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sonrotoclax (BGB 11417) plus zanubrutinib (BGB-3111) vergeleken met venetoclax plus acalabrutinib bij patiënten met eerder onbehandelde chronische lymfatische leukemie","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911711,"uuid":"1735657a-8bd7-4968-93e5-5678dc36ed64","attributeTranslation":"Eine Studie zur Untersuchung von Sonrotoclax (BGB-11417) plus Zanubrutinib \n(BGB-3111) im Vergleich zu Venetoclax plus Acalabrutinib bei Patienten mit zuvor \nunbehandelter chronisch lymphatischer Leukämie","language":29,"languageDescription":"German (Germany)"},{"id":11911712,"uuid":"1735657a-8bd7-4968-93e5-5678dc36ed64","attributeTranslation":"En studie för att utvärdera sonrotoclax (BGB-11417) i kombination med zanubrutinib (BGB-3111) jämfört med venetoklax i kombination med acalabrutinib hos patienter med tidigare obehandlad kronisk lymfatisk leukemi","language":24,"languageDescription":"Swedish"},{"id":11911714,"uuid":"1735657a-8bd7-4968-93e5-5678dc36ed64","attributeTranslation":"Étude comparant le sonrotoclax (BGB-11417) associé au zanubrutinib (BGB-3111) au vénétoclax associé à l’acalabrutinib chez des patients atteints de leucémie lymphoïde chronique non préalablement traitée","language":10,"languageDescription":"French"}],"shortTitle":"BGB-11417-304","secondaryIdentifyingNumbers":{"nctNumber":{"id":572548,"number":"NCT07277231"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"This is a phase 3 trial","trialCategoryId":130292},"medicalCondition":{"partIMedicalConditions":[{"id":147647,"medicalCondition":"treatment-naive Chronic Lymphocytic Leukemia","medicalConditionTranslations":[{"id":11911467,"uuid":"d92a61ac-7e76-4ad5-beeb-36a6aaa4c4da","attributeTranslation":"eerder onbehandelde chronische lymfatische leukemie","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911463,"uuid":"d92a61ac-7e76-4ad5-beeb-36a6aaa4c4da","attributeTranslation":"Leucemia linfocítica crónica sin tratamiento previo","language":7,"languageDescription":"Spanish"},{"id":11911464,"uuid":"d92a61ac-7e76-4ad5-beeb-36a6aaa4c4da","attributeTranslation":"tidigare obehandlad kronisk lymfatisk leukemi","language":24,"languageDescription":"Swedish"},{"id":11911466,"uuid":"d92a61ac-7e76-4ad5-beeb-36a6aaa4c4da","attributeTranslation":"wcześniej nieleczona przewlekła białaczka limfocytowa","language":19,"languageDescription":"Polish"},{"id":11911465,"uuid":"d92a61ac-7e76-4ad5-beeb-36a6aaa4c4da","attributeTranslation":"Leucémie lymphoïde chronique naïve de traitement","language":10,"languageDescription":"French"}],"isConditionRareDisease":true}],"meddraConditionTerms":[{"termId":100000059764,"version":"28.0","level":"LLT","termName":"B-Lymphocytic CLL (Kiel Classification)","classificationCode":"10003946","organClass":10029104,"active":false}]},"trialObjective":{"trialScopes":[{"code":"3","trialScopeId":428591},{"code":"5","trialScopeId":428590},{"code":"4","trialScopeId":428592}],"mainObjective":"To compare efficacy between Arm A (SZ) vs Arm B (AV), as measured by PFS determined by the Independent Review Committee (IRC) in all enrolled patients.","mainObjectiveTranslations":[{"id":11911708,"uuid":"fc08d2b3-8939-447b-838e-cbea8b83b59e","attributeTranslation":"Porównanie skuteczności pomiędzy Grupą A (SZ) a Grupą B (AV) mierzonej czasem PFS ocenianym przez niezależną komisję weryfikacyjną (ang. independent review committee, IRC) u wszystkich włączonych pacjentów.","language":19,"languageDescription":"Polish"},{"id":11911704,"uuid":"fc08d2b3-8939-447b-838e-cbea8b83b59e","attributeTranslation":"De werkzaamheid vergelijken tussen groep A (SZ) en groep B (AV), gemeten op basis van de PFS zoals bepaald door de onafhankelijke beoordelingscommissie (IRC) onder alle ingeschreven patiënten.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911705,"uuid":"fc08d2b3-8939-447b-838e-cbea8b83b59e","attributeTranslation":"Att jämföra effekten i arm A (SZ) med den i arm B (AV), mätt genom progressionsfri överlevnad (PFS), enligt bedömning av den oberoende granskningskommittén (IRC), hos alla inskrivna patienter.","language":24,"languageDescription":"Swedish"},{"id":11911706,"uuid":"fc08d2b3-8939-447b-838e-cbea8b83b59e","attributeTranslation":"Comparer l’efficacité entre le bras A (SZ) et le bras B (AV), mesurée par la SSP déterminée par le comité de revue indépendant (IRC) chez tous les patients recrutés.","language":10,"languageDescription":"French"},{"id":11911707,"uuid":"fc08d2b3-8939-447b-838e-cbea8b83b59e","attributeTranslation":"Comparar la eficacia entre el grupo A (SZ) frente al grupo B (AV), medida por la supervivencia sin progresión (SSP) determinada por el comité de revisión independiente (CRI) en todos los pacientes incluidos.","language":7,"languageDescription":"Spanish"}],"secondaryObjectives":[{"id":504265,"number":1,"secondaryObjective":"•\tTo compare the rate of undetectable MRD at < 10-4 sensitivity (uMRD4) in both PB and BMA among patients enrolled to Arm A vs Arm B","secondaryObjectiveTranslations":[{"id":11911716,"uuid":"a47fc625-c7e9-4f65-9ebc-9e8ebf65f477","attributeTranslation":"Att jämföra frekvensen av odetekterbar MRD vid känslighet < 10-4 (uMRD4) i både PB och BMA bland patienter inskrivna i arm A jämfört med arm B","language":24,"languageDescription":"Swedish"},{"id":11911715,"uuid":"a47fc625-c7e9-4f65-9ebc-9e8ebf65f477","attributeTranslation":"Porównanie wskaźnika uMRD przy czułości <10-4 (uMRD4) w próbkach PB i BMA u pacjentów włączonych do Grupy A w porównaniu do pacjentów włączonych do Grupy B","language":19,"languageDescription":"Polish"},{"id":11911718,"uuid":"a47fc625-c7e9-4f65-9ebc-9e8ebf65f477","attributeTranslation":"Comparar la tasa de enfermedad residual mínima (ERM) indetectable con una sensibilidad <10-4 (ERMi4) tanto en SP como en AMO entre los pacientes incluidos en el grupo A frente al grupo B","language":7,"languageDescription":"Spanish"},{"id":11911717,"uuid":"a47fc625-c7e9-4f65-9ebc-9e8ebf65f477","attributeTranslation":"Comparer le taux de réponse objective (TRO) déterminé par l’IRC chez les patients à haut risque inclus dans le bras A par rapport au bras B","language":10,"languageDescription":"French"},{"id":11911719,"uuid":"a47fc625-c7e9-4f65-9ebc-9e8ebf65f477","attributeTranslation":"Het percentage niet-detecteerbare MRD bij een sensitiviteit van < 10-4 (uMRD4) in zowel PB als BMA vergelijken tussen patiënten in groep A en groep B.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":504266,"number":2,"secondaryObjective":"•\tTo compare PFS determined by IRC among high-risk patients enrolled to Arm A vs Arm B","secondaryObjectiveTranslations":[{"id":11911721,"uuid":"a6764089-bdbd-4516-b684-4130fcfb52cf","attributeTranslation":"Porównanie czasu PFS określonego przez IRC u pacjentów wysokiego ryzyka włączonych do Grupy A w porównaniu z Grupą B","language":19,"languageDescription":"Polish"},{"id":11911722,"uuid":"a6764089-bdbd-4516-b684-4130fcfb52cf","attributeTranslation":"Comparer la survie globale (SG) chez les patients recrutés dans le bras A par rapport aux patients recrutés dans le bras B","language":10,"languageDescription":"French"},{"id":11911724,"uuid":"a6764089-bdbd-4516-b684-4130fcfb52cf","attributeTranslation":"De door de IRC bepaalde PFS vergelijken tussen hoogrisicopatiënten in groep A en groep B.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911720,"uuid":"a6764089-bdbd-4516-b684-4130fcfb52cf","attributeTranslation":"Comparar la SSP según lo determinado por el CRI entre pacientes de alto riesgo incluidos en el grupo A frente al grupo B.","language":7,"languageDescription":"Spanish"},{"id":11911723,"uuid":"a6764089-bdbd-4516-b684-4130fcfb52cf","attributeTranslation":"Att jämföra PFS fastställd av IRC bland högriskpatienter inskrivna i arm A jämfört med arm B","language":24,"languageDescription":"Swedish"}]},{"id":504267,"number":3,"secondaryObjective":"•\tTo compare overall survival (OS) among patients enrolled to Arm A vs Arm B","secondaryObjectiveTranslations":[{"id":11911728,"uuid":"b73babb7-86d7-4a50-9a6b-9839384dd608","attributeTranslation":"Comparer le taux de réponse objective (TRO) déterminé par l’IRC chez les patients à haut risque inclus dans le bras A par rapport au bras B","language":10,"languageDescription":"French"},{"id":11911729,"uuid":"b73babb7-86d7-4a50-9a6b-9839384dd608","attributeTranslation":"De totale overleving (OS) vergelijken tussen patiënten in groep A en groep B.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911726,"uuid":"b73babb7-86d7-4a50-9a6b-9839384dd608","attributeTranslation":"Att jämföra total överlevnad (OS) bland patienter inskrivna i arm A jämfört med arm B","language":24,"languageDescription":"Swedish"},{"id":11911725,"uuid":"b73babb7-86d7-4a50-9a6b-9839384dd608","attributeTranslation":"Comparar la supervivencia global (SG) entre los pacientes incluidos en el grupo A frente al grupo B.","language":7,"languageDescription":"Spanish"},{"id":11911727,"uuid":"b73babb7-86d7-4a50-9a6b-9839384dd608","attributeTranslation":"Porównanie całkowitego czasu przeżycia (ang. overall survival, OS) u pacjentów włączonych do Grupy A w porównaniu z Grupą B","language":19,"languageDescription":"Polish"}]},{"id":504268,"number":4,"secondaryObjective":"•\tTo compare overall response rate (ORR) among patients enrolled to Arm A vs Arm B determined by IRC","secondaryObjectiveTranslations":[{"id":11911733,"uuid":"799eade4-7ead-4841-83be-e15fa90d0017","attributeTranslation":"Att jämföra total svarsfrekvens (ORR) bland patienter inskrivna i arm A jämfört med arm B enligt bedömning av IRC","language":24,"languageDescription":"Swedish"},{"id":11911730,"uuid":"799eade4-7ead-4841-83be-e15fa90d0017","attributeTranslation":"Porównanie ogólnego odsetka odpowiedzi (ang. overall response rate, ORR) określonego przez IRC u pacjentów włączonych do Grupy A w porównaniu z Grupą B","language":19,"languageDescription":"Polish"},{"id":11911734,"uuid":"799eade4-7ead-4841-83be-e15fa90d0017","attributeTranslation":"Comparer le taux de réponse objective (TRO) déterminé par l’IRC chez les patients à haut risque inclus dans le bras A par rapport au bras B","language":10,"languageDescription":"French"},{"id":11911732,"uuid":"799eade4-7ead-4841-83be-e15fa90d0017","attributeTranslation":"Comparar la tasa de respuesta global (TRG) entre pacientes incluidos en el grupo A frente al grupo B según lo determinado por el CRI.","language":7,"languageDescription":"Spanish"},{"id":11911731,"uuid":"799eade4-7ead-4841-83be-e15fa90d0017","attributeTranslation":"Het door de IRC bepaalde totale responspercentage (ORR) vergelijken tussen patiënten in groep A en groep B.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":504269,"number":5,"secondaryObjective":"•\tTo compare the rate of undetectable MRD at < 10-5 sensitivity (uMRD5) in both PB and BMA among patients enrolled to Arm A vs Arm B","secondaryObjectiveTranslations":[{"id":11911736,"uuid":"7a7fee65-8a04-4aad-bb01-f65fdbfff247","attributeTranslation":"Porównanie wskaźnika uMRD przy czułości <10-5 (uMRD5) w próbkach PB i BMA u pacjentów włączonych do Grupy A w porównaniu do pacjentów włączonych do Grupy B","language":19,"languageDescription":"Polish"},{"id":11911738,"uuid":"7a7fee65-8a04-4aad-bb01-f65fdbfff247","attributeTranslation":"Comparar la tasa de ERM indetectable con una sensibilidad <10-5 (ERMi5) tanto en SP como en AMO entre los pacientes incluidos en el grupo A frente al grupo B","language":7,"languageDescription":"Spanish"},{"id":11911739,"uuid":"7a7fee65-8a04-4aad-bb01-f65fdbfff247","attributeTranslation":"Het percentage niet-detecteerbare MRD bij een sensitiviteit van < 10-5 (uMRD5) in zowel PB als BMA vergelijken tussen patiënten in groep A en groep B.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911735,"uuid":"7a7fee65-8a04-4aad-bb01-f65fdbfff247","attributeTranslation":"Comparer le taux de MRD indétectable à une sensibilité < 10-5 (uMRD5) dans le SP et la PMO chez les patients inclus dans le bras A par rapport au bras B","language":10,"languageDescription":"French"},{"id":11911737,"uuid":"7a7fee65-8a04-4aad-bb01-f65fdbfff247","attributeTranslation":"Att jämföra frekvensen av odetekterbar MRD vid känslighet < 10-5 (uMRD5) i både PB och BMA bland patienter inskrivna i arm A jämfört med arm B","language":24,"languageDescription":"Swedish"}]},{"id":504270,"number":6,"secondaryObjective":"•\tSafety","secondaryObjectiveTranslations":[{"id":11911742,"uuid":"10e3907a-4444-4f88-9461-7ed044e3135e","attributeTranslation":"Seguridad","language":7,"languageDescription":"Spanish"},{"id":11911744,"uuid":"10e3907a-4444-4f88-9461-7ed044e3135e","attributeTranslation":"Bezpieczeństwo","language":19,"languageDescription":"Polish"},{"id":11911740,"uuid":"10e3907a-4444-4f88-9461-7ed044e3135e","attributeTranslation":"Säkerhet","language":24,"languageDescription":"Swedish"},{"id":11911741,"uuid":"10e3907a-4444-4f88-9461-7ed044e3135e","attributeTranslation":"Veiligheid","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911743,"uuid":"10e3907a-4444-4f88-9461-7ed044e3135e","attributeTranslation":"Sécurité","language":10,"languageDescription":"French"}]},{"id":504271,"number":7,"secondaryObjective":"•\tTo further compare the outcomes of Arms A and Arm B","secondaryObjectiveTranslations":[{"id":11911746,"uuid":"bd10856c-8f0f-49fc-86d2-0a7639bde538","attributeTranslation":"Att ytterligare jämföra utfallen i arm A och arm B","language":24,"languageDescription":"Swedish"},{"id":11911745,"uuid":"bd10856c-8f0f-49fc-86d2-0a7639bde538","attributeTranslation":"Comparar en mayor profundidad los resultados de los grupos A y grupo B.","language":7,"languageDescription":"Spanish"},{"id":11911748,"uuid":"bd10856c-8f0f-49fc-86d2-0a7639bde538","attributeTranslation":"Comparer de manière plus approfondie les résultats du bras A et du bras B","language":10,"languageDescription":"French"},{"id":11911749,"uuid":"bd10856c-8f0f-49fc-86d2-0a7639bde538","attributeTranslation":"De uitkomsten van groep A en groep B verder vergelijken","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911747,"uuid":"bd10856c-8f0f-49fc-86d2-0a7639bde538","attributeTranslation":"Dalsze porównania wyników w Grupie A i Grupie B","language":19,"languageDescription":"Polish"}]},{"id":504272,"number":8,"secondaryObjective":"•\tTo evaluate the patient-reported disease and treatment specific symptoms and functioning in patients receiving SZ compared with patients receiving AV; and compare changes in the key patient-reported outcomes (PRO) endpoints in patients receiving SZ vs AV","secondaryObjectiveTranslations":[{"id":11911752,"uuid":"d9dc7e05-af8b-4004-b97f-b93f7bfb4e4e","attributeTranslation":"Evaluar los síntomas y el funcionamiento relacionados con la enfermedad y el tratamiento, según lo informado por los pacientes que reciben SZ en comparación con los que reciben AV; y comparar los cambios en los criterios de valoración principales de resultados comunicados por los pacientes (RCP) en pacientes que reciben SZ frente a AV.","language":7,"languageDescription":"Spanish"},{"id":11911750,"uuid":"d9dc7e05-af8b-4004-b97f-b93f7bfb4e4e","attributeTranslation":"Att utvärdera patientrapporterade sjukdoms- och behandlingsspecifika symtom och funktion hos patienter som får SZ jämfört med patienter som får AV, samt att jämföra förändringar i de viktigaste patientrapporterade utfallsmåtten (PRO) hos patienter som får SZ jämfört med de som får AV.","language":24,"languageDescription":"Swedish"},{"id":11911751,"uuid":"d9dc7e05-af8b-4004-b97f-b93f7bfb4e4e","attributeTranslation":"Évaluer les symptômes spécifiques de la maladie et du traitement rapportés par les patients ainsi que le fonctionnement chez les patients recevant SZ par rapport aux patients recevant AV ; et comparer les changements dans les principaux critères de jugement des résultats rapportés par les patients (PRO) chez les patients recevant SZ par rapport aux patients recevant AV","language":10,"languageDescription":"French"},{"id":11911754,"uuid":"d9dc7e05-af8b-4004-b97f-b93f7bfb4e4e","attributeTranslation":"De door de patiënt gemelde specifieke symptomen door de ziekte en behandeling en het functioneren van patiënten die SZ krijgen vergelijken met die van patiënten die AV krijgen, en veranderingen in de belangrijkste eindpunten met betrekking tot door de patiënt gemelde uitkomsten (PRO) vergelijken tussen patiënten die SZ en AV krijgen.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911753,"uuid":"d9dc7e05-af8b-4004-b97f-b93f7bfb4e4e","attributeTranslation":"Ocena zgłaszanych przez pacjentów objawów związanych z chorobą i leczeniem oraz funkcjonowania u pacjentów otrzymujących skojarzenie SZ w porównaniu z pacjentami otrzymującymi skojarzenie AV; oraz porównanie zmian w kluczowych punktach końcowych wyników zgłaszanych przez pacjentów (ang. patient-reported outcomes, PRO) u pacjentów otrzymujących skojarzenie SZ w porównaniu z pacjentami otrzymującymi skojarzenie AV","language":19,"languageDescription":"Polish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":959778,"number":1,"principalInclusionCriteria":"1.\tConfirmed diagnosis of CLL that meets the iwCLL criteria: a.\tClonal, either kappa or lambda light chain restricted, monoclonal B cells that are co-expressing CD5 surface antigen together with B-cell antigens CD19, CD20, and CD23. b.\tClonal B-cells ≥ 5 x 109/L in peripheral blood at any timepoint since the initial diagnosis.  c.\tAbsence of t(11:14) in FISH","principalInclusionCriteriaTranslations":[{"id":11911650,"uuid":"591e0de0-9495-46d6-936f-62ee685c786f","attributeTranslation":"1. Diagnostic confirmé de LLC répondant aux critères de l’iwCLL : a. Cellules B monoclonales avec chaîne légère kappa ou lambda d’intensité faible, qui co-expriment l’antigène de surface pour CD5 et expriment les antigènes des lymphocytes B CD19, CD20 et CD23. b. Cellules B clonales ≥ 5 x 109/L dans le sang périphérique à tout moment depuis le diagnostic initial. c. Absence de t(11:14) dans l’hybridation in situ en fluorescence (FISH)","language":10,"languageDescription":"French"},{"id":11911653,"uuid":"591e0de0-9495-46d6-936f-62ee685c786f","attributeTranslation":"1. Bekräftad diagnos av KLL som uppfyller iwCLL-kriterierna: a.\tKlonala, antingen kappa- eller lambda-lättkedjebegränsade, monoklonala B-celler som samuttrycker CD5-ytantigen tillsammans med B-cellsantigenerna CD19, CD20 och CD23. b.\tKlonala B-celler ≥ 5 x 109/l i perifert blod vid någon tidpunkt sedan den initiala diagnosen. c.\tFrånvaro av t(11:14) i FISH.","language":24,"languageDescription":"Swedish"},{"id":11911652,"uuid":"591e0de0-9495-46d6-936f-62ee685c786f","attributeTranslation":"1. Diagnóstico confirmado de LLC que cumple los criterios de iwCLL [27]:\na. Células B clónicas, restringidas a cadenas ligeras kappa o lambda, que expresan en conjunto el antígeno de superficie CD5 junto con los antígenos de células B CD19, CD20 y CD23.\nb. Células B clónicas ≥5 x 109/l en sangre periférica en cualquier momento desde el diagnóstico inicial. \nc. Ausencia de t(11;14) en FISH.","language":7,"languageDescription":"Spanish"},{"id":11911651,"uuid":"591e0de0-9495-46d6-936f-62ee685c786f","attributeTranslation":"1. Potwierdzone rozpoznanie przewlekłej białaczki limfocytowej (ang. Chronic Lymphocytic Leukemia, CLL), która spełnia kryteria iwCLL: a.\tKlonalne, ograniczone do lekkich łańcuchów łańcucha kappa albo lambda, monoklonalne limfocyty B charakteryzujące się koekspresją antygenu powierzchniowego CD5 oraz antygenów limfocytów B CD19, CD20 i CD23. b.\tObecność klonalnych limfocytów B we krwi obwodowej w ilości ≥ 5 x 109/l w dowolnym momencie od początkowego rozpoznania. c.\tBrak translokacji t(11:14) w badaniu FISH.","language":19,"languageDescription":"Polish"},{"id":11911649,"uuid":"591e0de0-9495-46d6-936f-62ee685c786f","attributeTranslation":"1. Bevestigde diagnose van CLL die voldoet aan de iwCLL-criteria: a.\tKlonale, met restrictie van kappa of lambda lichte ketens, monoklonale B-cellen die CD5-oppervlakteantigeen tot expressie brengen samen met B-celantigenen CD19, CD20 en CD23. b.\tKlonale B-cellen ≥ 5 x 109/l in perifeer bloed op enig moment sinds de aanvankelijke diagnose. c.\tAfwezigheid van t(11:14) in FISH","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":959779,"number":10,"principalInclusionCriteria":"10.\tFemale patients of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for the following, whichever comes last:   7 days after the last dose of sonrotoclax,  \t≥ 30 days after the last dose of zanubrutinib or venetoclax, \t≥ 7 days after the last dose of acalabrutinib. Female patients must also have a negative serum pregnancy test result ≤ 7 days before enrollment and randomization, as well as a negative highly sensitive urine or serum pregnancy test result within 24 hours prior to Day 1 of Cycle 1 dosing.","principalInclusionCriteriaTranslations":[{"id":11911654,"uuid":"683a6dd4-e383-4c96-9b9a-8c3e99090bb7","attributeTranslation":"10.\tVrouwelijke patiënten die zwanger kunnen worden, moeten bereid zijn om een zeer effectieve anticonceptiemethode te gebruiken en af te zien van eiceldonatie gedurende de gehele duur van het onderzoek en tot de volgende tijdpunten, waarvan het laatste tijdpunt van toepassing is: \t7 dagen na de laatste dosis sonrotoclax, \t≥ 30 dagen na de laatste dosis zanubrutinib of venetoclax, \t≥ 7 dagen na de laatste dosis acalabrutinib. Daarnaast moeten vrouwelijke patiënten een negatieve serumzwangerschapstest hebben ≤ 7 dagen vóór inschrijving en randomisatie, evenals een negatieve zeer gevoelige urine- of serumzwangerschapstest binnen 24 uur vóór dosering op dag 1 van cyclus 1.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911658,"uuid":"683a6dd4-e383-4c96-9b9a-8c3e99090bb7","attributeTranslation":"10.\tPacjentki zdolne do zajścia w ciążę muszą wyrazić zgodę na stosowanie wysoce skutecznej metody antykoncepcji i nieoddawanie komórek jajowych przez cały okres trwania badania oraz przez następujące okresy, w zależności od tego, co nastąpi najpóźniej:  \t7 dni od podania ostatniej dawki sonrotoklaksu, \t≥ 30 dni od podania ostatniej dawki zanubrutynibu lub wenetoklaksu, \t≥ 7 dni od podania ostatniej dawki akalabrutynibu. Wynik testu ciążowego z surowicy pacjentek musi również być ujemny ≤ 7 dni przed rekrutacją i randomizacją, jak również wynik testu ciążowego o wysokiej czułości z moczu lub surowicy musi być ujemny w ciągu 24 godzin przed podaniem dawki w 1. dniu cyklu 1.","language":19,"languageDescription":"Polish"},{"id":11911655,"uuid":"683a6dd4-e383-4c96-9b9a-8c3e99090bb7","attributeTranslation":"10.\tKvinnliga patienter i fertil ålder måste vara villiga att använda en mycket effektiv preventivmetod och avstå från äggdonation under studiens varaktighet och under följande, beroende på vilket som inträffar sist: \t≥ 7 dagar efter den sista dosen av sonrotoklax, \t≥ 30 dagar efter den sista dosen av zanubrutinib eller venetoklax, \t≥ 7 dagar efter den sista dosen av akalabrutinib. Kvinnliga patienter måste också uppvisa ett negativt resultat på ett graviditetstest i serum ≤ 7 dagar före rekrytering och randomisering, samt ett negativt resultat på ett mycket känsligt graviditetstest i urin eller serum inom 24 timmar före dag 1 av doseringscykel 1.","language":24,"languageDescription":"Swedish"},{"id":11911657,"uuid":"683a6dd4-e383-4c96-9b9a-8c3e99090bb7","attributeTranslation":"10. Las pacientes de sexo femenino con capacidad gestante deben estar dispuestas a utilizar un método anticonceptivo altamente eficaz y abstenerse de la donación de óvulos (Nota: Cuando se seleccionan anticonceptivos hormonales orales, se requiere otro método de barrera) mientras dure el estudio y lo siguiente, lo que ocurra más tarde: \n7 días después de la última dosis de sonrotoclax, \n≥30 días después de la última dosis de zanubrutinib o venetoclax,\n≥7 días después de la última dosis de acalabrutinib.\nLas pacientes de sexo femenino también deben tener un resultado negativo de la prueba de embarazo en suero ≤7 días antes de la inclusión y la aleatorización, así como un resultado negativo de la prueba de embarazo en orina o suero de alta sensibilidad dentro de las 24 horas previas al día 1 de la dosis del ciclo 1.","language":7,"languageDescription":"Spanish"},{"id":11911656,"uuid":"683a6dd4-e383-4c96-9b9a-8c3e99090bb7","attributeTranslation":"10. Les patientes en âge de procréer doivent être disposées à utiliser une méthode de contraception hautement efficace et à s’abstenir de faire un don d’ovules pendant toute la durée de l’étude et pendant les périodes suivantes, selon la période la plus longue : - 7 jours après la dernière dose de sonrotoclax, - ≥ 30 jours après la dernière dose de zanubrutinib ou de vénétoclax, - ≥ 7 jours après la dernière dose d’acalabrutinib. (Remarque : les médicaments expérimentaux peuvent provoquer des nausées, des vomissements et de la diarrhée ; les contraceptifs hormonaux oraux ne peuvent pas être considérés comme hautement efficaces dans ce contexte). Les patientes doivent également avoir un résultat de test de grossesse sérique négatif ≤ 7 jours avant l’inscription et la randomisation, ainsi qu’un résultat de test de grossesse sérique ou urinaire hautement sensible négatif dans les 24 heures précédant l’administration au jour 1 du cycle 1.","language":10,"languageDescription":"French"}]},{"id":959780,"number":11,"principalInclusionCriteria":"11.\tNonsterile male patients must be willing to use a highly effective method of birth control and must refrain from donating sperm for the duration of the study and for the following, whichever comes last:  \t7 days after the last dose of sonrotoclax, or zanubrutinib  \t≥ 30 days after the last dose of venetoclax, \t≥ 7 days after the last dose of acalabrutinib A sterile male is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Males with known “low sperm counts” (consistent with “subfertility”) are not to be considered sterile for purposes of this study.","principalInclusionCriteriaTranslations":[{"id":11911660,"uuid":"b4de8236-c4c4-4afe-b467-8f90db2e8c49","attributeTranslation":"11. Los pacientes varones no estériles deben estar dispuestos a utilizar un método anticonceptivo altamente eficaz y deben abstenerse de donar esperma mientras dure el estudio y lo siguiente, lo que ocurra más tarde: \n≥7 días después de la última dosis de sonrotoclax  o zanubrutinib, \n≥30 días después de la última dosis de venetoclax,\n≥7 días después de la última dosis de acalabrutinib.\nSe define como varón estéril a aquella persona en la que se ha demostrado previamente la azoospermia en un examen de muestra de semen como prueba definitiva de infertilidad.\nLos varones con un recuento bajo de espermatozoides conocido (compatible con subfertilidad) no se considerarán estériles para los fines de este estudio.","language":7,"languageDescription":"Spanish"},{"id":11911661,"uuid":"b4de8236-c4c4-4afe-b467-8f90db2e8c49","attributeTranslation":"11.\tNiet-steriele mannelijke patiënten moeten bereid zijn een zeer effectieve anticonceptiemethode te gebruiken en moeten afzien van spermadonatie gedurende de duur van het onderzoek en tot de volgende tijdpunten, waarvan het laatste tijdpunt van toepassing is: \t7 dagen na de laatste dosis sonrotoclax of zanubrutinib, \t≥ 30 dagen na de laatste dosis venetoclax, \t≥ 7 dagen na de laatste dosis acalabrutinib. Een steriele man wordt gedefinieerd als een man bij wie eerder azoöspermie is aangetoond bij onderzoek van een semenmonster als definitief bewijs van onvruchtbaarheid. Mannen met een bekende \"lage spermatelling\" (overeenkomend met \"subfertiliteit\") worden voor dit onderzoek niet als onvruchtbaar beschouwd.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911662,"uuid":"b4de8236-c4c4-4afe-b467-8f90db2e8c49","attributeTranslation":"11.\tPłodni pacjenci muszą wyrazić zgodę na stosowanie wysoce skutecznej metody antykoncepcji i nieoddawanie nasienia przez cały okres trwania badania oraz przez następujące okresy, w zależności od tego, co nastąpi najpóźniej:  \t 7 dni od podania ostatniej dawki sonrotoklaksu lub zanubrutynibu, \t≥ 30 dni od podania ostatniej dawki wenetoklaksu, \t≥ 7 dni od podania ostatniej dawki akalabrutynibu. Za mężczyznę bezpłodnego uważa się mężczyznę, u którego w badaniu nasienia stwierdzono wcześniej azoospermię, co stanowi ostateczny dowód niepłodności. Mężczyźni ze stwierdzoną „niską liczbą plemników” (co jest oznaką „obniżonej płodności”) nie mogą być uznawani za bezpłodnych na potrzeby tego badania.","language":19,"languageDescription":"Polish"},{"id":11911659,"uuid":"b4de8236-c4c4-4afe-b467-8f90db2e8c49","attributeTranslation":"11. Les patients masculins non stériles doivent être disposés à utiliser une méthode de contraception hautement efficace et doivent s’abstenir d’effectuer des dons de sperme pendant toute la durée de l’étude et pendant les périodes suivantes, selon la dernière éventualité : - 7 jours après la dernière dose de sonrotoclax ou de zanubrutinib, - ≥ 30 jours après la dernière dose de vénétoclax, - ≥ 7 jours après la dernière dose d’acalabrutinib. Un homme stérile est défini comme un homme pour lequel une azoospermie a été précédemment démontrée lors d’un examen d’échantillon de sperme comme preuve définitive d’infertilité. Les hommes ayant une numération des spermatozoïdes faible connue (correspondant à une « subfertilité ») ne doivent pas être considérés comme stériles aux fins de cette étude.","language":10,"languageDescription":"French"},{"id":11911663,"uuid":"b4de8236-c4c4-4afe-b467-8f90db2e8c49","attributeTranslation":"11.\tEj sterila manliga patienter måste vara villiga att använda en mycket effektiv preventivmetod och måste avstå från spermiedonation under studiens varaktighet och under följande, beroende på vilket som inträffar sist: \t≥ 7 dagar efter den sista dosen av sonrotoklax, \t≥ 30 dagar efter den sista dosen av zanubrutinib eller venetoklax, \t≥ 7 dagar efter den sista dosen av akalabrutinib. En steril man definieras som en man för vilken azoospermi tidigare har påvisats i ett spermaprov som definitivt bevis på infertilitet. Män med känt ”lågt spermieantal” (vilket överensstämmer med ”subfertilitet”) ska inte betraktas som sterila för denna studies syften.","language":24,"languageDescription":"Swedish"}]},{"id":959781,"number":2,"principalInclusionCriteria":"2.\tCLL requiring treatment as defined by ≥ 1 of the following criteria: a.\tEvidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia. Hemoglobin concentrations < 10 g/dL or platelet counts < 100 x 109 cells/L are generally regarded as indications for treatment. b.\tMassive (ie, ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly. c.\tMassive (ie, ≥ 10 cm in longest diameter [LDi]), progressive, or symptomatic lymphadenopathy. d.\tProgressive lymphocytosis with an increase of ≥ 50% over a 2-month period, or lymphocyte doubling time (LDT) < 6 months.  NOTE: LDT can be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months; patients with initial blood lymphocyte counts < 30 x 109 cells/L may require a longer observation period to determine the LDT. Factors contributing to lymphocytosis other than CLL (eg, infections and steroid administration) should be excluded. e.\tSymptomatic or functional extranodal involvement (eg, skin, kidney, lung, and spine). f.\tDisease-related symptoms as defined by any of the following: \tUnintentional weight loss ≥ 10% within the previous 6 months. \tFevers ≥ 100.5°F or ≥ 38.0°C for 2 or more weeks without evidence of infection. \tNight sweats for ≥ 1 month without evidence of infection. \tSignificant fatigue (ie, ECOG Performance Status score of 2 or worse; cannot work or unable to perform usual activities). NOTE: Patients with significant fatigue cannot have an ECOG score of 0.","principalInclusionCriteriaTranslations":[{"id":11911668,"uuid":"1f6587f4-da87-4664-b9a4-eafe44c1a43b","attributeTranslation":"2. CLL wymagająca leczenia zgodnie z ≥ 1 z następujących kryteriów: a.\tObjawy postępującej niewydolności szpiku kostnego objawiającej się rozwojem lub pogorszeniem niedokrwistości i (lub) małopłytkowości. Ogólnie za wskazania do leczenia uznaje się stężenie hemoglobiny < 10 g/dl lub liczbę płytek krwi < 100 x 109 komórek/l. b.\tMasywna (tj. ≥ 6 cm poniżej lewego łuku żebrowego), postępująca lub objawowa splenomegalia. c.\tMasywna (tj. najdłuższa średnica [LDi] ≥ 10 cm), postępująca lub objawowa limfadenopatia. d.\tPostępująca limfocytoza ze wzrostem o ≥ 50% w ciągu 2 miesięcy lub czas podwojenia liczby limfocytów (LDT) < 6 miesięcy. UWAGA: LDT można uzyskać poprzez ekstrapolację wyniku analizy metodą regresji liniowej bezwzględnej liczby limfocytów uzyskanej w odstępach co 2 tygodnie w okresie obserwacji trwającym od 2 do 3 miesięcy; u pacjentów z początkową liczbą limfocytów we krwi < 30 x 109 komórek/l w celu określenia LDT może być konieczny dłuższy okres obserwacji. Należy wykluczyć czynniki przyczyniające się do limfocytozy inne niż CLL (np. zakażenia i podawanie steroidów). e.\tObjawowe lub czynnościowe zajęcie pozawęzłowe (np. skóry, nerek, płuc i kręgosłupa). f.\tObjawy związane z chorobą zdefiniowane jako dowolny z poniższych: \tNiezamierzona utrata masy ciała ≥ 10% w ciągu ostatnich 6 miesięcy. \tGorączka ≥ 100,5°F lub ≥ 38,0°C przez 2 lub więcej tygodni bez objawów zakażenia. \tNocne poty trwające ≥ 1 miesiąc bez objawów zakażenia. \tZnaczne zmęczenie (tj. status sprawności w skali ECOG równy 2 lub gorszy; niezdolność do pracy lub wykonywania zwykłych czynności). UWAGA: Pacjenci ze znacznym zmęczeniem nie mogą mieć wyniku ECOG równego 0.","language":19,"languageDescription":"Polish"},{"id":11911667,"uuid":"1f6587f4-da87-4664-b9a4-eafe44c1a43b","attributeTranslation":"2. KLL som kräver behandling enligt definitionen av ≥ 1 av följande kriterier: a.\tTecken på progressiv benmärgssvikt uttryckt genom uppkomst av, eller försämring av, anemi och/eller trombocytopeni. Hemoglobinkoncentrationer < 10 g/dl eller trombocytantal < 100 x 109 celler/l anses generellt som indikationer för behandling. b.\tMassiv (dvs. ≥ 6 cm under vänster revbenskant), progressiv eller symtomatisk mjältförstoring. c.\tMassiv (dvs. ≥ 10 cm i längsta diameter [LDi]), progressiv eller symtomatisk lymfadenopati. d.\tProgressiv lymfocytos med en ökning på ≥ 50 % under en 2-månadersperiod, eller lymfocytfördubblingstid (LDT) < 6 månader. OBS! LDT kan erhållas genom linjär regressionsextrapolering av absoluta lymfocytantal erhållna med intervaller på 2 veckor under en observationsperiod på 2 till 3 månader. Patienter med initiala blodlymfocytantal < 30 x 109 celler/l kan behöva en längre observationsperiod för att bestämma LDT. Faktorer som bidrar till lymfocytos, förutom KLL (t.ex. infektioner och steroidadministrering), ska uteslutas. e.\tSymtomatiskt eller funktionellt extranodalt engagemang (t.ex. hud, njure, lunga och ryggrad). f.\tSjukdomsrelaterade symtom enligt något av följande: \tOavsiktlig viktminskning ≥ 10 % under de senaste 6 månaderna.  \tFeber ≥ 38,0 °C (eller 100,5 °F) i 2 veckor eller mer utan tecken på infektion. \tNattliga svettningar i ≥ 1 månad utan tecken på infektion. \tBetydande utmattning (dvs. poäng på ECOG-skattningsskala 2 eller sämre; kan inte arbeta eller oförmögen att utföra vanliga aktiviteter). OBS! Patienter med betydande utmattning kan inte ha en ECOG-poäng på 0.","language":24,"languageDescription":"Swedish"},{"id":11911665,"uuid":"1f6587f4-da87-4664-b9a4-eafe44c1a43b","attributeTranslation":"2. LLC nécessitant un traitement tel que défini par ≥ 1 des critères suivants : a. Preuve d’une aplasie médullaire progressive se manifestant par l’apparition ou l’aggravation d’une anémie et/ou d’une thrombocytopénie. Des concentrations d’hémoglobine < 10 g/dL ou une numération plaquettaire < 100 x 109 cellules/L sont généralement considérées comme des indications de traitement. b. Splénomégalie massive (c’est-à-dire ≥ 6 cm sous l’arc costal gauche), progressive ou symptomatique. c. Lymphadénopathie massive (c’est-à-dire ≥ 10 cm de diamètre le plus long [LDi]), progressive ou symptomatique. d. Lymphocytose progressive avec une augmentation ≥ 50 % sur une période de 2 mois, ou temps de doublement des lymphocytes (TDL) < 6 mois. REMARQUE : Le TDL peut être obtenu par extrapolation par régression linéaire de la numération absolue des lymphocytes obtenue à des intervalles de 2 semaines sur une période d’observation de 2 à 3 mois ; les patients avec une numération initiale de lymphocytes sanguins < 30 x 109 cellules/L peuvent nécessiter une période d’observation plus longue pour déterminer le TDL. Les facteurs contribuant à la lymphocytose autres que la LLC (par exemple, les infections et l’administration de stéroïdes) doivent être exclus. e. Atteinte extraganglionnaire symptomatique ou fonctionnelle (par exemple, peau, rein, poumon et colonne vertébrale). f. Symptômes liés à la maladie tels que définis par l’un des éléments suivants : - Perte de poids non intentionnelle ≥ 10 % au cours des 6 derniers mois. - Fièvre ≥ 100,5 °F ou ≥ 38,0 °C pendant 2 semaines ou plus sans signe d’infection. - Sueurs nocturnes depuis ≥ 1 mois sans signe d’infection. - Fatigue importante (c.-à-d. indice de performance de l’ECOG de 2 ou moins ; incapacité à travailler ou à effectuer les activités habituelles). REMARQUE : les patients présentant une fatigue importante ne peuvent pas avoir un score ECOG de 0.","language":10,"languageDescription":"French"},{"id":11911666,"uuid":"1f6587f4-da87-4664-b9a4-eafe44c1a43b","attributeTranslation":"2. LLC que requiere tratamiento según se define por ≥1 de los siguientes criterios:\na.\tPruebas de insuficiencia progresiva de la médula ósea manifestada por el desarrollo o el empeoramiento de anemia y/o trombocitopenia. Las concentraciones de hemoglobina <10 g/dl o recuentos de plaquetas <100 × 109 células/l generalmente se consideran indicaciones de tratamiento.\nb.\tEsplenomegalia masiva (es decir, ≥6 cm por debajo del reborde costal izquierdo), progresiva o sintomática.\nc.\tLinfadenopatía masiva (es decir, ≥10 cm en el diámetro más largo [LDi]), progresiva o sintomática.\nd.\tLinfocitosis progresiva con un aumento de ≥50 % durante un periodo de 2 meses, o tiempo de duplicación de linfocitos (LDT) <6 meses. \nNOTA: El LDT se puede obtener mediante extrapolación de regresión lineal de los recuentos absolutos de linfocitos obtenidos en intervalos de 2 semanas durante un periodo de observación de 2 a 3 meses; los pacientes con recuentos iniciales de linfocitos en sangre <30 x 109 células/l pueden requerir un periodo de observación más prolongado para determinar el LDT. Deben excluirse los factores que contribuyen a la linfocitosis diferentes a la LLC (por ejemplo, infecciones y administración de esteroides).\ne.\tAfectación extraganglionar sintomática o funcional (p. ej., piel, riñón, pulmón o columna vertebral).\nf.\tSíntomas relacionados con la enfermedad, según se definen a continuación:\n\tPérdida de peso involuntaria ≥10 % en los últimos 6 meses.\n\tFiebre ≥38,0 °C durante 2 semanas o más sin pruebas de infección.\n\tSudores nocturnos durante ≥1 mes sin pruebas de infección.\n\tFatiga significativa (es decir, puntuación de escala de estado funcional ECOG de 2 o menos; no puede trabajar o no puede realizar actividades habituales).\nNOTA: Los pacientes con fatiga significativa no pueden tener una puntuación ECOG de 0","language":7,"languageDescription":"Spanish"},{"id":11911664,"uuid":"1f6587f4-da87-4664-b9a4-eafe44c1a43b","attributeTranslation":"2. CLL waarvoor behandeling nodig is, zoals gedefinieerd door ten minste 1 van de volgende criteria: a.\tBewijs van toenemend beenmergfalen, zich manifesterend door het ontstaan of de verergering van anemie en/of trombocytopenie. Hemoglobineconcentratie < 10 g/dl of plaatjestelling < 100 x 109 cellen/l worden over het algemeen beschouwd als indicaties voor behandeling. b. \tMassale (d.w.z. ≥ 6 cm links onder de ribbenboog), progressieve of symptomatische splenomegalie. c.\tMassale (d.w.z. ≥ 10 cm bij langste diameter [LDi]), progressieve of symptomatische lymfadenopathie. d.\tProgressieve lymfocytose met een toename van ≥ 50% over een periode van 2 maanden, of een verdubbelingstijd van de lymfocyten (LDT) < 6 maanden. OPMERKING: de LDT kan worden verkregen door lineaire regressie-extrapolatie van absolute lymfocytentellingen die met tussenpozen van 2 weken worden verkregen gedurende een observatieperiode van 2 tot 3 maanden; bij patiënten met een aanvankelijke lymfocytentelling in het bloed van < 30 x 109 cellen/l is mogelijk een langere observatieperiode nodig om de LDT te bepalen. Factoren anders dan CLL die bijdragen aan lymfocytose (bijv. infecties en toediening van steroïden) moeten worden uitgesloten. e.\tSymptomatische of functionele extranodale betrokkenheid (bijv. huid, nieren, longen en wervelkolom). f.\tZiektegerelateerde symptomen, zoals hieronder gedefinieerd: \tOnopzettelijk gewichtsverlies van ≥ 10% in de voorgaande 6 maanden. \n\tKoorts van ≥ 38,0 °C gedurende 2 weken of langer zonder tekenen van infectie. \tNachtzweten gedurende ≥ 1 maand zonder tekenen van infectie. \tErnstige vermoeidheid (d.w.z. een score voor de ECOG-performance status van 2 of lager; kan niet werken of is niet in staat om de gebruikelijke activiteiten uit te voeren). OPMERKING: patiënten met ernstige vermoeidheid kunnen geen ECOG-score van 0 hebben.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":959782,"number":3,"principalInclusionCriteria":"3.\tECOG Performance Status of 0, 1, or 2.","principalInclusionCriteriaTranslations":[{"id":11911670,"uuid":"80452849-6d94-4bf5-9f9c-f16a6827c5fa","attributeTranslation":"3. Poäng på ECOG-skattningsskalan 0, 1 eller 2.","language":24,"languageDescription":"Swedish"},{"id":11911669,"uuid":"80452849-6d94-4bf5-9f9c-f16a6827c5fa","attributeTranslation":"3. Indice de performance de l’ECOG de 0, 1 ou 2.","language":10,"languageDescription":"French"},{"id":11911671,"uuid":"80452849-6d94-4bf5-9f9c-f16a6827c5fa","attributeTranslation":"3.\tEscala de estado funcional ECOG de 0, 1 o 2.","language":7,"languageDescription":"Spanish"},{"id":11911672,"uuid":"80452849-6d94-4bf5-9f9c-f16a6827c5fa","attributeTranslation":"3. Status sprawności w skali ECOG wynoszący 0, 1 lub 2.","language":19,"languageDescription":"Polish"},{"id":11911673,"uuid":"80452849-6d94-4bf5-9f9c-f16a6827c5fa","attributeTranslation":"3. ECOG-performance status van 0, 1 of 2.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":959783,"number":4,"principalInclusionCriteria":"4.\tMeasurable disease by CT/MRI. Measurable disease is defined as ≥ 1 lymph node ≥ 1.5 cm in LDi and measurable in 2 perpendicular diameters.","principalInclusionCriteriaTranslations":[{"id":11911674,"uuid":"5b53359f-1b1b-4207-8fe7-44104f8ddd73","attributeTranslation":"4.\tMeetbare ziekte vastgesteld met behulp van CT/MRI. Meetbare ziekte wordt gedefinieerd als ≥ 1 lymfeklier met een LDi van ≥ 1,5 cm en meetbaar in 2 loodrechte diameters.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911678,"uuid":"5b53359f-1b1b-4207-8fe7-44104f8ddd73","attributeTranslation":"3. Indice de performance de l’ECOG de 0, 1 ou 2.","language":10,"languageDescription":"French"},{"id":11911675,"uuid":"5b53359f-1b1b-4207-8fe7-44104f8ddd73","attributeTranslation":"4.\tChoroba mierzalna za pomocą TK/RM. Za mierzalną chorobę uznaje się stan, w którym ≥ 1 węzeł chłonny ma średnicę LDi ≥ 1,5 cm i jest mierzalny w 2 prostopadłych średnicach.","language":19,"languageDescription":"Polish"},{"id":11911676,"uuid":"5b53359f-1b1b-4207-8fe7-44104f8ddd73","attributeTranslation":"4.\tEnfermedad medible mediante TC/RMN. La enfermedad medible se define como ≥1 ganglio linfático ≥1,5 cm en LDi y medible en 2 diámetros perpendiculares.","language":7,"languageDescription":"Spanish"},{"id":11911677,"uuid":"5b53359f-1b1b-4207-8fe7-44104f8ddd73","attributeTranslation":"4. Mätbar sjukdom med DT/MRT. Mätbar sjukdom definieras som ≥ 1 lymfkörtel ≥ 1,5 cm i LDi och mätbar i 2 vinkelräta diametrar.","language":24,"languageDescription":"Swedish"}]},{"id":959784,"number":5,"principalInclusionCriteria":"5.\tAdequate marrow function as defined by:  a.\tAbsolute neutrophil count ≥ 1.0 x 109 cells/L with an exception for patients with bone marrow involvement, in which case, the absolute neutrophil count must be ≥ 0.75 x 109 cells/L (without growth factor support within the past 14 days).  b.\tPlatelet counts ≥ 50 x 109 cells/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL, platelet count should be ≥ 30 x 109 cells/L (without growth factor support or transfusion within the past 14 days). c.\tHemoglobin > 75 g/L (may be posttransfusion).","principalInclusionCriteriaTranslations":[{"id":11911681,"uuid":"303313b9-d707-497d-88b0-0986827537dc","attributeTranslation":"5.\tFunción adecuada de la médula ósea, definida del modo siguiente: \na.\tRecuento absoluto de neutrófilos ≥ 1,0 x 109 células/l con excepción de los pacientes con afectación de la médula ósea, en cuyo caso, el recuento absoluto de neutrófilos debe ser ≥0,75 x 109 células/l (sin apoyo de factor de crecimiento en los últimos 14 días). \nb.\tRecuento de plaquetas ≥50 x 109 células/l; en casos de trombocitopenia claramente debida a afectación de la médula ósea por LLC, el recuento de plaquetas debe ser ≥ 30 x 109 células/l (sin apoyo de factor de crecimiento ni transfusión en los últimos 14 días).\nc.\tHemoglobina >75 g/l (puede ser después de una transfusión).","language":7,"languageDescription":"Spanish"},{"id":11911683,"uuid":"303313b9-d707-497d-88b0-0986827537dc","attributeTranslation":"5.\tAdequate beenmergfunctie zoals gedefinieerd door: a.\tAbsolute neutrofielentelling ≥ 1,0 x 109 cellen/l, met uitzondering van patiënten met beenmergbetrokkenheid, in welk geval de absolute neutrofielentelling ≥ 0,75 x 109 cellen/l moet zijn (zonder ondersteuning door groeifactoren in de voorgaande 14 dagen). \nb.\tPlaatjestelling ≥ 50 x 109 cellen/l; in gevallen van trombocytopenie die duidelijk het gevolg zijn van beenmergbetrokkenheid van CLL, moet de plaatjestelling ≥ 30 x 109 cellen/l zijn (zonder ondersteuning door groeifactoren of transfusie in de voorgaande 14 dagen). c.\tHemoglobine > 75 g/l (kan na transfusie zijn).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911680,"uuid":"303313b9-d707-497d-88b0-0986827537dc","attributeTranslation":"5. Adekvat märgfunktion enligt definitionen av: a.\tAbsolut antal neutrofila granulocyter ≥ 1,0 x 109 celler/l med undantag för patienter med benmärgsengagemang, i vilket fall det absoluta antalet neutrofila granulocyter måste vara ≥ 0,75 x 109 celler/l (utan tillväxtfaktorstöd under de senaste 14 dagarna). b.\tTrombocytantal ≥ 50 x 109 celler/l; vid trombocytopeni som tydligt beror på benmärgsengagemang av KLL ska trombocytantalet vara ≥ 30 x 109 celler/l (utan tillväxtfaktorstöd eller transfusion under de senaste 14 dagarna). c.\tHemoglobin > 75 g/l (kan vara posttransfusion).","language":24,"languageDescription":"Swedish"},{"id":11911679,"uuid":"303313b9-d707-497d-88b0-0986827537dc","attributeTranslation":"5.\tOdpowiednia czynność szpiku kostnego zdefiniowana jako: a.\tBezwzględna liczba neutrofili ≥ 1,0 x 109 komórek/l, z wyjątkiem pacjentów z zajęciem szpiku kostnego, w którym to przypadku bezwzględna liczba neutrofili musi wynosić ≥ 0,75 x 109 komórek/l (bez wsparcia czynnikami wzrostu w ciągu ostatnich 14 dni). b.\tLiczba płytek krwi ≥ 50 x 109 komórek/l; w przypadku małopłytkowości wyraźnie spowodowanej zajęciem szpiku kostnego przez CLL (wedle uznania badacza) liczba płytek krwi powinna wynosić ≥ 30 x 109 komórek/l (bez wspomagania czynnikami wzrostu lub przetoczenia w ciągu ostatnich 14 dni). c.\tHemoglobina > 75 g/l (może być po przetoczeniu).","language":19,"languageDescription":"Polish"},{"id":11911682,"uuid":"303313b9-d707-497d-88b0-0986827537dc","attributeTranslation":"5. Fonction adéquate de la moelle osseuse, définie comme telle :  a. Numération absolue des neutrophiles ≥ 1,0 x 109 cellules/L, à l’exception des patients présentant une atteinte de la moelle osseuse, auquel cas la numération absolue des neutrophiles doit être ≥ 0,75 x 109 cellules/L (sans soutien par facteurs de croissance au cours des 14 derniers jours).  b. Numération plaquettaire ≥ 50 x 109 cellules/L ; en cas de thrombocytopénie clairement due à une atteinte de la moelle osseuse par la LLC, la numération plaquettaire doit être ≥ 30 x 109 cellules/L (sans soutien par facteurs de croissance ni transfusion au cours des 14 derniers jours). c. Hémoglobine > 75 g/L (peut être post-transfusionnel).","language":10,"languageDescription":"French"}]},{"id":959785,"number":6,"principalInclusionCriteria":"6.\tAdequate liver function as indicated by AST and ALT ≤ 2.5 x the institutional ULN value; serum total bilirubin ≤ 2.0 x ULN (unless documented Gilbert syndrome when serum total bilirubin ≤ 3.0 x ULN and conjugated bilirubin ≤ 1.0 x ULN).","principalInclusionCriteriaTranslations":[{"id":11911688,"uuid":"5a411ab3-4f46-4fd6-83a9-0905b5684f64","attributeTranslation":"6.\tTillräcklig leverfunktion indikerad av ASAT och ALAT ≤ 2,5 x det institutionella ULN-värdet. Totalt serumbilirubin ≤ 2,0 x ULN (såvida inte Gilberts syndrom dokumenterats då totalt serumbilirubin ≤ 3,0 x ULN och konjugerat bilirubin ≤ 1,5 x ULN).","language":24,"languageDescription":"Swedish"},{"id":11911686,"uuid":"5a411ab3-4f46-4fd6-83a9-0905b5684f64","attributeTranslation":"6.\tOdpowiednia czynność wątroby, zdefiniowana jako wartości AST i ALT ≤ 2,5 x GGN w danej placówce; stężenie całkowitej bilirubiny w surowicy ≤ 2,0 x GGN (chyba że udokumentowano zespół Gilberta, gdy stężenie całkowitej bilirubiny w surowicy ≤ 3,0 x GGN i stężenie bilirubiny sprzężonej ≤ 1,0 x GGN).","language":19,"languageDescription":"Polish"},{"id":11911684,"uuid":"5a411ab3-4f46-4fd6-83a9-0905b5684f64","attributeTranslation":"6. Fonction hépatique adéquate telle qu’indiquée par ASAT et ALAT ≤ 2,5 x la valeur LSN institutionnelle ; bilirubine totale sérique ≤ 2,0 x LSN (sauf en cas de syndrome de Gilbert documenté lorsque la bilirubine totale sérique ≤ 3,0 x LSN et la bilirubine conjuguée ≤ 1, 0 x LSN).","language":10,"languageDescription":"French"},{"id":11911685,"uuid":"5a411ab3-4f46-4fd6-83a9-0905b5684f64","attributeTranslation":"6. Función hepática adecuada, indicada por AST y ALT ≤2,5 veces el valor LSN institucional; bilirrubina total sérica ≤2,0 veces el valor LSN (a menos que se haya documentado el síndrome de Gilbert, en cuyo caso la bilirrubina total sérica debe ser ≤3,0 veces el valor LSN y la bilirrubina conjugada debe ser ≤1,0 veces el valor LSN).","language":7,"languageDescription":"Spanish"},{"id":11911687,"uuid":"5a411ab3-4f46-4fd6-83a9-0905b5684f64","attributeTranslation":"6.\tAdequate leverfunctie, blijkend uit een ASAT en ALAT ≤ 2,5 x de institutionele ULN-waarde; totaal serumbilirubine ≤ 2,0 x ULN (tenzij er sprake is van gedocumenteerd syndroom van Gilbert, waarbij totaal serumbilirubine ≤ 3,0 x ULN en geconjugeerd bilirubine ≤ 1,0 x ULN moet zijn).","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":959786,"number":7,"principalInclusionCriteria":"7.\tAdequate renal function defined as creatinine clearance ≥ 30 mL/min directly measured with a 24-hour urine collection or ≥ 30 mL/min calculated according to the BSA-adjusted CKD-EPI calculation","principalInclusionCriteriaTranslations":[{"id":11911690,"uuid":"eb7c1e27-d1c1-4d9d-800f-9d0735c81ed1","attributeTranslation":"7.\tTillräcklig njurfunktion definierad som kreatininclearance ≥ 30 ml/min direkt mätt med en 24-timmars urininsamling eller ≥ 30 ml/min beräknat enligt BSA-justerad CKD-EPI-beräkning","language":24,"languageDescription":"Swedish"},{"id":11911693,"uuid":"eb7c1e27-d1c1-4d9d-800f-9d0735c81ed1","attributeTranslation":"7. Fonction rénale adéquate définie comme une clairance de la créatinine ≥ 30 mL/min mesurée directement à l’aide d’un recueil d’urine de 24 heures ou ≥ 30 mL/min calculée selon le calcul CKD-EPI ajusté à la BSA.","language":10,"languageDescription":"French"},{"id":11911692,"uuid":"eb7c1e27-d1c1-4d9d-800f-9d0735c81ed1","attributeTranslation":"7.\tFunción renal adecuada definida como aclaramiento de creatinina ≥30 ml/min medido directamente con una recolección de orina de 24 horas o ≥30 ml/min calculado de acuerdo con el cálculo CKD-EPI ajustado por BSA.","language":7,"languageDescription":"Spanish"},{"id":11911691,"uuid":"eb7c1e27-d1c1-4d9d-800f-9d0735c81ed1","attributeTranslation":"7.\tAdequate nierfunctie, gedefinieerd als een creatinineklaring van ≥ 30 ml/min, rechtstreeks gemeten door middel van een urineverzameling over 24 uur, of ≥ 30 ml/min berekend volgens de voor het lichaamsoppervlak aangepaste CKD-EPI-berekening.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911689,"uuid":"eb7c1e27-d1c1-4d9d-800f-9d0735c81ed1","attributeTranslation":"7.\tOdpowiednia czynność nerek zdefiniowana jako klirens kreatyniny ≥ 30 ml/min mierzony bezpośrednio w 24-godzinnej zbiórce moczu lub ≥ 30 ml/min obliczony zgodnie ze wzorem CKD-EPI skorygowanym o powierzchnię ciała (BSA)","language":19,"languageDescription":"Polish"}]},{"id":959787,"number":8,"principalInclusionCriteria":"8.\tLife expectancy > 6 months.","principalInclusionCriteriaTranslations":[{"id":11911697,"uuid":"ed7d3401-0012-4e35-a8dd-ff95afffa997","attributeTranslation":"8.\tOczekiwana długość życia > 6 miesięcy.","language":19,"languageDescription":"Polish"},{"id":11911696,"uuid":"ed7d3401-0012-4e35-a8dd-ff95afffa997","attributeTranslation":"8.\tFörväntad livslängd > 6 månader.","language":24,"languageDescription":"Swedish"},{"id":11911698,"uuid":"ed7d3401-0012-4e35-a8dd-ff95afffa997","attributeTranslation":"Esperanza de vida >6 meses.","language":7,"languageDescription":"Spanish"},{"id":11911695,"uuid":"ed7d3401-0012-4e35-a8dd-ff95afffa997","attributeTranslation":"8. Espérance de vie > 6 mois.","language":10,"languageDescription":"French"},{"id":11911694,"uuid":"ed7d3401-0012-4e35-a8dd-ff95afffa997","attributeTranslation":"8.\tLevensverwachting van > 6 maanden.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":959788,"number":9,"principalInclusionCriteria":"9.\tAdult patient ≥ 18 years of age, inclusive, at the time of signing the ICF and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Prisoners, individuals institutionalized by regulatory or court order, and persons who may be dependent on the sponsor or an investigator are excluded from the study.","principalInclusionCriteriaTranslations":[{"id":11911702,"uuid":"e1cc6eb5-7f95-4227-90dd-4e445ae39e5a","attributeTranslation":"9.\tPacjenci dorośli w wieku ≥ 18 lat włącznie w chwili podpisywania formularza świadomej zgody (ICF) oraz zdolni do wyrażenia świadomej zgody na piśmie, co obejmuje zobowiązanie do przestrzegania wymagań i ograniczeń wymienionych w formularzu ICF i w niniejszym protokole. Więźniowie, osoby umieszczone w zakładach zamkniętych na mocy przepisów lub nakazu sądowego oraz osoby, które mogą być zależne od sponsora lub badacza nie mogą być włączone do badania.","language":19,"languageDescription":"Polish"},{"id":11911701,"uuid":"e1cc6eb5-7f95-4227-90dd-4e445ae39e5a","attributeTranslation":"9. Patient adulte ≥ 18 ans inclus, au moment de la signature du FCE et capable de fournir un consentement éclairé par écrit, ce qui inclut le respect des exigences et des restrictions énumérées dans le FCE et dans ce protocole. Les détenus, les personnes placées en institution en vertu d’une décision administrative ou judiciaire, ainsi que les personnes dépendantes du promoteur ou d’un investigateur sont exclues de l’étude.","language":10,"languageDescription":"French"},{"id":11911703,"uuid":"e1cc6eb5-7f95-4227-90dd-4e445ae39e5a","attributeTranslation":"9.\tVuxen patient ≥ 18 år vid tidpunkten för undertecknandet av ICF, och förmögen att ge skriftligt informerat samtycke, vilket inkluderar efterlevnad av de krav och begränsningar som anges i ICF och i detta protokoll. Fångar, personer som är institutionaliserade genom myndighets- eller domstolsbeslut, samt personer som kan vara beroende av sponsorn eller en prövare, är exkluderade från studien.","language":24,"languageDescription":"Swedish"},{"id":11911700,"uuid":"e1cc6eb5-7f95-4227-90dd-4e445ae39e5a","attributeTranslation":"9.\tVolwassen patiënt van 18 jaar of ouder op het moment van ondertekening van de ICF, moet in staat zijn om schriftelijk geïnformeerde toestemming te geven; dit houdt ook in dat de patiënt in staat is zich te houden aan de vereisten en beperkingen die in de ICF en in dit protocol worden genoemd. Gevangenen, individuen die door een regulering of gerechtelijke uitspraak zijn geïnstitutionaliseerd, en personen die afhankelijk kunnen zijn van de sponsor of een onderzoeker, worden uitgesloten van de studie.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911699,"uuid":"e1cc6eb5-7f95-4227-90dd-4e445ae39e5a","attributeTranslation":"9.\tPacientes adultos de ≥18 años de edad (inclusive) en el momento de firmar el FCI y ser capaces de dar su consentimiento informado por escrito, lo que incluye el cumplimiento de los requisitos y restricciones enumerados en el FCI y en este protocolo. Quedan excluidos del estudio los reclusos, las personas internadas por orden administrativa o judicial y aquellas que puedan depender del promotor o de un investigador.","language":7,"languageDescription":"Spanish"}]}],"principalExclusionCriteria":[{"id":1638623,"number":1,"principalExclusionCriteria":"1.\tPrevious systemic treatment for CLL. (Note: Up to 4 doses of anti-CD-20 antibody specifically for autoimmune cytopenia is allowed; the last dose should be given ≥ 6 months before screening).","principalExclusionCriteriaTranslations":[{"id":11911535,"uuid":"c65785af-bb7f-482f-8022-8210d682d336","attributeTranslation":"1. Tidigare systemisk behandling för KLL. (Obs! Upp till 4 doser av anti-CD-20-antikropp specifikt för autoimmun cytopeni är tillåtet. Den sista dosen ska ges ≥ 6 månader före screening).","language":24,"languageDescription":"Swedish"},{"id":11911536,"uuid":"c65785af-bb7f-482f-8022-8210d682d336","attributeTranslation":"1.\tEerdere systemische behandeling voor CLL. (N.B.: tot 4 doses anti-CD-20-antilichaam specifiek voor auto-immuuncytopenie is toegestaan; de laatste dosis moet ≥ 6 maanden vóór de screening zijn toegediend).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911537,"uuid":"c65785af-bb7f-482f-8022-8210d682d336","attributeTranslation":"1.\tTratamiento sistémico previo para la LLC. (Nota: Se permiten hasta 4 dosis de anticuerpo anti CD-20 específicamente para citopenia autoinmunitaria; la última dosis debe administrarse ≥6 meses antes de la selección).","language":7,"languageDescription":"Spanish"},{"id":11911533,"uuid":"c65785af-bb7f-482f-8022-8210d682d336","attributeTranslation":"1.\tWcześniejsze leczenie układowe CLL. (Uwaga: dozwolone jest podanie maksymalnie 4 dawek przeciwciał anty-CD-20 stosowanych w leczeniu cytopenii autoimmunologicznej; ostatnia dawka powinna zostać podana ≥ 6 miesięcy przed badaniem przesiewowym).","language":19,"languageDescription":"Polish"},{"id":11911534,"uuid":"c65785af-bb7f-482f-8022-8210d682d336","attributeTranslation":"1. Traitement systémique antérieur pour la LLC. (Remarque : jusqu’à 4 doses d’anticorps anti-CD-20 spécifiquement pour la cytopénie auto-immune sont autorisées ; la dernière dose doit être administrée ≥ 6 mois avant la sélection).","language":10,"languageDescription":"French"}]},{"id":1638624,"number":10,"principalExclusionCriteria":"10.\tActive fungal, bacterial, and/or viral infection requiring systemic therapy.","principalExclusionCriteriaTranslations":[{"id":11911541,"uuid":"8dfaf466-2c86-4c43-a10c-08c10f42fcab","attributeTranslation":"10.\tActieve schimmel-, bacteriële en/of virusinfectie waarvoor systemische therapie nodig is.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911542,"uuid":"8dfaf466-2c86-4c43-a10c-08c10f42fcab","attributeTranslation":"10.\tInfección por hongos, vírica o bacteriana activa que requiera un tratamiento sistémico.","language":7,"languageDescription":"Spanish"},{"id":11911538,"uuid":"8dfaf466-2c86-4c43-a10c-08c10f42fcab","attributeTranslation":"10. Infection fongique, bactérienne et/ou virale active nécessitant un traitement systémique.","language":10,"languageDescription":"French"},{"id":11911540,"uuid":"8dfaf466-2c86-4c43-a10c-08c10f42fcab","attributeTranslation":"10.\tAktywne zakażenie grzybicze, bakteryjne i/lub wirusowe wymagające leczenia układowego.","language":19,"languageDescription":"Polish"},{"id":11911539,"uuid":"8dfaf466-2c86-4c43-a10c-08c10f42fcab","attributeTranslation":"10.\tAktiv svamp-, bakterie- och/eller virusinfektion som kräver systemisk behandling.","language":24,"languageDescription":"Swedish"}]},{"id":1638625,"number":11,"principalExclusionCriteria":"History or known hypersensitivity to zanubrutinib, sonrotoclax, acalabrutinib, venetoclax, or any of its excipients (eg, trehalose), xanthine oxidase inhibitors, or rasburicase.","principalExclusionCriteriaTranslations":[{"id":11911546,"uuid":"c809f0d4-bc9f-4879-81a2-d089df721e4a","attributeTranslation":"11. Występująca w przeszłości lub rozpoznana nadwrażliwość na zanubrutynib, sonrotoklaks, akalabrutynib, wenetoklaks lub którekolwiek z ich składników pomocniczych (np. trehalozę), inhibitory oksydazy ksantynowej lub rasburykazę.","language":19,"languageDescription":"Polish"},{"id":11911544,"uuid":"c809f0d4-bc9f-4879-81a2-d089df721e4a","attributeTranslation":"11. \tVoorgeschiedenis van of bekende overgevoeligheid voor zanubrutinib, sonrotoclax, acalabrutinib, venetoclax of een van de hulpstoffen daarvan (bijv. trehalose), xanthine-oxidaseremmers of rasburicase.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911545,"uuid":"c809f0d4-bc9f-4879-81a2-d089df721e4a","attributeTranslation":"11. Anamnes på eller känd överkänslighet mot zanubrutinib, sonrotoklax, akalabrutinib, venetoklax eller något av dess hjälpämnen (t.ex. trehalos), xantinoxidashämmare eller rasburikas.","language":24,"languageDescription":"Swedish"},{"id":11911547,"uuid":"c809f0d4-bc9f-4879-81a2-d089df721e4a","attributeTranslation":"11.\tAntecedentes o hipersensibilidad conocida a zanubrutinib, sonrotoclax, acalabrutinib, venetoclax o cualquiera de sus excipientes (p. ej., trehalosa), inhibidores de la xantina oxidasa o rasburicasa.","language":7,"languageDescription":"Spanish"},{"id":11911543,"uuid":"c809f0d4-bc9f-4879-81a2-d089df721e4a","attributeTranslation":"11. Antécédents ou hypersensibilité connue au zanubrutinib, au sonrotoclax, à l’acalabrutinib, au vénétoclax ou à l’un de ses excipients (par exemple, le tréhalose), aux inhibiteurs de la xanthine-oxydase ou à la rasburicase.","language":10,"languageDescription":"French"}]},{"id":1638626,"number":12,"principalExclusionCriteria":"12.\tHistory of severe bleeding disorder, such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.","principalExclusionCriteriaTranslations":[{"id":11911551,"uuid":"1b881c5e-57a2-4313-8d56-395d55955ba3","attributeTranslation":"12. Antécédents de troubles sévères de la coagulation, tels qu’une hémophilie A, une hémophilie B ou la maladie de Von Willebrand, ou antécédents de saignements spontanés nécessitant une transfusion sanguine ou une autre intervention médicale","language":10,"languageDescription":"French"},{"id":11911550,"uuid":"1b881c5e-57a2-4313-8d56-395d55955ba3","attributeTranslation":"12.\tVoorgeschiedenis van ernstige bloedingsstoornis zoals hemofilie A, hemofilie B, de ziekte van Von Willebrand of een voorgeschiedenis van spontane bloedingen waarvoor bloedtransfusie of andere medische interventie nodig was.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911549,"uuid":"1b881c5e-57a2-4313-8d56-395d55955ba3","attributeTranslation":"12.\tCiężkie zaburzenia krzepliwości krwi w wywiadzie, takie jak hemofilia A, hemofilia B, choroba von Willebranda albo spontaniczne krwawienia w wywiadzie wymagające przetoczenia krwi lub innej interwencji medycznej.","language":19,"languageDescription":"Polish"},{"id":11911552,"uuid":"1b881c5e-57a2-4313-8d56-395d55955ba3","attributeTranslation":"12.\tAntecedentes de trastorno hemorrágico grave, como hemofilia A, hemofilia B y enfermedad de von Willebrand; o antecedentes de hemorragia espontánea que requiere una transfusión sanguínea u otra intervención médica.","language":7,"languageDescription":"Spanish"},{"id":11911548,"uuid":"1b881c5e-57a2-4313-8d56-395d55955ba3","attributeTranslation":"12.\tAnamnes på allvarlig blödningsrubbning, såsom hemofili A, hemofili B, von Willebrands sjukdom, eller anamnes på spontan blödning som kräver blodtransfusion eller annan medicinsk intervention.","language":24,"languageDescription":"Swedish"}]},{"id":1638627,"number":13,"principalExclusionCriteria":"13.\tFemale patients who are pregnant or are breastfeeding.","principalExclusionCriteriaTranslations":[{"id":11911554,"uuid":"94f8d90f-1703-4e09-ba6d-9aab4662be54","attributeTranslation":"13.\tPacientes de sexo femenino embarazadas o en periodo de lactancia.","language":7,"languageDescription":"Spanish"},{"id":11911556,"uuid":"94f8d90f-1703-4e09-ba6d-9aab4662be54","attributeTranslation":"13.\tVrouwelijke patiënten die zwanger zijn of borstvoeding geven.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911555,"uuid":"94f8d90f-1703-4e09-ba6d-9aab4662be54","attributeTranslation":"13.\tPacjentki w ciąży lub karmiące piersią.","language":19,"languageDescription":"Polish"},{"id":11911557,"uuid":"94f8d90f-1703-4e09-ba6d-9aab4662be54","attributeTranslation":"13.\tKvinnliga patienter som är gravida eller ammar.","language":24,"languageDescription":"Swedish"},{"id":11911553,"uuid":"94f8d90f-1703-4e09-ba6d-9aab4662be54","attributeTranslation":"13. Les femmes enceintes ou qui allaitent.","language":10,"languageDescription":"French"}]},{"id":1638628,"number":14,"principalExclusionCriteria":"14.\tVaccination with a live vaccine within 28 days before enrollment and randomization","principalExclusionCriteriaTranslations":[{"id":11911560,"uuid":"379b9821-0927-4b76-83ed-dbcec56f249a","attributeTranslation":"14.\tVacunación con una vacuna elaborada con microbios vivos en los 28 días previos a la inclusión y la aleatorización (consultar también medicamentos prohibidos)","language":7,"languageDescription":"Spanish"},{"id":11911562,"uuid":"379b9821-0927-4b76-83ed-dbcec56f249a","attributeTranslation":"14.\tVaccinatie met een levend vaccin binnen 28 dagen vóór inschrijving en randomisatie.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911559,"uuid":"379b9821-0927-4b76-83ed-dbcec56f249a","attributeTranslation":"14.\tSzczepienie żywą szczepionką w ciągu 28 dni przed włączeniem do badania i randomizacją.","language":19,"languageDescription":"Polish"},{"id":11911561,"uuid":"379b9821-0927-4b76-83ed-dbcec56f249a","attributeTranslation":"14.\tVaccination med ett levande vaccin inom 28 dagar före inskrivning och randomisering","language":24,"languageDescription":"Swedish"},{"id":11911558,"uuid":"379b9821-0927-4b76-83ed-dbcec56f249a","attributeTranslation":"14. Vaccination avec un vaccin vivant dans les 28 jours précédant le recrutement et la randomisation.","language":10,"languageDescription":"French"}]},{"id":1638629,"number":15,"principalExclusionCriteria":"15.\tPatients with underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that will be unfavorable for the administration of study treatment, precludes the patient’s safe participation in the study or will affect the explanation of drug toxicity or AEs, or will result in insufficient or impaired compliance with study conduct. This includes patients who meet Child-Pugh Grade C criteria.","principalExclusionCriteriaTranslations":[{"id":11911567,"uuid":"53263539-c9c9-49a3-84fa-2d04cd4b9f01","attributeTranslation":"15.\tAls bij patiënten sprake is van onderliggende medische aandoeningen (waaronder afwijkende laboratoriumwaarden) of alcohol- of drugsmisbruik of afhankelijkheid van alcohol of drugs die ongunstig zijn voor de toediening van de onderzoeksbehandeling, belet dit de veilige deelname van de patiënt aan het onderzoek of heeft dit gevolgen voor de uitleg van de toxiciteit of bijwerkingen van geneesmiddelen, of leidt dit tot onvoldoende of verminderde therapietrouw. Hieronder vallen ook patiënten die voldoen aan de criteria van Child-Pugh klasse C","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911564,"uuid":"53263539-c9c9-49a3-84fa-2d04cd4b9f01","attributeTranslation":"15. Pacientes con enfermedades subyacentes (incluidas las anomalías de laboratorio), o abuso o dependencia de alcohol o drogas que sean desfavorables para la administración del tratamiento del estudio, impida la participación segura del paciente en el estudio o que afecten a la explicación de la toxicidad farmacológica o los AA, o que den lugar a un cumplimiento inadecuado (o insuficiente) de la conducta del estudio. Esto incluye a los pacientes que cumplen los criterios del grado C de la escala de Child-Pugh","language":7,"languageDescription":"Spanish"},{"id":11911565,"uuid":"53263539-c9c9-49a3-84fa-2d04cd4b9f01","attributeTranslation":"15. Patients présentant des problèmes médicaux sous-jacents (y compris les anomalies d’analyses en laboratoire), un abus ou une dépendance à l’alcool ou aux drogues qui seront défavorables à l’administration du traitement à l’étude, qui empêcheront la participation en toute sécurité du patient à l’étude ou qui affecteront l’explication de la toxicité médicamenteuse ou des EI, ou qui entraîneront une insuffisance ou une altération du respect de la conduite de l’étude. Cela inclut les patients répondant aux critères du grade C de l'échelle de Child-Pugh.","language":10,"languageDescription":"French"},{"id":11911566,"uuid":"53263539-c9c9-49a3-84fa-2d04cd4b9f01","attributeTranslation":"15.\tPatienter med underliggande medicinska tillstånd (inklusive laboratorieavvikelser) eller alkohol- eller drogmissbruk eller -beroende som kommer att vara ogynnsamma för administrering av studiebehandling, förhindra ett säkert deltagande i studien för patienten eller som kommer att påverka förklaringen av läkemedelstoxicitet eller biverkningar, eller som kommer att resultera i otillräcklig eller försämrad följsamhet med studiens genomförande.","language":24,"languageDescription":"Swedish"},{"id":11911563,"uuid":"53263539-c9c9-49a3-84fa-2d04cd4b9f01","attributeTranslation":"15.\tPacjenci z chorobami podstawowymi (w tym odbiegającymi od normy wynikami badań laboratoryjnych) lub z nadużywaniem bądź uzależnieniem od alkoholu lub narkotyków, które będą niekorzystne dla podawania leku w ramach badania, uniemożliwią bezpieczny udział pacjenta w badaniu lub wpłyną na interpretację toksyczności leku lub działań niepożądanych bądź spowodują niedostateczne lub zaburzone przestrzeganie procedur badania. Obejmuje to pacjentów spełniających kryteria klasy C w skali Childa-Pugha.","language":19,"languageDescription":"Polish"}]},{"id":1638630,"number":16,"principalExclusionCriteria":"16.\tPositive HIV serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection as follows: a.\tPresence of HBsAg. b.\tPatients with presence of HBcAb, in the absence of HBsAg, with detectable HBV DNA. NOTE: The limit of detection for HBV DNA must have a sensitivity of < 20 IU/mL;  Patients with presence of HBcAb but undetectable HBV DNA who are willing to undergo HBV DNA monitoring every 4 weeks for HBV reactivation are eligible. c.\tPatients with presence of HCV antibody and HCV RNA detectable NOTE: The limit of detection for HCV RNA must have a sensitivity of < 15 IU/mL; Patients with presence of HCVAb and undetectable HCV RNA who are willing to undergo HCV RNA monitoring every 4 weeks for HCV reactivation are eligible.","principalExclusionCriteriaTranslations":[{"id":11911572,"uuid":"73877077-b0b3-4020-9c28-fb0a2aa2357e","attributeTranslation":"16.\tSerología positiva para el VIH (HIVAb) o estado serológico que refleje una infección activa por hepatitis B o C, como se indica a continuación:\na.\tPresencia de HBsAg.\nb.\tPacientes con presencia de HBcAb, en ausencia de HBsAg, con ADN del VHB detectable. \nNOTA: El límite de detección del ADN del VHB debe tener una sensibilidad <20 IU/ml. Pueden participar los pacientes con presencia de HBcAb pero ADN del VHB no detectable que estén dispuestos a someterse a un seguimiento del ADN del VHB cada 4 semanas para la reactivación del VHB.\nc.\tPacientes con presencia de anticuerpos contra el VHC y ARN del VHC detectable. NOTA: El límite de detección para el ARN del VHC debe tener una sensibilidad <15 IU/ml. Los pacientes con presencia de HCVAb pero ARN del VHC indetectable pueden cumplir los requisitos si están dispuestos a someterse a un seguimiento del ARN del VHC cada 4 semanas para la reactivación del VHC.","language":7,"languageDescription":"Spanish"},{"id":11911570,"uuid":"73877077-b0b3-4020-9c28-fb0a2aa2357e","attributeTranslation":"16.\tPozytywny status serologiczny w kierunku HIV (HIVAb) lub status serologiczny oznaczający aktywne zakażenie wirusem zapalenia wątroby typu B lub C, jak poniżej: a.\tObecność antygenu HBsAg. b.\tPacjenci z przeciwciałami HBcAb, przy braku HBsAg, z wykrywalnym DNA HBV. UWAGA: granica wykrywalności DNA wirusa HBV musi charakteryzować się czułością < 20 IU/ml; do badania kwalifikują się pacjenci z obecnością przeciwciał HBcAb, ale niewykrywalnym DNA wirusa HBV, którzy wyrażą zgodę na monitorowanie DNA wirusa HBV co 4 tygodnie w celu kontroli reaktywacji HBV. c.\tPacjenci z wykrywalną obecnością przeciwciał HCV i RNA wirusa HCV. UWAGA: granica wykrywalności RNA wirusa HCV musi charakteryzować się czułością < 15 IU/ml; do badania kwalifikują się pacjenci z obecnością przeciwciał HCVAb i niewykrywalnym RNA wirusa HCV, którzy wyrażą zgodę na monitorowanie RNA wirusa HCV co 4 tygodnie w celu kontroli reaktywacji HCV.","language":19,"languageDescription":"Polish"},{"id":11911569,"uuid":"73877077-b0b3-4020-9c28-fb0a2aa2357e","attributeTranslation":"16. Statut sérologique positif au VIH (HIVAb) ou statut sérologique reflétant une infection active par l’hépatite B ou C comme suit : a. Présence d’HBsAg. b. Patients avec présence d’HBcAb, en l’absence d’HBsAg, avec ADN du VHB détectable. REMARQUE : la limite de détection de l’ADN du VHB doit avoir une sensibilité < 20 UI/mL. Les patients avec présence d’HBcAb, mais un ADN du VHB indétectable, disposés à se soumettre à un dépistage d’une éventuelle réactivation du VHB toutes les 4 semaines sont admissibles. c. Patients présentant des anticorps anti-VHC et un ARN du VHC détectable. REMARQUE : la limite de détection de l’ARN du VHC doit avoir une sensibilité < 15 UI/mL. Patients présentant des anticorps anti-VHC et un ARN du VHC indétectable, disposés à se soumettre au dépistage d’une éventuelle réactivation du VHC toutes les 4 semaines sont admissibles.","language":10,"languageDescription":"French"},{"id":11911571,"uuid":"73877077-b0b3-4020-9c28-fb0a2aa2357e","attributeTranslation":"16.\tPositiv HIV-serologi (HIVAb) eller serologisk status som återspeglar aktiv hepatit B- eller C-infektion enligt följande: a.\tFörekomst av HBsAg. b.\tPatienter med förekomst av HBcAb, i frånvaro av HBsAg, med detekterbart HBV-DNA. OBS! Detektionsgränsen för HBV-DNA måste ha en sensitivitet på < 20 IE/ml. Patienter med förekomst av HBcAb men odetekterbart HBV-DNA som är villiga att genomgå HBV-DNA-övervakning var fjärde vecka för HBV-reaktivering är kvalificerade. c.\tPatienter med förekomst av HCV-antikroppar och detekterbart HCV-RNA. OBS! Detektionsgränsen för HCV-RNA måste ha en sensitivitet på <15 IE/ml. Patienter med förekomst av HCVAb och odetekterbart HCV-RNA som är villiga att genomgå HCV-RNA-övervakning var fjärde vecka för HCV-reaktivering är kvalificerade.","language":24,"languageDescription":"Swedish"},{"id":11911568,"uuid":"73877077-b0b3-4020-9c28-fb0a2aa2357e","attributeTranslation":"16.\tPositieve serologische status voor hiv (HIVAb) of serologische status die duidt op een actieve hepatitis B- of C-infectie door het volgende: a.\tAanwezigheid van HBsAg. b.\tPatiënten met HBcAb, bij afwezigheid van HBsAg, met detecteerbaar HBV-DNA. N.B.: de detectielimiet voor HBV-DNA moet een sensitiviteit hebben van < 20 IE/ml. Patiënten met HBc-antistoffen maar zonder detecteerbaar HBV-DNA die bereid zijn om elke 4 weken HBV-DNA-monitoring voor HBV-reactivatie te ondergaan, komen in aanmerking. c.\tPatiënten met HCV-antistoffen en detecteerbaar HCV-RNA N.B.: de detectielimiet voor HCV-RNA moet een sensitiviteit hebben van < 15 IE/ml; Patiënten met HCV-antistoffen en niet-detecteerbaar HCV-RNA die bereid zijn om elke 4 weken HCV RNA-monitoring voor HCV-reactivatie te ondergaan, komen in aanmerking.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1638631,"number":17,"principalExclusionCriteria":"17.\tRequires the use of warfarin, marcumar, phenprocoumon, or vitamin K antagonist.","principalExclusionCriteriaTranslations":[{"id":11911573,"uuid":"57df7029-2b2a-4f70-a953-2b9388ef43bd","attributeTranslation":"17. Nécessite l’utilisation de warfarine, de marcumar, de phenprocoumone ou d’un antagoniste de la vitamine K.","language":10,"languageDescription":"French"},{"id":11911576,"uuid":"57df7029-2b2a-4f70-a953-2b9388ef43bd","attributeTranslation":"17.\tRequiere el uso de warfarina, Marcumar, fenprocumon o antagonista de la vitamina K.","language":7,"languageDescription":"Spanish"},{"id":11911577,"uuid":"57df7029-2b2a-4f70-a953-2b9388ef43bd","attributeTranslation":"17.\tPacjent wymaga stosowania warfaryny, markumaru, fenprokumonu lub antagonisty witaminy K.","language":19,"languageDescription":"Polish"},{"id":11911574,"uuid":"57df7029-2b2a-4f70-a953-2b9388ef43bd","attributeTranslation":"17.\tMoet warfarine, Marcoumar, fenprocoumon of een vitamine K-antagonist gebruiken.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911575,"uuid":"57df7029-2b2a-4f70-a953-2b9388ef43bd","attributeTranslation":"17.\tKräver användning av warfarin, marcumar, fenprokumon eller vitamin K-antagonist.","language":24,"languageDescription":"Swedish"}]},{"id":1638632,"number":18,"principalExclusionCriteria":"18.\tReceiving treatment with any moderate or strong CYP3A4 inhibitor or strong CYP3A4 inducer (≤ 14 days or 5 half lives, whichever is shorter) before the first dose of study drug, or requiring ongoing treatment with a moderate or strong CYP3A inhibitor or a strong CYP3A inducer.","principalExclusionCriteriaTranslations":[{"id":11911578,"uuid":"02fb8422-5d2f-4d0c-8104-a510a42f9de3","attributeTranslation":"18.\tBehandling med en måttlig eller stark CYP3A4-hämmare eller stark CYP3A4-inducerare (≤ 14 dagar eller 5 halveringstider, beroende på vilket som är kortast) före den första dosen av studieläkemedlet, eller som kräver fortsatt behandling med en måttlig eller stark CYP3A-hämmare eller en stark CYP3A-inducerare.","language":24,"languageDescription":"Swedish"},{"id":11911582,"uuid":"02fb8422-5d2f-4d0c-8104-a510a42f9de3","attributeTranslation":"18.\tWordt behandeld met een matige of sterke CYP3A4-remmer of sterke CYP3A4-inductor (≤ 14 dagen of 5 halfwaardetijden, de kortste is van toepassing) vóór de eerste dosis van het onderzoeksgeneesmiddel, of heeft langdurige behandeling met een matige of sterke CYP3A-remmer of een sterke CYP3A-inductor nodig.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911580,"uuid":"02fb8422-5d2f-4d0c-8104-a510a42f9de3","attributeTranslation":"18.\tRecibir tratamiento con cualquier inhibidor moderado o potente del CYP3A4 o inductor potente del CYP3A4 (≤14 días o 5 semividas, lo que sea menor) antes de la primera dosis del fármaco del estudio o requerir tratamiento en curso con un inhibidor moderado o potente del CYP3A o un inductor potente del CYP3A.","language":7,"languageDescription":"Spanish"},{"id":11911579,"uuid":"02fb8422-5d2f-4d0c-8104-a510a42f9de3","attributeTranslation":"18.\tOtrzymanie leczenia jakimkolwiek umiarkowanym lub silnym inhibitorem CYP3A4 lub silnym induktorem CYP3A4 (≤ 14 dni lub 5 okresów półtrwania w zależności od tego, który okres jest krótszy) przed pierwszą dawką leku badanego lub konieczność dalszego leczenia umiarkowanym lub silnym inhibitorem CYP3A lub silnym induktorem CYP3A.","language":19,"languageDescription":"Polish"},{"id":11911581,"uuid":"02fb8422-5d2f-4d0c-8104-a510a42f9de3","attributeTranslation":"18. Recevoir un traitement avec un inhibiteur modéré ou puissant du CYP3A4 ou un inducteur puissant du CYP3A4 (≤ 14 jours ou 5 demi-vies, selon la durée la plus courte) avant la première dose du médicament à l’étude, ou nécessiter un traitement continu avec un inhibiteur modéré ou puissant du CYP3A ou un inducteur puissant du CYP3A.","language":10,"languageDescription":"French"}]},{"id":1638633,"number":19,"principalExclusionCriteria":"19.\tConsumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days before the first dose of study treatment.","principalExclusionCriteriaTranslations":[{"id":11911585,"uuid":"0c512818-15e8-4b57-945d-597425fc2f56","attributeTranslation":"19.\tSpożycie grejpfrutów, produktów na bazie grejpfrutów, pomarańczy sewilskich (w tym marmolady zawierającej pomarańcze sewilskie) lub karamboli w ciągu 3 dni przed pierwszą dawką leku badanego.","language":19,"languageDescription":"Polish"},{"id":11911584,"uuid":"0c512818-15e8-4b57-945d-597425fc2f56","attributeTranslation":"19.\tIntag av grapefrukt, grapefruktprodukter, Sevilla-apelsiner (inklusive marmelad innehållande Sevilla-apelsiner) eller stjärnfrukt inom de 3 dagarna före första dosen av studiebehandlingen.","language":24,"languageDescription":"Swedish"},{"id":11911583,"uuid":"0c512818-15e8-4b57-945d-597425fc2f56","attributeTranslation":"19. Consommer du pamplemousse, des produits à base de pamplemousse, des oranges de Séville (y compris la marmelade contenant des oranges de Séville) ou des caramboles dans les 3 jours avant la première dose du traitement à l’étude.","language":10,"languageDescription":"French"},{"id":11911587,"uuid":"0c512818-15e8-4b57-945d-597425fc2f56","attributeTranslation":"19.\tHeeft grapefruit, grapefruitproducten, bittersinaasappels (inclusief marmelade met bittersinaasappels) of stervrucht geconsumeerd binnen 3 dagen vóór de eerste dosis van de onderzoeksbehandeling.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911586,"uuid":"0c512818-15e8-4b57-945d-597425fc2f56","attributeTranslation":"19.\tConsumo de pomelo, productos derivados del pomelo, naranjas amargas (incluida mermelada que contenga naranjas amargas) o carambola dentro de los 3 días anteriores a la primera dosis del tratamiento del estudio.","language":7,"languageDescription":"Spanish"}]},{"id":1638634,"number":2,"principalExclusionCriteria":"2.\tKnown prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation (biopsy based on clinical suspicion may be needed to rule out transformation).","principalExclusionCriteriaTranslations":[{"id":11911592,"uuid":"1a8b8fbf-312f-4072-9639-27a9bb335f81","attributeTranslation":"2. Leucémie prolymphocytaire connue, ou antécédents ou suspicion actuelle d’un syndrome de Richter (une biopsie basée sur une suspicion clinique peut être nécessaire pour exclure la transformation).","language":10,"languageDescription":"French"},{"id":11911591,"uuid":"1a8b8fbf-312f-4072-9639-27a9bb335f81","attributeTranslation":"2.\tBekende prolymfocytaire leukemie of voorgeschiedenis of vermoeden van het syndroom van Richter (een biopsie op basis van klinische verdenking kan nodig zijn om Richter-transformatie uit te sluiten).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911590,"uuid":"1a8b8fbf-312f-4072-9639-27a9bb335f81","attributeTranslation":"2.\tRozpoznana, w wywiadzie lub aktualnie podejrzewana białaczka prolimfocytowa, transformacja Richtera (w celu wykluczenia transformacji może być konieczna biopsja w związku z podejrzeniem klinicznym).","language":19,"languageDescription":"Polish"},{"id":11911589,"uuid":"1a8b8fbf-312f-4072-9639-27a9bb335f81","attributeTranslation":"2.\tLeucemia prolinfocítica conocida o antecedentes o sospecha actual de transformación de Richter (puede ser necesaria una biopsia basada en la sospecha clínica para descartar la transformación).","language":7,"languageDescription":"Spanish"},{"id":11911588,"uuid":"1a8b8fbf-312f-4072-9639-27a9bb335f81","attributeTranslation":"2. Känd prolymfocytisk leukemi eller anamnes på, eller misstänkt aktuell, Richters transformation (biopsi baserad på klinisk misstanke kan krävas för att utesluta transformation).","language":24,"languageDescription":"Swedish"}]},{"id":1638635,"number":20,"principalExclusionCriteria":"20.\tUnable to swallow capsules or tablets or diseases significantly affecting GI function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.","principalExclusionCriteriaTranslations":[{"id":11911593,"uuid":"06652cb3-2661-4dcf-af3e-42e4c2202032","attributeTranslation":"20.\tNiemożność połykania kapsułek lub tabletek lub choroba znacząco wpływająca na czynność przewodu pokarmowego, taka jak zespół zaburzeń wchłaniania, resekcja żołądka lub jelita cienkiego, operacje bariatryczne, objawowe nieswoiste zapalenie jelit lub częściowa lub całkowita niedrożność jelit.","language":19,"languageDescription":"Polish"},{"id":11911595,"uuid":"06652cb3-2661-4dcf-af3e-42e4c2202032","attributeTranslation":"20.\tIs niet in staat om capsules of tabletten door te slikken of heeft een ziekte die de GI functie aanzienlijk beïnvloedt, zoals malabsorptiesyndroom, maag- of dunnedarmresectie, bariatrische chirurgische ingrepen, symptomatische inflammatoire darmziekte, of gedeeltelijke of volledige darmobstructie.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911597,"uuid":"06652cb3-2661-4dcf-af3e-42e4c2202032","attributeTranslation":"20. Incapacité à avaler des gélules ou des comprimés ou maladies affectant de manière significative la fonction GI, telles que le syndrome de malabsorption, la résection de l’estomac ou de l’intestin grêle, des interventions de chirurgie bariatrique, une maladie entérique inflammatoire symptomatique ou une occlusion intestinale partielle ou complète.","language":10,"languageDescription":"French"},{"id":11911594,"uuid":"06652cb3-2661-4dcf-af3e-42e4c2202032","attributeTranslation":"20.\tOförmåga att svälja kapslar eller tabletter, eller sjukdomar som signifikant påverkar mag-tarmfunktionen, såsom malabsorptionssyndrom, resektion av magsäck eller tunntarm, bariatriska kirurgiska ingrepp, symtomatisk inflammatorisk tarmsjukdom eller partiell eller fullständig tarmobstruktion.","language":24,"languageDescription":"Swedish"},{"id":11911596,"uuid":"06652cb3-2661-4dcf-af3e-42e4c2202032","attributeTranslation":"20.\tIncapacidad para tragar cápsulas o comprimidos o enfermedades que afecten significativamente la función gastrointestinal, como síndrome de mala absorción, resección del estómago o del intestino delgado, procedimientos de cirugía bariátrica, enfermedad inflamatoria intestinal sintomática u obstrucción intestinal parcial o total.","language":7,"languageDescription":"Spanish"}]},{"id":1638636,"number":21,"principalExclusionCriteria":"21.\tAt time of enrollment, receiving systemic corticosteroids unless administered for adrenal replacement.","principalExclusionCriteriaTranslations":[{"id":11911601,"uuid":"95c2d34f-468d-4f77-acfc-73a92a0ea6c7","attributeTranslation":"21.\tBehandling med systemiska kortikosteroider vid tidpunkten för inskrivning, förutom om de administreras för binjurebarksersättning.","language":24,"languageDescription":"Swedish"},{"id":11911600,"uuid":"95c2d34f-468d-4f77-acfc-73a92a0ea6c7","attributeTranslation":"21.\tW momencie włączenia do badania otrzymywanie kortykosteroidów układowych, chyba że są podawane w ramach nadnerczowej terapii zastępczej.","language":19,"languageDescription":"Polish"},{"id":11911602,"uuid":"95c2d34f-468d-4f77-acfc-73a92a0ea6c7","attributeTranslation":"21.\tEn el momento de la inclusión, estar recibiendo corticoesteroides sistémicos, a menos que se administren para reemplazo suprarrenal.","language":7,"languageDescription":"Spanish"},{"id":11911599,"uuid":"95c2d34f-468d-4f77-acfc-73a92a0ea6c7","attributeTranslation":"21. Au moment du recrutement, recevoir des corticostéroïdes systémiques, sauf s’ils sont administrés pour une substitution surrénalienne.","language":10,"languageDescription":"French"},{"id":11911598,"uuid":"95c2d34f-468d-4f77-acfc-73a92a0ea6c7","attributeTranslation":"21.\tKrijgt op het moment van inschrijven systemische corticosteroïden, tenzij toegediend voor bijnierschorsinsufficiëntie.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1638637,"number":22,"principalExclusionCriteria":"22.\tMajor surgery within 4 weeks of the first dose of study treatment.","principalExclusionCriteriaTranslations":[{"id":11911603,"uuid":"59e7b17d-d69c-402e-8158-7228075cb124","attributeTranslation":"22.\tStörre operation inom 4 veckor före den första dosen av studiebehandlingen.","language":24,"languageDescription":"Swedish"},{"id":11911605,"uuid":"59e7b17d-d69c-402e-8158-7228075cb124","attributeTranslation":"22.\tPoważny zabieg chirurgiczny w ciągu 4 tygodni przed podaniem pierwszej dawki leczenia w ramach badania.","language":19,"languageDescription":"Polish"},{"id":11911604,"uuid":"59e7b17d-d69c-402e-8158-7228075cb124","attributeTranslation":"22.\tSe sometió a una cirugía mayor dentro de las 4 semanas posteriores a la primera dosis del tratamiento en estudio.","language":7,"languageDescription":"Spanish"},{"id":11911606,"uuid":"59e7b17d-d69c-402e-8158-7228075cb124","attributeTranslation":"22.\tZware operatie binnen 4 weken na de eerste dosis van de onderzoeksbehandeling.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911607,"uuid":"59e7b17d-d69c-402e-8158-7228075cb124","attributeTranslation":"22. Intervention chirurgicale majeure dans les 4 semaines suivant la première dose du traitement à l’étude.","language":10,"languageDescription":"French"}]},{"id":1638638,"number":3,"principalExclusionCriteria":"3.\tKnown CNS involvement.","principalExclusionCriteriaTranslations":[{"id":11911612,"uuid":"3423798e-e7cf-4e6f-9a4e-65ac288391d4","attributeTranslation":"3.\tRozpoznane zajęcie ośrodkowego układu nerwowego.","language":19,"languageDescription":"Polish"},{"id":11911610,"uuid":"3423798e-e7cf-4e6f-9a4e-65ac288391d4","attributeTranslation":"3.\tBekende betrokkenheid van het CZS.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911608,"uuid":"3423798e-e7cf-4e6f-9a4e-65ac288391d4","attributeTranslation":"3. Atteinte connue du SNC.","language":10,"languageDescription":"French"},{"id":11911611,"uuid":"3423798e-e7cf-4e6f-9a4e-65ac288391d4","attributeTranslation":"3. Känt CNS-engagemang.","language":24,"languageDescription":"Swedish"},{"id":11911609,"uuid":"3423798e-e7cf-4e6f-9a4e-65ac288391d4","attributeTranslation":"Afectación conocida del SNC","language":7,"languageDescription":"Spanish"}]},{"id":1638639,"number":4,"principalExclusionCriteria":"4.\tPatients with a history of confirmed progressive multifocal leukoencephalopathy.","principalExclusionCriteriaTranslations":[{"id":11911613,"uuid":"409d39bc-ceb9-427d-8c46-e6d70fe54a98","attributeTranslation":"4. Patienter med en anamnes på bekräftad progressiv multifokal leukoencefalopati.","language":24,"languageDescription":"Swedish"},{"id":11911617,"uuid":"409d39bc-ceb9-427d-8c46-e6d70fe54a98","attributeTranslation":"4. Patients ayant des antécédents de leucoencéphalopathie multifocale progressive confirmée.","language":10,"languageDescription":"French"},{"id":11911616,"uuid":"409d39bc-ceb9-427d-8c46-e6d70fe54a98","attributeTranslation":"4.\tPacjenci z potwierdzoną postępującą wieloogniskową leukoencefalopatią w wywiadzie.","language":19,"languageDescription":"Polish"},{"id":11911615,"uuid":"409d39bc-ceb9-427d-8c46-e6d70fe54a98","attributeTranslation":"4.\tPatiënten met een voorgeschiedenis van bevestigde progressieve multifocale leuko-encefalopathie.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911614,"uuid":"409d39bc-ceb9-427d-8c46-e6d70fe54a98","attributeTranslation":"4.\tPacientes con antecedentes de leucoencefalopatía multifocal progresiva confirmada.","language":7,"languageDescription":"Spanish"}]},{"id":1638640,"number":5,"principalExclusionCriteria":"5.\tSevere or debilitating pulmonary disease, defined as chronic supplementation of oxygen and/or respiratory failure requiring assisted ventilation.","principalExclusionCriteriaTranslations":[{"id":11911620,"uuid":"62222632-fe6b-4df4-9931-5a21520547ed","attributeTranslation":"5.\tErnstige of invaliderende longziekte, gedefinieerd als chronische zuurstofsuppletie en/of respiratoir falen waarvoor ondersteunde ademhaling nodig is.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911618,"uuid":"62222632-fe6b-4df4-9931-5a21520547ed","attributeTranslation":"5.\tEnfermedad pulmonar grave o debilitante, definida como suplementación crónica de oxígeno o insuficiencia respiratoria que requiere ventilación asistida.","language":7,"languageDescription":"Spanish"},{"id":11911619,"uuid":"62222632-fe6b-4df4-9931-5a21520547ed","attributeTranslation":"5. Allvarlig eller funktionsnedsättande lungsjukdom, definierad som kroniskt syrgastillskott och/eller andningssvikt som kräver understödd ventilation.","language":24,"languageDescription":"Swedish"},{"id":11911621,"uuid":"62222632-fe6b-4df4-9931-5a21520547ed","attributeTranslation":"5. Maladie pulmonaire grave ou invalidante, définie comme une supplémentation chronique en oxygène et/ou une insuffisance respiratoire nécessitant une ventilation assistée.","language":10,"languageDescription":"French"},{"id":11911622,"uuid":"62222632-fe6b-4df4-9931-5a21520547ed","attributeTranslation":"5.\tCiężka lub wyniszczająca choroba płuc, definiowana jako konieczność przewlekłego podawania tlenu i/lub niewydolność oddechowa wymagająca wentylacji wspomaganej.","language":19,"languageDescription":"Polish"}]},{"id":1638641,"number":6,"principalExclusionCriteria":"6.\tClinically significant cardiovascular disease including the following: a.\tMyocardial infarction within 6 months before screening. b.\tUnstable angina within 3 months before screening. c.\tNew York Heart Association class III or IV congestive heart failure. d.\tHistory of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes). e.\tQTcF > 480 milliseconds based on Fridericia’s formula.  \tNOTE: QTcF value may be calculated as the numerical average of up to 3 separate readings for eligibility. f.\tHistory of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place. g.\tUncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg at screening.","principalExclusionCriteriaTranslations":[{"id":11911623,"uuid":"5ca2bb2c-c33e-4b6a-bc89-21d586b61d5a","attributeTranslation":"6.\tKlinicznie istotna choroba układu sercowo-naczyniowego, między innymi: a.\tZawał mięśnia sercowego przebyty w ciągu 6 miesięcy przed badaniem przesiewowym. b.\tNiestabilna dławica piersiowa przebyta w ciągu 3 miesięcy przed badaniem przesiewowym. c.\tZastoinowa niewydolność serca klasy III lub IV według New York Heart Association (NYHA). d.\tKlinicznie istotne arytmie w wywiadzie (np. utrwalony częstoskurcz komorowy, migotanie komór lub torsades de pointes). e.\tQTcF > 480 milisekund na podstawie wzoru Fridericii.  \tUWAGA: w celu sprawdzenia kwalifikacji do badania wartość QTcF można obliczyć jako średnią liczbową z maksymalnie 3 oddzielnych odczytów. f.\tBlok serca drugiego lub trzeciego stopnia typu Mobitz II w wywiadzie bez stałego rozrusznika serca. g.\tNiekontrolowane nadciśnienie tętnicze, zdefiniowane jako co najmniej 2 kolejne pomiary ciśnienia krwi wykazujące ciśnienie skurczowe > 170 mmHg i ciśnienie rozkurczowe > 105 mmHg w momencie badania przesiewowego.","language":19,"languageDescription":"Polish"},{"id":11911625,"uuid":"5ca2bb2c-c33e-4b6a-bc89-21d586b61d5a","attributeTranslation":"6. Maladie cardiovasculaire cliniquement significative, notamment : a. Infarctus du myocarde dans les 6 mois avant la sélection. b. Angor instable dans les 3 mois avant la sélection. c. Insuffisance cardiaque congestive de classe III ou IV de la New York Heart Association. d. Antécédents d’arythmies significatives sur le plan clinique (p. ex., tachycardie ventriculaire soutenue, fibrillation ventriculaire ou torsades de pointes). e. QTcF > 480 millisecondes selon la formule de Fridericia. REMARQUE : la valeur QTcF peut être calculée comme la moyenne numérique de 3 lectures distinctes au maximum pour l’éligibilité. f. Antécédents de bloc cardiaque de deuxième ou troisième degré de type Mobitz II sans stimulateur cardiaque permanent en place. g. Hypertension incontrôlée, indiquée par un minimum de 2 mesures consécutives de la pression artérielle montrant une pression artérielle systolique > 170 mmHg et une pression artérielle diastolique > 105 mmHg lors de la sélection.","language":10,"languageDescription":"French"},{"id":11911627,"uuid":"5ca2bb2c-c33e-4b6a-bc89-21d586b61d5a","attributeTranslation":"6.\tKlinisch significante hart- en vaatziekte, waaronder de volgende: a.\tMyocardinfarct binnen 6 maanden vóór screening. b.\tInstabiele angina pectoris binnen 3 maanden vóór screening. c.\tCongestief hartfalen van New York Heart Association-klasse III of IV. d.\tVoorgeschiedenis van klinisch significante aritmieën (bijv. aanhoudende ventriculaire tachycardie, ventriculaire fibrillatie of torsades de pointes). \ne.\tQTcF > 480 milliseconden gebaseerd op de formule van Fridericia. \tN.B.: de QTcF-waarde kan worden berekend als het numerieke gemiddelde van maximaal 3 afzonderlijke metingen voor geschiktheid. \nf.\tVoorgeschiedenis van tweedegraads of derdegraads Mobitz II-hartblok zonder een permanente pacemaker. g.\tNiet-gereguleerde hypertensie, blijkend uit minimaal 2 opeenvolgende bloeddrukmetingen bij screening waarbij de systolische bloeddruk > 170 mmHg is en de diastolische bloeddruk > 105 mmHg","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911624,"uuid":"5ca2bb2c-c33e-4b6a-bc89-21d586b61d5a","attributeTranslation":"6. Kliniskt signifikant hjärt-kärlsjukdom inklusive följande: a.\tHjärtinfarkt inom 6 månader före screening. b.\tInstabil angina inom 3 månader före screening. c.\tKongestiv hjärtsvikt klass III eller IV enligt New York Heart Association. d.\tKliniskt signifikanta arytmier i anamnesen (t.ex. ihållande ventrikulär takykardi, ventrikelflimmer eller torsades de pointes). e. \tQTcF > 480 millisekunder baserat på Fridericias formel. \tOBS! QTcF-värdet kan beräknas som det numeriska medelvärdet av upp till 3 separata avläsningar för kvalificering. f.\tAnamnes på Mobitz II hjärtblock av andra eller tredje graden utan permanent pacemaker. g.\tOkontrollerad hypertoni indikerad av minst två på varandra följande blodtrycksmätningar som visar systoliskt blodtryck > 170 mmHg och diastoliskt blodtryck > 105 mmHg vid screening.","language":24,"languageDescription":"Swedish"},{"id":11911626,"uuid":"5ca2bb2c-c33e-4b6a-bc89-21d586b61d5a","attributeTranslation":"6.\tEnfermedad cardiovascular clínicamente significativa, incluidos los siguientes:\na.\tInfarto de miocardio en los 6 meses previos a la selección.\nb.\tAngina inestable en los 3 meses previos a la selección.\nc.\tInsuficiencia cardíaca congestiva de clase III o IV según la New York Heart Association.\nd.\tAntecedentes de arritmia clínicamente relevantes (p. ej., taquicardia ventricular sostenida, fibrilación ventricular, torsades de pointes).\ne.\tQTcF >480 milisegundos según la fórmula de Fridericia. \n\tNOTA: El valor QTcF puede calcularse como el promedio numérico de hasta 3 lecturas separadas para su idoneidad.\nf.\tAntecedentes de bloqueo cardíaco de Mobitz II, de segundo o tercer grado sin marcapasos permanente colocado.\ng.\tHipertensión no controlada en el momento de la selección, indicada por un mínimo de 2 mediciones consecutivas de la presión arterial que muestren presión arterial sistólica >170 mmHg y presión arterial diastólica >105 mmHg","language":7,"languageDescription":"Spanish"}]},{"id":1638642,"number":7,"principalExclusionCriteria":"7.\tUncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment.","principalExclusionCriteriaTranslations":[{"id":11911630,"uuid":"0714adfc-b134-43c7-9d90-194b7d1061f5","attributeTranslation":"7.\tAnemia hemolítica autoinmunitaria no controlada o trombocitopenia inmunitaria que requiere tratamiento.","language":7,"languageDescription":"Spanish"},{"id":11911631,"uuid":"0714adfc-b134-43c7-9d90-194b7d1061f5","attributeTranslation":"7.\tNiekontrolowana niedokrwistość autoimmunohemolityczna lub małopłytkowość immunologiczna wymagająca leczenia.","language":19,"languageDescription":"Polish"},{"id":11911632,"uuid":"0714adfc-b134-43c7-9d90-194b7d1061f5","attributeTranslation":"7.\tOkontrollerad autoimmun hemolytisk anemi eller immun trombocytopeni som kräver behandling.","language":24,"languageDescription":"Swedish"},{"id":11911628,"uuid":"0714adfc-b134-43c7-9d90-194b7d1061f5","attributeTranslation":"7. Anémie hémolytique auto-immune non contrôlée ou thrombopénie immunitaire nécessitant un traitement.","language":10,"languageDescription":"French"},{"id":11911629,"uuid":"0714adfc-b134-43c7-9d90-194b7d1061f5","attributeTranslation":"7.\tNiet-gereguleerde auto-immuunhemolytische anemie of immune trombocytopenie waarvoor behandeling nodig is.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1638643,"number":8,"principalExclusionCriteria":"8.\tHistory of prior malignancy, except for conditions as listed below and as long as patients have recovered from the acute side effects incurred because of previous therapy: a.\tMalignancies surgically treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and randomization. b.\tAdequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease. c.\tAdequately treated cervical carcinoma in situ without evidence of disease. d.\tLocalized prostate cancer with Gleason score ≤ 6.","principalExclusionCriteriaTranslations":[{"id":11911636,"uuid":"3029e45b-cd3a-4ab6-9b14-c0363305619d","attributeTranslation":"8.\tWcześniejsza choroba nowotworowa w wywiadzie, z wyjątkiem chorób wymienionych poniżej, pod warunkiem że pacjent powrócił do normy po ostrych skutkach ubocznych spowodowanych wcześniejszym leczeniem: a.\tNowotwory złośliwe leczone operacyjnie w celu wyleczenia, bez rozpoznania aktywnej choroby przez ≥ 3 lata przed włączeniem do badania i randomizacją. b.\tOdpowiednio leczony rak skóry inny niż czerniak lub plama soczewicowata złośliwa bez objawów choroby. c.\tOdpowiednio leczony rak szyjki macicy in situ bez objawów choroby. d.\tLokalny rak prostaty z wynikiem w skali Gleasona ≤ 6.","language":19,"languageDescription":"Polish"},{"id":11911634,"uuid":"3029e45b-cd3a-4ab6-9b14-c0363305619d","attributeTranslation":"8.\tVoorgeschiedenis van eerdere maligniteit, met uitzondering van de hieronder vermelde aandoeningen en mits de patiënt is hersteld van de acute bijwerkingen als gevolg van eerdere therapie: a.\tMaligniteiten die chirurgisch zijn behandeld met curatieve intentie en waarbij er gedurende ≥ 3 jaar vóór inschrijving en randomisatie geen bekende actieve ziekte aanwezig was. b.\tAdequaat behandelde niet-melanoom huidkanker of lentigo maligne zonder tekenen van ziekte. c.\tAdequaat behandeld baarmoederhalscarcinoom in situ, zonder tekenen van ziekte. d.\tGelokaliseerde prostaatkanker met Gleason-score ≤ 6.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911633,"uuid":"3029e45b-cd3a-4ab6-9b14-c0363305619d","attributeTranslation":"8.\tAntecedentes de neoplasia maligna previa, excepto las afecciones que se enumeran a continuación y siempre que los pacientes se hayan recuperado de los efectos secundarios inmediatos sufridos por un tratamiento anterior:\na.\tNeoplasias malignas tratadas quirúrgicamente con intención curativa y sin enfermedad activa conocida presente durante ≥3 años antes de la inclusión y la aleatorización.\nb.\tCáncer de piel no melanoma o lentigo maligno tratado adecuadamente sin prueba de enfermedad.\nc.\tCarcinoma de cuello uterino in situ tratado adecuadamente sin prueba de enfermedad.\nd.\tCáncer de próstata localizado con puntuación de Gleason ≤6.","language":7,"languageDescription":"Spanish"},{"id":11911635,"uuid":"3029e45b-cd3a-4ab6-9b14-c0363305619d","attributeTranslation":"nge patienterna har tillfrisknat från de akuta biverkningarna som uppstått på grund av tidigare behandling: a.\tMaligniteter som behandlats kirurgiskt med avsikt att bota och utan känd aktiv sjukdom i ≥ 3 år före inskrivning och randomisering. b.\tAdekvat behandlad icke-melanom hudcancer eller lentigo maligna utan tecken på sjukdom. c.\tAdekvat behandlad livmoderhalskarcinom in situ utan tecken på sjukdom. d.\tLokaliserad prostatacancer med Gleason-poäng ≤ 6.","language":24,"languageDescription":"Swedish"},{"id":11911637,"uuid":"3029e45b-cd3a-4ab6-9b14-c0363305619d","attributeTranslation":"8. Antécédents de malignité, à l’exception des affections énumérées ci-dessous et à condition que les patients se soient remis des effets secondaires aigus survenus en raison du traitement antérieur : a. Malignités traitées chirurgicalement à des fins curatives et sans maladie active connue présente depuis ≥ 3 ans avant le recrutement et la randomisation. b. Cancer de la peau sans présence de mélanome ou lentigo malin correctement traités sans signe de maladie. c. Carcinome cervical in situ correctement traité sans signe de maladie. d. Cancer de la prostate localisé avec score de Gleason ≤ 6.","language":10,"languageDescription":"French"}]},{"id":1638644,"number":9,"principalExclusionCriteria":"9.\tUse of investigational agents within the last 4 weeks before screening.","principalExclusionCriteriaTranslations":[{"id":11911638,"uuid":"f18ccfdf-3d16-4551-b896-c70008410007","attributeTranslation":"9.\tStosowanie środków eksperymentalnych w ciągu ostatnich 4 tygodni przed badaniem przesiewowym.","language":19,"languageDescription":"Polish"},{"id":11911642,"uuid":"f18ccfdf-3d16-4551-b896-c70008410007","attributeTranslation":"9.\tAnvändning av prövningsläkemedel under de senaste fyra veckorna före screening.","language":24,"languageDescription":"Swedish"},{"id":11911641,"uuid":"f18ccfdf-3d16-4551-b896-c70008410007","attributeTranslation":"9.\tUso de agentes en investigación en las últimas 4 semanas antes de la selección.","language":7,"languageDescription":"Spanish"},{"id":11911640,"uuid":"f18ccfdf-3d16-4551-b896-c70008410007","attributeTranslation":"9. Utilisation d’agents expérimentaux au cours des 4 dernières semaines précédant la sélection.","language":10,"languageDescription":"French"},{"id":11911639,"uuid":"f18ccfdf-3d16-4551-b896-c70008410007","attributeTranslation":"9.\tGebruik van experimentele middelen in de laatste 4 weken vóór de screening.","language":37,"languageDescription":"Dutch (Netherlands)"}]}]},"endPoint":{"primaryEndPoints":[{"id":1122019,"number":1,"endPoint":"•\tPFS, defined as time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.","isPrimary":true,"endPointTranslations":[{"id":11911468,"uuid":"0e5882e3-9eb5-442c-b092-94cc83ec4d3d","attributeTranslation":"La SSP, définie comme le délai entre la date de randomisation et la date de progression de la maladie, déterminée par l’IRC, ou le décès toutes causes confondues, selon la première éventualité.","language":10,"languageDescription":"French"},{"id":11911472,"uuid":"0e5882e3-9eb5-442c-b092-94cc83ec4d3d","attributeTranslation":"PFS, definierat som tiden från randomisering till datumet för sjukdomsprogression enligt bedömning av en IRC eller dödsfall oavsett orsak, beroende på vilket som inträffar först.","language":24,"languageDescription":"Swedish"},{"id":11911470,"uuid":"0e5882e3-9eb5-442c-b092-94cc83ec4d3d","attributeTranslation":"PFS, gedefinieerd als de tijd vanaf de datum van randomisatie tot de datum van ziekteprogressie, zoals bepaald door de IRC, of overlijden door welke oorzaak dan ook, afhankelijk van wat zich het eerst voordoet.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911471,"uuid":"0e5882e3-9eb5-442c-b092-94cc83ec4d3d","attributeTranslation":"SSP, definida como el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha de progresión de la enfermedad según lo determinado por el CRI o la muerte por cualquier causa, lo que ocurra primero.","language":7,"languageDescription":"Spanish"},{"id":11911469,"uuid":"0e5882e3-9eb5-442c-b092-94cc83ec4d3d","attributeTranslation":"PFS definiowany jako czas od daty randomizacji do daty progresji choroby w ocenie IRC lub zgonu z dowolnej przyczyny, w zależności od tego, co nastąpi pierwsze","language":19,"languageDescription":"Polish"}]}],"secondaryEndPoints":[{"id":1122020,"number":1,"endPoint":"•\tuMRD4 rate defined as the proportion of patients that achieved uMRD4 measured in both PB and BMA at the PTFU1 Visit based on next-generation sequencing (NGS [clonoSEQ])","isPrimary":false,"endPointTranslations":[{"id":11911473,"uuid":"5767506e-b04d-4e2d-8b4e-813718ec6b4f","attributeTranslation":"Percentage uMRD4, gedefinieerd als het aandeel patiënten dat uMRD4 bereikte, gemeten in zowel PB als BMA bij bezoek PTFU 1 op basis van next-generation sequencing (NGS [clonoSEQ])","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911476,"uuid":"5767506e-b04d-4e2d-8b4e-813718ec6b4f","attributeTranslation":"Le taux d’uMRD4 est défini comme la proportion de patients ayant atteint l’uMRD4 mesuré à la fois dans le SP et la PMO lors de la visite PTFU1 sur la base du séquençage de nouvelle génération (NGS [clonoSEQ])","language":10,"languageDescription":"French"},{"id":11911475,"uuid":"5767506e-b04d-4e2d-8b4e-813718ec6b4f","attributeTranslation":"uMRD4-frekvens definierad som andelen patienter som uppnådde uMRD4 mätt i både PB och BMA vid PTFU1-besöket baserat på nästa generations sekvensering (NGS [clonoSEQ])","language":24,"languageDescription":"Swedish"},{"id":11911474,"uuid":"5767506e-b04d-4e2d-8b4e-813718ec6b4f","attributeTranslation":"Wskaźnik uMRD4 zdefiniowany jako odsetek pacjentów, u których uzyskano uMRD4 zmierzony zarówno w próbkach PB, jak i BMA podczas wizyty PTFU1 na podstawie sekwencjonowania nowej generacji (NGS [clonoSEQ])","language":19,"languageDescription":"Polish"},{"id":11911477,"uuid":"5767506e-b04d-4e2d-8b4e-813718ec6b4f","attributeTranslation":"La tasa de ERMi4 se define como la proporción de pacientes que alcanzaron ERMi4 medida tanto en SP como en AMO en la visita PTFU1 según la secuenciación de nueva generación (NGS [clonoSEQ]).","language":7,"languageDescription":"Spanish"}]},{"id":1122021,"number":2,"endPoint":"•\tPFS as determined by IRC in high-risk patients that have unmutated IGHV and/or TP53 aberrations (del(17p) present and/or TP53 mutated)","isPrimary":false,"endPointTranslations":[{"id":11911479,"uuid":"2b813bf1-6392-474c-be5f-5eccb925ae1c","attributeTranslation":"SSP según lo determinado por el CRI en pacientes de alto riesgo que tienen IGHV no mutado y/o anomalías de TP53 (del(17p) presente y/o TP53 mutado).","language":7,"languageDescription":"Spanish"},{"id":11911480,"uuid":"2b813bf1-6392-474c-be5f-5eccb925ae1c","attributeTranslation":"Określenie czasu PFS określonego przez IRC u pacjentów wysokiego ryzyka bez mutacji IGHV i/lub z aberracją TP53 – obecność (del(17p) i/lub z mutacją TP53)","language":19,"languageDescription":"Polish"},{"id":11911481,"uuid":"2b813bf1-6392-474c-be5f-5eccb925ae1c","attributeTranslation":"PFS enligt bedömning av IRC hos högriskpatienter som har omuterad IGHV och/eller föreliggande TP53-avvikelser (del(17p) och/eller muterad TP53)","language":24,"languageDescription":"Swedish"},{"id":11911482,"uuid":"2b813bf1-6392-474c-be5f-5eccb925ae1c","attributeTranslation":"PFS zoals bepaald door de IRC bij hoogrisicopatiënten met niet-gemuteerd IGHV en/of TP53-afwijkingen (del(17p) aanwezig en/of TP53 gemuteerd)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911478,"uuid":"2b813bf1-6392-474c-be5f-5eccb925ae1c","attributeTranslation":"SSP telle que déterminée par l’IRC chez les patients à haut risque qui présentent des aberrations d’IGHV et/ou de TP53 non mutés (del(17p) présent et/ou TP53 muté)","language":10,"languageDescription":"French"}]},{"id":1122022,"number":3,"endPoint":"•\tOS, defined as time from the date of randomization to the date of death due to any cause","isPrimary":false,"endPointTranslations":[{"id":11911487,"uuid":"b828746c-ec06-4991-8a43-47659113e27e","attributeTranslation":"OS definiowany jako czas od daty randomizacji do daty zgonu z dowolnej przyczyny","language":19,"languageDescription":"Polish"},{"id":11911483,"uuid":"b828746c-ec06-4991-8a43-47659113e27e","attributeTranslation":"SG, definida como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa.","language":7,"languageDescription":"Spanish"},{"id":11911484,"uuid":"b828746c-ec06-4991-8a43-47659113e27e","attributeTranslation":"SG, définie comme le délai entre la date de randomisation et la date de décès toutes causes confondues","language":10,"languageDescription":"French"},{"id":11911485,"uuid":"b828746c-ec06-4991-8a43-47659113e27e","attributeTranslation":"OS, definierat som tiden från randomisering till datum för dödsfall, oavsett orsak.","language":24,"languageDescription":"Swedish"},{"id":11911486,"uuid":"b828746c-ec06-4991-8a43-47659113e27e","attributeTranslation":"OS, gedefinieerd als de tijd vanaf de datum van randomisatie tot de datum van overlijden door welke oorzaak dan ook","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1122023,"number":4,"endPoint":"•\tORR defined as the proportion of patients with a CR, CRi, nodular partial response (nPR), or partial response (PR) per the IRC assessment","isPrimary":false,"endPointTranslations":[{"id":11911492,"uuid":"8cac8ba2-73f9-4d86-aee9-62a120c99a03","attributeTranslation":"ORR, gedefinieerd als het aandeel patiënten met een CR, CRi, nodulaire gedeeltelijke respons (nPR) of gedeeltelijke respons (PR) volgens de beoordeling door de IRC","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911490,"uuid":"8cac8ba2-73f9-4d86-aee9-62a120c99a03","attributeTranslation":"ORR definierad som andelen patienter med CR, CRi, nodulärt partiellt svar (nPR) eller partiellt svar (PR) enligt bedömning av IRC","language":24,"languageDescription":"Swedish"},{"id":11911489,"uuid":"8cac8ba2-73f9-4d86-aee9-62a120c99a03","attributeTranslation":"TRO défini comme la proportion de patients avec une RC, une RCi, une réponse partielle nodulaire (RPn) ou une réponse partielle (RP) selon l’évaluation de l’IRC","language":10,"languageDescription":"French"},{"id":11911488,"uuid":"8cac8ba2-73f9-4d86-aee9-62a120c99a03","attributeTranslation":"ORR zdefiniowany jako odsetek pacjentów, u których w ocenie IRC wykazano odpowiedź całkowitą (ang. complete response, CR), odpowiedź częściową z niepełną regeneracją szpiku (ang. complete remission with incomplete count recovery, CRi), częściową odpowiedź guzkową (ang. nodular partial response, nPR) lub odpowiedź częściową (ang. partial response, PR)","language":19,"languageDescription":"Polish"},{"id":11911491,"uuid":"8cac8ba2-73f9-4d86-aee9-62a120c99a03","attributeTranslation":"La TRG se define como la proporción de pacientes con RC, RCi, respuesta parcial nodular (RPn) o respuesta parcial (RP) según la evaluación del CRI.","language":7,"languageDescription":"Spanish"}]},{"id":1122024,"number":5,"endPoint":"•\tuMRD5 rate defined as the proportion of patients that achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS (clonoSEQ)","isPrimary":false,"endPointTranslations":[{"id":11911493,"uuid":"fa9c19cf-0478-41f3-9811-de32fb72631a","attributeTranslation":"La tasa de ERMi5 se define como la proporción de pacientes que alcanzaron ERMi5 medida tanto en SP como en AMO en la visita PTFU1 según la secuenciación de nueva generación NGS (clonoSEQ).","language":7,"languageDescription":"Spanish"},{"id":11911496,"uuid":"fa9c19cf-0478-41f3-9811-de32fb72631a","attributeTranslation":"Le taux d’uMRD5 est défini comme la proportion de patients ayant atteint l’uMRD5 mesuré à la fois dans le SP et la PMO lors de la visite PTFU1 sur la base du NGS (clonoSEQ)","language":10,"languageDescription":"French"},{"id":11911495,"uuid":"fa9c19cf-0478-41f3-9811-de32fb72631a","attributeTranslation":"Percentage uMRD5, gedefinieerd als het aandeel patiënten dat uMRD5 bereikte, gemeten in zowel PB als BMA bij bezoek PTFU 1 op basis van NGS (clonoSEQ)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911494,"uuid":"fa9c19cf-0478-41f3-9811-de32fb72631a","attributeTranslation":"uMRD5-frekvens definierad som andelen patienter som uppnådde uMRD5 mätt i både PB och BMA vid PTFU1-besöket baserat på (NGS [clonoSEQ])","language":24,"languageDescription":"Swedish"},{"id":11911497,"uuid":"fa9c19cf-0478-41f3-9811-de32fb72631a","attributeTranslation":"Wskaźnik uMRD5 zdefiniowany jako odsetek pacjentów, u których uzyskano uMRD5 zmierzony zarówno w próbkach PB, jak i BMA podczas wizyty PTFU1 na podstawie sekwencjonowania nowej generacji (clonoSEQ)","language":19,"languageDescription":"Polish"}]},{"id":1122025,"number":6,"endPoint":"•\tAdverse events (AEs), adverse events of clinical interest (AECIs), serious adverse events (SAEs), changes from baseline in clinical laboratory tests, physical examinations, and vital signs","isPrimary":false,"endPointTranslations":[{"id":11911501,"uuid":"0469bde3-b51f-4876-b007-9260264dcab0","attributeTranslation":"Bijwerkingen (AE's), bijwerkingen van klinisch belang (AECI's), ernstige bijwerkingen (SAE's), veranderingen ten opzichte van baseline in klinische laboratoriumtests, lichamelijk onderzoek en vitale functies.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911499,"uuid":"0469bde3-b51f-4876-b007-9260264dcab0","attributeTranslation":"Événements indésirables (EI), événements indésirables d’intérêt clinique (EIIP), événements indésirables graves (EIG), changements par rapport à la référence dans les analyses de laboratoire clinique, les examens cliniques et les signes vitaux","language":10,"languageDescription":"French"},{"id":11911498,"uuid":"0469bde3-b51f-4876-b007-9260264dcab0","attributeTranslation":"Biverkningar (AEs), biverkningar av kliniskt intresse (AECIs), allvarliga biverkningar (SAEs), förändringar från baslinjen avseende kliniska laboratorietester, hälsokontroller och vitala tecken","language":24,"languageDescription":"Swedish"},{"id":11911502,"uuid":"0469bde3-b51f-4876-b007-9260264dcab0","attributeTranslation":"Zdarzenia niepożądane (ang. adverse events, AEs), zdarzenia niepożądane zainteresowania klinicznego (ang. adverse events of clinical interest, AECI), ciężkie zdarzenia niepożądane (ang. serious adverse events, SAEs), zmiany w wynikach badań laboratoryjnych względem punktu początkowego, badania przedmiotowe i pomiary parametrów życiowych","language":19,"languageDescription":"Polish"},{"id":11911500,"uuid":"0469bde3-b51f-4876-b007-9260264dcab0","attributeTranslation":"Acontecimientos adversos (AA), acontecimientos adversos de interés clínico (AAIC), acontecimientos adversos graves (AAG), cambios con respecto al inicio en las pruebas de laboratorio clínico, las exploraciones físicas y las constantes vitales.","language":7,"languageDescription":"Spanish"}]},{"id":1122026,"number":7,"endPoint":"•\tPFS determined by investigator assessment","isPrimary":false,"endPointTranslations":[{"id":11911504,"uuid":"df6ad4cd-f4b4-4c88-8035-38b453c48648","attributeTranslation":"PFS som fastställs enligt prövarens bedömning","language":24,"languageDescription":"Swedish"},{"id":11911506,"uuid":"df6ad4cd-f4b4-4c88-8035-38b453c48648","attributeTranslation":"SSP évaluée par l’évaluation de l’investigateur","language":10,"languageDescription":"French"},{"id":11911505,"uuid":"df6ad4cd-f4b4-4c88-8035-38b453c48648","attributeTranslation":"SSP según lo determinado por la evaluación del investigador.","language":7,"languageDescription":"Spanish"},{"id":11911507,"uuid":"df6ad4cd-f4b4-4c88-8035-38b453c48648","attributeTranslation":"PFS vastgesteld door beoordeling van de onderzoeker.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911503,"uuid":"df6ad4cd-f4b4-4c88-8035-38b453c48648","attributeTranslation":"PFS określony na podstawie oceny badacza","language":19,"languageDescription":"Polish"}]},{"id":1122027,"number":8,"endPoint":"•\tOverall CRR determined by IRC and by investigator assessment.","isPrimary":false,"endPointTranslations":[{"id":11911508,"uuid":"740adb8e-0dd3-4293-bc40-5e1588f4d63d","attributeTranslation":"Ogólny wskaźnik odpowiedzi (overall response rate, CRR) określony przez IRC i w ramach oceny przeprowadzanej przez badacza","language":19,"languageDescription":"Polish"},{"id":11911512,"uuid":"740adb8e-0dd3-4293-bc40-5e1588f4d63d","attributeTranslation":"Totale CRR vastgesteld door de IRC en door beoordeling van de onderzoeker.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911511,"uuid":"740adb8e-0dd3-4293-bc40-5e1588f4d63d","attributeTranslation":"TRC global déterminé par l’IRC et l’évaluation de l’investigateur","language":10,"languageDescription":"French"},{"id":11911509,"uuid":"740adb8e-0dd3-4293-bc40-5e1588f4d63d","attributeTranslation":"TRC global según lo determinado por el CRI y la evaluación del investigador.","language":7,"languageDescription":"Spanish"},{"id":11911510,"uuid":"740adb8e-0dd3-4293-bc40-5e1588f4d63d","attributeTranslation":"Total svarsfrekvens (CRR) fastställd av IRC och enligt prövarens bedömning.","language":24,"languageDescription":"Swedish"}]},{"id":1122028,"number":9,"endPoint":"•\tORR determined by investigator assessment","isPrimary":false,"endPointTranslations":[{"id":11911514,"uuid":"cb94207a-1378-4b45-b364-04b6be433673","attributeTranslation":"ORR vastgesteld door beoordeling van de onderzoeker","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911513,"uuid":"cb94207a-1378-4b45-b364-04b6be433673","attributeTranslation":"TRO évalué par l’évaluation de l’investigateur","language":10,"languageDescription":"French"},{"id":11911516,"uuid":"cb94207a-1378-4b45-b364-04b6be433673","attributeTranslation":"ORR som fastställs enligt prövarens bedömning","language":24,"languageDescription":"Swedish"},{"id":11911515,"uuid":"cb94207a-1378-4b45-b364-04b6be433673","attributeTranslation":"TRG según lo determinado por la evaluación del investigador.","language":7,"languageDescription":"Spanish"},{"id":11911517,"uuid":"cb94207a-1378-4b45-b364-04b6be433673","attributeTranslation":"ORR określony na podstawie oceny badacza","language":19,"languageDescription":"Polish"}]},{"id":1122029,"number":10,"endPoint":"•\tDuration of response (DOR; determined by both IRC and investigator assessment) defined as the time from first qualifying response (CR, CRi, nPR, or PR) until disease progression or death","isPrimary":false,"endPointTranslations":[{"id":11911522,"uuid":"e5c1fbdc-0cd6-4e7d-9d9e-bc17bbe3d7ef","attributeTranslation":"Czas trwania odpowiedzi (ang. duration of response, DOR; określony zarówno przez IRC, jak i w ramach oceny badacza) zdefiniowany jako czas od pierwszej kwalifikującej odpowiedzi (CR, CRi, nPR lub PR) do wystąpienia progresji choroby lub zgonu","language":19,"languageDescription":"Polish"},{"id":11911519,"uuid":"e5c1fbdc-0cd6-4e7d-9d9e-bc17bbe3d7ef","attributeTranslation":"Durée de la réponse (DDR ; déterminée par l’IRC et l’évaluation de l’investigateur) définie comme le délai entre la première réponse qualifiante (RC, RCi, RPn ou RP) et la progression de la maladie ou le décès","language":10,"languageDescription":"French"},{"id":11911518,"uuid":"e5c1fbdc-0cd6-4e7d-9d9e-bc17bbe3d7ef","attributeTranslation":"Duur van de respons (DOR; vastgesteld door zowel de IRC als beoordeling van de onderzoeker), gedefinieerd als de tijd vanaf de eerste in aanmerking komende respons (CR, CRi, nPR of PR) tot ziekteprogressie of overlijden","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911520,"uuid":"e5c1fbdc-0cd6-4e7d-9d9e-bc17bbe3d7ef","attributeTranslation":"Svarsduration (DOR; fastställd av både IRC och prövarens bedömning) definierad som tiden från första kvalificerande svar (CR, CRi, nPR eller PR) till sjukdomsprogression eller dödsfall","language":24,"languageDescription":"Swedish"},{"id":11911521,"uuid":"e5c1fbdc-0cd6-4e7d-9d9e-bc17bbe3d7ef","attributeTranslation":"Duración de la respuesta (DR; según lo determinado por el CRI y la evaluación del investigador), definida como el tiempo transcurrido desde la primera respuesta que cumple los criterios de inclusión (RC, RCi, RPn o RP) hasta la progresión de la enfermedad o la muerte.","language":7,"languageDescription":"Spanish"}]},{"id":1122030,"number":11,"endPoint":"•\tTime to next treatment (TTNT) defined as the time from randomization to the start of next treatment for CLL","isPrimary":false,"endPointTranslations":[{"id":11911524,"uuid":"c1d9514f-153f-4754-ba4a-fc84f53b4008","attributeTranslation":"Czas do następnego leczenia (ang. time to next treatment, TTNT) zdefiniowany jako czas od randomizacji do rozpoczęcia następnego leczenia przewlekłej białaczki limfocytowej","language":19,"languageDescription":"Polish"},{"id":11911525,"uuid":"c1d9514f-153f-4754-ba4a-fc84f53b4008","attributeTranslation":"Tid till nästa behandling (TTNT) definierad som tiden från randomisering till starten av nästa behandling för KLL","language":24,"languageDescription":"Swedish"},{"id":11911526,"uuid":"c1d9514f-153f-4754-ba4a-fc84f53b4008","attributeTranslation":"El tiempo hasta el próximo tratamiento (THPT), definido como el tiempo transcurrido desde la aleatorización hasta el inicio del siguiente tratamiento para la LLC.","language":7,"languageDescription":"Spanish"},{"id":11911527,"uuid":"c1d9514f-153f-4754-ba4a-fc84f53b4008","attributeTranslation":"Tijd tot volgende behandeling (TTNT), gedefinieerd als de tijd vanaf randomisatie tot de start van de volgende behandeling voor CLL","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11911523,"uuid":"c1d9514f-153f-4754-ba4a-fc84f53b4008","attributeTranslation":"Délai avant le prochain traitement (TTNT) défini comme le temps écoulé entre la randomisation et le début du prochain traitement pour la LLC","language":10,"languageDescription":"French"}]},{"id":1122031,"number":12,"endPoint":"•\tPatient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden, and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409","isPrimary":false,"endPointTranslations":[{"id":11911529,"uuid":"6d633890-6aba-487f-811d-9beec755a863","attributeTranslation":"Síntomas comunicados por el paciente sobre el estado de salud global (ESG), el desempeño de roles y el funcionamiento físico, la carga de síntomas y la condición física/fatiga, medidos mediante el cuestionario de calidad de vida de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC IL-409) (una versión detallada del cuestionario central de calidad de vida [EORTC] QLQ-C30 y su módulo CLL CLL17).","language":7,"languageDescription":"Spanish"},{"id":11911528,"uuid":"6d633890-6aba-487f-811d-9beec755a863","attributeTranslation":"Zgłaszane przez pacjentów objawy ogólnego stanu zdrowia (ang. global health status, GHS), funkcjonowanie społeczne i fizyczne, obciążenie objawami oraz kondycja fizyczna / zmęczenie mierzone kwestionariuszem jakości życia Europejskiej Organizacji Badań i Leczenia Raka (European Organization for Research and Treatment of Cancer) EORTC IL-409","language":19,"languageDescription":"Polish"},{"id":11911532,"uuid":"6d633890-6aba-487f-811d-9beec755a863","attributeTranslation":"Symptômes rapportés par les patients concernant l’état de santé général, l’activité sociale et professionnelle et les fonctions physiques, la charge des symptômes et la condition physique/la fatigue mesurés par le questionnaire sur la qualité de vie de l’Organisation européenne pour la recherche et le traitement du cancer EORTC \nIL-409 (une version détaillée du questionnaire « Core 30 » de l’EORTC sur la qualité de vie [QLQ-C30] et son module sur la LLC « CLL17 »)","language":10,"languageDescription":"French"},{"id":11911531,"uuid":"6d633890-6aba-487f-811d-9beec755a863","attributeTranslation":"Patientrapporterade symtom på global hälsostatus (GHS), rollfunktion och fysisk funktion, symtombörda och fysiskt tillstånd/utmattning mätt med livskvalitetsformuläret EORTC IL-409 från European·Organization·for·Research·and·Treatment·of·Cancer","language":24,"languageDescription":"Swedish"},{"id":11911530,"uuid":"6d633890-6aba-487f-811d-9beec755a863","attributeTranslation":"Door de patiënt gemelde symptomen van de algehele gezondheidsstatus (GHS), rolfunctioneren en fysiek functioneren, symptoombelasting en fysieke conditie/vermoeidheid gemeten met behulp van de vragenlijst EORTC IL409 over de kwaliteit van leven van de European Organisation for Research and Treatment of Cancer","language":37,"languageDescription":"Dutch 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