{"ctNumber":"2022-501697-19-01","ctStatus":"Authorised","startDateEU":"2024-06-18","decisionDate":"2024-06-12T10:03:10.919","publishDate":"2026-07-09T03:41:45.336388809","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":134878,"rowSubjectCount":948,"rowCountriesInfo":[{"eutctId":100000000465,"name":"Mexico","isoNumber":484,"isoAlpha2Code":"MX","isoAlpha3Code":"MEX","current":true},{"eutctId":100000000346,"name":"Brazil","isoNumber":76,"isoAlpha2Code":"BR","isoAlpha3Code":"BRA","current":true},{"eutctId":100000000541,"name":"Thailand","isoNumber":764,"isoAlpha2Code":"TH","isoAlpha3Code":"THA","current":true},{"eutctId":100000000538,"name":"Taiwan","isoNumber":158,"isoAlpha2Code":"TW","isoAlpha3Code":"TWN","current":true},{"eutctId":100000000354,"name":"Canada","isoNumber":124,"isoAlpha2Code":"CA","isoAlpha3Code":"CAN","current":true},{"eutctId":100000000549,"name":"Turkey","isoNumber":792,"isoAlpha2Code":"TR","isoAlpha3Code":"TUR","current":true},{"eutctId":100000000556,"name":"United Kingdom","isoNumber":826,"isoAlpha2Code":"GB","isoAlpha3Code":"GBR","current":true},{"eutctId":100000000456,"name":"Malaysia","isoNumber":458,"isoAlpha2Code":"MY","isoAlpha3Code":"MYS","current":true},{"eutctId":100000000329,"name":"Australia","isoNumber":36,"isoAlpha2Code":"AU","isoAlpha3Code":"AUS","current":true},{"eutctId":100000000497,"name":"Peru","isoNumber":604,"isoAlpha2Code":"PE","isoAlpha3Code":"PER","current":true},{"eutctId":100000000420,"name":"Hong Kong","isoNumber":344,"isoAlpha2Code":"HK","isoAlpha3Code":"HKG","current":true},{"eutctId":100000000527,"name":"South Africa","isoNumber":710,"isoAlpha2Code":"ZA","isoAlpha3Code":"ZAF","current":true},{"eutctId":100000000362,"name":"China","isoNumber":156,"isoAlpha2Code":"CN","isoAlpha3Code":"CHN","current":true},{"eutctId":100000000482,"name":"New Zealand","isoNumber":554,"isoAlpha2Code":"NZ","isoAlpha3Code":"NZL","current":true},{"eutctId":100000000366,"name":"Colombia","isoNumber":170,"isoAlpha2Code":"CO","isoAlpha3Code":"COL","current":true},{"eutctId":100000000429,"name":"Israel","isoNumber":376,"isoAlpha2Code":"IL","isoAlpha3Code":"ISR","current":true},{"eutctId":100000000361,"name":"Chile","isoNumber":152,"isoAlpha2Code":"CL","isoAlpha3Code":"CHL","current":true},{"eutctId":100000000432,"name":"Japan","isoNumber":392,"isoAlpha2Code":"JP","isoAlpha3Code":"JPN","current":true},{"eutctId":100000000557,"name":"United States","isoNumber":840,"isoAlpha2Code":"US","isoAlpha3Code":"USA","current":true}],"products":[{"id":560644,"part1MpRoleTypeCode":"2","productDictionaryInfo":{"productPharmForm":"PHF00006MIG","euMpNumber":"SCP674865","marketingAuthNumber":"-","prodAuthStatus":2,"activeSubstanceName":"IBRUTINIB","euSubstNumber":"SUB120863","productSubstances":[{"substancePk":"424326","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"IBRUTINIB","substanceEvCode":"SUB120863","synonyms":["1-((3R)-3-(4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO(3,4-D)PYRIMIDIN-1-YL)PIPERIDIN-1- YL)PROP-2-EN-1-ONE"]}],"atcCode":"L01EL01","atcName":"IBRUTINIB\r","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"2","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"420","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"1381","productChangedRelationMA":false,"maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","miaNumber":"IMP11011/00003","scientificProductEvCode":"SCP674865","scientificProductPharmEvCode":"PHF00006MIG","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"IBRUTINIB\r","jsonActiveSubstanceNames":"ibrutinib","pharmaceuticalFormDisplay":"PHF00006MIG"},{"id":560643,"part1MpRoleTypeCode":"2","productDictionaryInfo":{"productPharmForm":"PHF00006MIG","euMpNumber":"SCP46660836","marketingAuthNumber":"-","prodAuthStatus":2,"activeSubstanceName":"ACALABRUTINIB","euSubstNumber":"SUB182073","productSubstances":[{"substancePk":"424398","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"ACALABRUTINIB","substanceEvCode":"SUB182073","synonyms":["ACP-196","(S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-α]pyrazin-1-yl)-N-(pyridin-2-yl)-benzamide"]}],"atcCode":"L01EL02","atcName":"ACALABRUTINIB\r","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"2","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"200","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"657","productChangedRelationMA":false,"maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","miaNumber":"IMP11011/00003","scientificProductEvCode":"SCP46660836","scientificProductPharmEvCode":"PHF00006MIG","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"ACALABRUTINIB\r","jsonActiveSubstanceNames":"acalabrutinib","pharmaceuticalFormDisplay":"PHF00006MIG"},{"id":560648,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11385048","productPharmForm":"FILM-COATED TABLET","euMpNumber":"PRD11385048","prodAuthStatus":1,"prodName":"Nemtabrutinib","pharmForm":"FILM-COATED TABLET","sponsorProductCode":"MK-1026","activeSubstanceName":"NEMTABRUTINIB","euSubstNumber":"SUB201199","nameOrg":"MERCK & CO. INC.","productSubstances":[{"productPk":"11385048","substancePk":"338707","nameOrg":"MERCK & CO. INC.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"NEMTABRUTINIB","substanceEvCode":"SUB201199","synonyms":["ARQ-531","ARQ 531","(2-chloro-4-phenoxyphenyl)(4-(((3R,6S)-6-(hydroxymethyl)tetrahydro-2H-pyran-3-yl)amino)-7H-pyrrolo[2,3-d]pyrimidin-5-yl)methanone","MK-1026"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"65","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"213.7","maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","evCode":"PRD11385048","sponsorProductCodeEdit":"MK-1026","miaNumber":"IMP11011/00003","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Nemtabrutinib","jsonActiveSubstanceNames":"nemtabrutinib","pharmaceuticalFormDisplay":"FILM-COATED TABLET"},{"id":560646,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11385047","productPharmForm":"FILM-COATED TABLET","euMpNumber":"PRD11385047","prodAuthStatus":1,"prodName":"Nemtabrutinib","pharmForm":"FILM-COATED TABLET","sponsorProductCode":"MK-1026","activeSubstanceName":"NEMTABRUTINIB","euSubstNumber":"SUB201199","nameOrg":"MERCK & CO. INC.","productSubstances":[{"productPk":"11385047","substancePk":"338707","nameOrg":"MERCK & CO. INC.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"NEMTABRUTINIB","substanceEvCode":"SUB201199","synonyms":["ARQ-531","ARQ 531","(2-chloro-4-phenoxyphenyl)(4-(((3R,6S)-6-(hydroxymethyl)tetrahydro-2H-pyran-3-yl)amino)-7H-pyrrolo[2,3-d]pyrimidin-5-yl)methanone","MK-1026"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"65","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"213.7","maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","evCode":"PRD11385047","sponsorProductCodeEdit":"MK-1026","miaNumber":"IMP11011/00003","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Nemtabrutinib","jsonActiveSubstanceNames":"nemtabrutinib","pharmaceuticalFormDisplay":"FILM-COATED TABLET"},{"id":560647,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"9964080","productPharmForm":"TABLET","euMpNumber":"PRD7571581","prodAuthStatus":1,"prodName":"Nemtabrutinib","pharmForm":"TABLET","sponsorProductCode":"MK-1026","activeSubstanceName":"NEMTABRUTINIB","euSubstNumber":"SUB201199","nameOrg":"MERCK & CO. INC.","productSubstances":[{"productPk":"9964080","substancePk":"235551","nameOrg":"MERCK & CO. INC.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"NEMTABRUTINIB","substanceEvCode":"SUB201199"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"65","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"213.7","maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","evCode":"PRD7571581","sponsorProductCodeEdit":"MK-1026","miaNumber":"IMP11011/00003","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Nemtabrutinib","jsonActiveSubstanceNames":"nemtabrutinib","pharmaceuticalFormDisplay":"TABLET"},{"id":560645,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"9964081","productPharmForm":"TABLET","euMpNumber":"PRD7571582","prodAuthStatus":1,"prodName":"Nemtabrutinib","pharmForm":"TABLET","sponsorProductCode":"MK-1026","activeSubstanceName":"NEMTABRUTINIB","euSubstNumber":"SUB201199","nameOrg":"MERCK & CO. INC.","productSubstances":[{"productPk":"9964081","substancePk":"235551","nameOrg":"MERCK & CO. INC.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"NEMTABRUTINIB","substanceEvCode":"SUB201199"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"65","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"213.7","maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","evCode":"PRD7571582","sponsorProductCodeEdit":"MK-1026","miaNumber":"IMP11011/00003","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Nemtabrutinib","jsonActiveSubstanceNames":"nemtabrutinib","pharmaceuticalFormDisplay":"TABLET"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator’s Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)","fullTitleTranslations":[{"id":11313208,"uuid":"998964f9-5dce-4696-92c3-491b86520be5","attributeTranslation":"Estudio de fase 3, aleatorizado, para comparar nemtabrutinib frente a comparador (elección del investigador de ibrutinib o acalabrutinib) en participantes con leucemia linfocítica crónica/linfoma linfocítico de células pequeñas no tratada (BELLWAVE 011)","language":7,"languageDescription":"Spanish"},{"id":11313205,"uuid":"998964f9-5dce-4696-92c3-491b86520be5","attributeTranslation":"Randomizowane badanie fazy 3 porównujące nemtabrutynib z lekiem porównawczym (wybór ibrutynibu lub akalabrutynibu należy do badacza) u uczestników z nieleczoną przewlekłą białaczką limfocytową/chłoniakiem z małych limfocytów (BELLWAVE-011)","language":19,"languageDescription":"Polish"},{"id":11313207,"uuid":"998964f9-5dce-4696-92c3-491b86520be5","attributeTranslation":"Μία φάσης 3, Τυχαιοποιημένη μελέτη για τη σύγκριση της νεμταμπρουτινίμπης έναντι του συγκριτικού παράγοντα (επιλογή του ερευνητή μεταξύ ιμπρουτινίμπης ή ακαλαμπρουτινίμπης) σε συμμετέχοντες με χρόνια λεμφοκυτταρική λευχαιμία/μικρό λεμφοκυτταρικό λέμφωμα που δεν έχουν λάβει καμία θεραπεία (BELLWAVE 011)","language":5,"languageDescription":"Greek"},{"id":11313206,"uuid":"998964f9-5dce-4696-92c3-491b86520be5","attributeTranslation":"Estudo de fase 3, aleatorizado, para comparar nemtabrutinib versus comparador (escolha do investigador: ibrutinib ou acalabrutinib) em participantes com leucemia linfocítica crónica / pequeno linfoma linfocítico não tratado (BELLWAVE 011)","language":20,"languageDescription":"Portuguese"}],"publicTitle":"A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator’s Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE 011)","publicTitleTranslations":[{"id":11313242,"uuid":"27b328b9-52b5-401b-bd24-25b153b2c35b","attributeTranslation":"Estudio de fase 3, aleatorizado, para comparar nemtabrutinib frente a comparador (elección del investigador de ibrutinib o acalabrutinib) en participantes con leucemia linfocítica crónica/linfoma linfocítico de células pequeñas no tratada (BELLWAVE 011)","language":7,"languageDescription":"Spanish"},{"id":11313243,"uuid":"27b328b9-52b5-401b-bd24-25b153b2c35b","attributeTranslation":"Randomizowane badanie fazy III porównujące nemtabrutynib z lekiem porównawczym (ibrutynib lub akalabrutynib według decyzji badacza) u uczestników z nieleczoną wcześniej przewlekłą białaczką limfocytową/chłoniakiem z małych limfocytów (BELLWAVE 011)","language":19,"languageDescription":"Polish"},{"id":11313241,"uuid":"27b328b9-52b5-401b-bd24-25b153b2c35b","attributeTranslation":"Estudo de fase 3, aleatorizado, para comparar nemtabrutinib versus comparador (escolha do investigador: ibrutinib ou acalabrutinib) em participantes com leucemia linfocítica crónica / pequeno linfoma linfocítico não tratado (BELLWAVE 011)","language":20,"languageDescription":"Portuguese"},{"id":11313244,"uuid":"27b328b9-52b5-401b-bd24-25b153b2c35b","attributeTranslation":"Μια Φάση 3, Τυχαιοποιημένη Μελέτη για Σύγκριση Nemtabrutinib έναντι Συγκριτή (Επιλογή Ερευνητή Ibrutinib ή Acalabrutinib) σε Συμμετέχοντες με Χρόνια Λεμφοκυτταρική Λευχαιμία/Μικρό Λεμφοκυτταρικό Λέμφωμα χωρίς λήψη θεραπείας (BELLWAVE 011)","language":5,"languageDescription":"Greek"}],"shortTitle":"MK-1026-011","secondaryIdentifyingNumbers":{"whoUniversalTrialNumber":{"id":545878,"number":"U1111-1281-7895"},"additionalRegistries":[{"id":545879,"number":"133989","otherRegistryName":"IND","ctRegistryCode":"6"}]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"Phase III, confirm safety and efficacy trial in patients, or target populations for prophylaxis.","trialCategoryId":124348},"medicalCondition":{"partIMedicalConditions":[{"id":140933,"medicalCondition":"Small Lymphocytic Lymphoma (SLL) / Untreated Chronic Lymphocytic Leukemia (CLL)","medicalConditionTranslations":[{"id":11313119,"uuid":"306fe5ca-d844-4025-9b0f-34637044f8f1","attributeTranslation":"Χωρίς λήψη θεραπείας Χρόνια λεμφοκυτταρική λευχαιμία (ΧΛΛ) / Μικρό λεμφοκυτταρικό λέμφωμα (SLL)","language":5,"languageDescription":"Greek"},{"id":11313118,"uuid":"306fe5ca-d844-4025-9b0f-34637044f8f1","attributeTranslation":"Leucemia linfocítica crónica(CLL)/linfoma linfocítico de células pequeñas (SLL) no tratada","language":7,"languageDescription":"Spanish"},{"id":11313120,"uuid":"306fe5ca-d844-4025-9b0f-34637044f8f1","attributeTranslation":"Nieleczona wcześniej przewlekła białaczka limfocytowa (CLL) / chłoniak z małych limfocytów (SL","language":19,"languageDescription":"Polish"},{"id":11313117,"uuid":"306fe5ca-d844-4025-9b0f-34637044f8f1","attributeTranslation":"Leucemia linfocítica crónica (LLC) / pequeno linfoma linfocítico (PLL) não tratado","language":20,"languageDescription":"Portuguese"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000063698,"version":"21.0","level":"LLT","termName":"Small cell lymphocytic lymphoma","classificationCode":"10051812","organClass":10029104,"active":false},{"termId":100000027075,"version":"20.0","level":"LLT","termName":"Leukemia lymphocytic chronic","classificationCode":"10024340","organClass":10029104,"active":false}]},"trialObjective":{"trialScopes":[{"code":"5","trialScopeId":409524},{"code":"11","trialScopeId":409525},{"code":"6","trialScopeId":409523},{"code":"4","trialScopeId":409522},{"code":"7","trialScopeId":409521}],"mainObjective":"1. To compare nemtabrutinib to ibrutinib or acalabrutinib with respect to ORR per iwCLL criteria 2018 as assessed by BICR.\n2. To compare nemtabrutinib to ibrutinib or acalabrutinib with respect to PFS per iwCLL criteria 2018 as assessed by BICR.","mainObjectiveTranslations":[{"id":11313239,"uuid":"ca3561c0-2a60-4f7a-8cf2-e08df54996bc","attributeTranslation":"1.\tComparar nemtabrutinib com ibrutinib ou acalabrutinib em relação à TRO de acordo com os critérios da iwCLL de 2018 conforme a avaliação por Revisão Central Independente com Ocultação (Blinded Independent Central Review — BICR).\n2.\tComparar nemtabrutinib com ibrutinib ou acalabrutinib em relação à SLP de acordo com os critérios da iwCLL de 2018 conforme a avaliação por Revisão Central Independente com Ocultação (Blinded Independent Central Review — BICR).","language":20,"languageDescription":"Portuguese"},{"id":11313238,"uuid":"ca3561c0-2a60-4f7a-8cf2-e08df54996bc","attributeTranslation":"1. Porównanie nemtabrutynibu z ibrutynibem lub akalabrutynibem pod względem ORR, według kryteriów iwCLL 2018, na podstawie oceny BICR.\n2. Porównanie nemtabrutynibu z ibrutynibem lub akalabrutynibem pod względem PFS, według kryteriów iwCLL 2018, na podstawie oceny BICR.","language":19,"languageDescription":"Polish"},{"id":11313237,"uuid":"ca3561c0-2a60-4f7a-8cf2-e08df54996bc","attributeTranslation":"1.\tΓια τη σύγκριση του nemtabrutinib με το ibrutinib ή το acalabrutinib σε σχέση με τα κριτήρια Αντικειμενικού ποσοστού απόκρισης (ORR) σύμφωνα με τα κριτήρια του International Workshop on Chronic Lymphocytic Leukemia (iwCLL) του 2018, όπως αξιολογήθηκαν από την Ανεξάρτητη Κεντρική Επιτροπή Αξιολόγησης (BICR).\n2.\tΓια τη σύγκριση του nemtabrutinib με το ibrutinib ή το acalabrutinib σε σχέση με Επιβίωση Ελεύθερη Προόδου Νόσου (PFS) σύμφωνα με τα κριτήρια του International Workshop on Chronic Lymphocytic Leukemia (iwCLL) του 2018, όπως αξιολογήθηκαν από την Ανεξάρτητη Κεντρική Επιτροπή Αξιολόγησης (BICR).","language":5,"languageDescription":"Greek"},{"id":11313240,"uuid":"ca3561c0-2a60-4f7a-8cf2-e08df54996bc","attributeTranslation":"1.\tComparar el nemtabrutinib con el ibrutinib o el acalabrutinib en relación con la ORR según los criterios del iwCLL de 2018, de acuerdo con la evaluación de la BICR\n2.\tComparar el nemtabrutinib con el ibrutinib o el acalabrutinib en relación con la PFS según los criterios del iwCLL de 2018, de acuerdo con la evaluación de la BICR","language":7,"languageDescription":"Spanish"}],"secondaryObjectives":[{"id":479994,"number":1,"secondaryObjective":"To compare nemtabrutinib to ibrutinib or acalabrutinib with respect to OS.","secondaryObjectiveTranslations":[{"id":11313245,"uuid":"eadaac7d-c72b-4b0d-ae1f-54c925bf4c95","attributeTranslation":"Porównanie nemtabrutynibu z ibrutynibem lub akalabrutynibem pod względem OS.","language":19,"languageDescription":"Polish"},{"id":11313248,"uuid":"eadaac7d-c72b-4b0d-ae1f-54c925bf4c95","attributeTranslation":"Comparar el nemtabrutinib con el ibrutinib o el acalabrutinib en relación con la OS","language":7,"languageDescription":"Spanish"},{"id":11313247,"uuid":"eadaac7d-c72b-4b0d-ae1f-54c925bf4c95","attributeTranslation":"Comparar nemtabrutinib com ibrutinib ou acalabrutinib em relação à SG.","language":20,"languageDescription":"Portuguese"},{"id":11313246,"uuid":"eadaac7d-c72b-4b0d-ae1f-54c925bf4c95","attributeTranslation":"Για τη σύγκριση του nemtabrutinib με το ibrutinib ή το acalabrutinib σε σχέση με τη συνολική επιβίωση (OS).","language":5,"languageDescription":"Greek"}]},{"id":479995,"number":2,"secondaryObjective":"To evaluate DOR per iwCLL criteria 2018 as assessed by BICR.","secondaryObjectiveTranslations":[{"id":11313251,"uuid":"29b72e52-e980-4361-b119-d77aa56d7cbf","attributeTranslation":"Ocena DOR według kryteriów iwCLL 2018, na podstawie oceny BICR.","language":19,"languageDescription":"Polish"},{"id":11313249,"uuid":"29b72e52-e980-4361-b119-d77aa56d7cbf","attributeTranslation":"Για την αξιολόγηση της διάρκειας της ανταπόκρισης (DOR) σύμφωνα με τα κριτήρια του International Workshop on Chronic Lymphocytic Leukemia (iwCLL) του 2018, όπως αξιολογήθηκαν από την Ανεξάρτητη Κεντρική Επιτροπή Αξιολόγησης (BICR).","language":5,"languageDescription":"Greek"},{"id":11313252,"uuid":"29b72e52-e980-4361-b119-d77aa56d7cbf","attributeTranslation":"Evaluar la DOR según los criterios del iwCLL de 2018, de acuerdo con la evaluación de la BICR","language":7,"languageDescription":"Spanish"},{"id":11313250,"uuid":"29b72e52-e980-4361-b119-d77aa56d7cbf","attributeTranslation":"Avaliar a DR de acordo com os critérios da iwCLL de 2018 conforme a avaliação por Revisão Central Independente com Ocultação (Blinded Independent Central Review — BICR).","language":20,"languageDescription":"Portuguese"}]},{"id":479996,"number":3,"secondaryObjective":"To evaluate the safety and tolerability of nemtabrutinib.","secondaryObjectiveTranslations":[{"id":11313255,"uuid":"d1326bb0-7ab9-4911-be63-ba492eb2750f","attributeTranslation":"Evaluar la seguridad y la tolerabilidad del nemtabrutinib","language":7,"languageDescription":"Spanish"},{"id":11313254,"uuid":"d1326bb0-7ab9-4911-be63-ba492eb2750f","attributeTranslation":"Ocena bezpieczeństwa i tolerancji nemtabrutynibu.","language":19,"languageDescription":"Polish"},{"id":11313253,"uuid":"d1326bb0-7ab9-4911-be63-ba492eb2750f","attributeTranslation":"Για την αξιολόγηση της ασφάλειας και της ανεκτικότητας του nemtabrutinib.","language":5,"languageDescription":"Greek"},{"id":11313256,"uuid":"d1326bb0-7ab9-4911-be63-ba492eb2750f","attributeTranslation":"Avaliar a segurança e tolerabilidade de nemtabrutinib.","language":20,"languageDescription":"Portuguese"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":915324,"number":1,"principalInclusionCriteria":"Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to have a need to initiate therapy.","principalInclusionCriteriaTranslations":[{"id":11313209,"uuid":"3be81a18-96ca-4782-9467-9b5a3bf712d6","attributeTranslation":"Diagnóstico confirmado de leucemia linfocítica crónica/linfoma linfocítico de células pequeñas (CLL/SLL) y enfermedad activa claramente documentada que requiera iniciar el tratamiento.","language":7,"languageDescription":"Spanish"},{"id":11313212,"uuid":"3be81a18-96ca-4782-9467-9b5a3bf712d6","attributeTranslation":"Diagnóstico confirmado de leucemia linfocítica crónica / pequeno linfoma linfocítico (LLC/PLL) e doença ativa claramente documentada que requer o início de terapêutica.","language":20,"languageDescription":"Portuguese"},{"id":11313211,"uuid":"3be81a18-96ca-4782-9467-9b5a3bf712d6","attributeTranslation":"Για την επιβεβαιωμένη διάγνωση χρόνιας λεμφοκυτταρικής λευχαιμίας/μικρού λεμφοκυτταρικού λεμφώματος (CLL/SLL) και ενεργού νόσου τεκμηριώνεται σαφώς ότι υπάρχει ανάγκη έναρξης θεραπείας.","language":5,"languageDescription":"Greek"},{"id":11313210,"uuid":"3be81a18-96ca-4782-9467-9b5a3bf712d6","attributeTranslation":"Potwierdzone rozpoznanie przewlekłej białaczki limfocytowej/chłoniaka z małych limfocytów (CLL/SLL) i aktywna choroba o wyraźnie udokumentowanej potrzebie rozpoczęcia terapii.","language":19,"languageDescription":"Polish"}]},{"id":915325,"number":2,"principalInclusionCriteria":"Has at least 1 marker of disease burden.","principalInclusionCriteriaTranslations":[{"id":11313216,"uuid":"744083e6-fd58-46ed-9545-997af867702d","attributeTranslation":"Tener al menos 1 marcador de carga de enfermedad.","language":7,"languageDescription":"Spanish"},{"id":11313213,"uuid":"744083e6-fd58-46ed-9545-997af867702d","attributeTranslation":"Pacjenci z co najmniej jednym markerem obciążenia chorobą.","language":19,"languageDescription":"Polish"},{"id":11313215,"uuid":"744083e6-fd58-46ed-9545-997af867702d","attributeTranslation":"Έχει τουλάχιστον 1 δείκτη επιβάρυνσης της νόσου.","language":5,"languageDescription":"Greek"},{"id":11313214,"uuid":"744083e6-fd58-46ed-9545-997af867702d","attributeTranslation":"Com, pelo menos, 1 marcador de impacto de doença.","language":20,"languageDescription":"Portuguese"}]},{"id":915326,"number":3,"principalInclusionCriteria":"Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.","principalInclusionCriteriaTranslations":[{"id":11313218,"uuid":"6286f38d-ca66-424c-b6d7-4ec4d601bff2","attributeTranslation":"Com um índice de desempenho do Eastern Cooperative Oncology Group (ECOG) de 0 a 2 nos 7 dias anteriores à aleatorização.","language":20,"languageDescription":"Portuguese"},{"id":11313219,"uuid":"6286f38d-ca66-424c-b6d7-4ec4d601bff2","attributeTranslation":"Wynik stanu sprawności 0 do 2 w skali sprawności według Eastern Cooperative Oncology Group (ECOG), ocenianej w ciągu 7 dni przed randomizacją.","language":19,"languageDescription":"Polish"},{"id":11313220,"uuid":"6286f38d-ca66-424c-b6d7-4ec4d601bff2","attributeTranslation":"Tener un estado funcional de 0 a 2 en la escala del Grupo Oncológico Cooperativo del Este (ECOG) dentro de los 7 días previos a la aleatorización.","language":7,"languageDescription":"Spanish"},{"id":11313217,"uuid":"6286f38d-ca66-424c-b6d7-4ec4d601bff2","attributeTranslation":"Έχει κατάσταση απόδοσης κατά Eastern Cooperative Oncology Group (ECOG) (Συνεργαζόμενη Ογκολογική Ομάδα της Ανατολικής Ακτής των ΗΠΑ) 0 έως 2, αξιολογημένη εντός διαστήματος 7 ημερών πριν από την εγγραφή στη μελέτη.","language":5,"languageDescription":"Greek"}]},{"id":915327,"number":4,"principalInclusionCriteria":"Has the ability to swallow and retain oral medication.","principalInclusionCriteriaTranslations":[{"id":11313221,"uuid":"7e6ecff3-5151-4e58-8b7d-044e356f3863","attributeTranslation":"Com capacidade de engolir e reter medicação oral.","language":20,"languageDescription":"Portuguese"},{"id":11313224,"uuid":"7e6ecff3-5151-4e58-8b7d-044e356f3863","attributeTranslation":"Έχει την ικανότητα κατάποσης και συγκράτησης του από του στόματος φάρμακο.","language":5,"languageDescription":"Greek"},{"id":11313223,"uuid":"7e6ecff3-5151-4e58-8b7d-044e356f3863","attributeTranslation":"Pacjenci, którzy są w stanie połknąć i nie zwymiotować leku doustnego.","language":19,"languageDescription":"Polish"},{"id":11313222,"uuid":"7e6ecff3-5151-4e58-8b7d-044e356f3863","attributeTranslation":"Tener la capacidad de tragar y retener medicamentos administrados por vía oral.","language":7,"languageDescription":"Spanish"}]},{"id":915328,"number":5,"principalInclusionCriteria":"Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.","principalInclusionCriteriaTranslations":[{"id":11313228,"uuid":"8eadce29-2686-4990-8a6b-9b0a2edfe891","attributeTranslation":"Los participantes con resultados positivos para el antígeno de superficie del virus la hepatitis B (HBsAg) son elegibles si han recibido un tratamiento antiviral contra el virus de la hepatitis B (VHB) durante al menos 4 semanas y tienen una carga viral del VHB indetectable en el ácido desoxirribonucleico (ADN) antes de la aleatorización.","language":7,"languageDescription":"Spanish"},{"id":11313226,"uuid":"8eadce29-2686-4990-8a6b-9b0a2edfe891","attributeTranslation":"Οι συμμετέχοντες που είναι θετικοί στο επιφανειακό αντιγόνο της ηπατίτιδας Β (HBsAg) είναι επιλέξιμοι εάν έχουν λάβει αντιική θεραπεία κατά του ιού της ηπατίτιδας Β (HBV) για τουλάχιστον 4 εβδομάδες και έχουν μη ανιχνεύσιμο ιικό φορτίο δεοξυριβονουκλεϊκού οξέος (DNA) HBV πριν από την τυχαιοποίηση.","language":5,"languageDescription":"Greek"},{"id":11313227,"uuid":"8eadce29-2686-4990-8a6b-9b0a2edfe891","attributeTranslation":"Uczestnicy z dodatnim wynikiem badania w kierunku antygenu powierzchniowego wirusa zapalenia wątroby typu B (HBsAg) kwalifikują się do udziału w badaniu, jeśli stosowali leczenie przeciwwirusowe przeciwko wirusowi zapalenia wątroby typu B (HBV) przez co najmniej 4 tygodnie i mają niewykrywalne miano kwasu dezoksyrybonukleinowego (DNA) wirusa HBV przed randomizacją.","language":19,"languageDescription":"Polish"},{"id":11313225,"uuid":"8eadce29-2686-4990-8a6b-9b0a2edfe891","attributeTranslation":"São elegíveis participantes positivos para o antigénio de superfície da hepatite B (Ag HBs) se tiverem recebido terapêutica antiviral para o vírus da hepatite B (VHB) durante, pelo menos, 4 semanas e tenham uma carga viral de VHB de ácido desoxirribonucleico (ADN) não detetável antes da aleatorização.","language":20,"languageDescription":"Portuguese"}]},{"id":915329,"number":6,"principalInclusionCriteria":"Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.","principalInclusionCriteriaTranslations":[{"id":11313229,"uuid":"492f4ce8-3247-4445-ac5a-14ee1ac1ca46","attributeTranslation":"Los participantes con antecedentes de infección por virus de la hepatitis C (VHC) son elegibles si la carga viral del VHC en el ácido ribonucleico (ARN) es indetectable en la selección.","language":7,"languageDescription":"Spanish"},{"id":11313232,"uuid":"492f4ce8-3247-4445-ac5a-14ee1ac1ca46","attributeTranslation":"Οι συμμετέχοντες με ιστορικό λοίμωξης από τον ιό της ηπατίτιδας C (HCV) είναι επιλέξιμοι εάν το ιικό φορτίο HCV ριβονουκλεϊκού οξέος (RNA) δεν είναι ανιχνεύσιμο κατά τον έλεγχο.","language":5,"languageDescription":"Greek"},{"id":11313230,"uuid":"492f4ce8-3247-4445-ac5a-14ee1ac1ca46","attributeTranslation":"Uczestnicy z zakażeniem wirusem zapalenia wątroby typu C (HCV) w wywiadzie kwalifikują się do udziału w badaniu, jeśli miano kwasu rybonukleinowego (RNA) wirusa HCV podczas badania przesiewowego jest niewykrywalne.","language":19,"languageDescription":"Polish"},{"id":11313231,"uuid":"492f4ce8-3247-4445-ac5a-14ee1ac1ca46","attributeTranslation":"São elegíveis participantes com historial de infeção por vírus da hepatite C (VHC) se não for detetável carga viral de VHC de ácido ribonucleico (ARN) aquando da seleção.","language":20,"languageDescription":"Portuguese"}]},{"id":915330,"number":7,"principalInclusionCriteria":"Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.","principalInclusionCriteriaTranslations":[{"id":11313236,"uuid":"428863bf-45c8-4170-9e09-59854ee079ff","attributeTranslation":"Συμμετέχοντες με ιό ανθρώπινης ανοσοανεπάρκειας (HIV) που πληρούν ΟΛΑ τα κριτήρια επιλεξιμότητας.","language":5,"languageDescription":"Greek"},{"id":11313235,"uuid":"428863bf-45c8-4170-9e09-59854ee079ff","attributeTranslation":"Participantes con infección por virus de la inmunodeficiencia humana (VIH) que cumplan con TODOS los criterios de elegibilidad.","language":7,"languageDescription":"Spanish"},{"id":11313234,"uuid":"428863bf-45c8-4170-9e09-59854ee079ff","attributeTranslation":"Participantes com vírus da imunodeficiência humana (VIH) que cumpram TODOS os critérios de elegibilidade.","language":20,"languageDescription":"Portuguese"},{"id":11313233,"uuid":"428863bf-45c8-4170-9e09-59854ee079ff","attributeTranslation":"Uczestnicy zakażeni ludzkim wirusem niedoboru odporności (HIV), którzy spełniają WSZYSTKIE kryteria kwalifikujące.","language":19,"languageDescription":"Polish"}]}],"principalExclusionCriteria":[{"id":1565004,"number":1,"principalExclusionCriteria":"Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.","principalExclusionCriteriaTranslations":[{"id":11313148,"uuid":"617e91d2-3e02-47eb-9980-ec0b5f343cc8","attributeTranslation":"Pacjenci z aktywnym zakażeniem wirusem zapalenia wątroby typu B/ typu C (HBV/HCV).","language":19,"languageDescription":"Polish"},{"id":11313146,"uuid":"617e91d2-3e02-47eb-9980-ec0b5f343cc8","attributeTranslation":"Com infeção ativa por vírus da hepatite B / vírus da hepatite C (VHB/VHC).","language":20,"languageDescription":"Portuguese"},{"id":11313145,"uuid":"617e91d2-3e02-47eb-9980-ec0b5f343cc8","attributeTranslation":"Tener una infección por el virus de la hepatitis B/hepatitis C (VHB/VHC) activa.","language":7,"languageDescription":"Spanish"},{"id":11313147,"uuid":"617e91d2-3e02-47eb-9980-ec0b5f343cc8","attributeTranslation":"Πάσχει από ενεργό λοίμωξη από τον ιό της ηπατίτιδας Β / ιό της ηπατίτιδας C (HBV/HCV).","language":5,"languageDescription":"Greek"}]},{"id":1565005,"number":10,"principalExclusionCriteria":"Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.","principalExclusionCriteriaTranslations":[{"id":11313152,"uuid":"4c7e1429-b065-477a-9a81-406d84abee9f","attributeTranslation":"Estar recibiendo actualmente tratamiento con sustratos de glicoproteína p (P-gp) con un índice terapéutico estrecho, inductores fuertes o moderados del citocromo P450 3A (CYP3A), o inhibidores fuertes del CYP3A.","language":7,"languageDescription":"Spanish"},{"id":11313149,"uuid":"4c7e1429-b065-477a-9a81-406d84abee9f","attributeTranslation":"Επί του παρόντος υπόκειται σε θεραπεία με υποστρώματα p-γλυκοπρωτεΐνης (P-gp) με στενό θεραπευτικό δείκτη, ισχυρούς ή μέτριους επαγωγείς του κυτοχρώματος P450 3A (CYP3A) ή ισχυρούς αναστολείς του CYP3A.","language":5,"languageDescription":"Greek"},{"id":11313150,"uuid":"4c7e1429-b065-477a-9a81-406d84abee9f","attributeTranslation":"Atualmente em tratamento com substratos da glicoproteína-P (gp-P) com um índice terapêutico estreito, indutores fortes ou moderados do citocromo P450 3A (CYP3A) ou inibidores fortes de CYP3A.","language":20,"languageDescription":"Portuguese"},{"id":11313151,"uuid":"4c7e1429-b065-477a-9a81-406d84abee9f","attributeTranslation":"Pacjenci obecnie leczeni substratami p-glikoproteiny (P-gp) o wąskim indeksie terapeutycznym, silnymi lub umiarkowanymi induktorami cytochromu P450 3A (CYP3A) lub silnymi inhibitorami CYP3A.","language":19,"languageDescription":"Polish"}]},{"id":1565006,"number":11,"principalExclusionCriteria":"Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.","principalExclusionCriteriaTranslations":[{"id":11313155,"uuid":"75562b65-16fa-4b3b-a2ae-bb1941c19ed7","attributeTranslation":"Haber recibido radioterapia previa dentro de las 2 semanas del comienzo de la intervención del estudio o tener toxicidades relacionadas con la radiación que requieran corticoesteroides.","language":7,"languageDescription":"Spanish"},{"id":11313156,"uuid":"75562b65-16fa-4b3b-a2ae-bb1941c19ed7","attributeTranslation":"Pacjenci, którzy otrzymali wcześniej radioterapię w ciągu 2 tygodni od rozpoczęcia interwencji w ramach badania lub działania toksyczne związane z radioterapią, wymagające zastosowania kortykosteroidów.","language":19,"languageDescription":"Polish"},{"id":11313154,"uuid":"75562b65-16fa-4b3b-a2ae-bb1941c19ed7","attributeTranslation":"Έχει λάβει προηγούμενη ακτινοθεραπεία εντός διαστήματος 2 εβδομάδων από την έναρξη της παρέμβασης της μελέτης, ή τοξικότητες που σχετίζονται με την ακτινοβολία, που απαιτούν κορτικοστεροειδή.","language":5,"languageDescription":"Greek"},{"id":11313153,"uuid":"75562b65-16fa-4b3b-a2ae-bb1941c19ed7","attributeTranslation":"Com radioterapia prévia nas 2 semanas anteriores ao início da intervenção do estudo, ou toxicidades relacionadas com a radiação, que exija corticosteroides.","language":20,"languageDescription":"Portuguese"}]},{"id":1565007,"number":12,"principalExclusionCriteria":"Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.","principalExclusionCriteriaTranslations":[{"id":11313157,"uuid":"221375ed-fd45-43d1-9782-0c7eb7a34646","attributeTranslation":"Haber recibido una vacuna elaborada con virus vivos o atenuados dentro de los 30 días previos a la primera dosis de la intervención del estudio. Se permite la administración de vacunas inactivadas.","language":7,"languageDescription":"Spanish"},{"id":11313158,"uuid":"221375ed-fd45-43d1-9782-0c7eb7a34646","attributeTranslation":"Έχει λάβει ζωντανό ή ζωντανό εξασθενημένο εμβόλιο εντός διαστήματος 30 ημερών πριν από την πρώτη δόση της παρέμβασης της μελέτης. Επιτρέπεται η χορήγηση αδρανοποιημένων εμβολίων.","language":5,"languageDescription":"Greek"},{"id":11313160,"uuid":"221375ed-fd45-43d1-9782-0c7eb7a34646","attributeTranslation":"Com uma vacina viva ou viva-atenuada nos 30 dias anteriores à primeira dose da intervenção do estudo. É permitida a administração de vacinas inativadas.","language":20,"languageDescription":"Portuguese"},{"id":11313159,"uuid":"221375ed-fd45-43d1-9782-0c7eb7a34646","attributeTranslation":"Pacjenci, którzy otrzymali żywą lub żywą szczepionkę atenuowaną w ciągu 30 dni przed przyjęciem pierwszej dawki interwencji podawanej w ramach badania. Dozwolone są szczepionki „zabite”.","language":19,"languageDescription":"Polish"}]},{"id":1565008,"number":13,"principalExclusionCriteria":"Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.","principalExclusionCriteriaTranslations":[{"id":11313164,"uuid":"5a333e16-ce4b-4590-b914-5ced96ff2774","attributeTranslation":"Haber recibido un fármaco en investigación o haber usado un dispositivo en investigación dentro de las 4 semanas previas a la administración de la intervención del estudio.","language":7,"languageDescription":"Spanish"},{"id":11313163,"uuid":"5a333e16-ce4b-4590-b914-5ced96ff2774","attributeTranslation":"Pacjenci, którzy stosowali dowolny badany produkt leczniczy lub dowolny badany wyrób w ciągu 4 tygodni przed podaniem interwencji w ramach badania.","language":19,"languageDescription":"Polish"},{"id":11313161,"uuid":"5a333e16-ce4b-4590-b914-5ced96ff2774","attributeTranslation":"Com um agente experimental ou uso de dispositivo experimental nas 4 semanas anteriores à administração da intervenção do estudo.","language":20,"languageDescription":"Portuguese"},{"id":11313162,"uuid":"5a333e16-ce4b-4590-b914-5ced96ff2774","attributeTranslation":"Έχει λάβει υπό έρευνα ουσία ή έχει χρησιμοποιήσει υπό έρευνα συσκευή εντός 4 εβδομάδων πριν από τη χορήγηση της παρέμβασης της μελέτης.","language":5,"languageDescription":"Greek"}]},{"id":1565009,"number":14,"principalExclusionCriteria":"Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.","principalExclusionCriteriaTranslations":[{"id":11313167,"uuid":"7536fd27-7012-400f-bf21-c5085ea77a9b","attributeTranslation":"Πάσχει από ενεργό λοίμωξη που απαιτεί συστηματική θεραπεία, συμπεριλαμβανομένων ενδοφλέβια (ΕΦ) χορηγούμενων αντιβιοτικών κατά τη διάρκεια του προληπτικού ελέγχου.","language":5,"languageDescription":"Greek"},{"id":11313166,"uuid":"7536fd27-7012-400f-bf21-c5085ea77a9b","attributeTranslation":"Tener una infección activa que requiera tratamiento sistémico, incluidos antibióticos por vía intravenosa (IV) durante la selección.","language":7,"languageDescription":"Spanish"},{"id":11313165,"uuid":"7536fd27-7012-400f-bf21-c5085ea77a9b","attributeTranslation":"Pacjenci z aktywną infekcją wymagającą terapii ogólnoustrojowej, w tym dożylnych (IV) antybiotyków podczas badań przesiewowych.","language":19,"languageDescription":"Polish"},{"id":11313168,"uuid":"7536fd27-7012-400f-bf21-c5085ea77a9b","attributeTranslation":"Com infeção ativa que exija terapêutica sistémica, incluindo antibióticos intravenosos (IV) durante a seleção.","language":20,"languageDescription":"Portuguese"}]},{"id":1565010,"number":15,"principalExclusionCriteria":"Participants who have not adequately recovered from major surgery or have ongoing surgical complications.","principalExclusionCriteriaTranslations":[{"id":11313169,"uuid":"2001385f-3d6a-4c9c-90f4-c1329f64bf80","attributeTranslation":"Participantes que no se han recuperado adecuadamente de una cirugía mayor o tienen complicaciones quirúrgicas en curso.","language":7,"languageDescription":"Spanish"},{"id":11313172,"uuid":"2001385f-3d6a-4c9c-90f4-c1329f64bf80","attributeTranslation":"Participantes que não tenham recuperado devidamente de cirurgia major ou tenham complicações cirúrgicas em curso.","language":20,"languageDescription":"Portuguese"},{"id":11313171,"uuid":"2001385f-3d6a-4c9c-90f4-c1329f64bf80","attributeTranslation":"Uczestnicy, którzy nie wyzdrowieli w wystarczającym stopniu po poważnym zabiegu chirurgicznym lub z utrzymującymi się powikłaniami chirurgicznymi.","language":19,"languageDescription":"Polish"},{"id":11313170,"uuid":"2001385f-3d6a-4c9c-90f4-c1329f64bf80","attributeTranslation":"Συμμετέχοντες που δεν έχουν αναρρώσει επαρκώς από μείζονα χειρουργική επέμβαση ή έχουν συνεχείς χειρουργικές επιπλοκές.","language":5,"languageDescription":"Greek"}]},{"id":1565011,"number":2,"principalExclusionCriteria":"Has gastrointestinal (GI) dysfunction that may affect drug absorption.","principalExclusionCriteriaTranslations":[{"id":11313174,"uuid":"88452222-3393-4d56-8ada-e5a41fde5bb1","attributeTranslation":"Tener una disfunción gastrointestinal (GI) que pueda afectar la absorción del fármaco.","language":7,"languageDescription":"Spanish"},{"id":11313173,"uuid":"88452222-3393-4d56-8ada-e5a41fde5bb1","attributeTranslation":"Πάσχει από γαστρεντερική δυσλειτουργία που μπορεί να επηρεάσει την απορρόφηση του φαρμάκου.","language":5,"languageDescription":"Greek"},{"id":11313176,"uuid":"88452222-3393-4d56-8ada-e5a41fde5bb1","attributeTranslation":"Pacjenci z zaburzeniami układu pokarmowego, które mogą wpływać na wchłanianie leku.","language":19,"languageDescription":"Polish"},{"id":11313175,"uuid":"88452222-3393-4d56-8ada-e5a41fde5bb1","attributeTranslation":"Com disfunção gastrointestinal (GI) que possa afetar a absorção de medicamentos.","language":20,"languageDescription":"Portuguese"}]},{"id":1565012,"number":3,"principalExclusionCriteria":"Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.","principalExclusionCriteriaTranslations":[{"id":11313177,"uuid":"56013d22-f711-42e3-9cf1-7941d9380fb6","attributeTranslation":"Tener un diagnóstico de transformación de Richter o afectación del sistema nervioso central (SNC) activa por CLL/SLL.","language":7,"languageDescription":"Spanish"},{"id":11313178,"uuid":"56013d22-f711-42e3-9cf1-7941d9380fb6","attributeTranslation":"Pacjenci z rozpoznaniem zespołu Richtera lub aktywnym zajęciem ośrodkowego układu nerwowego (OUN) przez CLL/SLL.","language":19,"languageDescription":"Polish"},{"id":11313179,"uuid":"56013d22-f711-42e3-9cf1-7941d9380fb6","attributeTranslation":"Com diagnóstico de Transformação de Richter ou envolvimento ativo no sistema nervoso central (SNC) por LLC/PLL.","language":20,"languageDescription":"Portuguese"},{"id":11313180,"uuid":"56013d22-f711-42e3-9cf1-7941d9380fb6","attributeTranslation":"Έχει διάγνωση Μετασχηματισμού του Ρίχτερ ή προσβολή ενεργού κεντρικού νευρικού συστήματος (ΚΝΣ) από ΧΛΛ/ΣΛΛ.","language":5,"languageDescription":"Greek"}]},{"id":1565013,"number":4,"principalExclusionCriteria":"Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.","principalExclusionCriteriaTranslations":[{"id":11313182,"uuid":"f6033d12-09bc-45ef-80bc-be6180fcdd73","attributeTranslation":"Tener una infección oportunista definitoria del síndrome de la inmunodeficiencia adquirida (SIDA) en los últimos 12 meses antes de la selección.","language":7,"languageDescription":"Spanish"},{"id":11313183,"uuid":"f6033d12-09bc-45ef-80bc-be6180fcdd73","attributeTranslation":"Pacjenci z zakażeniem oportunistycznym charakterystycznym dla zespołu nabytego niedoboru odporności (AIDS) w ciągu ostatnich 12 miesięcy przed badaniem przesiewowym.","language":19,"languageDescription":"Polish"},{"id":11313184,"uuid":"f6033d12-09bc-45ef-80bc-be6180fcdd73","attributeTranslation":"Είχε αποκτήσει ευκαιριακή λοίμωξη που προσδιορίζει το σύνδρομο ανοσολογικής ανεπάρκειας (AIDS) τους τελευταίους 12 μήνες πριν από τον προληπτικό έλεγχο.","language":5,"languageDescription":"Greek"},{"id":11313181,"uuid":"f6033d12-09bc-45ef-80bc-be6180fcdd73","attributeTranslation":"Com infeção oportunista definidora de síndrome de imunodeficiência adquirida (SIDA) nos últimos 12 meses antes da seleção.","language":20,"languageDescription":"Portuguese"}]},{"id":1565014,"number":5,"principalExclusionCriteria":"Has clinically significant cardiovascular disease.","principalExclusionCriteriaTranslations":[{"id":11313185,"uuid":"4fbb4af4-8bf5-48c5-8275-a3a052034d72","attributeTranslation":"Pacjenci z klinicznie istotną chorobą układu sercowo-naczyniowego.","language":19,"languageDescription":"Polish"},{"id":11313188,"uuid":"4fbb4af4-8bf5-48c5-8275-a3a052034d72","attributeTranslation":"Tener una enfermedad cardiovascular clínicamente significativa.","language":7,"languageDescription":"Spanish"},{"id":11313187,"uuid":"4fbb4af4-8bf5-48c5-8275-a3a052034d72","attributeTranslation":"Com doença cardiovascular clinicamente significativa.","language":20,"languageDescription":"Portuguese"},{"id":11313186,"uuid":"4fbb4af4-8bf5-48c5-8275-a3a052034d72","attributeTranslation":"Έχει κλινικά σημαντική καρδιαγγειακή νόσο.","language":5,"languageDescription":"Greek"}]},{"id":1565015,"number":6,"principalExclusionCriteria":"Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.","principalExclusionCriteriaTranslations":[{"id":11313192,"uuid":"dfad965e-c14a-4501-bf4c-54afe9c7d83b","attributeTranslation":"Com hipersensibilidade a nemtabrutinib ou contraindicação para ibrutinib ou acalabrutinib, ou algum dos excipientes.","language":20,"languageDescription":"Portuguese"},{"id":11313189,"uuid":"dfad965e-c14a-4501-bf4c-54afe9c7d83b","attributeTranslation":"Tener hipersensibilidad al nemtabrutinib o una contraindicación al ibrutinib o al acalabrutinib, o a cualquiera de los excipientes.","language":7,"languageDescription":"Spanish"},{"id":11313190,"uuid":"dfad965e-c14a-4501-bf4c-54afe9c7d83b","attributeTranslation":"Pacjenci z nadwrażliwością na nemtabrutynib lub przeciwwskazaniem do stosowania ibrutynibu lub akalabrutynibu, lub dowolnych z ich składników.","language":19,"languageDescription":"Polish"},{"id":11313191,"uuid":"dfad965e-c14a-4501-bf4c-54afe9c7d83b","attributeTranslation":"Έχει υπερευαισθησία στο nemtabrutinib ή αντένδειξη στο ibrutinib ή acalabrutinib ή σε οποιοδήποτε από τα έκδοχα.","language":5,"languageDescription":"Greek"}]},{"id":1565016,"number":7,"principalExclusionCriteria":"Has history of severe bleeding disorder.","principalExclusionCriteriaTranslations":[{"id":11313195,"uuid":"4d1c4748-8691-4ea9-b901-75201207a44a","attributeTranslation":"Έχει ιστορικό σοβαρής αιμορραγικής διαταραχής.","language":5,"languageDescription":"Greek"},{"id":11313196,"uuid":"4d1c4748-8691-4ea9-b901-75201207a44a","attributeTranslation":"Tener antecedentes de trastornos hemorrágicos graves.","language":7,"languageDescription":"Spanish"},{"id":11313193,"uuid":"4d1c4748-8691-4ea9-b901-75201207a44a","attributeTranslation":"W wywiadzie ciężkie zaburzenie krzepliwości krwi.","language":19,"languageDescription":"Polish"},{"id":11313194,"uuid":"4d1c4748-8691-4ea9-b901-75201207a44a","attributeTranslation":"Com historial de distúrbios hemorrágicos graves.","language":20,"languageDescription":"Portuguese"}]},{"id":1565017,"number":8,"principalExclusionCriteria":"Has known additional malignancy that is progressing or has required active treatment within the past 2 years.","principalExclusionCriteriaTranslations":[{"id":11313199,"uuid":"cd3ff15b-c1f8-44ac-8775-3198bc37ac72","attributeTranslation":"Pacjenci z dodatkowym nowotworem złośliwym, który postępuje lub wymagał aktywnego leczenia w ciągu ostatnich 2 lat.","language":19,"languageDescription":"Polish"},{"id":11313197,"uuid":"cd3ff15b-c1f8-44ac-8775-3198bc37ac72","attributeTranslation":"Έχει γνωστή πρόσθετη κακοήθεια που εξελίσσεται ή για την οποία έχει απαιτηθεί ενεργός θεραπεία εντός των τελευταίων 2 ετών.","language":5,"languageDescription":"Greek"},{"id":11313200,"uuid":"cd3ff15b-c1f8-44ac-8775-3198bc37ac72","attributeTranslation":"Com malignidade adicional conhecida que esteja a progredir ou tenha exigido tratamento ativo nos últimos 2 anos.","language":20,"languageDescription":"Portuguese"},{"id":11313198,"uuid":"cd3ff15b-c1f8-44ac-8775-3198bc37ac72","attributeTranslation":"Tener una neoplasia maligna adicional conocida que esté en progresión o que haya requerido tratamiento activo durante los últimos 2 años.","language":7,"languageDescription":"Spanish"}]},{"id":1565018,"number":9,"principalExclusionCriteria":"Has received any systemic anticancer therapy for CLL/SLL.","principalExclusionCriteriaTranslations":[{"id":11313202,"uuid":"3617ed45-b5a4-4bc4-82c2-d14bd27241b2","attributeTranslation":"Com qualquer terapêutica anticancerígena sistémica para LLC/PLL.","language":20,"languageDescription":"Portuguese"},{"id":11313204,"uuid":"3617ed45-b5a4-4bc4-82c2-d14bd27241b2","attributeTranslation":"9.\tΈχει λάβει οποιαδήποτε συστηματική αντικαρκινική θεραπεία για ΧΛΛ/ΣΛΛ.","language":5,"languageDescription":"Greek"},{"id":11313203,"uuid":"3617ed45-b5a4-4bc4-82c2-d14bd27241b2","attributeTranslation":"Pacjenci, którzy otrzymali ogólnoustrojową terapię przeciwnowotworową na CLL/SLL.","language":19,"languageDescription":"Polish"},{"id":11313201,"uuid":"3617ed45-b5a4-4bc4-82c2-d14bd27241b2","attributeTranslation":"Haber recibido algún tratamiento oncológico sistémico para CLL/SLL.","language":7,"languageDescription":"Spanish"}]}]},"endPoint":{"primaryEndPoints":[{"id":1069622,"number":1,"endPoint":"Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)","isPrimary":true,"endPointTranslations":[{"id":11313121,"uuid":"89244881-ffcb-406c-8931-aafb825fb987","attributeTranslation":"Odsetek odpowiedzi obiektywnej (ORR) według kryteriów ustalonych na Międzynarodowych Warsztatach Przewlekłej Białaczki Limfocytowej (International Workshop on Chronic Lymphocytic Leukemia, iwCLL) 2018, na podstawie zaślepionej niezależnej oceny centralnej (Blinded Independent Central Review, BICR)","language":19,"languageDescription":"Polish"},{"id":11313124,"uuid":"89244881-ffcb-406c-8931-aafb825fb987","attributeTranslation":"Tasa de respuesta objetiva (ORR) según los criterios del grupo de trabajo internacional sobre leucemia linfocítica crónica (iwCLL) de 2018, de acuerdo con la evaluación de la revisión central independiente ciega (BICR)","language":7,"languageDescription":"Spanish"},{"id":11313122,"uuid":"89244881-ffcb-406c-8931-aafb825fb987","attributeTranslation":"Taxa de Resposta Objetiva (TRO) de acordo com os critérios da iwCLL (leucemia linfocítica crónica) de 2018 conforme a avaliação por Revisão Central Independente com Ocultação (Blinded Independent Central Review — BICR)","language":20,"languageDescription":"Portuguese"},{"id":11313123,"uuid":"89244881-ffcb-406c-8931-aafb825fb987","attributeTranslation":"Αντικειμενικό ποσοστό ανταπόκρισης (ORR) με βάση τα κριτήρια του International Workshop on Chronic Lymphocytic Leukemia (iwCLL) του 2018, όπως αξιολογήθηκαν από την Ανεξάρτητη Κεντρική Επιτροπή Αξιολόγησης (BICR).","language":5,"languageDescription":"Greek"}]},{"id":1069623,"number":2,"endPoint":"Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR","isPrimary":true,"endPointTranslations":[{"id":11313128,"uuid":"423ca86b-0872-4a7a-9079-87ee6f83b4e8","attributeTranslation":"Επιβίωση Ελεύθερη Προόδου Νόσου (PFS) σύμφωνα με τα κριτήρια του International Workshop on Chronic Lymphocytic Leukemia (iwCLL) του 2018, όπως αξιολογήθηκε από την Ανεξάρτητη Κεντρική Επιτροπή Αξιολόγησης (BICR)","language":5,"languageDescription":"Greek"},{"id":11313126,"uuid":"423ca86b-0872-4a7a-9079-87ee6f83b4e8","attributeTranslation":"Supervivencia sin progresión (PFS) según los criterios del iwCLL de 2018, de acuerdo con la evaluación de la BICR","language":7,"languageDescription":"Spanish"},{"id":11313127,"uuid":"423ca86b-0872-4a7a-9079-87ee6f83b4e8","attributeTranslation":"Sobrevida Livre de Progressão (SLP) de acordo com os critérios da iwCLL de 2018 conforme a avaliação por Revisão Central Independente com Ocultação (Blinded Independent Central Review — BICR)","language":20,"languageDescription":"Portuguese"},{"id":11313125,"uuid":"423ca86b-0872-4a7a-9079-87ee6f83b4e8","attributeTranslation":"Czas przeżycia wolny od progresji choroby (PFS) według kryteriów iwCLL 2018, na podstawie oceny BICR","language":19,"languageDescription":"Polish"}]}],"secondaryEndPoints":[{"id":1069624,"number":1,"endPoint":"Overall Survival (OS)","isPrimary":false,"endPointTranslations":[{"id":11313129,"uuid":"03dd8a8e-17ba-4355-802b-7bb16cde2ac1","attributeTranslation":"Sobrevida Global (SG)","language":20,"languageDescription":"Portuguese"},{"id":11313131,"uuid":"03dd8a8e-17ba-4355-802b-7bb16cde2ac1","attributeTranslation":"Całkowite przeżycie (OS)","language":19,"languageDescription":"Polish"},{"id":11313130,"uuid":"03dd8a8e-17ba-4355-802b-7bb16cde2ac1","attributeTranslation":"Supervivencia general (OS).","language":7,"languageDescription":"Spanish"},{"id":11313132,"uuid":"03dd8a8e-17ba-4355-802b-7bb16cde2ac1","attributeTranslation":"Συνολική επιβίωση (OS)","language":5,"languageDescription":"Greek"}]},{"id":1069625,"number":2,"endPoint":"Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR","isPrimary":false,"endPointTranslations":[{"id":11313136,"uuid":"493d3b5b-6219-442c-9ac3-43bbfb959fb4","attributeTranslation":"Duração da Resposta (DR) de acordo com os critérios da iwCLL de 2018 conforme a avaliação por Revisão Central Independente com Ocultação (Blinded Independent Central Review — BICR)","language":20,"languageDescription":"Portuguese"},{"id":11313135,"uuid":"493d3b5b-6219-442c-9ac3-43bbfb959fb4","attributeTranslation":"Διάρκειας της ανταπόκρισης (DOR) σύμφωνα με τα κριτήρια του International Workshop on Chronic Lymphocytic Leukemia (iwCLL) του 2018, όπως αξιολογήθηκαν από την Ανεξάρτητη Κεντρική Επιτροπή Αξιολόγησης (BICR).","language":5,"languageDescription":"Greek"},{"id":11313134,"uuid":"493d3b5b-6219-442c-9ac3-43bbfb959fb4","attributeTranslation":"Duración de la respuesta (DOR) según los criterios del iwCLL de 2018, de acuerdo con la evaluación de la BICR.","language":7,"languageDescription":"Spanish"},{"id":11313133,"uuid":"493d3b5b-6219-442c-9ac3-43bbfb959fb4","attributeTranslation":"Czas trwania odpowiedzi (DOR) według kryteriów iwCLL 2018, na podstawie oceny BICR","language":19,"languageDescription":"Polish"}]},{"id":1069626,"number":3,"endPoint":"Number of Participants Who Experience One or More Adverse Events (AEs)","isPrimary":false,"endPointTranslations":[{"id":11313137,"uuid":"641a4192-4879-4324-abed-0b5a24a85235","attributeTranslation":"Liczba uczestników, u których wystąpiło jedno lub więcej zdarzeń niepożądanych (AE)","language":19,"languageDescription":"Polish"},{"id":11313139,"uuid":"641a4192-4879-4324-abed-0b5a24a85235","attributeTranslation":"Αριθμός συμμετεχόντων που εμφάνισαν ένα ή περισσότερα ανεπιθύμητα συμβάντα (ΑΣ)","language":5,"languageDescription":"Greek"},{"id":11313138,"uuid":"641a4192-4879-4324-abed-0b5a24a85235","attributeTranslation":"Número de participantes com ocorrência de um ou mais acontecimentos adversos (AA)","language":20,"languageDescription":"Portuguese"},{"id":11313140,"uuid":"641a4192-4879-4324-abed-0b5a24a85235","attributeTranslation":"Cantidad de participantes que presentaron uno o más eventos adversos (AE).","language":7,"languageDescription":"Spanish"}]},{"id":1069627,"number":4,"endPoint":"Number of Participants Who Discontinue Study Treatment Due to an AE","isPrimary":false,"endPointTranslations":[{"id":11313144,"uuid":"aeb673ad-118d-4c93-8769-18e1c72f8544","attributeTranslation":"Αριθμός συμμετεχόντων που διέκοψαν τη θεραπεία της μελέτης λόγω ενός ΑΣ","language":5,"languageDescription":"Greek"},{"id":11313143,"uuid":"aeb673ad-118d-4c93-8769-18e1c72f8544","attributeTranslation":"Cantidad de participantes que interrumpen el tratamiento del estudio debido a un AE.","language":7,"languageDescription":"Spanish"},{"id":11313142,"uuid":"aeb673ad-118d-4c93-8769-18e1c72f8544","attributeTranslation":"Número de participantes que descontinuam o tratamento do estudo devido a um AA","language":20,"languageDescription":"Portuguese"},{"id":11313141,"uuid":"aeb673ad-118d-4c93-8769-18e1c72f8544","attributeTranslation":"Liczba uczestników, którzy przerywają leczenie w ramach badania ze względu na AE","language":19,"languageDescription":"Polish"}]}]},"trialDuration":{"estimatedGlobalEndDate":"2032-09-30","estimatedEndDate":"2032-09-30","estimatedRecruitmentStartDate":"2024-06-16"},"sourceOfMonetarySupport":[{"id":99033,"organisationName":"Merck Sharp & Dohme LLC"}],"populationOfTrialSubjects":{"ageRanges":[{"id":370497,"ageRangeCategoryCode":"4","ageRangeCategory":"4"},{"id":370498,"ageRangeCategoryCode":"3","ageRangeCategory":"3"}],"ageRangeSecondaryIds":[{"id":370500,"ageRangeCategoryCode":"4","ctAgeRangeCode":"8","ageRangeCategory":"4","ctAgeRange":"8"},{"id":370499,"ageRangeCategoryCode":"4","ctAgeRangeCode":"7","ageRangeCategory":"4","ctAgeRange":"7"}],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":false},"individualParticipantData":{"planToShareIPD":"1"}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[{"id":58101,"competentAuthority":{"id":207730,"organisation":{"id":211353,"type":"EU Institution/Body/Agency","typeCode":"14","name":"European Medicines Agency","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100013412","organisationLocationStatus":"Active"},"address":{"addressId":220926,"oneLine":"Domenico Scarlattilaan 6","addressLine1":"Domenico Scarlattilaan 6","addressLine2":"","addressLine3":"","addressLine4":"","city":"Amsterdam","postcode":"1083 HS","country":2029,"countryName":"Netherlands"},"isBusinessKeyValidated":true,"businessKey":"ORG-100013412"}}],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-28","conclusionDate":"2026-04-28","therapeuticAreas":[{"code":"4","name":"Diseases [C] - Neoplasms [C04]"}],"medicalConditions":[{"id":140933,"medicalCondition":"Small Lymphocytic Lymphoma (SLL) / Untreated Chronic Lymphocytic Leukemia (CLL)","isConditionRareDisease":false}],"sponsors":[{"id":153356,"primary":true,"publicContacts":[{"id":452521,"type":"Public","functionalName":"Siyang Leng","functionalEmailAddress":"siyang.leng@merck.com","telephone":"+17325945796","organisation":{"id":34778,"type":"Pharmaceutical company","typeCode":"10","name":"Merck Sharp & Dohme LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100006323","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":452522,"type":"Scientific","functionalName":"Siyang Leng","functionalEmailAddress":"siyang.leng@merck.com","telephone":"+17325945796","organisation":{"id":34778,"type":"Pharmaceutical company","typeCode":"10","name":"Merck Sharp & Dohme LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100006323","organisationLocationStatus":"Active"}}],"thirdParties":[{"id":696570,"organisationAddress":{"id":854244,"organisation":{"id":896037,"type":"Pharmaceutical company","typeCode":"10","name":"Foundation Medicine Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100040457","organisationLocationStatus":"Active"},"address":{"addressId":950749,"oneLine":"400 Summer Street","addressLine1":"400 Summer Street","addressLine2":"","addressLine3":"","addressLine4":"","city":"Boston","postcode":"02210-1717","country":840,"countryName":"United States"},"phone":"+17817335796","email":"lshannon@foundationmedicine.com","isBusinessKeyValidated":true,"businessKey":"ORG-100040457"},"sponsorDuties":[{"id":1080747,"code":"4"}],"phoneNumber":"+17817335796","email":"lshannon@foundationmedicine.com"},{"id":696572,"organisationAddress":{"id":207047,"organisation":{"id":210661,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Bioclinica Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100033079","organisationLocationStatus":"Active"},"address":{"addressId":220175,"oneLine":"211 Carnegie Center","addressLine1":"211 Carnegie Center","addressLine2":"","addressLine3":"","addressLine4":"","city":"Princeton","postcode":"08540-6299","country":840,"countryName":"United States"},"phone":"+50641193266","email":"Priscilla.ZunigaSolis@clario.com","isBusinessKeyValidated":true,"businessKey":"ORG-100033079"},"sponsorDuties":[{"id":1080749,"code":"15","value":"Central Imaging"}],"phoneNumber":"+50641193266","email":"Priscilla.ZunigaSolis@clario.com"},{"id":696571,"organisationAddress":{"id":207079,"organisation":{"id":210697,"type":"Pharmaceutical company","typeCode":"10","name":"Parexel International Corp.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100007310","organisationLocationStatus":"Active"},"address":{"addressId":220209,"oneLine":"275 Grove Street","addressLine1":"275 Grove Street","addressLine2":"","addressLine3":"","addressLine4":"","city":"Auburndale","postcode":"02466-2272","country":840,"countryName":"United States"},"phone":"+16174549300","email":"+MSDEMU@parexel.com","isBusinessKeyValidated":true,"businessKey":"ORG-100007310"},"sponsorDuties":[{"id":1080748,"code":"15","value":"EUB services (call center and medical services)"}],"phoneNumber":"+16174549300","email":"+MSDEMU@parexel.com"},{"id":696573,"organisationAddress":{"id":90218,"organisation":{"id":92922,"type":"Industry","typeCode":"3","name":"Reify Health","commercial":true,"isBusinessKeyValidated":false,"businessKey":"ORL-000000515","organisationLocationStatus":"Active"},"address":{"addressId":94557,"oneLine":"33 Arch Street, 17th Floor","addressLine1":"33 Arch Street, 17th Floor","addressLine2":"","addressLine3":"","addressLine4":"","city":"Boston","postcode":"MA 02110-1424","country":840,"countryName":"United States"},"phone":"+19785788958","email":"roxanne.roesch@onestudyteam.com","isBusinessKeyValidated":false,"businessKey":"ORL-000000515"},"sponsorDuties":[{"id":1080750,"code":"15","value":"recruitment activities"}],"phoneNumber":"+19785788958","email":"roxanne.roesch@onestudyteam.com"},{"id":696567,"organisationAddress":{"id":207053,"organisation":{"id":210667,"type":"Pharmaceutical company","typeCode":"10","name":"Signant Health Management Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100040504","organisationLocationStatus":"Active"},"address":{"addressId":220181,"oneLine":"1 London Street","addressLine1":"1 London Street","addressLine2":"","addressLine3":"","addressLine4":"","city":"Reading","postcode":"RG1 4PN","country":826,"countryName":"United Kingdom"},"phone":"+12674174031","email":"Fabiola.fajardofregoso@signanthealth.com","isBusinessKeyValidated":true,"businessKey":"ORG-100040504"},"sponsorDuties":[{"id":1080744,"code":"7"}],"phoneNumber":"+12674174031","email":"Fabiola.fajardofregoso@signanthealth.com"},{"id":696568,"organisationAddress":{"id":207040,"organisation":{"id":210654,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Neogenomics Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100044076","organisationLocationStatus":"Active"},"address":{"addressId":220168,"oneLine":"9490 Neogenomics Way","addressLine1":"9490 Neogenomics Way","addressLine2":"","addressLine3":"","addressLine4":"","city":"Fort Myers","postcode":"33912-4553","country":840,"countryName":"United States"},"phone":"+19494457300","email":"negin.baghdadchi@neogenomics.com","isBusinessKeyValidated":true,"businessKey":"ORG-100044076"},"sponsorDuties":[{"id":1080745,"code":"4"}],"phoneNumber":"+19494457300","email":"negin.baghdadchi@neogenomics.com"},{"id":696566,"organisationAddress":{"id":207032,"organisation":{"id":210646,"type":"Pharmaceutical company","typeCode":"10","name":"IQVIA Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100008655","organisationLocationStatus":"Active"},"address":{"addressId":220160,"oneLine":"The Alba Campus, Rosebank","addressLine1":"The Alba Campus","addressLine2":"Rosebank","addressLine3":"","addressLine4":"","city":"Livingston","postcode":"EH54 7EG","country":826,"countryName":"United Kingdom"},"phone":"+16612347557","email":"yaid.moreno@iqvia.com","isBusinessKeyValidated":true,"businessKey":"ORG-100008655"},"sponsorDuties":[{"id":1080743,"code":"4"}],"phoneNumber":"+16612347557","email":"yaid.moreno@iqvia.com"},{"id":696569,"organisationAddress":{"id":207050,"organisation":{"id":210664,"type":"Pharmaceutical company","typeCode":"10","name":"Signant Health LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100040732","organisationLocationStatus":"Active"},"address":{"addressId":220178,"oneLine":"785 Arbor Way","addressLine1":"785 Arbor Way","addressLine2":"","addressLine3":"","addressLine4":"","city":"Blue Bell","postcode":"19422-1986","country":840,"countryName":"United States"},"phone":"+918951225181","email":"Priyadarshini.kasi@signanthealth.com","isBusinessKeyValidated":true,"businessKey":"ORG-100040732"},"sponsorDuties":[{"id":1080746,"code":"3"}],"phoneNumber":"+918951225181","email":"Priyadarshini.kasi@signanthealth.com"}],"organisation":{"id":34778,"type":"Pharmaceutical company","typeCode":"10","name":"Merck Sharp & Dohme LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100006323","organisationLocationStatus":"Active"},"addresses":[{"id":33066,"organisation":{"id":34778,"type":"Pharmaceutical company","typeCode":"10","name":"Merck Sharp & Dohme LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100006323","organisationLocationStatus":"Active"},"address":{"addressId":34081,"oneLine":"126 East Lincoln Avenue","addressLine1":"126 East Lincoln Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Rahway","postcode":"07065-4607","country":840,"countryName":"United States"},"isBusinessKeyValidated":true,"businessKey":"LOC-100021431"}],"isCommercial":true,"commercial":"Commercial"}],"trialCategoryCode":"2","trialCategoryJustificationComment":"Phase III, confirm safety and efficacy trial in patients, or target populations for prophylaxis.","partOneTherapeuticAreas":[{"id":1197100,"therapeuticArea":{"code":"4","name":"Diseases [C] - Neoplasms [C04]"}}],"productRoleGroupInfos":[{"id":417307,"comments":"Nemtabrutinib, Nemtabrutinib, Nemtabrutinib, Nemtabrutinib","miaNumber":"IMP11011/00003","productRoleCode":"1","productRoleName":"Test","products":[{"id":560645,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"9964081","productPharmForm":"TABLET","euMpNumber":"PRD7571582","prodAuthStatus":1,"prodName":"Nemtabrutinib","pharmForm":"TABLET","sponsorProductCode":"MK-1026","activeSubstanceName":"NEMTABRUTINIB","euSubstNumber":"SUB201199","nameOrg":"MERCK & CO. INC.","productSubstances":[{"productPk":"9964081","substancePk":"235551","nameOrg":"MERCK & CO. INC.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"NEMTABRUTINIB","substanceEvCode":"SUB201199"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"65","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"213.7","maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","evCode":"PRD7571582","sponsorProductCodeEdit":"MK-1026","miaNumber":"IMP11011/00003","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Nemtabrutinib","jsonActiveSubstanceNames":"nemtabrutinib","pharmaceuticalFormDisplay":"TABLET"},{"id":560646,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11385047","productPharmForm":"FILM-COATED TABLET","euMpNumber":"PRD11385047","prodAuthStatus":1,"prodName":"Nemtabrutinib","pharmForm":"FILM-COATED TABLET","sponsorProductCode":"MK-1026","activeSubstanceName":"NEMTABRUTINIB","euSubstNumber":"SUB201199","nameOrg":"MERCK & CO. INC.","productSubstances":[{"productPk":"11385047","substancePk":"338707","nameOrg":"MERCK & CO. INC.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"NEMTABRUTINIB","substanceEvCode":"SUB201199","synonyms":["ARQ-531","ARQ 531","(2-chloro-4-phenoxyphenyl)(4-(((3R,6S)-6-(hydroxymethyl)tetrahydro-2H-pyran-3-yl)amino)-7H-pyrrolo[2,3-d]pyrimidin-5-yl)methanone","MK-1026"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"65","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"213.7","maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","evCode":"PRD11385047","sponsorProductCodeEdit":"MK-1026","miaNumber":"IMP11011/00003","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Nemtabrutinib","jsonActiveSubstanceNames":"nemtabrutinib","pharmaceuticalFormDisplay":"FILM-COATED TABLET"},{"id":560647,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"9964080","productPharmForm":"TABLET","euMpNumber":"PRD7571581","prodAuthStatus":1,"prodName":"Nemtabrutinib","pharmForm":"TABLET","sponsorProductCode":"MK-1026","activeSubstanceName":"NEMTABRUTINIB","euSubstNumber":"SUB201199","nameOrg":"MERCK & CO. INC.","productSubstances":[{"productPk":"9964080","substancePk":"235551","nameOrg":"MERCK & CO. INC.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"NEMTABRUTINIB","substanceEvCode":"SUB201199"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"65","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"213.7","maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","evCode":"PRD7571581","sponsorProductCodeEdit":"MK-1026","miaNumber":"IMP11011/00003","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Nemtabrutinib","jsonActiveSubstanceNames":"nemtabrutinib","pharmaceuticalFormDisplay":"TABLET"},{"id":560648,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11385048","productPharmForm":"FILM-COATED TABLET","euMpNumber":"PRD11385048","prodAuthStatus":1,"prodName":"Nemtabrutinib","pharmForm":"FILM-COATED TABLET","sponsorProductCode":"MK-1026","activeSubstanceName":"NEMTABRUTINIB","euSubstNumber":"SUB201199","nameOrg":"MERCK & CO. INC.","productSubstances":[{"productPk":"11385048","substancePk":"338707","nameOrg":"MERCK & CO. INC.","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"NEMTABRUTINIB","substanceEvCode":"SUB201199","synonyms":["ARQ-531","ARQ 531","(2-chloro-4-phenoxyphenyl)(4-(((3R,6S)-6-(hydroxymethyl)tetrahydro-2H-pyran-3-yl)amino)-7H-pyrrolo[2,3-d]pyrimidin-5-yl)methanone","MK-1026"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"65","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"213.7","maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","evCode":"PRD11385048","sponsorProductCodeEdit":"MK-1026","miaNumber":"IMP11011/00003","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Nemtabrutinib","jsonActiveSubstanceNames":"nemtabrutinib","pharmaceuticalFormDisplay":"FILM-COATED TABLET"}]},{"id":417305,"comments":"ACALABRUTINIB\r","miaNumber":"IMP11011/00003","productRoleCode":"2","productRoleName":"Comparator","products":[{"id":560643,"part1MpRoleTypeCode":"2","productDictionaryInfo":{"productPharmForm":"PHF00006MIG","euMpNumber":"SCP46660836","marketingAuthNumber":"-","prodAuthStatus":2,"activeSubstanceName":"ACALABRUTINIB","euSubstNumber":"SUB182073","productSubstances":[{"substancePk":"424398","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"ACALABRUTINIB","substanceEvCode":"SUB182073","synonyms":["ACP-196","(S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-α]pyrazin-1-yl)-N-(pyridin-2-yl)-benzamide"]}],"atcCode":"L01EL02","atcName":"ACALABRUTINIB\r","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"2","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"200","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"657","productChangedRelationMA":false,"maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","miaNumber":"IMP11011/00003","scientificProductEvCode":"SCP46660836","scientificProductPharmEvCode":"PHF00006MIG","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"ACALABRUTINIB\r","jsonActiveSubstanceNames":"acalabrutinib","pharmaceuticalFormDisplay":"PHF00006MIG"}]},{"id":417306,"comments":"IBRUTINIB\r","miaNumber":"IMP11011/00003","productRoleCode":"2","productRoleName":"Comparator","products":[{"id":560644,"part1MpRoleTypeCode":"2","productDictionaryInfo":{"productPharmForm":"PHF00006MIG","euMpNumber":"SCP674865","marketingAuthNumber":"-","prodAuthStatus":2,"activeSubstanceName":"IBRUTINIB","euSubstNumber":"SUB120863","productSubstances":[{"substancePk":"424326","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"IBRUTINIB","substanceEvCode":"SUB120863","synonyms":["1-((3R)-3-(4-AMINO-3-(4-PHENOXYPHENYL)-1H-PYRAZOLO(3,4-D)PYRIMIDIN-1-YL)PIPERIDIN-1- YL)PROP-2-EN-1-ONE"]}],"atcCode":"L01EL01","atcName":"IBRUTINIB\r","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"2","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"420","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"1381","productChangedRelationMA":false,"maxTreatmentPeriod":108,"timeUnitCode":"3","otherMedicinalProduct":"Chemical origin","miaNumber":"IMP11011/00003","scientificProductEvCode":"SCP674865","scientificProductPharmEvCode":"PHF00006MIG","devices":[],"characteristics":["11"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"IBRUTINIB\r","jsonActiveSubstanceNames":"ibrutinib","pharmaceuticalFormDisplay":"PHF00006MIG"}]}],"isLowIntervention":false},"authorizedPartsII":[{"id":241011,"mscId":24542,"mscInfo":{"id":24542,"clinicalTrialId":12778,"countryOrganisationId":2002,"reportingStatusCode":"Authorised","fromDate":"2024-06-14","toDate":"2024-06-14","isProposedRms":false,"expressDecision":"unwilling","countryName":"Belgium","organisationInfo":{},"firstDecisionDate":"2024-07-01","trialStatus":"Authorised","trialPeriod":[{"id":32360,"trialStartDate":"2024-08-28","fromDate":"2024-08-28"},{"id":32361,"trialStartDate":"2024-08-28","fromDate":"2024-08-28"}],"trialRecruitmentPeriod":[{"id":46237,"recruitmentStartDate":"2024-09-12","fromDate":"2024-09-24"},{"id":46238,"recruitmentStartDate":"2024-09-12","fromDate":"2024-09-24"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":43069,"trialStartDate":"2024-08-28","fromDate":"2024-08-28"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-09-12"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28135,"mscId":24542,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.045"},{"id":41391,"mscId":24542,"trialStatus":"Authorised","trialStatusDate":"2024-07-01T16:12:43.585"}],"applicationTypeMsc":"1","mscName":"Belgium","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-01-29","decision":"authorized","decisionDate":"2024-07-01"},"decisionDate":"2024-07-01","recruitmentSubjectCount":16,"trialSites":[{"id":1637235,"organisationAddressInfo":{"id":206917,"organisation":{"id":210529,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"UZ Leuven","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100006001","organisationLocationStatus":"Active"},"address":{"addressId":220037,"oneLine":"Herestraat 49","addressLine1":"Herestraat 49","addressLine2":"","addressLine3":"","addressLine4":"","city":"Leuven","postcode":"3000","country":2002,"countryName":"Belgium"},"phone":"+3216346880","email":"Ann.janssens@uzleuven.be","isBusinessKeyValidated":true,"businessKey":"ORG-100006001"},"personInfo":{"id":1820315,"firstName":"Ann","lastName":"Janssens","telephone":"+3216346880","email":"Ann.janssens@uzleuven.be","title":"1"},"departmentName":"Department of Hematology"},{"id":1637236,"organisationAddressInfo":{"id":206920,"organisation":{"id":210532,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"A.Z. Sint-Maarten","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041054","organisationLocationStatus":"Active"},"address":{"addressId":220040,"oneLine":"Liersesteenweg 435","addressLine1":"Liersesteenweg 435","addressLine2":"","addressLine3":"","addressLine4":"","city":"Mechelen","postcode":"2800","country":2002,"countryName":"Belgium"},"phone":"+3215891011","email":"Toine.mercier@emmaus.be","isBusinessKeyValidated":true,"businessKey":"ORG-100041054"},"personInfo":{"id":1820316,"firstName":"Toine","lastName":"Mercier","telephone":"+3215891011","email":"Toine.mercier@emmaus.be","title":"1"},"departmentName":"Department of Hematology"}],"applicationStatusCode":"Authorised"},{"id":241019,"mscId":24549,"mscInfo":{"id":24549,"clinicalTrialId":12778,"countryOrganisationId":2030,"reportingStatusCode":"Authorised","fromDate":"2024-04-11","toDate":"2024-04-11","isProposedRms":false,"expressDecision":"unwilling","countryName":"Norway","organisationInfo":{},"firstDecisionDate":"2024-06-13","trialStatus":"Authorised","trialPeriod":[{"id":23024,"trialStartDate":"2024-06-18","fromDate":"2024-06-20"},{"id":23025,"trialStartDate":"2024-06-18","fromDate":"2024-06-20"}],"trialRecruitmentPeriod":[{"id":41010,"recruitmentStartDate":"2024-08-19","fromDate":"2024-08-26"},{"id":41011,"recruitmentStartDate":"2024-08-19","fromDate":"2024-08-26"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":30425,"trialStartDate":"2024-06-18","fromDate":"2024-06-20"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-08-19"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28143,"mscId":24549,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.371"},{"id":38521,"mscId":24549,"trialStatus":"Authorised","trialStatusDate":"2024-06-13T14:45:57.467"}],"applicationTypeMsc":"1","mscName":"Norway","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-11","decision":"authorized","decisionDate":"2024-06-13"},"decisionDate":"2024-06-13","recruitmentSubjectCount":30,"trialSites":[{"id":1637272,"organisationAddressInfo":{"id":206995,"organisation":{"id":210608,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Oslo University Hospital HF","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100021349","organisationLocationStatus":"Active"},"address":{"addressId":220117,"oneLine":"Sognsvannsveien 20","addressLine1":"Sognsvannsveien 20","addressLine2":"","addressLine3":"","addressLine4":"","city":"Oslo","postcode":"0372","country":2030,"countryName":"Norway"},"phone":"+4748269428","email":"anlena@ous-hf.no","isBusinessKeyValidated":true,"businessKey":"ORG-100021349"},"personInfo":{"id":1820352,"firstName":"Andrea","lastName":"Lenartova","telephone":"+4748269428","email":"anlena@ous-hf.no"},"departmentName":"Department of blood disorders"},{"id":1637271,"organisationAddressInfo":{"id":717906,"organisation":{"id":756164,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Sykehuset I Vestfold HF","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100011126","organisationLocationStatus":"Active"},"address":{"addressId":786665,"oneLine":"Halfdan Wilhelmsens Alle 17","addressLine1":"Halfdan Wilhelmsens Alle 17","addressLine2":"","addressLine3":"","addressLine4":"","city":"Toensberg","postcode":"3116","country":2030,"countryName":"Norway"},"phone":"+4733342000","email":"magmok@siv.no","isBusinessKeyValidated":true,"businessKey":"ORG-100011126"},"personInfo":{"id":1820351,"firstName":"Magnus","lastName":"Moksnes","telephone":"+4733342000","email":"magmok@siv.no"},"departmentName":"Clinical Trial unit"},{"id":1637273,"organisationAddressInfo":{"id":206993,"organisation":{"id":210606,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Akershus University Hospital","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100010785","organisationLocationStatus":"Active"},"address":{"addressId":220115,"oneLine":"Sykehusveien 25","addressLine1":"Sykehusveien 25","addressLine2":"","addressLine3":"","addressLine4":"","city":"Loerenskog","postcode":"1474","country":2030,"countryName":"Norway"},"phone":"+4797595035","email":"hoa.thi.tuyet.tran@ahus.no","isBusinessKeyValidated":true,"businessKey":"ORG-100010785"},"personInfo":{"id":1820353,"firstName":"Hoa","lastName":"Tran","telephone":"+4797595035","email":"hoa.thi.tuyet.tran@ahus.no"},"departmentName":"Hematology department"}],"applicationStatusCode":"Authorised"},{"id":241014,"mscId":24545,"mscInfo":{"id":24545,"clinicalTrialId":12778,"countryOrganisationId":2009,"reportingStatusCode":"Authorised","fromDate":"2024-06-19","toDate":"2024-06-19","isProposedRms":true,"expressDecision":"willing","countryName":"Denmark","organisationInfo":{},"firstDecisionDate":"2024-06-27","trialStatus":"Authorised","trialPeriod":[{"id":33160,"trialStartDate":"2024-08-28","fromDate":"2024-09-04"},{"id":33161,"trialStartDate":"2024-08-28","fromDate":"2024-09-04"}],"trialRecruitmentPeriod":[{"id":51315,"recruitmentStartDate":"2024-10-16","fromDate":"2024-10-21"},{"id":51316,"recruitmentStartDate":"2024-10-16","fromDate":"2024-10-21"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":44138,"trialStartDate":"2024-08-28","fromDate":"2024-09-04"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-10-16"},"isWillingAtDayThreeView":true,"clinicalTrialStatusHistory":[{"id":28137,"mscId":24545,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.143"},{"id":40762,"mscId":24545,"trialStatus":"Authorised","trialStatusDate":"2024-06-27T10:43:33.34"}],"applicationTypeMsc":"1","mscName":"Denmark","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-11-27","decision":"authorized","decisionDate":"2024-06-27"},"decisionDate":"2024-06-27","recruitmentSubjectCount":25,"trialSites":[{"id":1637246,"organisationAddressInfo":{"id":207754,"organisation":{"id":211377,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Odense University Hospital","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100007716","organisationLocationStatus":"Active"},"address":{"addressId":220958,"oneLine":"J B Winsloews Vej 4","addressLine1":"J B Winsloews Vej 4","addressLine2":"","addressLine3":"","addressLine4":"","city":"Odense C","postcode":"5000","country":2009,"countryName":"Denmark"},"phone":"+4524634689","email":"annika.rewes@rsyd.dk","isBusinessKeyValidated":true,"businessKey":"ORG-100007716"},"personInfo":{"id":1820326,"firstName":"Annika","lastName":"Rewes","telephone":"+4524634689","email":"annika.rewes@rsyd.dk"},"departmentName":"Department of Hematology"},{"id":1637247,"organisationAddressInfo":{"id":207766,"organisation":{"id":211389,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Region Sjaelland","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100023219","organisationLocationStatus":"Active"},"address":{"addressId":220970,"oneLine":"Sygehusvej 10","addressLine1":"Sygehusvej 10","addressLine2":"","addressLine3":"","addressLine4":"","city":"Roskilde","postcode":"4000","country":2009,"countryName":"Denmark"},"phone":"+4547324809","email":"cbpo@regionsjaelland.dk","isBusinessKeyValidated":true,"businessKey":"ORG-100023219"},"personInfo":{"id":1820327,"firstName":"Christian","lastName":"Poulsen","telephone":"+4547324809","email":"cbpo@regionsjaelland.dk"},"departmentName":"Department of Hematology"},{"id":1637248,"organisationAddressInfo":{"id":207772,"organisation":{"id":211395,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Aalborg University Hospital","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100022335","organisationLocationStatus":"Active"},"address":{"addressId":220976,"oneLine":"Hobrovej 18/22","addressLine1":"Hobrovej 18/22","addressLine2":"","addressLine3":"","addressLine4":"","city":"Aalborg","postcode":"9000","country":2009,"countryName":"Denmark"},"phone":"+4561276282","email":"thhc@rn.dk","isBusinessKeyValidated":true,"businessKey":"ORG-100022335"},"personInfo":{"id":1820328,"firstName":"Thor","lastName":"Høyer","telephone":"+4561276282","email":"thhc@rn.dk"},"departmentName":"Department of Hematology"}],"applicationStatusCode":"Authorised"},{"id":241016,"mscId":24547,"mscInfo":{"id":24547,"clinicalTrialId":12778,"countryOrganisationId":2028,"reportingStatusCode":"Authorised","fromDate":"2024-06-14","toDate":"2024-06-14","isProposedRms":false,"expressDecision":"unwilling","countryName":"Sweden","organisationInfo":{},"firstDecisionDate":"2024-07-08","trialStatus":"Authorised","trialPeriod":[{"id":39920,"trialStartDate":"2024-10-16","fromDate":"2024-10-24"},{"id":39921,"trialStartDate":"2024-10-16","fromDate":"2024-10-24"}],"trialRecruitmentPeriod":[{"id":52295,"recruitmentStartDate":"2024-10-21","fromDate":"2024-10-24"},{"id":52296,"recruitmentStartDate":"2024-10-21","fromDate":"2024-10-24"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":53850,"trialStartDate":"2024-10-16","fromDate":"2024-10-24"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-10-21"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28142,"mscId":24547,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.337"},{"id":42310,"mscId":24547,"trialStatus":"Authorised","trialStatusDate":"2024-07-08T13:28:30.972"}],"applicationTypeMsc":"1","mscName":"Sweden","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-01","decision":"authorized","decisionDate":"2024-07-08"},"decisionDate":"2024-07-08","recruitmentSubjectCount":28,"trialSites":[{"id":1637258,"organisationAddressInfo":{"id":207787,"organisation":{"id":211410,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Karolinska University Hospital","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100000573","organisationLocationStatus":"Active"},"address":{"addressId":220992,"oneLine":"Eugeniavagen 3","addressLine1":"Eugeniavagen 3","addressLine2":"","addressLine3":"","addressLine4":"","city":"Solna","postcode":"171 64","country":2028,"countryName":"Sweden"},"phone":"+4681237000","email":"anders.osterborg@regionstockholm.se","isBusinessKeyValidated":true,"businessKey":"ORG-100000573"},"personInfo":{"id":1820338,"firstName":"Anders","lastName":"Österborg","telephone":"+4681237000","email":"anders.osterborg@regionstockholm.se"},"departmentName":"ME Hematologi"}],"applicationStatusCode":"Authorised"},{"id":273077,"mscId":24544,"mscInfo":{"id":24544,"clinicalTrialId":12778,"countryOrganisationId":2008,"reportingStatusCode":"Authorised","fromDate":"2024-04-11","toDate":"2024-04-11","isProposedRms":false,"expressDecision":"unwilling","countryName":"Czechia","organisationInfo":{},"firstDecisionDate":"2024-06-12","trialStatus":"Authorised","trialPeriod":[{"id":30149,"trialStartDate":"2024-07-30","fromDate":"2024-08-09"},{"id":30150,"trialStartDate":"2024-07-30","fromDate":"2024-08-09"}],"trialRecruitmentPeriod":[{"id":38305,"recruitmentStartDate":"2024-08-08","fromDate":"2024-08-09"},{"id":38306,"recruitmentStartDate":"2024-08-08","fromDate":"2024-08-09"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":39913,"trialStartDate":"2024-07-30","fromDate":"2024-08-09"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-08-08"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28136,"mscId":24544,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.096"},{"id":38242,"mscId":24544,"trialStatus":"Authorised","trialStatusDate":"2024-06-12T10:03:10.046"}],"applicationTypeMsc":"1","mscName":"Czechia","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-02-09","decision":"authorized","decisionDate":"2024-06-12"},"decisionDate":"2024-06-12","recruitmentSubjectCount":30,"trialSites":[{"id":1872127,"organisationAddressInfo":{"id":206947,"organisation":{"id":210559,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"University Hospital Olomouc","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100032988","organisationLocationStatus":"Active"},"address":{"addressId":220067,"oneLine":"Zdravotniku 248/7","addressLine1":"Zdravotniku 248/7","addressLine2":"","addressLine3":"","addressLine4":"","city":"Olomouc","postcode":"779 00","country":2008,"countryName":"Czechia"},"phone":"+420588443940","email":"Peter.Turcsanyi@fnol.cz","isBusinessKeyValidated":true,"businessKey":"ORG-100032988"},"personInfo":{"id":2080372,"firstName":"Peter","lastName":"Turcsányi","telephone":"+420588443940","email":"Peter.Turcsanyi@fnol.cz"},"departmentName":"Hemato-onkologická klinika"},{"id":1872126,"organisationAddressInfo":{"id":207777,"organisation":{"id":211400,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Fakultni Nemocnice Hradec Kralove","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100022983","organisationLocationStatus":"Active"},"address":{"addressId":220981,"oneLine":"Sokolska 581","addressLine1":"Sokolska 581","addressLine2":"","addressLine3":"","addressLine4":"","city":"Novy Hradec Kralove","postcode":"500 03","country":2008,"countryName":"Czechia"},"phone":"+420495832886","email":"simkovicm@lfhk.cuni.cz","isBusinessKeyValidated":true,"businessKey":"ORG-100022983"},"personInfo":{"id":2080371,"firstName":"Martin","lastName":"Šimkovič","telephone":"+420495832886","email":"simkovicm@lfhk.cuni.cz"},"departmentName":"Interní hematologická klinika"},{"id":1872125,"organisationAddressInfo":{"id":206941,"organisation":{"id":210553,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Vseobecna Fakultni Nemocnice V Praze","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100031413","organisationLocationStatus":"Active"},"address":{"addressId":220061,"oneLine":"U Nemocnice 499/2, Nove Mesto","addressLine1":"U Nemocnice 499/2","addressLine2":"Nove Mesto","addressLine3":"","addressLine4":"","city":"Prague 2","postcode":"128 00","country":2008,"countryName":"Czechia"},"phone":"+420224962527","email":"marek.trneny@lf1.cuni.cz","isBusinessKeyValidated":true,"businessKey":"ORG-100031413"},"personInfo":{"id":2080370,"firstName":"Marek","lastName":"Trněný","telephone":"+420224962527","email":"marek.trneny@lf1.cuni.cz"},"departmentName":"Interní klinika, Klinika hematologie"}],"applicationStatusCode":"Authorised"},{"id":241015,"mscId":24546,"mscInfo":{"id":24546,"clinicalTrialId":12778,"countryOrganisationId":2027,"reportingStatusCode":"Authorised","fromDate":"2024-04-11","toDate":"2024-04-11","isProposedRms":false,"expressDecision":"unwilling","countryName":"Spain","organisationInfo":{},"firstDecisionDate":"2024-06-17","trialStatus":"Authorised","trialPeriod":[{"id":25560,"trialStartDate":"2024-07-08","fromDate":"2024-07-08"},{"id":25561,"trialStartDate":"2024-07-08","fromDate":"2024-07-08"}],"trialRecruitmentPeriod":[{"id":36178,"recruitmentStartDate":"2024-07-24","fromDate":"2024-07-30"},{"id":36179,"recruitmentStartDate":"2024-07-24","fromDate":"2024-07-30"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":33813,"trialStartDate":"2024-07-08","fromDate":"2024-07-08"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-07-24"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28141,"mscId":24546,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.302"},{"id":39473,"mscId":24546,"trialStatus":"Authorised","trialStatusDate":"2024-06-17T23:59:59"}],"applicationTypeMsc":"1","mscName":"Spain","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-01-12","decision":"authorized","decisionDate":"2024-06-17"},"decisionDate":"2024-06-17","recruitmentSubjectCount":50,"trialSites":[{"id":1637254,"organisationAddressInfo":{"id":207010,"organisation":{"id":210624,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Institut Catala D'oncologia","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100030394","organisationLocationStatus":"Active"},"address":{"addressId":220134,"oneLine":"Avinguda De La Gran Via De L'hospitalet 199-203","addressLine1":"Avinguda De La Gran Via De L'hospitalet 199-203","addressLine2":"","addressLine3":"","addressLine4":"","city":"L'hospitalet De Llobregat","postcode":"08908","country":2027,"countryName":"Spain"},"phone":"+34932607750","email":"contactfortrialsicolh@iconcologia.cat","isBusinessKeyValidated":true,"businessKey":"ORG-100030394"},"personInfo":{"id":1820334,"firstName":"Eva","lastName":"Gonzalez Barca","telephone":"+34932607750","email":"contactfortrialsicolh@iconcologia.cat"},"departmentName":"Hematology"},{"id":1637255,"organisationAddressInfo":{"id":207009,"organisation":{"id":210623,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Vall D'hebron Institut De Recerca","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100008455","organisationLocationStatus":"Active"},"address":{"addressId":220133,"oneLine":"Passeig De La Vall D'hebron 119-129","addressLine1":"Passeig De La Vall D'hebron 119-129","addressLine2":"","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08035","country":2027,"countryName":"Spain"},"phone":"+34934893806","email":"fboschct@vhio.net","isBusinessKeyValidated":true,"businessKey":"ORG-100008455"},"personInfo":{"id":1820335,"firstName":"Francesc","lastName":"Bosch","telephone":"+34934893806","email":"fboschct@vhio.net"},"departmentName":"Hematology"},{"id":1637251,"organisationAddressInfo":{"id":381236,"organisation":{"id":410869,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Universitario Quironsalud Madrid","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100030938","organisationLocationStatus":"Active"},"address":{"addressId":407324,"oneLine":"Calle De Diego De Velazquez 1","addressLine1":"Calle De Diego De Velazquez 1","addressLine2":"","addressLine3":"","addressLine4":"","city":"Pozuelo De Alarcon","postcode":"28223","country":2027,"countryName":"Spain"},"phone":"+34914521900","email":"mcarmen.chamorro@quironsalud.es","isBusinessKeyValidated":true,"businessKey":"ORG-100030938"},"personInfo":{"id":1820331,"firstName":"Carmen","lastName":"Martinez Chamorro","telephone":"+34914521900","email":"mcarmen.chamorro@quironsalud.es"},"departmentName":"Hematology"},{"id":1637253,"organisationAddressInfo":{"id":207001,"organisation":{"id":210615,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Clinic De Barcelona","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100009329","organisationLocationStatus":"Active"},"address":{"addressId":220123,"oneLine":"Calle Villarroel 170","addressLine1":"Calle Villarroel 170","addressLine2":"","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08036","country":2027,"countryName":"Spain"},"phone":"+34619085109","email":"mozas@clinic.cat","isBusinessKeyValidated":true,"businessKey":"ORG-100009329"},"personInfo":{"id":1820333,"firstName":"Pablo","lastName":"Mozas Fernández","telephone":"+34619085109","email":"mozas@clinic.cat"},"departmentName":"Hematology"},{"id":1637250,"organisationAddressInfo":{"id":207013,"organisation":{"id":210627,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Universitario Puerta De Hierro De Majadahonda","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028532","organisationLocationStatus":"Active"},"address":{"addressId":220138,"oneLine":"Calle De Joaquin Rodrigo 2","addressLine1":"Calle De Joaquin Rodrigo 2","addressLine2":"","addressLine3":"","addressLine4":"","city":"Majadahonda","postcode":"28222","country":2027,"countryName":"Spain"},"phone":"911917620","email":"garciavela.joseantonio@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100028532"},"personInfo":{"id":1820330,"firstName":"José Antonio","lastName":"García Vela","telephone":"911917620","email":"garciavela.joseantonio@gmail.com"},"departmentName":"Hematology"},{"id":1637249,"organisationAddressInfo":{"id":206997,"organisation":{"id":210610,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Universitario De Salamanca","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028551","organisationLocationStatus":"Active"},"address":{"addressId":220119,"oneLine":"Paseo De San Vicente 58-182","addressLine1":"Paseo De San Vicente 58-182","addressLine2":"","addressLine3":"","addressLine4":"","city":"Salamanca","postcode":"37007","country":2027,"countryName":"Spain"},"phone":"+34923291100","email":"anavarrob@saludcastillayleon.es","isBusinessKeyValidated":true,"businessKey":"ORG-100028551"},"personInfo":{"id":1820329,"firstName":"Almudena","lastName":"Navarro Bailon","telephone":"+34923291100","email":"anavarrob@saludcastillayleon.es"},"departmentName":"Hematology"},{"id":1637252,"organisationAddressInfo":{"id":207008,"organisation":{"id":210622,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"University Hospital Of Canary Islands","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100031202","organisationLocationStatus":"Active"},"address":{"addressId":220131,"oneLine":"Carretera De La Cuesta Taco S/n, Cuesta La","addressLine1":"Carretera De La Cuesta Taco S/n","addressLine2":"Cuesta La","addressLine3":"","addressLine4":"","city":"San Cristobal De La Laguna","postcode":"38320","country":2027,"countryName":"Spain"},"phone":"+34922678207","email":"sandrairaheta@hotmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100031202"},"personInfo":{"id":1820332,"firstName":"Sandra","lastName":"Iraheta Reyes","telephone":"+34922678207","email":"sandrairaheta@hotmail.com"},"departmentName":"Hematology"}],"applicationStatusCode":"Authorised"},{"id":241020,"mscId":24551,"mscInfo":{"id":24551,"clinicalTrialId":12778,"countryOrganisationId":2031,"reportingStatusCode":"Authorised","fromDate":"2024-06-12","toDate":"2024-06-12","isProposedRms":false,"expressDecision":"unwilling","countryName":"Poland","organisationInfo":{},"firstDecisionDate":"2024-07-17","trialStatus":"Authorised","trialPeriod":[{"id":31473,"trialStartDate":"2024-08-20","fromDate":"2024-08-21"},{"id":31474,"trialStartDate":"2024-08-20","fromDate":"2024-08-21"}],"trialRecruitmentPeriod":[{"id":40554,"recruitmentStartDate":"2024-08-22","fromDate":"2024-08-22"},{"id":40555,"recruitmentStartDate":"2024-08-22","fromDate":"2024-08-22"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":41826,"trialStartDate":"2024-08-20","fromDate":"2024-08-21"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-08-22"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28144,"mscId":24551,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.404"},{"id":43779,"mscId":24551,"trialStatus":"Authorised","trialStatusDate":"2024-07-17T10:28:47.874"}],"applicationTypeMsc":"1","mscName":"Poland","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-01-09","decision":"authorized","decisionDate":"2024-07-17"},"decisionDate":"2024-07-17","recruitmentSubjectCount":100,"trialSites":[{"id":1637280,"organisationAddressInfo":{"id":381222,"organisation":{"id":410855,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Pratia S.A.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100040716","organisationLocationStatus":"Active"},"address":{"addressId":407310,"oneLine":"Ul. Pana Tadeusza 2","addressLine1":"Ul. Pana Tadeusza 2","addressLine2":"","addressLine3":"","addressLine4":"","city":"Cracow","postcode":"30-727","country":2031,"countryName":"Poland"},"phone":"+48122954139","email":"biuro.mcm@pratia.com","isBusinessKeyValidated":true,"businessKey":"ORG-100040716"},"personInfo":{"id":1820360,"firstName":"Wojciech","lastName":"Jurczak","telephone":"+48122954139","email":"biuro.mcm@pratia.com"},"departmentName":"PRATIA MCM KRAKÓW"},{"id":1637278,"organisationAddressInfo":{"id":381219,"organisation":{"id":410852,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043010","organisationLocationStatus":"Active"},"address":{"addressId":407307,"oneLine":"Ul. Stanislawa Staszica 11","addressLine1":"Ul. Stanislawa Staszica 11","addressLine2":"","addressLine3":"","addressLine4":"","city":"Lublin","postcode":"20-081","country":2031,"countryName":"Poland"},"phone":"815345468","email":"hematoonkologia@spsk1.lublin.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100043010"},"personInfo":{"id":1820358,"firstName":"Marek","lastName":"Hus","telephone":"815345468","email":"hematoonkologia@spsk1.lublin.pl"},"departmentName":"Klinika Hematologii i Transplantacji Szpiku"},{"id":1637277,"organisationAddressInfo":{"id":212775,"organisation":{"id":216422,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100009191","organisationLocationStatus":"Active"},"address":{"addressId":226396,"oneLine":"Ul. Wybrzeze Armii Krajowej 15","addressLine1":"Ul. Wybrzeze Armii Krajowej 15","addressLine2":"","addressLine3":"","addressLine4":"","city":"Gliwice","postcode":"44-102","country":2031,"countryName":"Poland"},"phone":"322788523","email":"ktsbadaniakliniczne@gliwice.nio.gov.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100009191"},"personInfo":{"id":1820357,"firstName":"Sebastian","lastName":"Giebel","telephone":"322788523","email":"ktsbadaniakliniczne@gliwice.nio.gov.pl"},"departmentName":"Klinika Transplantacji Szpiku i Onkohematologii"},{"id":1637275,"organisationAddressInfo":{"id":212784,"organisation":{"id":216431,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Uniwersyteckie Centrum Kliniczne","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100042500","organisationLocationStatus":"Active"},"address":{"addressId":226406,"oneLine":"Ul. Mariana Smoluchowskiego 17","addressLine1":"Ul. Mariana Smoluchowskiego 17","addressLine2":"","addressLine3":"","addressLine4":"","city":"Gdansk","postcode":"80-214","country":2031,"countryName":"Poland"},"phone":"585844340","email":"hematologia@uck.gda.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100042500"},"personInfo":{"id":1820355,"firstName":"Aleksandra","lastName":"Wadolowska","telephone":"585844340","email":"hematologia@uck.gda.pl"},"departmentName":"Klinika Hematologii i Transplantologii"},{"id":1637279,"organisationAddressInfo":{"id":212777,"organisation":{"id":216424,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100009191","organisationLocationStatus":"Active"},"address":{"addressId":226398,"oneLine":"Ul. Wilhelma Konrada Roentgena 5","addressLine1":"Ul. Wilhelma Konrada Roentgena 5","addressLine2":"","addressLine3":"","addressLine4":"","city":"Warsaw","postcode":"02-781","country":2031,"countryName":"Poland"},"phone":"225462366","email":"sekretariat.hemat@kopernik.lodz.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100009191"},"personInfo":{"id":1820359,"firstName":"Ewa","lastName":"Paszkiewicz-Kozik","telephone":"225462366","email":"sekretariat.hemat@kopernik.lodz.pl"},"departmentName":"Klinika Nowotworów Układu Chłonnego"},{"id":1637276,"organisationAddressInfo":{"id":381212,"organisation":{"id":410845,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043435","organisationLocationStatus":"Active"},"address":{"addressId":407299,"oneLine":"Al. Wojska Polskiego 37","addressLine1":"Al. Wojska Polskiego 37","addressLine2":"","addressLine3":"","addressLine4":"","city":"Olsztyn","postcode":"10-228","country":2031,"countryName":"Poland"},"phone":"895398078","email":"clinicaltrialsoffice@poliklinika.net","isBusinessKeyValidated":true,"businessKey":"ORG-100043435"},"personInfo":{"id":1820356,"firstName":"Janusz","lastName":"Hałka","telephone":"895398078","email":"clinicaltrialsoffice@poliklinika.net"},"departmentName":"Oddzial Kliniczny Hematologii"},{"id":1637281,"organisationAddressInfo":{"id":212783,"organisation":{"id":216430,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Pratia Hematologia Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100040044","organisationLocationStatus":"Active"},"address":{"addressId":226404,"oneLine":"Ul. Tadeusza Kosciuszki 92","addressLine1":"Ul. Tadeusza Kosciuszki 92","addressLine2":"","addressLine3":"","addressLine4":"","city":"Katowice","postcode":"40-519","country":2031,"countryName":"Poland"},"phone":"+48501714019","email":"anna.jakubiec@pratia.com","isBusinessKeyValidated":true,"businessKey":"ORG-100040044"},"personInfo":{"id":1820361,"firstName":"Sebastian","lastName":"Grosicki","telephone":"+48501714019","email":"anna.jakubiec@pratia.com"},"departmentName":"Pratia Onkologia Katowice"}],"applicationStatusCode":"Authorised"},{"id":289065,"mscId":24543,"mscInfo":{"id":24543,"clinicalTrialId":12778,"countryOrganisationId":2024,"reportingStatusCode":"Authorised","fromDate":"2024-06-07","toDate":"2024-06-07","isProposedRms":false,"expressDecision":"unwilling","countryName":"Portugal","organisationInfo":{},"firstDecisionDate":"2024-06-26","trialStatus":"Authorised","trialPeriod":[{"id":29466,"trialStartDate":"2024-08-01","fromDate":"2024-08-05"},{"id":29467,"trialStartDate":"2024-08-01","fromDate":"2024-08-05"}],"trialRecruitmentPeriod":[{"id":38000,"recruitmentStartDate":"2024-08-06","fromDate":"2024-08-08"},{"id":38001,"recruitmentStartDate":"2024-08-06","fromDate":"2024-08-08"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":39018,"trialStartDate":"2024-08-01","fromDate":"2024-08-05"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-08-06"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28140,"mscId":24543,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.267"},{"id":40624,"mscId":24543,"trialStatus":"Authorised","trialStatusDate":"2024-06-26T10:27:53.404"}],"applicationTypeMsc":"1","mscName":"Portugal","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-10","decision":"authorized","decisionDate":"2024-06-26"},"decisionDate":"2024-06-26","recruitmentSubjectCount":38,"trialSites":[{"id":1991042,"organisationAddressInfo":{"id":207027,"organisation":{"id":210641,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Centro Hospitalar Universitario De Lisboa Norte E.P.E.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041769","organisationLocationStatus":"Active"},"address":{"addressId":220154,"oneLine":"Avenida Professor Egas Moniz","addressLine1":"Avenida Professor Egas Moniz","addressLine2":"","addressLine3":"","addressLine4":"","city":"Lisbon","postcode":"1649-035","country":2024,"countryName":"Portugal"},"phone":"+351210405814","email":"daniela.p.alves@ulssm.min-saude.pt","isBusinessKeyValidated":true,"businessKey":"ORG-100041769"},"personInfo":{"id":2211449,"firstName":"Daniela","lastName":"Alves","telephone":"+351210405814","email":"daniela.p.alves@ulssm.min-saude.pt"},"departmentName":"Department of Hematology and Bone Marrow Transplant"},{"id":1991038,"organisationAddressInfo":{"id":207024,"organisation":{"id":210638,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100029371","organisationLocationStatus":"Active"},"address":{"addressId":220151,"oneLine":"Rua Professor Lima Basto","addressLine1":"Rua Professor Lima Basto","addressLine2":"","addressLine3":"","addressLine4":"","city":"Lisbon","postcode":"1099-023","country":2024,"countryName":"Portugal"},"phone":"+351965578024","email":"iacoelho@ipolisboa.min-saude.pt","isBusinessKeyValidated":true,"businessKey":"ORG-100029371"},"personInfo":{"id":2211445,"firstName":"Inês","lastName":"Coelho","telephone":"+351965578024","email":"iacoelho@ipolisboa.min-saude.pt"},"departmentName":"Department of Hematology"},{"id":1991043,"organisationAddressInfo":{"id":207022,"organisation":{"id":210636,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Champalimaud Clinical Centre","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028249","organisationLocationStatus":"Active"},"address":{"addressId":220149,"oneLine":"Avenida Brasilia S/n","addressLine1":"Avenida Brasilia S/n","addressLine2":"","addressLine3":"","addressLine4":"","city":"Lisbon","postcode":"1400-038","country":2024,"countryName":"Portugal"},"phone":"+351210480200","email":"sonia.leocadio@fundacaochampalimaud.pt","isBusinessKeyValidated":true,"businessKey":"ORG-100028249"},"personInfo":{"id":2211450,"firstName":"Sónia","lastName":"Leocádio","telephone":"+351210480200","email":"sonia.leocadio@fundacaochampalimaud.pt"},"departmentName":"Department of Hemato-Oncology"},{"id":1991041,"organisationAddressInfo":{"id":207025,"organisation":{"id":210639,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Centro Hospitalar De Lisboa Ocidental E.P.E.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041786","organisationLocationStatus":"Active"},"address":{"addressId":220152,"oneLine":"Estrada Forte Do Alto Duque","addressLine1":"Estrada Forte Do Alto Duque","addressLine2":"","addressLine3":"","addressLine4":"","city":"Lisbon","postcode":"1449-005","country":2024,"countryName":"Portugal"},"phone":"+351210431730","email":"ccafonso@chlo.min-saude.pt","isBusinessKeyValidated":true,"businessKey":"ORG-100041786"},"personInfo":{"id":2211448,"firstName":"Celina","lastName":"Alfonso","telephone":"+351210431730","email":"ccafonso@chlo.min-saude.pt"},"departmentName":"Department of Clinical Hematology"},{"id":1991040,"organisationAddressInfo":{"id":207028,"organisation":{"id":210642,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100029768","organisationLocationStatus":"Active"},"address":{"addressId":220155,"oneLine":"Rua Conceicao Fernandes S/n","addressLine1":"Rua Conceicao Fernandes S/n","addressLine2":"","addressLine3":"","addressLine4":"","city":"Vila Nova De Gaia","postcode":"4434-502","country":2024,"countryName":"Portugal"},"phone":"+351227865100","email":"marta.soares.nunes@chvng.min-saude.pt","isBusinessKeyValidated":true,"businessKey":"ORG-100029768"},"personInfo":{"id":2211447,"firstName":"Marta","lastName":"Soares","telephone":"+351227865100","email":"marta.soares.nunes@chvng.min-saude.pt"},"departmentName":"Department of Hematology"},{"id":1991039,"organisationAddressInfo":{"id":207020,"organisation":{"id":210634,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100033662","organisationLocationStatus":"Active"},"address":{"addressId":220147,"oneLine":"Rua Dr. Antonio Bernardino De Almeida","addressLine1":"Rua Dr. Antonio Bernardino De Almeida","addressLine2":"","addressLine3":"","addressLine4":"","city":"Porto","postcode":"4200-072","country":2024,"countryName":"Portugal"},"phone":"+351225084000","email":"isabeloliveira@ipoporto.min-saude.pt","isBusinessKeyValidated":true,"businessKey":"ORG-100033662"},"personInfo":{"id":2211446,"firstName":"Isabel","lastName":"Oliveira","telephone":"+351225084000","email":"isabeloliveira@ipoporto.min-saude.pt"},"departmentName":"Department of Hematology and Bone Marrow Transplant"}],"applicationStatusCode":"Authorised"},{"id":289066,"mscId":24548,"mscInfo":{"id":24548,"clinicalTrialId":12778,"countryOrganisationId":2013,"reportingStatusCode":"Authorised","fromDate":"2024-04-11","toDate":"2024-04-11","isProposedRms":false,"expressDecision":"unwilling","countryName":"Germany","organisationInfo":{},"firstDecisionDate":"2024-06-13","trialStatus":"Authorised","trialPeriod":[{"id":25763,"trialStartDate":"2024-07-10","fromDate":"2024-07-10"},{"id":25764,"trialStartDate":"2024-07-10","fromDate":"2024-07-10"}],"trialRecruitmentPeriod":[{"id":54782,"recruitmentStartDate":"2024-11-08","fromDate":"2024-11-11"},{"id":54783,"recruitmentStartDate":"2024-11-08","fromDate":"2024-11-11"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":34097,"trialStartDate":"2024-07-10","fromDate":"2024-07-10"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-11-08"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28138,"mscId":24548,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.18"},{"id":38461,"mscId":24548,"trialStatus":"Authorised","trialStatusDate":"2024-06-13T11:58:16.473"}],"applicationTypeMsc":"1","mscName":"Germany","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-29","decision":"authorized","decisionDate":"2024-06-13"},"decisionDate":"2024-06-13","recruitmentSubjectCount":50,"trialSites":[{"id":1991044,"organisationAddressInfo":{"id":206966,"organisation":{"id":210578,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Universitaetsklinikum Ulm AöR","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100006370","organisationLocationStatus":"Active"},"address":{"addressId":220087,"oneLine":"Albert-Einstein-Allee 23, Eselsberg","addressLine1":"Albert-Einstein-Allee 23","addressLine2":"Eselsberg","addressLine3":"","addressLine4":"","city":"Ulm","postcode":"89081","country":2013,"countryName":"Germany"},"phone":"+497315000","email":"christof.schneider@uniklinik-ulm.de","isBusinessKeyValidated":true,"businessKey":"ORG-100006370"},"personInfo":{"id":2211451,"firstName":"Christof","lastName":"Schneider","telephone":"+497315000","email":"christof.schneider@uniklinik-ulm.de"},"departmentName":"Klinik für Innere Medizin III, Sektion CCL"},{"id":1991049,"organisationAddressInfo":{"id":206977,"organisation":{"id":210590,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Institut Fuer Versorgungsforschung In Der Onkologie GbR","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041075","organisationLocationStatus":"Active"},"address":{"addressId":220098,"oneLine":"Neversstrasse 5, Sued","addressLine1":"Neversstrasse 5","addressLine2":"Sued","addressLine3":"","addressLine4":"","city":"Koblenz","postcode":"56068","country":2013,"countryName":"Germany"},"phone":"+4926192156930","email":"chakupurakal@invo-koblenz.de","isBusinessKeyValidated":true,"businessKey":"ORG-100041075"},"personInfo":{"id":2211456,"firstName":"Geothy","lastName":"Chakupurakal","telephone":"+4926192156930","email":"chakupurakal@invo-koblenz.de"},"departmentName":"Institut Fuer Versorgungsforschung In Der Onkologie GbR"},{"id":1991045,"organisationAddressInfo":{"id":206987,"organisation":{"id":210600,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Dr. Vehling-Kaiser MVZ GmbH","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043415","organisationLocationStatus":"Active"},"address":{"addressId":220108,"oneLine":"Achdorfer Weg 5, Achdorf","addressLine1":"Achdorfer Weg 5","addressLine2":"Achdorf","addressLine3":"","addressLine4":"","city":"Landshut","postcode":"84036","country":2013,"countryName":"Germany"},"phone":"+4987197403449","email":"studien@vehling-kaiser.de","isBusinessKeyValidated":true,"businessKey":"ORG-100043415"},"personInfo":{"id":2211452,"firstName":"Ursula","lastName":"Vehling-Kaiser","telephone":"+4987197403449","email":"studien@vehling-kaiser.de"},"departmentName":"Dr. Vehling-Kaiser MVZ GmbH"},{"id":1991048,"organisationAddressInfo":{"id":206972,"organisation":{"id":210584,"type":"Educational Institution","typeCode":"1","name":"Martin-Luther-Universitaet Halle-Wittenberg","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100028379","organisationLocationStatus":"Active"},"address":{"addressId":220093,"oneLine":"Ernst-Grube-Strasse 40, Kroellwitz","addressLine1":"Ernst-Grube-Strasse 40","addressLine2":"Kroellwitz","addressLine3":"","addressLine4":"","city":"Halle (Saale)","postcode":"06120","country":2013,"countryName":"Germany"},"phone":"+493455572054","email":"innere4@uk-halle.de","isBusinessKeyValidated":true,"businessKey":"ORG-100028379"},"personInfo":{"id":2211455,"firstName":"Kinga","lastName":"Ligeti","telephone":"+493455572054","email":"innere4@uk-halle.de"},"departmentName":"Klinikum der Medizinischen Fakultät"},{"id":1991046,"organisationAddressInfo":{"id":381182,"organisation":{"id":410815,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Kliniken Maria Hilf GmbH Moenchengladbach","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100021396","organisationLocationStatus":"Active"},"address":{"addressId":407267,"oneLine":"Viersener Strasse 450, Windberg","addressLine1":"Viersener Strasse 450","addressLine2":"Windberg","addressLine3":"","addressLine4":"","city":"Moenchengladbach","postcode":"41063","country":2013,"countryName":"Germany"},"phone":"+4921618922201","email":"ullrich.graeven@mariahilf.de","isBusinessKeyValidated":true,"businessKey":"ORG-100021396"},"personInfo":{"id":2211453,"firstName":"Ullrich","lastName":"Graeven","telephone":"+4921618922201","email":"ullrich.graeven@mariahilf.de"},"departmentName":"Kliniken Maria Hilf GmbH Moenchengladbach"},{"id":1991047,"organisationAddressInfo":{"id":207894,"organisation":{"id":211517,"type":"Health care","typeCode":"2","name":"Onkologische Schwerpunktpraxis Kurfuerstendamm","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000002635","organisationLocationStatus":"Active"},"address":{"addressId":221106,"oneLine":"Kurfuerstendamm 65","addressLine1":"Kurfuerstendamm 65","addressLine2":"","addressLine3":"","addressLine4":"","city":"Berlin","postcode":"10707","country":2013,"countryName":"Germany"},"phone":"+4930887742570","email":"studien@onkologie-kurfuerstendamm.de","isBusinessKeyValidated":false,"businessKey":"ORL-000002635"},"personInfo":{"id":2211454,"firstName":"Ingo","lastName":"Schwaner","telephone":"+4930887742570","email":"studien@onkologie-kurfuerstendamm.de"},"departmentName":"Onkologische Schwerpunktpraxis Kurfuerstendamm"}],"applicationStatusCode":"Authorised"},{"id":315394,"mscId":24550,"mscInfo":{"id":24550,"clinicalTrialId":12778,"countryOrganisationId":2014,"reportingStatusCode":"Authorised","fromDate":"2024-04-11","toDate":"2024-04-11","isProposedRms":false,"expressDecision":"unwilling","countryName":"Greece","organisationInfo":{},"firstDecisionDate":"2024-07-22","trialStatus":"Authorised","trialPeriod":[{"id":38657,"trialStartDate":"2024-10-16","fromDate":"2024-10-16"},{"id":38658,"trialStartDate":"2024-10-16","fromDate":"2024-10-16"}],"trialRecruitmentPeriod":[{"id":53674,"recruitmentStartDate":"2024-11-04","fromDate":"2024-11-04"},{"id":53675,"recruitmentStartDate":"2024-11-04","fromDate":"2024-11-04"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":51996,"trialStartDate":"2024-10-16","fromDate":"2024-10-16"},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-11-04"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":28139,"mscId":24550,"trialStatus":"Under evaluation","trialStatusDate":"2024-03-26T11:27:17.223"},{"id":44486,"mscId":24550,"trialStatus":"Authorised","trialStatusDate":"2024-07-22T07:30:20.13"}],"applicationTypeMsc":"1","mscName":"Greece","decision":"authorized","decisionDate":"2024-07-22"},"decisionDate":"2024-07-22","recruitmentSubjectCount":40,"trialSites":[{"id":2202053,"organisationAddressInfo":{"id":212773,"organisation":{"id":216420,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"University General Hospital Of Ioannina","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043604","organisationLocationStatus":"Active"},"address":{"addressId":226394,"oneLine":"Niarchou Stavrou Avenue","addressLine1":"Niarchou Stavrou Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Ioannina","postcode":"455 00","country":2014,"countryName":"Greece"},"phone":"00302651099656","email":"ehatzim@uoi.gr","isBusinessKeyValidated":true,"businessKey":"ORG-100043604"},"personInfo":{"id":2442613,"firstName":"Eleftheria","lastName":"Hatzimichael","telephone":"00302651099656","email":"ehatzim@uoi.gr"},"departmentName":"Hematology Department"},{"id":2202051,"organisationAddressInfo":{"id":636985,"organisation":{"id":674920,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Laiko General Hospital Of Athens","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100023650","organisationLocationStatus":"Active"},"address":{"addressId":689800,"oneLine":"Agiou Thoma (goudi) 17","addressLine1":"Agiou Thoma (goudi) 17","addressLine2":"","addressLine3":"","addressLine4":"","city":"Athens","postcode":"115 27","country":2014,"countryName":"Greece"},"phone":"306976776260","email":"pandiamantopoulos@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100023650"},"personInfo":{"id":2442611,"firstName":"Panagiotis","lastName":"Diamantopoulos","telephone":"306976776260","email":"pandiamantopoulos@gmail.com"},"departmentName":"A' Department of Internal Medicine, University of Athens"},{"id":2202054,"organisationAddressInfo":{"id":212771,"organisation":{"id":216418,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Evangelismos S.A.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100032538","organisationLocationStatus":"Active"},"address":{"addressId":226392,"oneLine":"Ipsiladou 45-47","addressLine1":"Ipsiladou 45-47","addressLine2":"","addressLine3":"","addressLine4":"","city":"Athens","postcode":"106 76","country":2014,"countryName":"Greece"},"phone":"00306977318242","email":"mbouzani@yahoo.com","isBusinessKeyValidated":true,"businessKey":"ORG-100032538"},"personInfo":{"id":2442614,"firstName":"Maria","lastName":"Bouzani","telephone":"00306977318242","email":"mbouzani@yahoo.com"},"departmentName":"Hematology and Lymphoma Department Bone Marrow Transplantation Unit"},{"id":2202052,"organisationAddressInfo":{"id":212772,"organisation":{"id":216419,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"University General Hospital Of Alexandroupoli","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043994","organisationLocationStatus":"Active"},"address":{"addressId":226393,"oneLine":"6th Km Alex Polis Makris, Dragana","addressLine1":"6th Km Alex Polis Makris","addressLine2":"Dragana","addressLine3":"","addressLine4":"","city":"Alexandroupoli","postcode":"681 00","country":2014,"countryName":"Greece"},"phone":"00302551353739","email":"jankots@yahoo.gr","isBusinessKeyValidated":true,"businessKey":"ORG-100043994"},"personInfo":{"id":2442612,"firstName":"Ioannis","lastName":"Kotsianidis","telephone":"00302551353739","email":"jankots@yahoo.gr"},"departmentName":"Hematology Department"}],"applicationStatusCode":"Authorised"}],"applicationInfo":[{"id":20532,"type":"INITIAL","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2024-03-26","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-06-10"},"partIIInfo":[{"id":109599,"mscId":24542,"mscInfo":{"id":24542,"mscName":"Belgium","countryOrganisationId":2002,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-06-28","decision":"authorized","decisionDate":"2024-07-01","reportingStatusCode":"Authorised","countryName":"Belgium","trialStatus":"Authorised","firstDecisionDate":"2024-07-01"},"applicationStatusCode":"Authorised"},{"id":108463,"mscId":24551,"mscInfo":{"id":24551,"mscName":"Poland","countryOrganisationId":2031,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-07-12","decision":"authorized","decisionDate":"2024-07-17","reportingStatusCode":"Authorised","countryName":"Poland","trialStatus":"Authorised","firstDecisionDate":"2024-07-17"},"applicationStatusCode":"Authorised"},{"id":88515,"mscId":24550,"mscInfo":{"id":24550,"mscName":"Greece","countryOrganisationId":2014,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-07-15","decision":"authorized","decisionDate":"2024-07-22","reportingStatusCode":"Authorised","countryName":"Greece","trialStatus":"Authorised","firstDecisionDate":"2024-07-22"},"applicationStatusCode":"Authorised"},{"id":88511,"mscId":24546,"mscInfo":{"id":24546,"mscName":"Spain","countryOrganisationId":2027,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-06-11","decision":"authorized","decisionDate":"2024-06-17","reportingStatusCode":"Authorised","countryName":"Spain","trialStatus":"Authorised","firstDecisionDate":"2024-06-17"},"applicationStatusCode":"Authorised"},{"id":109389,"mscId":24547,"mscInfo":{"id":24547,"mscName":"Sweden","countryOrganisationId":2028,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-07-03","decision":"authorized","decisionDate":"2024-07-08","reportingStatusCode":"Authorised","countryName":"Sweden","trialStatus":"Authorised","firstDecisionDate":"2024-07-08"},"applicationStatusCode":"Authorised"},{"id":88513,"mscId":24548,"mscInfo":{"id":24548,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-06-10","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"},{"id":88509,"mscId":24544,"mscInfo":{"id":24544,"mscName":"Czechia","countryOrganisationId":2008,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-06-07","decision":"authorized","decisionDate":"2024-06-12","reportingStatusCode":"Authorised","countryName":"Czechia","trialStatus":"Authorised","firstDecisionDate":"2024-06-12"},"applicationStatusCode":"Authorised"},{"id":110794,"mscId":24545,"mscInfo":{"id":24545,"mscName":"Denmark","countryOrganisationId":2009,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-06-27","decision":"authorized","decisionDate":"2024-06-27","reportingStatusCode":"Authorised","countryName":"Denmark","trialStatus":"Authorised","firstDecisionDate":"2024-06-27"},"applicationStatusCode":"Authorised"},{"id":107081,"mscId":24543,"mscInfo":{"id":24543,"mscName":"Portugal","countryOrganisationId":2024,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-06-21","decision":"authorized","decisionDate":"2024-06-26","reportingStatusCode":"Authorised","countryName":"Portugal","trialStatus":"Authorised","firstDecisionDate":"2024-06-26"},"applicationStatusCode":"Authorised"},{"id":88514,"mscId":24549,"mscInfo":{"id":24549,"mscName":"Norway","countryOrganisationId":2030,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-06-10","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Norway","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"}],"decisionDate":"2024-06-12","ctMSCsByApplication":[{"id":24542,"mscName":"Belgium","reportingStatusCode":"Authorised"},{"id":24551,"mscName":"Poland","reportingStatusCode":"Authorised"},{"id":24550,"mscName":"Greece","reportingStatusCode":"Authorised"},{"id":24546,"mscName":"Spain","reportingStatusCode":"Authorised"},{"id":24547,"mscName":"Sweden","reportingStatusCode":"Authorised"},{"id":24548,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":24544,"mscName":"Czechia","reportingStatusCode":"Authorised"},{"id":24545,"mscName":"Denmark","reportingStatusCode":"Authorised"},{"id":24543,"mscName":"Portugal","reportingStatusCode":"Authorised"},{"id":24549,"mscName":"Norway","reportingStatusCode":"Authorised"}],"businessKey":"IN-1","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":24867,"applicationId":20532,"mscId":24544,"mscName":"Czechia","decisionDate":"2024-06-12T10:03:10.919","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":88509,"part1Id":35782,"applicationType":"INITIAL","isRMS":false},{"id":25061,"applicationId":20532,"mscId":24548,"mscName":"Germany","decisionDate":"2024-06-13T11:58:18.387","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":88513,"part1Id":35782,"applicationType":"INITIAL","isRMS":false},{"id":25102,"applicationId":20532,"mscId":24549,"mscName":"Norway","decisionDate":"2024-06-13T14:45:59.478","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":88514,"part1Id":35782,"applicationType":"INITIAL","isRMS":false},{"id":25556,"applicationId":20532,"mscId":24546,"mscName":"Spain","decisionDate":"2024-06-17T00:00:00","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":88511,"part1Id":35782,"applicationType":"INITIAL","isRMS":false},{"id":27284,"applicationId":20532,"mscId":24542,"mscName":"Belgium","decisionDate":"2024-07-01T16:12:45.091","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":109599,"part1Id":35782,"applicationType":"INITIAL","isRMS":false},{"id":29455,"applicationId":20532,"mscId":24551,"mscName":"Poland","decisionDate":"2024-07-17T10:28:48.935","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":108463,"part1Id":35782,"applicationType":"INITIAL","isRMS":false},{"id":29979,"applicationId":20532,"mscId":24550,"mscName":"Greece","decisionDate":"2024-07-22T07:30:21.298","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":88515,"part1Id":35782,"applicationType":"INITIAL","isRMS":false},{"id":26841,"applicationId":20532,"mscId":24545,"mscName":"Denmark","decisionDate":"2024-06-27T10:43:34.484","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":110794,"part1Id":35782,"applicationType":"INITIAL","isRMS":true},{"id":26694,"applicationId":20532,"mscId":24543,"mscName":"Portugal","decisionDate":"2024-06-26T10:27:54.392","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":107081,"part1Id":35782,"applicationType":"INITIAL","isRMS":false},{"id":28115,"applicationId":20532,"mscId":24547,"mscName":"Sweden","decisionDate":"2024-07-08T13:28:32.501","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":109389,"part1Id":35782,"applicationType":"INITIAL","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"4c258d76-496e-460e-ab53-fc3df61affd4","productRoleGroupId":108763},{"documentUuid":"2d5c57d3-4e07-4812-a56a-7875410e80dd","productRoleGroupId":108762}]},{"id":32508,"type":"SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2024-11-04","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-02-07"},"partIIInfo":[{"id":157185,"mscId":24546,"mscInfo":{"id":24546,"mscName":"Spain","countryOrganisationId":2027,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-01-17","decision":"authorized","decisionDate":"2024-06-17","reportingStatusCode":"Authorised","countryName":"Spain","trialStatus":"Authorised","firstDecisionDate":"2024-06-17"},"applicationStatusCode":"Authorised"},{"id":157190,"mscId":24551,"mscInfo":{"id":24551,"mscName":"Poland","countryOrganisationId":2031,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-01-20","decision":"authorized","decisionDate":"2024-07-17","reportingStatusCode":"Authorised","countryName":"Poland","trialStatus":"Authorised","firstDecisionDate":"2024-07-17"},"applicationStatusCode":"Authorised"},{"id":172626,"mscId":24548,"mscInfo":{"id":24548,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-01-31","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"},{"id":175198,"mscId":24542,"mscInfo":{"id":24542,"mscName":"Belgium","countryOrganisationId":2002,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-02-07","decision":"authorized","decisionDate":"2024-07-01","reportingStatusCode":"Authorised","countryName":"Belgium","trialStatus":"Authorised","firstDecisionDate":"2024-07-01"},"applicationStatusCode":"Authorised"},{"id":157189,"mscId":24550,"mscInfo":{"id":24550,"mscName":"Greece","countryOrganisationId":2014,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-02-21","decision":"authorized","decisionDate":"2024-07-22","reportingStatusCode":"Authorised","countryName":"Greece","trialStatus":"Authorised","firstDecisionDate":"2024-07-22"},"applicationStatusCode":"Authorised"},{"id":167081,"mscId":24545,"mscInfo":{"id":24545,"mscName":"Denmark","countryOrganisationId":2009,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-01-20","decision":"authorized","decisionDate":"2024-06-27","reportingStatusCode":"Authorised","countryName":"Denmark","trialStatus":"Authorised","firstDecisionDate":"2024-06-27"},"applicationStatusCode":"Authorised"},{"id":165074,"mscId":24543,"mscInfo":{"id":24543,"mscName":"Portugal","countryOrganisationId":2024,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-01-31","decision":"authorized","decisionDate":"2024-06-26","reportingStatusCode":"Authorised","countryName":"Portugal","trialStatus":"Authorised","firstDecisionDate":"2024-06-26"},"applicationStatusCode":"Authorised"},{"id":157188,"mscId":24549,"mscInfo":{"id":24549,"mscName":"Norway","countryOrganisationId":2030,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-01-28","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Norway","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"},{"id":157186,"mscId":24547,"mscInfo":{"id":24547,"mscName":"Sweden","countryOrganisationId":2028,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-01-17","decision":"authorized","decisionDate":"2024-07-08","reportingStatusCode":"Authorised","countryName":"Sweden","trialStatus":"Authorised","firstDecisionDate":"2024-07-08"},"applicationStatusCode":"Authorised"},{"id":157183,"mscId":24544,"mscInfo":{"id":24544,"mscName":"Czechia","countryOrganisationId":2008,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-01-20","decision":"authorized","decisionDate":"2024-06-12","reportingStatusCode":"Authorised","countryName":"Czechia","trialStatus":"Authorised","firstDecisionDate":"2024-06-12"},"applicationStatusCode":"Authorised"}],"decisionDate":"2025-02-07","ctMSCsByApplication":[{"id":24546,"mscName":"Spain","reportingStatusCode":"Authorised"},{"id":24551,"mscName":"Poland","reportingStatusCode":"Authorised"},{"id":24548,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":24542,"mscName":"Belgium","reportingStatusCode":"Authorised"},{"id":24550,"mscName":"Greece","reportingStatusCode":"Authorised"},{"id":24545,"mscName":"Denmark","reportingStatusCode":"Authorised"},{"id":24543,"mscName":"Portugal","reportingStatusCode":"Authorised"},{"id":24549,"mscName":"Norway","reportingStatusCode":"Authorised"},{"id":24547,"mscName":"Sweden","reportingStatusCode":"Authorised"},{"id":24544,"mscName":"Czechia","reportingStatusCode":"Authorised"}],"businessKey":"SM-1","modScope":"PART_I_AND_PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":57075,"applicationId":32508,"mscId":24544,"mscName":"Czechia","decisionDate":"2025-02-10T12:47:55.622","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":157183,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":56838,"applicationId":32508,"mscId":24545,"mscName":"Denmark","decisionDate":"2025-02-07T11:24:59.665","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":167081,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":true},{"id":57324,"applicationId":32508,"mscId":24551,"mscName":"Poland","decisionDate":"2025-02-11T11:14:17.007","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":157190,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":57078,"applicationId":32508,"mscId":24548,"mscName":"Germany","decisionDate":"2025-02-10T12:58:35.46","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":172626,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":56953,"applicationId":32508,"mscId":24546,"mscName":"Spain","decisionDate":"2025-02-07T17:59:05.676","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":157185,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":57654,"applicationId":32508,"mscId":24543,"mscName":"Portugal","decisionDate":"2025-02-12T15:47:59.867","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":165074,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":57084,"applicationId":32508,"mscId":24547,"mscName":"Sweden","decisionDate":"2025-02-10T13:09:14.432","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":157186,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":59202,"applicationId":32508,"mscId":24550,"mscName":"Greece","decisionDate":"2025-02-24T14:06:45.453","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":157189,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":57032,"applicationId":32508,"mscId":24542,"mscName":"Belgium","decisionDate":"2025-02-10T11:24:31.114","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":175198,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":56805,"applicationId":32508,"mscId":24549,"mscName":"Norway","decisionDate":"2025-02-07T09:28:11.909","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":157188,"part1Id":71553,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"4c258d76-496e-460e-ab53-fc3df61affd4","productRoleGroupId":223895},{"documentUuid":"2d5c57d3-4e07-4812-a56a-7875410e80dd","productRoleGroupId":223894}]},{"id":49106,"type":"NON SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2025-02-24","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-02-07"},"partIIInfo":[{"id":184480,"mscId":24551,"mscInfo":{"id":24551,"mscName":"Poland","countryOrganisationId":2031,"decision":"authorized","decisionDate":"2024-07-17","reportingStatusCode":"Authorised","countryName":"Poland","trialStatus":"Authorised","firstDecisionDate":"2024-07-17"},"applicationStatusCode":"Authorised"}],"decisionDate":"2025-02-24","ctMSCsByApplication":[{"id":24551,"mscName":"Poland","reportingStatusCode":"Authorised"}],"businessKey":"NSM-1","modScope":"PART_I_AND_PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":59252,"applicationId":49106,"mscId":24551,"mscName":"Poland","decisionDate":"2025-02-24T17:01:23.419","decision":"authorized","eventType":"decision","part2Id":184480,"part1Id":75702,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"4c258d76-496e-460e-ab53-fc3df61affd4","productRoleGroupId":236453},{"documentUuid":"2d5c57d3-4e07-4812-a56a-7875410e80dd","productRoleGroupId":236455}]},{"id":49488,"type":"SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2025-03-10","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-06-16"},"partIIInfo":[{"id":192590,"mscId":24550,"mscInfo":{"id":24550,"mscName":"Greece","countryOrganisationId":2014,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-04-15","decision":"authorized","decisionDate":"2024-07-22","reportingStatusCode":"Authorised","countryName":"Greece","trialStatus":"Authorised","firstDecisionDate":"2024-07-22"},"applicationStatusCode":"Authorised"},{"id":192588,"mscId":24548,"mscInfo":{"id":24548,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-05-12","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"},{"id":204855,"mscId":24543,"mscInfo":{"id":24543,"mscName":"Portugal","countryOrganisationId":2024,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-05-09","decision":"authorized","decisionDate":"2024-06-26","reportingStatusCode":"Authorised","countryName":"Portugal","trialStatus":"Authorised","firstDecisionDate":"2024-06-26"},"applicationStatusCode":"Authorised"},{"id":192589,"mscId":24549,"mscInfo":{"id":24549,"mscName":"Norway","countryOrganisationId":2030,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-04-24","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Norway","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"}],"decisionDate":"2025-06-16","ctMSCsByApplication":[{"id":24550,"mscName":"Greece","reportingStatusCode":"Authorised"},{"id":24548,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":24543,"mscName":"Portugal","reportingStatusCode":"Authorised"},{"id":24549,"mscName":"Norway","reportingStatusCode":"Authorised"}],"businessKey":"SM-2","modScope":"PART_I_AND_PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":76257,"applicationId":49488,"mscId":24544,"mscName":"Czechia","decisionDate":"2025-06-17T10:21:57.409","decision":"authorized","eventType":"decision","part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":76329,"applicationId":49488,"mscId":24546,"mscName":"Spain","decisionDate":"2025-06-17T14:03:44.11","decision":"authorized","eventType":"decision","part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":77153,"applicationId":49488,"mscId":24547,"mscName":"Sweden","decisionDate":"2025-06-23T15:59:06.413","decision":"authorized","eventType":"decision","part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":76262,"applicationId":49488,"mscId":24548,"mscName":"Germany","decisionDate":"2025-06-17T10:47:19.21","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":192588,"part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":77071,"applicationId":49488,"mscId":24551,"mscName":"Poland","decisionDate":"2025-06-23T12:46:35.873","decision":"authorized","eventType":"decision","part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":76154,"applicationId":49488,"mscId":24549,"mscName":"Norway","decisionDate":"2025-06-16T15:09:38.052","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":192589,"part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":76344,"applicationId":49488,"mscId":24543,"mscName":"Portugal","decisionDate":"2025-06-17T14:55:27.675","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":204855,"part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":76428,"applicationId":49488,"mscId":24542,"mscName":"Belgium","decisionDate":"2025-06-18T09:57:57.873","decision":"authorized","eventType":"decision","part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":76042,"applicationId":49488,"mscId":24545,"mscName":"Denmark","decisionDate":"2025-06-16T10:54:37.728","decision":"authorized","eventType":"decision","part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":true},{"id":76299,"applicationId":49488,"mscId":24550,"mscName":"Greece","decisionDate":"2025-06-17T12:49:32.692","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":192590,"part1Id":85351,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"4c258d76-496e-460e-ab53-fc3df61affd4","productRoleGroupId":265802},{"documentUuid":"5e09a101-5e13-4ebc-89ef-409f1865402c","productRoleGroupId":265801}]},{"id":58529,"type":"NON SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2025-06-23","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-06-16"},"partIIInfo":[{"id":219096,"mscId":24551,"mscInfo":{"id":24551,"mscName":"Poland","countryOrganisationId":2031,"decision":"authorized","decisionDate":"2024-07-17","reportingStatusCode":"Authorised","countryName":"Poland","trialStatus":"Authorised","firstDecisionDate":"2024-07-17"},"applicationStatusCode":"Authorised"}],"decisionDate":"2025-06-23","ctMSCsByApplication":[{"id":24551,"mscName":"Poland","reportingStatusCode":"Authorised"}],"businessKey":"NSM-2","modScope":"PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":77187,"applicationId":58529,"mscId":24551,"mscName":"Poland","decisionDate":"2025-06-23T19:06:03.962","decision":"authorized","eventType":"decision","part2Id":219096,"part1Id":90338,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"4c258d76-496e-460e-ab53-fc3df61affd4","productRoleGroupId":280984},{"documentUuid":"5e09a101-5e13-4ebc-89ef-409f1865402c","productRoleGroupId":280985}]},{"id":65022,"type":"SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2025-10-29","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-02-03"},"partIIInfo":[{"id":241011,"mscId":24542,"mscInfo":{"id":24542,"mscName":"Belgium","countryOrganisationId":2002,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-01-29","decision":"authorized","decisionDate":"2024-07-01","reportingStatusCode":"Authorised","countryName":"Belgium","trialStatus":"Authorised","firstDecisionDate":"2024-07-01"},"applicationStatusCode":"Authorised"},{"id":241017,"mscId":24548,"mscInfo":{"id":24548,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-01-08","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"},{"id":241019,"mscId":24549,"mscInfo":{"id":24549,"mscName":"Norway","countryOrganisationId":2030,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-11","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Norway","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"},{"id":241018,"mscId":24550,"mscInfo":{"id":24550,"mscName":"Greece","countryOrganisationId":2014,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-18","decision":"authorized","decisionDate":"2024-07-22","reportingStatusCode":"Authorised","countryName":"Greece","trialStatus":"Authorised","firstDecisionDate":"2024-07-22"},"applicationStatusCode":"Authorised"},{"id":241014,"mscId":24545,"mscInfo":{"id":24545,"mscName":"Denmark","countryOrganisationId":2009,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-11-27","decision":"authorized","decisionDate":"2024-06-27","reportingStatusCode":"Authorised","countryName":"Denmark","trialStatus":"Authorised","firstDecisionDate":"2024-06-27"},"applicationStatusCode":"Authorised"},{"id":241016,"mscId":24547,"mscInfo":{"id":24547,"mscName":"Sweden","countryOrganisationId":2028,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-01","decision":"authorized","decisionDate":"2024-07-08","reportingStatusCode":"Authorised","countryName":"Sweden","trialStatus":"Authorised","firstDecisionDate":"2024-07-08"},"applicationStatusCode":"Authorised"},{"id":273077,"mscId":24544,"mscInfo":{"id":24544,"mscName":"Czechia","countryOrganisationId":2008,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-02-09","decision":"authorized","decisionDate":"2024-06-12","reportingStatusCode":"Authorised","countryName":"Czechia","trialStatus":"Authorised","firstDecisionDate":"2024-06-12"},"applicationStatusCode":"Authorised"},{"id":241015,"mscId":24546,"mscInfo":{"id":24546,"mscName":"Spain","countryOrganisationId":2027,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-01-12","decision":"authorized","decisionDate":"2024-06-17","reportingStatusCode":"Authorised","countryName":"Spain","trialStatus":"Authorised","firstDecisionDate":"2024-06-17"},"applicationStatusCode":"Authorised"},{"id":241012,"mscId":24543,"mscInfo":{"id":24543,"mscName":"Portugal","countryOrganisationId":2024,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2025-12-12","decision":"authorized","decisionDate":"2024-06-26","reportingStatusCode":"Authorised","countryName":"Portugal","trialStatus":"Authorised","firstDecisionDate":"2024-06-26"},"applicationStatusCode":"Authorised"},{"id":241020,"mscId":24551,"mscInfo":{"id":24551,"mscName":"Poland","countryOrganisationId":2031,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-01-09","decision":"authorized","decisionDate":"2024-07-17","reportingStatusCode":"Authorised","countryName":"Poland","trialStatus":"Authorised","firstDecisionDate":"2024-07-17"},"applicationStatusCode":"Authorised"}],"decisionDate":"2026-02-03","ctMSCsByApplication":[{"id":24542,"mscName":"Belgium","reportingStatusCode":"Authorised"},{"id":24548,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":24549,"mscName":"Norway","reportingStatusCode":"Authorised"},{"id":24550,"mscName":"Greece","reportingStatusCode":"Authorised"},{"id":24545,"mscName":"Denmark","reportingStatusCode":"Authorised"},{"id":24547,"mscName":"Sweden","reportingStatusCode":"Authorised"},{"id":24544,"mscName":"Czechia","reportingStatusCode":"Authorised"},{"id":24546,"mscName":"Spain","reportingStatusCode":"Authorised"},{"id":24543,"mscName":"Portugal","reportingStatusCode":"Authorised"},{"id":24551,"mscName":"Poland","reportingStatusCode":"Authorised"}],"businessKey":"SM-3","modScope":"PART_I_AND_PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":108295,"applicationId":65022,"mscId":24550,"mscName":"Greece","decisionDate":"2026-02-05T13:17:41.498","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241018,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":108510,"applicationId":65022,"mscId":24546,"mscName":"Spain","decisionDate":"2026-02-06T14:05:27.52","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241015,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":108652,"applicationId":65022,"mscId":24551,"mscName":"Poland","decisionDate":"2026-02-08T22:22:45.729","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241020,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":108300,"applicationId":65022,"mscId":24549,"mscName":"Norway","decisionDate":"2026-02-05T13:22:48.543","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241019,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":108092,"applicationId":65022,"mscId":24548,"mscName":"Germany","decisionDate":"2026-02-04T10:42:41.144","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241017,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":108720,"applicationId":65022,"mscId":24544,"mscName":"Czechia","decisionDate":"2026-02-09T10:45:59.739","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":273077,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":107816,"applicationId":65022,"mscId":24545,"mscName":"Denmark","decisionDate":"2026-02-03T08:24:07.556","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241014,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":true},{"id":107939,"applicationId":65022,"mscId":24547,"mscName":"Sweden","decisionDate":"2026-02-03T13:44:17.386","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241016,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":108269,"applicationId":65022,"mscId":24542,"mscName":"Belgium","decisionDate":"2026-02-05T11:44:57.106","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241011,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":108452,"applicationId":65022,"mscId":24543,"mscName":"Portugal","decisionDate":"2026-02-06T11:10:40.913","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":241012,"part1Id":100302,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"5e09a101-5e13-4ebc-89ef-409f1865402c","productRoleGroupId":312258},{"documentUuid":"4c258d76-496e-460e-ab53-fc3df61affd4","productRoleGroupId":312256}]},{"id":77143,"type":"SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2026-03-02","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-28"},"partIIInfo":[{"id":289065,"mscId":24543,"mscInfo":{"id":24543,"mscName":"Portugal","countryOrganisationId":2024,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-10","decision":"authorized","decisionDate":"2024-06-26","reportingStatusCode":"Authorised","countryName":"Portugal","trialStatus":"Authorised","firstDecisionDate":"2024-06-26"},"applicationStatusCode":"Authorised"},{"id":289066,"mscId":24548,"mscInfo":{"id":24548,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-29","decision":"authorized","decisionDate":"2024-06-13","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2024-06-13"},"applicationStatusCode":"Authorised"},{"id":289067,"mscId":24550,"mscInfo":{"id":24550,"mscName":"Greece","countryOrganisationId":2014,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-03","decision":"authorized","decisionDate":"2024-07-22","reportingStatusCode":"Authorised","countryName":"Greece","trialStatus":"Authorised","firstDecisionDate":"2024-07-22"},"applicationStatusCode":"Authorised"}],"decisionDate":"2026-04-28","ctMSCsByApplication":[{"id":24543,"mscName":"Portugal","reportingStatusCode":"Authorised"},{"id":24548,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":24550,"mscName":"Greece","reportingStatusCode":"Authorised"}],"businessKey":"SM-4","modScope":"PART_I_AND_PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":121317,"applicationId":77143,"mscId":24545,"mscName":"Denmark","decisionDate":"2026-04-28T09:10:04.979","decision":"authorized","eventType":"decision","part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":true},{"id":121633,"applicationId":77143,"mscId":24550,"mscName":"Greece","decisionDate":"2026-04-29T11:28:37.941","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":289067,"part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":121928,"applicationId":77143,"mscId":24551,"mscName":"Poland","decisionDate":"2026-04-30T14:42:24.396","decision":"authorized","eventType":"decision","part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":122084,"applicationId":77143,"mscId":24548,"mscName":"Germany","decisionDate":"2026-05-04T09:47:52.681","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":289066,"part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":121690,"applicationId":77143,"mscId":24547,"mscName":"Sweden","decisionDate":"2026-04-29T12:31:36.911","decision":"authorized","eventType":"decision","part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":121866,"applicationId":77143,"mscId":24549,"mscName":"Norway","decisionDate":"2026-04-30T13:18:41.7","decision":"authorized","eventType":"decision","part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":121626,"applicationId":77143,"mscId":24544,"mscName":"Czechia","decisionDate":"2026-04-29T11:23:48.395","decision":"authorized","eventType":"decision","part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":121725,"applicationId":77143,"mscId":24542,"mscName":"Belgium","decisionDate":"2026-04-29T14:46:58.649","decision":"authorized","eventType":"decision","part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":122068,"applicationId":77143,"mscId":24546,"mscName":"Spain","decisionDate":"2026-05-04T07:54:19.031","decision":"authorized","eventType":"decision","part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false},{"id":122284,"applicationId":77143,"mscId":24543,"mscName":"Portugal","decisionDate":"2026-05-04T15:40:26.306","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":289065,"part1Id":122016,"applicationType":"SUBSTANTIAL MODIFICATION","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"d066c537-dfd2-4971-b475-662f618c78d3","productRoleGroupId":378105},{"documentUuid":"c7f69218-1c36-4ca0-891b-9064d20e6321","productRoleGroupId":378107}]},{"id":87604,"type":"NON SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2026-06-18","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-28"},"partIIInfo":[{"id":315394,"mscId":24550,"mscInfo":{"id":24550,"mscName":"Greece","countryOrganisationId":2014,"decision":"authorized","decisionDate":"2024-07-22","reportingStatusCode":"Authorised","countryName":"Greece","trialStatus":"Authorised","firstDecisionDate":"2024-07-22"},"applicationStatusCode":"Authorised"}],"decisionDate":"2026-06-18","ctMSCsByApplication":[{"id":24550,"mscName":"Greece","reportingStatusCode":"Authorised"}],"businessKey":"NSM-3","modScope":"PART_II","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":129117,"applicationId":87604,"mscId":24550,"mscName":"Greece","decisionDate":"2026-06-18T08:34:06.998","decision":"authorized","eventType":"decision","part2Id":315394,"part1Id":133778,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"d066c537-dfd2-4971-b475-662f618c78d3","productRoleGroupId":413954},{"documentUuid":"c7f69218-1c36-4ca0-891b-9064d20e6321","productRoleGroupId":413955}]},{"id":88378,"type":"NON SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2022-501697-19-01","trialStatus":"Authorised","submissionDate":"2026-07-08","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-28"},"partIIInfo":[],"decisionDate":"2026-07-08","ctMSCsByApplication":[{"id":24542,"mscName":"Belgium","reportingStatusCode":"Authorised"},{"id":24549,"mscName":"Norway","reportingStatusCode":"Authorised"},{"id":24545,"mscName":"Denmark","reportingStatusCode":"Authorised"},{"id":24547,"mscName":"Sweden","reportingStatusCode":"Authorised"},{"id":24544,"mscName":"Czechia","reportingStatusCode":"Authorised"},{"id":24546,"mscName":"Spain","reportingStatusCode":"Authorised"},{"id":24551,"mscName":"Poland","reportingStatusCode":"Authorised"},{"id":24543,"mscName":"Portugal","reportingStatusCode":"Authorised"},{"id":24548,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":24550,"mscName":"Greece","reportingStatusCode":"Authorised"}],"businessKey":"NSM-4","modScope":"PART_I","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":131941,"applicationId":88378,"mscId":24542,"mscName":"Belgium","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":131941,"applicationId":88378,"mscId":24549,"mscName":"Norway","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":131941,"applicationId":88378,"mscId":24545,"mscName":"Denmark","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":true},{"id":131941,"applicationId":88378,"mscId":24547,"mscName":"Sweden","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":131941,"applicationId":88378,"mscId":24544,"mscName":"Czechia","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":131941,"applicationId":88378,"mscId":24546,"mscName":"Spain","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":131941,"applicationId":88378,"mscId":24551,"mscName":"Poland","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":131941,"applicationId":88378,"mscId":24543,"mscName":"Portugal","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":131941,"applicationId":88378,"mscId":24548,"mscName":"Germany","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":131941,"applicationId":88378,"mscId":24550,"mscName":"Greece","decisionDate":"2026-07-08T09:02:35.186","decision":"authorized","eventType":"decision","part1Id":134878,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false}],"productRoleGroupDocument":[{"documentUuid":"d066c537-dfd2-4971-b475-662f618c78d3","productRoleGroupId":417305},{"documentUuid":"c7f69218-1c36-4ca0-891b-9064d20e6321","productRoleGroupId":417306}]}],"trialGlobalEnd":[],"memberStatesConcerned":[{"mscName":"Czechia","mscId":24544,"firstDecisionDate":"2024-06-12T10:03:10.919","lastDecisionDate":"2026-04-29T11:23:48.395","mscPublicStatusCode":4},{"mscName":"Germany","mscId":24548,"firstDecisionDate":"2024-06-13T11:58:18.387","lastDecisionDate":"2026-05-04T09:47:52.681","mscPublicStatusCode":4},{"mscName":"Norway","mscId":24549,"firstDecisionDate":"2024-06-13T14:45:59.478","lastDecisionDate":"2026-04-30T13:18:41.7","mscPublicStatusCode":4},{"mscName":"Spain","mscId":24546,"firstDecisionDate":"2024-06-17T00:00:00","lastDecisionDate":"2026-05-04T07:54:19.031","mscPublicStatusCode":4},{"mscName":"Belgium","mscId":24542,"firstDecisionDate":"2024-07-01T16:12:45.091","lastDecisionDate":"2026-04-29T14:46:58.649","mscPublicStatusCode":4},{"mscName":"Poland","mscId":24551,"firstDecisionDate":"2024-07-17T10:28:48.935","lastDecisionDate":"2026-04-30T14:42:24.396","mscPublicStatusCode":4},{"mscName":"Greece","mscId":24550,"firstDecisionDate":"2024-07-22T07:30:21.298","lastDecisionDate":"2026-06-18T08:34:06.998","mscPublicStatusCode":4},{"mscName":"Denmark","mscId":24545,"firstDecisionDate":"2024-06-27T10:43:34.484","lastDecisionDate":"2026-04-28T09:10:04.979","mscPublicStatusCode":4},{"mscName":"Portugal","mscId":24543,"firstDecisionDate":"2024-06-26T10:27:54.392","lastDecisionDate":"2026-05-04T15:40:26.306","mscPublicStatusCode":4},{"mscName":"Sweden","mscId":24547,"firstDecisionDate":"2024-07-08T13:28:32.501","lastDecisionDate":"2026-04-29T12:31:36.911","mscPublicStatusCode":4}],"eudraCt":{"isTransitioned":false}},"events":{"temporaryHaltList":[],"trialEvents":[{"mscId":24542,"mscName":"Belgium","events":[{"notificationType":"START_OF_TRIAL","date":"2024-08-28"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-09-12"}]},{"mscId":24543,"mscName":"Portugal","events":[{"notificationType":"START_OF_TRIAL","date":"2024-08-01"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-08-06"}]},{"mscId":24544,"mscName":"Czechia","events":[{"notificationType":"START_OF_TRIAL","date":"2024-07-30"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-08-08"}]},{"mscId":24545,"mscName":"Denmark","events":[{"notificationType":"START_OF_TRIAL","date":"2024-08-28"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-10-16"}]},{"mscId":24546,"mscName":"Spain","events":[{"notificationType":"START_OF_TRIAL","date":"2024-07-08"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-07-24"}]},{"mscId":24547,"mscName":"Sweden","events":[{"notificationType":"START_OF_TRIAL","date":"2024-10-16"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-10-21"}]},{"mscId":24548,"mscName":"Germany","events":[{"notificationType":"START_OF_TRIAL","date":"2024-07-10"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-11-08"}]},{"mscId":24549,"mscName":"Norway","events":[{"notificationType":"START_OF_TRIAL","date":"2024-06-18"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-08-19"}]},{"mscId":24550,"mscName":"Greece","events":[{"notificationType":"START_OF_TRIAL","date":"2024-10-16"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-11-04"}]},{"mscId":24551,"mscName":"Poland","events":[{"notificationType":"START_OF_TRIAL","date":"2024-08-20"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-08-22"}]}],"unexpectedEvents":[],"seriousBreaches":[],"urgentSafetyMeasures":[]},"results":{},"documents":[{"title":"K1_Recruitment Arrangements and IC Procedure_BEL_EN_for pub","uuid":"0f683957-8e12-4924-b077-2d627053012c","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"11MAR2024","systemVersion":"1"},{"title":"K2_Recruitment Doc Master Tissue Brochure_BEL_EN_for pub","uuid":"3e3647ff-efe3-4a32-940f-19484d2c99fa","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"00.1","systemVersion":"1"},{"title":"K2_Recruitment Doc Master Tissue Brochure_BEL_FR_for pub","uuid":"0863d840-344f-4b0d-8e2e-b628cb8b45c6","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"00.1","systemVersion":"1"},{"title":"K2_Recruitment Doc Master Tissue Brochure_BEL_NL_for pub","uuid":"6b40e533-0e76-4794-a4ca-528774787e0d","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"00.1","systemVersion":"1"},{"title":"K2_Recruitment Doc Patient Brochure_BEL_EN_for pub","uuid":"5912b41f-377a-461b-a18f-2b1e8253ade8","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"00.1","systemVersion":"1"},{"title":"K2_Recruitment Doc Patient Brochure_BEL_FR_for pub","uuid":"5b88ebf5-df2b-44d2-87e2-d707656cbb31","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"00.1","systemVersion":"1"},{"title":"K2_Recruitment Doc Patient Brochure_BEL_NL_for pub","uuid":"b69c083c-bdf2-4054-8cc8-a40887213cf1","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"00.1","systemVersion":"1"},{"title":"K2_Recruitment Doc Patient Visit Guide_BEL_EN_for pub","uuid":"7d6dc391-150b-4c3a-8474-e196ede7cf1f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"02.1","systemVersion":"2"},{"title":"K2_Recruitment Doc Patient Visit Guide_BEL_NL_for pub","uuid":"66def833-fe81-4fd5-9df7-993edb442319","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"02.1","systemVersion":"2"},{"title":"K2_Recruitment Doc Patient Visit Guide_BEL_FR_for pub","uuid":"7f06634b-44c9-459c-8d11-8d54d518f142","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"02.1","systemVersion":"2"},{"title":"L1_ICF_FBR consent_BEL_EN_for pub","uuid":"6184b4dc-34b1-460d-83ee-2c46d5495aff","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0-00R","systemVersion":"2"},{"title":"L1_ICF_FBR consent_BEL_FR_for pub","uuid":"215f0d59-af04-4c5d-a5f5-33e024b7b391","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0-00R","systemVersion":"2"},{"title":"L1_ICF_FBR consent_BEL_NL_for pub","uuid":"2d0aef4d-f1d6-4d31-b3bf-62d45dda1974","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0-00R","systemVersion":"2"},{"title":"L1_ICF_Main consent_BEL_EN_SM03_for pub","uuid":"a66e9917-da56-4364-8814-af36589985d7","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"AM01v1.01R","systemVersion":"4"},{"title":"L1_ICF_Main consent_BEL_FR_SM03_for pub","uuid":"a3018079-5b95-4159-b583-c041a377fa1d","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"AM01v1.01R","systemVersion":"4"},{"title":"L1_ICF_Main consent_BEL_NL_SM03_for pub","uuid":"8e0d5787-0be2-474e-a063-ceae33ed87b7","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"AM01v1.01R","systemVersion":"4"},{"title":"L1_ICF_Optional_Greenphire adults_BEL_FR_for pub","uuid":"d79bb9c4-09ea-4656-9bac-6d69c15eaa16","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0.01R","systemVersion":"2"},{"title":"L1_ICF_Optional_addendum_progression consent_BEL_FR_for pub","uuid":"704235f9-4dda-4c6e-ade3-979264671ef6","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0.00R","systemVersion":"1"},{"title":"L1_ICF_Optional_Greenphire adults_BEL_NL_for pub","uuid":"5d21df73-146a-4879-bbfa-4c2171923fd1","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0.01R","systemVersion":"2"},{"title":"L1_ICF_Optional_addendum_progression consent_BEL_NL_for pub","uuid":"cbffa28c-6e07-4abd-a15b-7aaefd086558","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0.00R","systemVersion":"1"},{"title":"L1_ICF_Optional_Greenphire adults_BEL_EN_for pub","uuid":"6d4ee82d-1b5b-4a0f-83c8-ec024b894f0d","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0.01R","systemVersion":"2"},{"title":"L1_ICF_Optional_addendum_progression consent_BEL_EN_for pub","uuid":"82db2fac-7c4f-4243-b87a-353ca930636b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0.00R","systemVersion":"1"},{"title":"L1_ICF_Optional_pregnancy follow-up_BEL_NL_for pub","uuid":"3e12461b-abdb-455d-96e9-2ec63cd63dff","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0-00","systemVersion":"2"},{"title":"L1_ICF_Optional_trial at a glance_BEL_EN_for pub","uuid":"1bfb2cdd-7e5a-4cd7-b57b-7d71317f5dbf","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"04Sep2023","systemVersion":"1"},{"title":"L1_ICF_Optional_pregnancy follow-up_BEL_EN_for pub","uuid":"51444609-d159-4781-8426-5752ee244987","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0-00","systemVersion":"2"},{"title":"L1_ICF_Optional_pregnancy follow-up_BEL_FR_for pub","uuid":"fcb86238-1203-4329-b7cd-bbd0570106da","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"0-00","systemVersion":"2"},{"title":"L1_ICF_Optional_trial at a glance_BEL_FR_for pub","uuid":"9b9ac602-527d-45fb-aa92-3929bc55aad2","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"04Sep2023","systemVersion":"1"},{"title":"L1_ICF_Optional_trial at a glance_BEL_NL_for pub","uuid":"d00c7d6f-3350-4dfe-9995-5fe032ee0c42","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":36,"fileType":"PDF","associatedEntityId":241011,"manualVersion":"04Sep2023","systemVersion":"1"},{"title":"K2_Recruitment Doc Brochure_NOR_NN_for pub","uuid":"a0cf46ae-8947-4841-9d8e-8ddf4686f5f2","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":26,"fileType":"PDF","associatedEntityId":241019,"manualVersion":"1.0","systemVersion":"1"},{"title":"K1_Recruitment Arrangements and ICF Procedure_NOR_EN_for pub","uuid":"445b1682-863e-4b77-a1c8-f5d23e91cfde","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241019,"manualVersion":"1.00","systemVersion":"1"},{"title":"L1_ICF_FBR consent_NOR_NN_for pub","uuid":"36b7c7f1-1677-4dd4-9a9f-50767b7b7380","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":26,"fileType":"PDF","associatedEntityId":241019,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_Optional_addendum_progression consent_NOR_NN_for pub","uuid":"2b157232-eb6e-48a3-a5b2-310998c7a93b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":26,"fileType":"PDF","associatedEntityId":241019,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_Main consent_NOR_NN_SM03_for pub","uuid":"36dceee0-68a6-4a92-8000-ba79fd3f47a6","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":26,"fileType":"PDF","associatedEntityId":241019,"manualVersion":"AM01v1.01","systemVersion":"3"},{"title":"K1_Recruitment Arrangements and IC Procedure_DNK_EN_for pub","uuid":"44d48a83-2844-4f5e-af2d-69db15d910d1","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":241014,"manualVersion":"01","systemVersion":"3"},{"title":"K2_Recruitment Doc Brochure_DNK_DA_for pub","uuid":"dcf3b091-0b54-4d6f-a29b-d87913749b7c","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":3,"fileType":"PDF","associatedEntityId":241014,"manualVersion":"001","systemVersion":"1"},{"title":"L1_ICF_Optional_addendum_progression consent_DNK_DA_for pub","uuid":"485fe344-8c24-4ff3-a2b1-cde3606a7377","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":3,"fileType":"PDF","associatedEntityId":241014,"manualVersion":"0.00","systemVersion":"1"},{"title":"L1_ICF_Optional_right not to know_DNK_DA_for pub","uuid":"c1d1bcc5-a2d2-4f1b-abc3-e95b38cbb5ac","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":3,"fileType":"PDF","associatedEntityId":241014,"manualVersion":"0.00","systemVersion":"1"},{"title":"L1_ICF_FBR consent_DNK_DA_for pub","uuid":"9eed2510-e710-4df4-9ec3-5fce728cf57c","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":3,"fileType":"PDF","associatedEntityId":241014,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_Main consent_DNK_DA_SM03_for pub","uuid":"0e05d570-9cee-436a-a952-4ae4eca06dac","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":3,"fileType":"PDF","associatedEntityId":241014,"manualVersion":"AM01v1.01R","systemVersion":"4"},{"title":"K1_Recruitment Arrangements and IC Procedure_SWE_SV_for pub","uuid":"d41610d5-3ed2-4b35-abaf-f45cdedde4f3","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":24,"fileType":"PDF","associatedEntityId":241016,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment Doc Patient Brochure_SWE_SV_for pub","uuid":"72e37fbe-f8ac-42b4-ae03-3aaf01e36e59","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":24,"fileType":"PDF","associatedEntityId":241016,"manualVersion":"00.1","systemVersion":"1"},{"title":"L1_ICF_FBR consent_SWE_SV_for pub","uuid":"d80e3a38-1374-4e8e-b7c3-b47305c31cc6","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":24,"fileType":"PDF","associatedEntityId":241016,"manualVersion":"00","systemVersion":"2"},{"title":"L1_ICF_Main addendum disease progression_SWE_SV_for pub","uuid":"176637fd-e980-4db4-9f5b-e3d231b21042","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":24,"fileType":"PDF","associatedEntityId":241016,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_Main consent_SWE_SV_SM03_for pub","uuid":"0dde93fb-5e78-48cf-b832-c495e8ae7cb8","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":24,"fileType":"PDF","associatedEntityId":241016,"manualVersion":"AM01v1.01","systemVersion":"4"},{"title":"K1_Recruitment Arrangements and IC Procedure_CZE_CS_for pub","uuid":"e94136c2-7cf2-47f0-b25e-18b9f9674eeb","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":2,"fileType":"PDF","associatedEntityId":273077,"manualVersion":"14Sep2023","systemVersion":"1"},{"title":"L1_ICF_FBR consent_CZE_CS_for pub","uuid":"62eb5ffd-57b0-4063-93ca-bd44a5ebd871","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":2,"fileType":"PDF","associatedEntityId":273077,"manualVersion":"czechv2","systemVersion":"1"},{"title":"L1_ICF_Main consent_CZE_CS_SM03-RFI004_for pub","uuid":"3fd09db8-3461-47bc-ad1f-b2a3367678aa","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":2,"fileType":"PDF","associatedEntityId":273077,"manualVersion":"5R","systemVersion":"4"},{"title":"L1_ICF_Main GDPR_CZE_CS_for pub","uuid":"7fab2ffd-3f19-45f5-84e4-3672431fc97a","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":2,"fileType":"PDF","associatedEntityId":273077,"manualVersion":"3.1","systemVersion":"2"},{"title":"L1_ICF_Optional_addendum_progression consent_CZE_CS_for pub","uuid":"137c0f6a-7138-466d-8b8f-65ec01bbd9dc","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":2,"fileType":"PDF","associatedEntityId":273077,"manualVersion":"00.cz.2","systemVersion":"1"},{"title":"x_L1_Patient ID Card_CZE_CS_for pub","uuid":"66e29757-4f25-4f0c-a224-19e1c737735e","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":2,"fileType":"PDF","associatedEntityId":273077,"manualVersion":"1.0.00.12R","systemVersion":"1"},{"title":"K1_Recruitment Arrangements_ESP_ES_for pub","uuid":"f43b5b46-20bf-4d00-8d8f-dfff6787d390","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":241015,"manualVersion":"08FEB2024R","systemVersion":"1"},{"title":"K2_Recruitment Doc Clinical Trial Brochure_ESP_ES_for pub","uuid":"43a65e7f-efec-460c-b4cd-ac9a06721420","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":241015,"manualVersion":"00","systemVersion":"1"},{"title":"K2_Recruitment Doc Poster_ESP_ES_for pub","uuid":"7e130243-7233-4393-9390-d3cbee7cc8bd","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":241015,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_FBR consent_ESP_ES_SM03_for pub","uuid":"01a584e8-f08f-4d2a-b7f1-9db978d26af2","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":241015,"manualVersion":"00","systemVersion":"2"},{"title":"L1_ICF_Main adult consent_ESP_ES_SM03_for pub","uuid":"de02b035-019c-42a9-a1c9-2326402af8f7","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":241015,"manualVersion":"AM01v1.01R","systemVersion":"3"},{"title":"L1_ICF_Main addendum disease progression_ESP_ES_for pub","uuid":"a86c92d5-c5a0-42ab-81dd-391bcf0157ad","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":241015,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_Optional_pregnancy follow-up_ESP_ES_SM03_for pub","uuid":"1f8ccc3d-5cd2-4f7a-bcfa-84b7b5ff2b8b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":241015,"manualVersion":"00","systemVersion":"1"},{"title":"K1_Recruitment Arrangements and IC Procedure_POL_PL_SM03_for pub","uuid":"f2f6bf54-5cf4-4b68-9fe3-72b9fb3941ac","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":241020,"manualVersion":"2.0","systemVersion":"2"},{"title":"K2_Recruitment Doc Website_POL_PL_SM03_for pub","uuid":"6b11cd66-db45-4dfa-9806-fc5f8d00643c","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":241020,"manualVersion":"10OCT2025","systemVersion":"1"},{"title":"L1_ICF_FBR consent_POL_PL_SM03_for pub","uuid":"005e7558-bcbd-4da7-ae67-902ccd9d7e0e","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":241020,"manualVersion":"00","systemVersion":"2"},{"title":"L1_ICF_Main addendum disease progression_POL_PL_SM03_for pub","uuid":"39e5818c-02b3-4719-be8a-b6c850730891","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":241020,"manualVersion":"00","systemVersion":"2"},{"title":"L1_ICF_Main consent_POL_PL_SM03_for pub","uuid":"8f61a38f-93f1-4fa2-b8ee-a143b356cd64","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":241020,"manualVersion":"AM01v1.01R","systemVersion":"4"},{"title":"K1_Recruitment Arrangements and IC Procedure_PRT_EN_for pub","uuid":"685d895e-111c-4438-a61a-ed3de226aee8","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"2.0","systemVersion":"2"},{"title":"K2_Recruitment Doc Poster_PRT_PT_for pub","uuid":"d0c0724f-68f0-4b5b-b563-caaf0a526590","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"00.1","systemVersion":"2"},{"title":"K2_Recruitment Doc Patient Visit Guide_PRT_PT_for pub","uuid":"978eb243-3b8a-494b-a277-718c32257bd3","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"02.1","systemVersion":"2"},{"title":"L1_ICF_Main addendum disease progression_PRT_PT_for pub","uuid":"be88e92a-55d5-4017-bd67-129db5e9c858","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_Optional_Greenphire adults_PRT_PT_SM03_for pub","uuid":"c70c0cc5-525f-4c9e-baf0-bb8b55a84d95","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"0.00","systemVersion":"2"},{"title":"L1_ICF_Optional_pregnancy follow-up_PRT_PT_for pub","uuid":"f687a2fc-8c60-4b69-a3f0-bc0713229c18","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"v0-00","systemVersion":"2"},{"title":"L1_ICF_Optional_withdrawal_PRT_PT_for pub","uuid":"dc723e32-59ea-4952-8704-af157090859d","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_Genetic consent_PRT_PT_SM04_for pub","uuid":"affde184-5aab-4e85-8c4b-25b6ecc86420","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"AM01v1.01","systemVersion":"2"},{"title":"L1_ICF_Main consent_PRT_PT_SM03_for pub","uuid":"76ca24be-99e5-4f77-b26b-5355ea4a6e02","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"AM01v1.01","systemVersion":"4"},{"title":"L1_ICF_Genetic consent_PRT_EN_SM04_for pub","uuid":"0e8fd9db-b02d-4341-8d1d-969d3cb5c2d2","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"AM01v1.01","systemVersion":"3"},{"title":"L1_ICF_Main consent_PRT_EN_SM03_for pub","uuid":"19e09591-858a-4695-80dc-b1eddf34e977","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"AM01v1.01","systemVersion":"2"},{"title":"L1_ICF_Main consent_PRT_EN__for pub","uuid":"4fd4f647-f115-4a6f-90d1-598ecb50eb65","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"0.01","systemVersion":"1"},{"title":"L1_ICF_Optional_Greenphire adults_PRT_EN_SM03_for pub","uuid":"b9f63ced-b259-43ee-9123-1868488b9be4","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"0.00","systemVersion":"2"},{"title":"L1_ICF_Optional_pregnancy follow-up_PRT_EN_for pub","uuid":"8e2a34b6-7041-4b4a-9ad3-2134636c71dd","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"0.00","systemVersion":"1"},{"title":"L1_ICF_Optional_withdrawal_PRT_EN_for pub","uuid":"ad3ae52e-647e-4dcc-bd7b-d02c7ff470d3","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"0.00","systemVersion":"1"},{"title":"L1_ICF_Main addendum disease progression_PRT_EN_for pub","uuid":"bc2aed5c-d3ca-4b6c-8647-62aeed6f6152","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289065,"manualVersion":"0.00","systemVersion":"1"},{"title":"K2_Recruitment Doc Poster_DEU_DE_for pub","uuid":"15e7b7c9-f660-4e4e-bba9-888d09a800f4","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"00.1","systemVersion":"2"},{"title":"K1_Recruitment Arrangements and IC Procedure_DEU_EN_SM04_for pub","uuid":"234cb2bc-ede4-4072-ad00-e43281af67b2","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"1","systemVersion":"3"},{"title":"K2_Recruitment Doc Master Tissue Brochure_DEU_DE_for pub","uuid":"8e00b13d-9e9c-4d45-87c8-69ecd54fa44d","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"00.1","systemVersion":"2"},{"title":"K2_Recruitment Doc Patient Brochure_DEU_DE_for pub","uuid":"fbe6d40f-fc41-4a9d-94ba-bb7d0e47ad4c","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"00.1","systemVersion":"2"},{"title":"K2_Recruitment Doc Patient Visit Guide_DEU_DE_for pub","uuid":"3d6deb33-f8ba-4945-ad77-cb61cda33a48","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"02.1","systemVersion":"1"},{"title":"K2_Recruitment Doc Recruitment Method_Iuvando_DEU_DE_SM04_for pub","uuid":"d230b849-f4e5-4250-99a7-fc2cbb97a7a4","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"1.0R","systemVersion":"1"},{"title":"L1_ICF_FBR consent_DEU_DE_for pub","uuid":"d2991b2a-4677-4ad4-bcad-78e03c653d1e","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"0.00","systemVersion":"1"},{"title":"L1_ICF_Main addendum disease progression_DEU_DE_for pub","uuid":"4e3ba870-2fe8-4a3b-9694-061ce23c0b99","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"0.00","systemVersion":"1"},{"title":"L1_ICF_Optional_add crossborder_DEU_DE_for pub","uuid":"a9ba5215-ba0c-48d7-8358-1d74c2dfa3f7","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"0.00R","systemVersion":"1"},{"title":"L1_ICF_Main consent_DEU_DE_SM03_for pub","uuid":"1035355d-0161-4d68-9f11-86774812ec54","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":289066,"manualVersion":"AM01v1.01R","systemVersion":"4"},{"title":"K1_Recruitment Arrangements and IC Procedure_GRC_EN_for pub","uuid":"d9e93ff3-c50f-4bab-89d7-729c39e27c0b","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"01","systemVersion":"1"},{"title":"K2_Recruitment Doc Study Card_GRC_EL_for pub","uuid":"a961a5d7-cf25-4a88-9cdb-d9ef0493165f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"001","systemVersion":"1"},{"title":"K2_Recruitment Doc Patient Visit Guide_GRC_EL_for pub","uuid":"14812c73-c037-4321-84c4-eb2155859a52","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"001","systemVersion":"1"},{"title":"K2_Recruitment Doc Advocacy Card_GRC_EL_for pub","uuid":"d56fa3e3-40ad-426f-b3cc-7f3378b481e1","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"001","systemVersion":"1"},{"title":"K2_Recruitment Doc Patient Brochure_GRC_EL_for pub","uuid":"4a96f411-e685-4563-83b4-e9751acb4700","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"00.1","systemVersion":"2"},{"title":"K2_Recruitment Doc Patient Print Ad_GRC_EL_for pub","uuid":"38dec659-2374-42e4-be39-73afd1823018","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"00.1","systemVersion":"1"},{"title":"K2_Recruitment Doc Master Tissue Brochure_GRC_EL_for pub","uuid":"3c718077-c449-4021-b0b9-df29bb32c1a1","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"001","systemVersion":"1"},{"title":"L1_ICF_Main addendum disease progression_GRC_EL_SM03_for pub","uuid":"79caea44-905a-4ca0-ba60-84e6ce3d169f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"0.0","systemVersion":"2"},{"title":"L1_ICF_Optional_Greenphire adults_GRC_EL_SM04_for pub","uuid":"5e1a2bd4-83b9-435c-9448-2f527a2d1f66","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"00","systemVersion":"4"},{"title":"L1_ICF_FBR consent_GRC_EL_for pub","uuid":"ef9f541e-0805-4f68-ab84-34d4f4f51565","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"00","systemVersion":"1"},{"title":"L1_ICF_Main consent adult_GRC_EL_SM04_for pub","uuid":"a82661f9-1438-4978-97b5-c6676c2aec74","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":315394,"manualVersion":"AM01v1.01","systemVersion":"4"},{"title":"D1_Protocol_2022-501697-19_NSM04_for pub","uuid":"b1e999c7-9ff5-4e60-b495-9463f7b66634","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"04R","systemVersion":"3.01"},{"title":"D4_Copyright statement_EN_SM02_for pub","uuid":"34ea2908-3df7-4a53-a6b7-6fb494988692","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"04DEC2024","systemVersion":"3"},{"title":"D1_Protocol_2022-501697-19_GRC_EL_NSM04_for pub","uuid":"c549350a-429b-476c-9270-76d90bde01c3","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"04R","systemVersion":"3.01"},{"title":"D1_PPLS_2022-501697-19 _EN_for pub","uuid":"8345cc97-82c7-4e2b-850f-80e91eb2dba5","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_PPLS_2022-501697-19_SWE_SV_for pub","uuid":"e4490ffc-9de2-4a1d-9260-2df4a8629a29","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":24,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_PPLS_2022-501697-19 _NOR_NN_for pub","uuid":"2c717d5e-3ee2-40dc-adae-b0ab82080b76","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":26,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_PPLS_CZE_CS_2022-501697-19-01_for pub","uuid":"7cc4acb7-77fb-4305-9fc7-6b80b50cf417","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":2,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"2.0","systemVersion":"1"},{"title":"D1_Protocol Scientific Synopsis_2022-501697-19_CZE_CS_SM03_for pub","uuid":"5d3fccda-eaf1-4740-a088-3ed187f3cf62","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":2,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"4R","systemVersion":"3"},{"title":"D1_Protocol Scientific Synopsis_2022-501697-19_PRT_PT_SM03_for pub","uuid":"38925cfe-087b-4de6-9bf6-77ae95af6479","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":20,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"03R","systemVersion":"3"},{"title":"D1_PPLS_2022-501697-19_BEL_NL_for pub","uuid":"812bbff8-7646-47a8-a543-cb250008fbe3","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":18,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_PPLS_2022-501697-19_ESP_ES_for pub","uuid":"d6259ff2-d62b-451c-865a-9f39db45e3ff","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_PPLS_2022-501697-19_GRC_EL_for pub","uuid":"4e92115a-f4b5-45fa-ab64-564f19932746","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_PPLS_2022-501697-19_POL_PL_for pub","uuid":"05c2a8d7-b1b8-494f-aea5-55e5f3a0b3c2","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_PPLS_2022-501697-19_BEL_FR_for pub","uuid":"6bd54f89-e4ea-4a67-a48d-0b20d55173e6","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":33,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_PPLS_2022-501697-19_BEL_DE_for pub","uuid":"139e5d22-658e-4511-bdc6-8403b4eb0558","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":28,"fileType":"PDF","associatedEntityId":134878,"manualVersion":"1.0","systemVersion":"1"},{"title":"E2_SmPC RSI_ACP-196 AstraZeneca UK Limited_SM04_for pub","uuid":"d066c537-dfd2-4971-b475-662f618c78d3","documentType":"19","documentTypeLabel":"Summary of Product Characteristics (SmPC) (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":417305,"manualVersion":"04SEP2025","systemVersion":"3"},{"title":"E2_SmPC RSI_IBRUTINIB Janssen-Cilag Ltd_SM04_for pub","uuid":"c7f69218-1c36-4ca0-891b-9064d20e6321","documentType":"19","documentTypeLabel":"Summary of Product Characteristics (SmPC) (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":417306,"manualVersion":"22AUG2025","systemVersion":"2"}],"trialRegion":"Both","trialRegionCode":3,"correctiveMeasures":[]}