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| Name | Class |
|---|---|
| Medtronic Cardiac Rhythm and Heart Failure | INDUSTRY |
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The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.
Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.
The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.
Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.
Study hypothesis: To determine whether the Zotarolimus-Eluting stent (Medtronic Endeavor-Resolute) is non-inferior to the Everolimus-eluting stent (Abbott XIENCE V) in terms of the primary endpoint at 12 months after stent implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Resolute | Active Comparator | Medtronic Endeavor Resolute |
|
| 2. XIENCE V | Active Comparator | Abbott Xience V |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Endeavor Resolute | Device | Medtronic Endeavor Resolute |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure | Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| In-Stent Percent Diameter Stenosis | In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Serruys, MD | Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands | Principal Investigator |
| Sigmund Silber, MD | Kardiologische Praxis und Praxisklinik, Munich, Germany | Principal Investigator |
| Stephan Windecker, MD | University Hospital Bern, Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stiftung Inselspital, Department of Cardiology | Bern | CH-3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26823484 | Derived | Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Raber L, Heg D, Juni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255. | |
| 26047993 |
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Start recruitment: April 30, 2008 > End recruitment: October 28, 2008
> Types of location: medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | 1. Resolute - 12-13 Months | Medtronic Resolute - 12-13 Months |
| FG001 | 2. XIENCE V - 12-13 Months | Abbott Xience V - 12-13 Months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1. Resolute - 12-13 Months | Medtronic Resolute - 12-13 Months |
| BG001 | 2. XIENCE V - 12-13 Months | Abbott Xience V - 12-13 Months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Target Lesion Failure | Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average. | Analysis per intention to treat | Posted | Number | percentage of participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1. Resolute - 12-13 Months | Medtronic Resolute - 12-13 Months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miraida Weldam | Medtronic Bakken Research Center B.V. | + 31 43 356 | 6652 | miraida.weldam@medtronic.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Abbott Xience V | Device | Abbott Xience V |
|
|
| 13 Months |
| Derived |
| Iqbal J, Serruys PW, Silber S, Kelbaek H, Richardt G, Morel MA, Negoita M, Buszman PE, Windecker S. Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002230. doi: 10.1161/CIRCINTERVENTIONS.114.002230. |
| 26040806 | Derived | Taniwaki M, Windecker S, Zaugg S, Stefanini GG, Baumgartner S, Zanchin T, Wenaweser P, Meier B, Juni P, Raber L. The association between in-stent neoatherosclerosis and native coronary artery disease progression: a long-term angiographic and optical coherence tomography cohort study. Eur Heart J. 2015 Aug 21;36(32):2167-76. doi: 10.1093/eurheartj/ehv227. Epub 2015 Jun 3. |
| 25825008 | Derived | Campos CM, Costa F, Garcia-Garcia HM, Bourantas C, Suwannasom P, Valgimigli M, Morel MA, Windecker S, Serruys PW. Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. Circ Cardiovasc Interv. 2015 Apr;8(4):e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279. |
| 25721728 | Derived | Taniwaki M, Radu MD, Garcia-Garcia HM, Heg D, Kelbaek H, Holmvang L, Moschovitis A, Noble S, Pedrazzini G, Saunamaki K, Dijkstra J, Landmesser U, Wenaweser P, Meier B, Stefanini GG, Roffi M, Luscher TF, Windecker S, Raber L. Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction: the IBIS-4 (integrated biomarker and imaging study) substudy. Int J Cardiovasc Imaging. 2015 Jun;31(5):915-26. doi: 10.1007/s10554-015-0631-0. Epub 2015 Feb 28. |
| 24530680 | Derived | Taniwaki M, Stefanini GG, Silber S, Richardt G, Vranckx P, Serruys PW, Buszman PE, Kelbaek H, Windecker S; RESOLUTE All-Comers Investigators. 4-year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from the RESOLUTE All-Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). J Am Coll Cardiol. 2014 Apr 29;63(16):1617-25. doi: 10.1016/j.jacc.2013.12.036. Epub 2014 Feb 13. |
| 24510638 | Derived | Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7. |
| 23954063 | Derived | Richardt G, Leschke M, Abdel-Wahab M, Toelg R, El-Mawardy M, Serruys PW, Silber S, Windecker S, Belardi JA, Neumann FJ, Widimsky P; RESOLUTE All Comers; RESOLUTE International Investigators. Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC Cardiovasc Interv. 2013 Sep;6(9):905-13. doi: 10.1016/j.jcin.2013.04.017. Epub 2013 Aug 14. |
| 23816026 | Derived | Gutierrez-Chico JL, Raber L, Regar E, Okamura T, di Mario C, van Es GA, Windecker S, Serruys PW. Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography. Am Heart J. 2013 Jul;166(1):83-94. doi: 10.1016/j.ahj.2013.04.001. Epub 2013 May 3. |
| 23523454 | Derived | Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20. |
| 23468513 | Derived | Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6. |
| 22821273 | Derived | Vranckx P, Farooq V, Garg S, Van Es GA, Silber S, Windecker S, Stone GW, Serruys PW. Different cardiac biomarkers to detect peri-procedural myocardial infarction in contemporary coronary stent trials: impact on outcome reporting. Heart. 2012 Oct;98(19):1424-30. doi: 10.1136/heartjnl-2012-302267. Epub 2012 Jul 21. |
| 22440496 | Derived | Stefanini GG, Kalesan B, Pilgrim T, Raber L, Onuma Y, Silber S, Serruys PW, Meier B, Juni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10. doi: 10.1016/j.jcin.2011.11.011. |
| 22319063 | Derived | Gutierrez-Chico JL, Wykrzykowska J, Nuesch E, van Geuns RJ, Koch KT, Koolen JJ, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Regar E, Serruys PW. Vascular tissue reaction to acute malapposition in human coronary arteries: sequential assessment with optical coherence tomography. Circ Cardiovasc Interv. 2012 Feb 1;5(1):20-9, S1-8. doi: 10.1161/CIRCINTERVENTIONS.111.965301. Epub 2012 Feb 7. |
| 22137081 | Derived | Gomez-Lara J, Heo JH, Brugaletta S, Garg S, Garcia-Garcia HM, van Geuns RJ, Silber S, Windecker S, Serruys PW. Risk of target lesion failure in relationship to vessel angiographic geometry and stent conformability using the second generation of drug-eluting stents. Am Heart J. 2011 Dec;162(6):1069-1079.e2. doi: 10.1016/j.ahj.2011.09.010. Epub 2011 Nov 8. |
| 21768536 | Derived | Gutierrez-Chico JL, Regar E, Nuesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18. |
| 21659439 | Derived | Gutierrez-Chico JL, van Geuns RJ, Regar E, van der Giessen WJ, Kelbaek H, Saunamaki K, Escaned J, Gonzalo N, di Mario C, Borgia F, Nuesch E, Garcia-Garcia HM, Silber S, Windecker S, Serruys PW. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur Heart J. 2011 Oct;32(19):2454-63. doi: 10.1093/eurheartj/ehr182. Epub 2011 Jun 9. |
| 21616282 | Derived | Stefanini GG, Serruys PW, Silber S, Khattab AA, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, Di Mario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli AL, Gobbens P, Windecker S. The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention). J Am Coll Cardiol. 2011 May 31;57(22):2221-32. doi: 10.1016/j.jacc.2011.01.036. |
| 21511223 | Derived | Garg S, Serruys PW, Silber S, Wykrzykowska J, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Van Remortel E, Ronden J, Windecker S. The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial. JACC Cardiovasc Interv. 2011 Apr;4(4):432-41. doi: 10.1016/j.jcin.2011.01.008. |
| 21459430 | Derived | Silber S, Windecker S, Vranckx P, Serruys PW; RESOLUTE All Comers investigators. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lancet. 2011 Apr 9;377(9773):1241-7. doi: 10.1016/S0140-6736(11)60395-4. Epub 2011 Apr 1. |
| 20554978 | Derived | Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010 Jul 8;363(2):136-46. doi: 10.1056/NEJMoa1004130. Epub 2010 Jun 16. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 2. XIENCE V - 12-13 Months |
Abbott Xience V - 12-13 Months |
|
|
| Secondary | In-Stent Percent Diameter Stenosis | In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory. | Posted | Mean | Standard Deviation | Percentage diameter stenosis | 13 Months |
|
|
|
| 435 |
| 1,140 |
| 0 |
| 1,140 |
| EG001 | 2. XIENCE V - 12-13 Months | Abbott Xience V - 12-13 Months | 432 | 1,152 | 59 | 1,152 |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancytopenia | 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 |
|
| Aortic Valve Stenosis | 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 | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bundle Branch Block Left | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bundle Branch Block Right | 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 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 |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Congestive Cardiomyopathy | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cor Pulmonale Acute | 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 Embolism | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary Artery Occlusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary Artery Perforation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary Artery Restenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary Artery Stenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dressler's Syndrome | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Extrasystoles | 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 |
|
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Left Ventricular Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mitral Valve Incompetence | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Papillary Muscle Disorder | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pericardial Rub | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Right Ventricular Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ventricular Flutter | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial Septal Defect | Congenital, familial and genetic disorders | MedDRA 10.0 | Systematic Assessment |
|
| Meniere's Disease | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Adrenal Disorder | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thyroid Disorder | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vitreous Haemorrhage | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Crohn's Disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Ulcer | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancreatic Disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest Discomfort | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gait Disturbance | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection Site Haematoma | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Multi-Organ Failure | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Orthostatic Intolerance | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Unevaluable Event | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hepatitis Acute | Hepatobiliary 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 |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gangrene | 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 |
|
| Haemophilus Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Implant Site Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Intervertebral Discitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Oesophageal Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Perianal Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Peritonsillar Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pyelonephritis | 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 |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Device Malfunction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Foreign Body Trauma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Haemothorax | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Implantable Defibrillator Malfunction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Multiple Injuries | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Pacemaker Complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Postoperative Thoracic Procedure Complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Postoperative Thrombosis | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Stent Occlusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Thrombosis In Device | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Tracheal Obstruction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Transfusion Reaction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Angiogram | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Arteriogram Coronary | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Biopsy Lung | Investigations | 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 Test Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| C-Reactive Protein Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Enzymes Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Stress Test | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Stress Test Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Carotid Pulse Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Colonoscopy | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Electrocardiogram ST Segment Depression | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Electrocardiogram ST Segment Elevation | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Investigation | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Sleep Study | 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 |
|
| Diabetes Mellitus Inadequate Control | 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 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Collagen Disorder | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | 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 |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Benign Neoplasm Of Thyroid Gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Breast Cancer Female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Bronchial Carcinoma | 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 |
|
| Laryngeal Cancer | 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 |
|
| Meningioma | 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 Abdominal Cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Metastases To Meninges | 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 |
|
| Myelodysplastic Syndrome | 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 |
|
| Oesophageal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Pancreatic Carcinoma | 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 |
|
| Prostate Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Thyroid Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Urethral Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Vocal Cord Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Apraxia | 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 |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| IIIrd Nerve Disorder | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Memory Impairment | 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 |
|
| Partial Seizures | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Radicular Syndrome | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope Vasovagal | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Psychosomatic Disease | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Schizophrenia, Paranoid Type | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Calculus Urinary | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal Artery Stenosis | 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 |
|
| Urethral Stenosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Bladder Haemorrhage | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Respiratory Distress Syndrome | 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 |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary Congestion | 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 |
|
| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Skin | 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 |
|
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angioplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Aortic Valve Replacement | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Arterial Aneurysm Repair | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Arteriovenous Shunt Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Baker's Cyst Excision | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Bladder Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Pacemaker Insertion | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Cardioversion | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Cataract Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Colon Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Coronary Angioplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Coronary Artery Bypass | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Coronary Revascularisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Foot Amputation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Hysterosalpingo-Oophorectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Ileostomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Implantable Defibrillator Insertion | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Knee Arthroplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Knee Meniscectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Knee Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Leg Amputation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Meniscus Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Nephrectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Percutaneous Coronary Intervention | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Preoperative Care | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Radiotherapy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Rehabilitation Therapy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Skin Graft | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Thrombectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Toe Amputation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Trabeculectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Aortic Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arterial Rupture | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arteriovenous Fistula | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Essential Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Extremity Necrosis | 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 |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypovolaemic Shock | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Iliac Artery Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Necrosis Ischaemic | 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 Artery Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral Ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vascular Pseudoaneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Prior to submission the Publication Committee (PC) and all co-authors will review and authorize the publication.>
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |