) |
| Number of Participants With Cardiac Death | 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. | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | ≤ 7 days post index procedure (In-hospital ) |
| Number of Participants With Cardiac Death | 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. | 0 to 30 days |
| Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | 0 to 30 days |
| Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| 0 to 30 days |
| Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| 0 to 30 days |
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 0 to 30 days |
| Number of Participants With Cardiac Death | 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. | 0 to 180 days |
| Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | 0 to 180 days |
| Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| 0 to 180 days |
| Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| 0 to 180 days |
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 0 to 180 days |
| Number of Participants With Cardiac Death | 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. | 0 to 1 year |
| Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | 0 to 1 year |
| Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| 0 to 1 year |
| Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| 0 to 1 year |
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 0 to 1 year |
| Number of Participants With Cardiac Death | 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. | 0 to 2 year |
| Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | 0 to 2 year |
| Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| 0 to 2 year |
| Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| 0 to 2 year |
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 0 to 2 year |
| Number of Participants With Cardiac Death | 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. | 0 to 3 years |
| Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | 0 to 3 years |
| Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| 0 to 3 years |
| Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| 0 to 3 years |
| Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 0 to 3 years |
| Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| ≤ 7 days post index procedure (In hospital) |
| Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| 0 to 30 days |
| Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| 0 to 180 days |
| Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| 0 to 1 year |
| Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| 0 to 2 years |
| Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| 0 to 3 years |
| Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). | 0 to 2 years |
| Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). | 0 to 3 years |
| Number of Participants With Scaffold Thrombosis (Early) | 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. | 0 to 30 days |
| Number of Participants With Scaffold Thrombosis | 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. | 0 to 180 days |
| Number of Participants With Scaffold Thrombosis (Late) | 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. | 31 - 365 days |
| Number of Participants With Scaffold Thrombosis | 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. | 0 to 1 year |
| Number of Participants With Scaffold Thrombosis (Very Late) | 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. | 366 days to 2 years |
| Number of Participants With Scaffold Thrombosis | 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. | 0 to 2 years |
| Number of Participants With Scaffold Thrombosis | 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. | 0 to 3 years |
| Area Stenosis (%) | 18 months |
| Minimum Lumen Area | 18 months |
| Mean Vessel Area | 18 months |
| Minimum Vessel Area | 18 months |
| Maximum Vessel Area | 18 months |
| Mean Lumen Area | 18 months |
| Maximum Lumen Area | 18 months |
| Mean Plaque Area | 18 months |
| Minimum Plaque Area | 18 months |
| Maximum Plaque Area | 18 months |
| Mean Reference Area | 18 months |
| Calculated Minimum Lumen Diameter | 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. | 18 months |
| Calculated Diameter Stenosis | 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). | 18 months |
| Randwick |
| New South Wales |
| 2031 |
| Australia |
| Wesley Hospital | Auchenflower | Queensland | Australia |
| St. Vincent's Hospital | Melbourne | Victoria | 3065 | Australia |
| Monash Medical Center | Melbourne | Victoria | 3168 | Australia |
| Allgemeines Krankenhaus Linz | Linz | 4020 | Austria |
| Onze-Lieve VrouweZiekenhuis | Aalst | Belgium |
| Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia | São Paulo | 04012-180 | Brazil |
| Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein | São Paulo | 05652-901 | Brazil |
| Instituto Coração Triângulo Mineiro | Uberlândia | 38400-368 | Brazil |
| Montreal Heart Institute | Montreal | H1T 1C8 | Canada |
| University of Ottawa Heart Institute | Ottawa | K1Y 4W7 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | G1V4G5 | Canada |
| St. Michael's Hospital | Toronto | M5B 1W8 | Canada |
| Prince of Wales Hospital | Hong Kong | China |
| Queen Mary Hospital | Hong Kong | China |
| Århus University Hospital | Århus N | 8200 | Denmark |
| Institut Jacques Cartier (ICPS) | Massy | 91300 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Hopital De Rangueil - CHU | Toulouse | 31403 | France |
| Charité Berlin Campus Steglitz | Berlin | 12203 | Germany |
| Uni.Klinikum Heidelberg | Heidelberg | 69115 | Germany |
| Apollo Hospital | Hyderabaad | Andhar Pradesh | 500033 | India |
| CARE Hospital | Hyderabaad | Andhra Pradesh | 500034 | India |
| SAL Hospital And Medical Institute | Ahmedabad | 380054 | India |
| Care Institute of Medical Sciences | Ahmedabad | 380060 | India |
| Madras Medical Mission | Chennai | 600 037 | India |
| Medanta -The Medicity | Gurgaon | 122001 | India |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | 226014 | India |
| Escorts Heart Institute & Research Centre | New Delhi | 110 070 | India |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Catanzaro University Hospital | Catanzaro | 88100 | Italy |
| Centro Cardiologico Monzino | Milan | Italy |
| Teikyo University | Tokyo | Itabashi | Japan |
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | Japan |
| Saiseikai Yokohama City Eastern Hospital | Yokohama | Kanagawa | Japan |
| Kyoto University Hospital | Kyoto | Kansai | Japan |
| Mitsui Memorial Hospital | Chiyoda-ku | 101-8643 | Japan |
| Institute Jantung Negara | Kuala Lumpur | Malaysia |
| Catharina ZH Eindhoven | Eindhoven | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | Netherlands |
| Mercy Angiography Unit | Auckland | 1023 | New Zealand |
| Christchurch Hospital | Christchurch | New Zealand |
| University Hospital Krakow | Krakow | 31-501 | Poland |
| National University Hospital | Singapore | 119228 | Singapore |
| Sunninghill Hospital | Johannesburg | South Africa |
| Clinico San Carlos | Madrid | Spain |
| La Paz | Madrid | Spain |
| Hospital do Meixoeiro | Pontevedra | 36200 | Spain |
| Lund University Hospital | Lund | 221 85 | Sweden |
| Inselspital Bern, Kardiologie | Bern | 3010 | Switzerland |
| Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Glenfield Hospital | Leicester | United Kingdom |
| King's College Hospital | London | United Kingdom |
| Derived |
| Moriyama N, Shishido K, Tanaka Y, Yokota S, Hayashi T, Miyashita H, Koike T, Yokoyama H, Takada T, Nishimoto T, Ochiai T, Tobita K, Yamanaka F, Mizuno S, Murakami M, Takahashi S, Saito S. Neoatherosclerosis 5 Years After Bioresorbable Vascular Scaffold Implantation. J Am Coll Cardiol. 2018 May 1;71(17):1882-1893. doi: 10.1016/j.jacc.2018.02.051. |
| 26585622 | Derived | Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026. |
| 24769555 | Derived | Abizaid A, Ribamar Costa J Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015 Apr;10(12):1396-401. doi: 10.4244/EIJV10I12A243. |
| 24746650 | Derived | Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16. |
| 23866188 | Derived | Gogas BD, King SB 3rd, Timmins LH, Passerini T, Piccinelli M, Veneziani A, Kim S, Molony DS, Giddens DP, Serruys PW, Samady H. Biomechanical assessment of fully bioresorbable devices. JACC Cardiovasc Interv. 2013 Jul;6(7):760-1. doi: 10.1016/j.jcin.2013.04.008. No abstract available. |
| 23517836 | Derived | Muramatsu T, Onuma Y, Garcia-Garcia HM, Farooq V, Bourantas CV, Morel MA, Li X, Veldhof S, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW; ABSORB-EXTEND Investigators. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013. |
| COMPLETED |
|
| NOT COMPLETED |
|
| 180-day Clinical Follow-up |
|
| 1 - Year Visit |
|
| 2 - Year Visit |
|
| 3 - Year Visit |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABSORB BVS | Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | The composite endpoint composed of
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In hospital) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | The composite endpoint composed of
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 30 days |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). | ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 180 days |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). | 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. | Posted | Count of Participants | Participants | 0 to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Device Success | 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. | 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. | Posted | Number | percentage of lesions | On day 0 (immediate post-index procedure) | Target Lesions | Target Lesions |
|
| |||||||||||||||||||||||||
| Secondary | Clinical Procedure Success | 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. | 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. | Posted | Number | percentage of participants | On day 0 (immediate post-index procedure) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death | 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. | ITT population (per subject analysis). | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | ITT population (per subject analysis). | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | ITT population (per subject analysis). | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In-hospital ) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death | 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. | ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 30 days |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death | 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. | ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 180 days |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death | 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. | 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. | Posted | Count of Participants | Participants | 0 to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | 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. | Posted | Count of Participants | Participants | 0 to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| 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. | Posted | Count of Participants | Participants | 0 to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| 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. | Posted | Count of Participants | Participants | 0 to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 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. | Posted | Count of Participants | Participants | 0 to 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death | 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. | 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. | Posted | Count of Participants | Participants | 0 to 2 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | 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. | Posted | Count of Participants | Participants | 0 to 2 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| 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. | Posted | Count of Participants | Participants | 0 to 2 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| 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. | Posted | Count of Participants | Participants | 0 to 2 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 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. | Posted | Count of Participants | Participants | 0 to 2 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death | 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. | 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. | Posted | Count of Participants | Participants | 0 to 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Myocardial Infarction (MI) - Per Protocol | 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 | 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. | Posted | Number | percentage of participants | 0 to 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR) | Revascularization at the target lesion associated with any of the following:
| 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. | Posted | Count of Participants | Participants | 0 to 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR) | Revascularization in the target vessel associated with any of the following:
| 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. | Posted | Count of Participants | Participants | 0 to 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR) | 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. | Posted | Count of Participants | Participants | 0 to 3 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | ≤ 7 days post index procedure (In hospital) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| ITT population (per subject analysis). | Posted | Count of Participants | Participants | 0 to 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| 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. | Posted | Count of Participants | Participants | 0 to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| 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. | Posted | Count of Participants | Participants | 0 to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR) | The composite endpoint composed of
| 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. | Posted | Count of Participants | Participants | 0 to 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). | 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. | Posted | Count of Participants | Participants | 0 to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR). | 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. | Posted | Count of Participants | Participants | 0 to 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Scaffold Thrombosis (Early) | 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. | ITT population (Per Subject Analysis) | Posted | Count of Participants | Participants | 0 to 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Scaffold Thrombosis | 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. | 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. | Posted | Count of Participants | Participants | 0 to 180 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Scaffold Thrombosis (Late) | 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. | 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. | Posted | Count of Participants | Participants | 31 - 365 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Scaffold Thrombosis | 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. | 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. | Posted | Count of Participants | Participants | 0 to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Scaffold Thrombosis (Very Late) | 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. | 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. | Posted | Count of Participants | Participants | 366 days to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Scaffold Thrombosis | 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. | 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. | Posted | Count of Participants | Participants | 0 to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Scaffold Thrombosis | 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. | 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. | Posted | Count of Participants | Participants | 0 to 3 years |
|
| |||||||||||||||||||||||||||
| Secondary | Area Stenosis (%) | 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. | Posted | Mean | Standard Deviation | Percentage | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Minimum Lumen Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Vessel Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Minimum Vessel Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Maximum Vessel Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Lumen Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Maximum Lumen Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Plaque Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Minimum Plaque Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Maximum Plaque Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Reference Area | 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. | Posted | Mean | Standard Deviation | mm^2 | 18 months |
|
| |||||||||||||||||||||||||||
| Secondary | Calculated Minimum Lumen Diameter | 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. | 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. | Posted | Mean | Standard Deviation | mm | 18 months |
|
| ||||||||||||||||||||||||||
| Secondary | Calculated Diameter Stenosis | 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). | 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. | Posted | Mean | Standard Deviation | Percent Diameter stenosis | 18 months |
|
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABSORB BVS | ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease | 7 | 812 | 295 | 812 | 808 | 812 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEMORRHAGIC ANEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IRON DEFICIENCY ANEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEUTROPHILIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPONTANEOUS HEMATOMA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTERIOSPASM CORONARY | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISSECTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT CORONARY ARTERY RESTENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTRACARDIAC THROMBUS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHEMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SINUS ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR EXTRA SYSTOLES | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THYROGLOSSAL CYST | Congenital, familial and genetic disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEAFNESS NEUROSENSORY | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GOITER | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRIMARY HYPERALDOSTERONISM | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATARACT NUCLEAR | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| UVEITIS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VITREOUS DEGENERATION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL WALL DISORDER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COLON CANCER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COLONIC POLYP | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC ULCER HEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GINGIVITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GLOSSODYNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MOUTH HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERITONEAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TOOTH SOCKET HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ADVERSE DRUG REACTION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| ASTHENIA | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE HAEMATOMA | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE HAEMORRHAGE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE PAIN | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE RELATED REACTION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE SWELLING | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CHEST DISCOMFORT | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CHILLS | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DEATH | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DEVICE DISLOCATION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DEVICE MALFUNCTION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DEVICE OCCLUSION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DROWNING | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| FATIGUE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| GENERAL SYMPTOM | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| MALAISE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| MASS | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| OEDEMA | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| PAIN | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| SUDDEN CARDIAC DEATH | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| SUDDEN DEATH | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| THROMBOSIS IN DEVICE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| VESSEL PUNCTURE SITE HAEMORRHAGE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLECYSTITIS CHRONIC | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NON-ALCOHOLIC STEATOHEPATITIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ALLERGY TO ARTHROPOD STING | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONTRAST MEDIA ALLERGY | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GROIN ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| HERPES SIMPLEX | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| INFECTED BITES | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| KIDNEY INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LIVER ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LYMPHANGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| NOSOCOMIAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEOMYELITIS ACUTE | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA PRIMARY ATYPICAL | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| RASH PUSTULAR | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| BACK INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC PROCEDURE COMPLICATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CATHETER SITE HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ENDOTRACHEAL INTUBATION COMPLICATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FOREIGN BODY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT ARTERIAL RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| LIMB CRUSHING INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PERIORBITAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PLAQUE SHIFT | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| POST PROCEDURAL MYOCARDIAL INFARCTION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| POST PROCEDURAL SWELLING | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PROCEDURAL HEADACHE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PROCEDURAL HYPERTENSION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PROCEDURAL HYPOTENSION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PROCEDURAL NAUSEA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| RADIATION OESOPHAGITIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| TENDON INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY RETENTION POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE MB INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE SYSTOLIC INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| CARCINOEMBRYONIC ANTIGEN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC ENZYMES INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC STRESS TEST ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM ST SEGMENT ELEVATION | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| FEMORAL BRUIT | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| GLYCOSYLATED HAEMOGLOBIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| LOW DENSITY LIPOPROTEIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| OXYGEN SATURATION DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| RED BLOOD CELL SEDIMENTATION RATE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TROPONIN I INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TROPONIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TROPONIN T INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GLUCOSE TOLERANCE IMPAIRED | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COSTOCHONDRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| JAW CYST | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPONDYLITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| BONE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| HAIR FOLLICLE TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| HODGKIN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| MEDIASTINUM NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| MESOTHELIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| MULTIPLE MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| RETROPERITONEAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| SKIN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| SOFT TISSUE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| VULVAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| AMYOTROPHIC LATERAL SCLEROSIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BURNING SENSATION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL HAEMATOMA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS POSTURAL | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ENCEPHALITIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EXERTIONAL HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LUMBAR RADICULOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARKINSON'S DISEASE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARKINSONISM | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABNORMAL BEHAVIOUR | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MENTAL DISORDER | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MOOD SWINGS | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NERVOUSNESS | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PANIC ATTACK | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BLADDER DILATATION | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BLADDER OBSTRUCTION | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CALCULUS URINARY | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL ARTERY STENOSIS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL MASS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| URETHRAL STENOSIS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BREAST CALCIFICATIONS | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GYNAECOMASTIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BRONCHITIS CHRONIC | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NOCTURNAL DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RALES | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IDIOPATHIC URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INCREASED TENDENCY TO BRUISE | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SKIN DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OCCUPATIONAL EXPOSURE TO AIR CONTAMINANTS | Social circumstances | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC ABLATION | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC PACEMAKER INSERTION | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLECYSTECTOMY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| FLUID REPLACEMENT | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERY ANGIOPLASTY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| PROSTATECTOMY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| TOOTH EXTRACTION | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| URETHRAL STENT REMOVAL | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| VASECTOMY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE INADEQUATELY CONTROLLED | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERTENSIVE EMERGENCY | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ILIAC ARTERY OCCLUSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERMITTENT CLAUDICATION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERIPHERAL COLDNESS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERIPHERAL VASCULAR DISORDER | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUBCLAVIAN ARTERY STENOSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENOUS INSUFFICIENCY | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEMORRHAGIC ANEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IRON DEFICIENCY ANEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEUTROPHILIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPONTANEOUS HEMATOMA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTERIOSPASM CORONARY | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISSECTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY OCCLUSION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT CORONARY ARTERY RESTENOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTRACARDIAC THROMBUS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHEMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SINUS ARREST | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR EXTRA SYSTOLES | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THYROGLOSSAL CYST | Congenital, familial and genetic disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEAFNESS NEUROSENSORY | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GOITER | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRIMARY HYPERALDOSTERONISM | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CATARACT NUCLEAR | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| UVEITIS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VITREOUS DEGENERATION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL WALL DISORDER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COLON CANCER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COLONIC POLYP | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRIC ULCER HEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GINGIVITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GLOSSODYNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEMATOCHEZIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEMORRHOIDS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MELENA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MOUTH HEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PERITONEAL HEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SMALL INTESTINAL HEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TOOTH SOCKET HEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ADVERSE DRUG REACTION | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE HAEMATOMA | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE HAEMORRHAGE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE PAIN | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE RELATED REACTION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CATHETER SITE SWELLING | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CHEST DISCOMFORT | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CHILLS | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DEVICE DISLOCATION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DEVICE MALFUNCTION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DEVICE OCCLUSION | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| DROWNING | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| FATIGUE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| GENERAL SYMPTOM | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| MALAISE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| MASS | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| OEDEMA | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| PAIN | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| THROMBOSIS IN DEVICE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| VESSEL PUNCTURE SITE HAEMORRHAGE | General disorders | MedDRA 10.0 | Systematic Assessment | General disorders and administration site conditions |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLECYSTITIS CHRONIC | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NON-ALCOHOLIC STEATOHEPATITIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ALLERGY TO ARTHROPOD STING | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONTRAST MEDIA ALLERGY | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GROIN ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| HERPES SIMPLEX | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| INFECTED BITES | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| KIDNEY INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LIVER ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LYMPHANGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| NOSOCOMIAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEOMYELITIS ACUTE | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA PRIMARY ATYPICAL | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| RASH PUSTULAR | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| BACK INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC PROCEDURE COMPLICATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CATHETER SITE HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ENDOTRACHEAL INTUBATION COMPLICATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| FOREIGN BODY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT ARTERIAL RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| IN-STENT CORONARY ARTERY RESTENOSIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| LIMB CRUSHING INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PERIORBITAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PLAQUE SHIFT | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| POST PROCEDURAL MYOCARDIAL INFARCTION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| POST PROCEDURAL SWELLING | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PROCEDURAL HEADACHE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PROCEDURAL HYPERTENSION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PROCEDURAL HYPOTENSION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| PROCEDURAL NAUSEA | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| RADIATION OESOPHAGITIS | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| TENDON INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY RETENTION POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE MB INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD PRESSURE SYSTOLIC INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| CARCINOEMBRYONIC ANTIGEN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC ENZYMES INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC STRESS TEST ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM ST SEGMENT ELEVATION | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| FEMORAL BRUIT | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| GLYCOSYLATED HAEMOGLOBIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| LOW DENSITY LIPOPROTEIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| OXYGEN SATURATION DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| RED BLOOD CELL SEDIMENTATION RATE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TROPONIN I INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TROPONIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TROPONIN T INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| FLUID RETENTION | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GLUCOSE TOLERANCE IMPAIRED | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COSTOCHONDRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| JAW CYST | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SPONDYLITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| BONE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| HAIR FOLLICLE TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| HODGKIN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| MEDIASTINUM NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| MESOTHELIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| MULTIPLE MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| RETROPERITONEAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| SKIN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| SOFT TISSUE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| VULVAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| AMYOTROPHIC LATERAL SCLEROSIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BURNING SENSATION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL HAEMATOMA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS POSTURAL | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ENCEPHALITIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EXERTIONAL HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LUMBAR RADICULOPATHY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARKINSON'S DISEASE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARKINSONISM | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABNORMAL BEHAVIOUR | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MENTAL DISORDER | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MOOD SWINGS | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NERVOUSNESS | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PANIC ATTACK | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BLADDER DILATATION | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BLADDER OBSTRUCTION | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CALCULUS URINARY | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL ARTERY STENOSIS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RENAL MASS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| URETHRAL STENOSIS | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| BREAST CALCIFICATIONS | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| GYNAECOMASTIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| UTERINE POLYP | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| BRONCHITIS CHRONIC | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| NOCTURNAL DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| RALES | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| IDIOPATHIC URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| INCREASED TENDENCY TO BRUISE | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| SKIN DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| OCCUPATIONAL EXPOSURE TO AIR CONTAMINANTS | Social circumstances | MedDRA 10.0 | Systematic Assessment |
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| CARDIAC ABLATION | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| CARDIAC PACEMAKER INSERTION | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| CHOLECYSTECTOMY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| FLUID REPLACEMENT | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| PERIPHERAL ARTERY ANGIOPLASTY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| PROSTATECTOMY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| TOOTH EXTRACTION | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| URETHRAL STENT REMOVAL | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| VASECTOMY | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| AORTIC ANEURYSM | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| BLOOD PRESSURE INADEQUATELY CONTROLLED | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| HAEMATOMA | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| HAEMORRHAGE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| HYPERTENSIVE EMERGENCY | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| ILIAC ARTERY OCCLUSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| INTERMITTENT CLAUDICATION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| PERIPHERAL COLDNESS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| PERIPHERAL VASCULAR DISORDER | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| SUBCLAVIAN ARTERY STENOSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| VENOUS INSUFFICIENCY | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| VENOUS THROMBOSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Veldhof | Abbott Vascular International BVBA | +31653428610 | susan.veldhof@av.abbott.com |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D023903 | Coronary Restenosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
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