[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589242":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":90,"collaborators":92,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":10,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"tezepelumab severe asthma patients",null,"patients with a diagnosis of severe asthma receiving tezepelumab",[13],"Drug: Tezepelumab",{"label":15,"type":10,"description":16,"interventionNames":10},"tezepelumab unexposed asthma patients","patients with a diagnosis of severe asthma receiving non-tezepelumab standard of care for severe asthma",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Tezepelumab","The exposure of primary interest is tezepelumab for severe asthma. Exposure will be assessed based on prescriptions or administrations depending on the data source. A comparable cohort of unexposed patients treated with high-intensity SOC will be identified based on the presence of a trigger exposure (i.e., augmentation or change of the non-biologic high-intensity treatment that does not represent treatment de-escalation) to mirror tezepelumab start in the exposed cohort. Due to the limited knowledge of the cardiovascular profile of biologics, SOC for comparative analyses will only include non-biologic high-intensity treatment.",[9],[24],"TEZSPIRE",[26],{"name":27,"affiliation":28,"role":29},"Peter Egger","IQVIA Pty Ltd","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[37,51,64,77],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":10},"Healthcare Integrated Research Database (HIRD)","RECRUITING","Wilmington","Delaware","19801","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-75.54659,39.74595,{"lat":49,"lon":48},{"facility":52,"status":39,"city":53,"state":10,"zip":10,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Danish registries (access\u002Fanalysis)","Copenhagen","Denmark","DK",{"type":46,"coordinates":57},[58,59],12.56553,55.67594,{"lat":59,"lon":58},[62],{"name":10,"role":33,"phone":10,"phoneExt":10,"email":63},"kontakt@sundhedsdata.dk",{"facility":65,"status":39,"city":66,"state":10,"zip":10,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"French National Health Data System (SNDS)","Paris","France","FR",{"type":46,"coordinates":70},[71,72],2.3488,48.85341,{"lat":72,"lon":71},[75],{"name":10,"role":33,"phone":10,"phoneExt":10,"email":76},"regis.lassalle@health-data-hub.fr",{"facility":78,"status":39,"city":79,"state":10,"zip":10,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Team Gesundheit GKV Claims data (SHI)","Berlin","Germany","DE",{"type":46,"coordinates":83},[84,85],13.41053,52.52437,{"lat":85,"lon":84},[88],{"name":10,"role":33,"phone":10,"phoneExt":10,"email":89},"friedel@teamgesundheit.de",{"type":91,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[93],{"name":94,"class":6},"IQVIA Pvt. Ltd","100589242","tezspire-cardiac-events-pass-100589242",false,"NCT06951867","Tezspire Cardiac Events PASS","An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients With Severe Asthma Taking Tezepelumab","TRESPASS","Inclusion Criteria:\n\n* patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.\n\nExclusion Criteria for both exposed and unexposed groups include:\n\n* \\\u003C12 months of data availability prior to index date,\n* age \\\u003C12 years at index date,\n* history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date\n* for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic\n* matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \\[PS\\] matching) will be applied to ensure exposed and unexposed patients' comparability","ALL","12 Years","130 Years",{"count":107,"type":108},16640,"ESTIMATED","OBSERVATIONAL","The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.",[112,113],"Cardiovascular Events","MACE",[115,116,117,118,119,120,121,122,123],"post Marketing Requirements (PMR) study","cardiovascular events","non-fatal myocardial infarction","non-fatal stroke","cardiovascular death","arrythmias","coronary artery disease","heart failure","myocardial disorders","2026-06-03",{"date":126,"type":127},"2026-06-04","ACTUAL",{"date":129,"type":127},"2025-09-15",{"date":131,"type":108},"2029-05-31",{"name":5,"class":6},4]