FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase 1 dose finding and safety study (SGN35-009), unacceptable pulmonary toxicity (including 2 fatal events) was noted in 11 of 25 patients (44%) treated with brentuximab vedotin plus ABVD.
Danish: I et fase 1-studie til fastlæggelse af dosis og sikkerhed (SGN35-009) blev der set uacceptabel lungetoksicitet (herunder 2 letale hændelser) hos 11 ud af 25 patienter (44 %), som fik behandling med brentuximab vedotin plus ABVD.
English: The most commonly reported opportunistic infections were herpes zoster and herpes simplex.
Danish: De mest almindelige rapporterede opportunistiske infektioner var herpes zoster og herpes simplex.
English: Grade 3 or Grade 4 anaemia, thrombocytopenia, and prolonged (≥ 1 week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS.
Danish: Grad 3 eller Grad 4 anæmi, trombocytopeni og forlænget (≥1 uge) Grad 3 eller Grad 4 neutropeni kan forekomme ved ADCETRIS.
English: Pneumonia, oral candidiasis, sepsis/septic shock, herpes simplex
Danish: Pneumoni, oral candidiasis, sepsis/septisk shock, herpes simplex
English: After reconstitution each mL of solution contains 5 mg of Adcetris.
Danish: Efter rekonstitution indeholder hver ml i opløsningen 5 mg Adcetris.
English: Each pack of Adcetris consists of one vial.
Danish: Hver pakning med Adcetris indeholder et hætteglas.
English: In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology.
Danish: I to enkeltarmede fase II-studier af ADCETRIS er der blevet vist sygdomsaktivitet i undertyperne Sézarys syndrom (SS), lymfomatoid papulose (LyP) og blandet CTCL-histologi.
English: Progressive multifocal leukoencephalopathy
Danish: Progressiv multifokal leukoencefalopati
English: The recommended dose of ADCETRIS is infused over 30 minutes.
Danish: Den anbefalede dosis af ADCETRIS gives som infusion over 30 minutter.
English: • HL that was refractory to frontline treatment
Danish: • HL, der var refraktært over for primær behandling
English: Adcetris is used to treat systemic anaplastic large cell lymphoma which is found in your lymph nodes and/or throughout other parts of your body that has: not responded to other types of anti-cancer treatments, or come back after previous anti-cancer treatment.
Danish: Adcetris bruges til at behandle systemiske anaplastiske storcellede lymfomer, der findes i dine lymfeknuder og/eller andre dele af kroppen, som: - Ikke har reageret på andre former for kræftbehandling, eller - Er vendt tilbage efter tidligere behandlinger mod kræft.
English: In the pivotal phase 2 population (SG035-0003 and SG035-0004), the median duration of Grade 3 or Grade 4 neutropenia was limited (1 week); 2% of patients had Grade 4 neutropenia that lasted ≥ 7 days.
Danish: I den pivotale fase 2-population (SG035-0003 og SG035-0004) var den mediane varighed af Grad 3 eller Grad 4 neutropeni begrænset (1 uge); 2 % af patienterne havde Grad 4 neutropeni, der varede ≥ 7 dage.
English: The median duration of response was 8.8 and 12.3 months in patients who achieved OR (CR+PR) and CR, respectively.
Danish: Den mediane responsvarighed var hhv. 8,8 og 12,3 måneder hos patienter, som opnåede OR (CR+PR) og CR.
English: The effects of brentuximab vedotin on human male and female fertility have not been studied.
Danish: Virkningerne af brentuximab vedotin på human mandlig og kvindelig fertilitet er ikke undersøgt.
English: Total volume per vial (10 mL/vial)
Danish: Totalt volumen per hætteglas (10 ml/hætteglas)
English: Adcetris will be given to you together with doxorubicin, vinblastine and dacarbazine which are other chemotherapy medicines used to treat Hodgkin lymphoma.
Danish: Du vil få Adcetris sammen med doxorubicin, vinblastin og dacarbazin, som er andre kemoterapilægemidler, der bruges til at behandle Hodgkins lymfom.
English: Of the ITT population, 846 patients (64%) had Stage IV disease.
Danish: 846 patienter (64 %) i ITT-populationen havde stadie IV-sygdom.
English: Demyelinating polyneuropathy Respiratory, thoracic and mediastinal disorders Very common:
Danish: Demyeliniserende polyneuropati Luftveje, thorax og mediastinum Meget almindelig:
English: Patients experiencing new or worsening peripheral neuropathy may require a delay and a dose reduction of ADCETRIS or discontinuation of treatment (see section 4.2).
Danish: Patienter, der oplever ny eller forværret perifer neuropati, kan behøve en udsættelse og en dosisreduktion af ADCETRIS eller seponering af behandlingen (se pkt.
English: Population PK analysis showed that baseline serum albumin concentration was a significant covariate of MMAE clearance.
Danish: Farmakokinetiske populationsanalyser viste, at serum-albuminkoncentrationen ved baseline var en vigtig kovariat for MMAE-clearance.
English: Reconstituted vial concentration (5 mg/ml)
Danish: Rekonstitueret hætteglaskoncentration (5 mg/ml)
English: Adcetris is used alone to treat classical Hodgkin lymphoma that has: - come back after or not responded to an infusion of your own healthy stem cells into your body (autologous stem cell transplant), or - come back after or never responded to at least two previous therapies, and where you cannot receive additional combination anti-cancer treatments or have an autologous stem cell transplant.
Danish: Adcetris alene bruges til at behandle klassisk Hodgkins lymfom, der er: - Vendt tilbage eller ikke har reageret på infusion af dine egne raske stamceller i din krop (autolog stamcelletransplantation), eller - Vendt tilbage efter eller aldrig har reageret på mindst to forudgående behandlinger, og hvor du ikke kan modtage yderligere kombinationer af lægemidler mod cancer eller modtage en autolog stamcelletransplantation.
English: The median time to best overall response, defined as the time from first dose to the clinical best response of CR or PR, was 11 weeks (range, 5 to 60 weeks).
Danish: Den mediane tid til bedste samlede respons, defineret som tiden fra første dosis til det klinisk bedste respons i form af CR eller PR, var 11 uger (interval 5 til 60 uger).
English: In vitro data indicate that the MMAE metabolism that occurs is primarily via oxidation by CYP3A4/5.
Danish: In vitro-data indikerer, at MMAEmetabolisme, der forekommer primært via oxidation af CYP3A4/5.
English: The estimated overall survival rate at 5 years was 41% (95% CI [31%, 51%]).
Danish: Den estimerede samlede overlevelsesrate efter 5 år var 41 % (95 % CI [31 %, 51 %]).
English: - are allergic to brentuximab vedotin or any of the other ingredients of this medicine (listed in section 6).
Danish: - er allergisk over for brentuximab vedotin eller et af de øvrige indholdsstoffer i Adcetris (angivet i pkt.
English: MMAE has been shown to have aneugenic properties (see section 5.3).
Danish: MMAE har vist sig at have aneugene egenskaber (se pkt.
English: Herpes zoster, pneumonia, herpes simplex, oral candidiasis
Danish: Herpes zoster, pneumoni, herpes simplex, oral candidiasis
English: Of the 20 evaluable patients with HL, 6 patients (30%) achieved a CR and 6 patients (30%) achieved a PR with ADCETRIS retreatment, for an ORR of 60%.
Danish: Af de 20 evaluerbare patienter med HL opnåede 6 patienter (30 %) CR, og 6 patienter (30 %) opnåede PR med genbehandling med ADCETRIS, dvs. en ORR på 60 %.
English: The ORR was 47% in response-evaluable patients with r/r HL, 53% in patients with r/r sALCL and 60% in sALCL patients in first relapse.
Danish: ORR for patienter, der kunne evalueres for respons, var henholdsvis 47 % for patienter med r/r HL, 53 % for patienter med r/r sALCL og 60 % for patienter med sALCL i første recidiv.
English: Data were also collected from patients (n = 15) in phase 1 dose escalation and clinical pharmacology studies, and from patients (n = 26) in a NPP, with relapsed or refractory HL who had not received an ASCT, and who were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Danish: Data blev også indsamlet fra patienter (n = 15) i fase 1 dosisoptrapning og klinisk farmakologiske studier, og fra patienter (n = 26) i et NPP, med recidiverende eller refraktær HL, som ikke havde modtaget en ASCT, og som blev behandlet med 1,8 mg/kg ADCETRIS hver 3. uge.
English: An excretion study was undertaken in patients who received a dose of 1.8 mg/kg of brentuximab vedotin.
Danish: Der blev gennemført et udskillelsesstudie på patienter, der fik en dosis på 1,8 mg/kg brentuximab vedotin.
English: Pneumocystis jiroveci pneumonia, staphylococcal bacteraemia, cytomegalovirus infection or reactivation, sepsis/septic shock
Danish: Pneumocystis jiroveci pneumoni, stafylokokbakteriæmi, cytomegalovirusinfektion eller reaktivering, sepsis/septisk shock
English: The median modified PFS by IRF assessment was not reached in either treatment arm.
Danish: IRF-vurdering blev ikke nået i nogen af behandlingsarmene.
English: At the time of the primary analysis, the median follow-up time for both arms was 30 months (range, 0 to 50).
Danish: På tidspunktet for den primære analyse var den mediane opfølgningstid 30 måneder (interval 0 til 50) for begge arme.
English: Progression Free Survival
Danish: Progressionsfri overlevelse
English: Patients ≥ 65 years old n (%) Gender n (%)
Danish: Patienter ≥ 65 år n (%) Køn n (%)
English: Table 2: Dosing recommendations for new or worsening peripheral sensory or motor neuropathy
Danish: Tabel 2: Doseringsanbefalinger for ny eller forværret perifer sensorisk eller motorisk neuropati
English: In all clinical trials, brentuximab vedotin was administered as an intravenous infusion.
Danish: I alle kliniske forsøg blev brentuximab vedotin administreret som en intravenøs infusion.
English: Not reached (95% CI [26.4, -])
Danish: Ikke nået (95% CI [26,4; -])
English: Histologically confirmed CD30-expressing disease Disease characteristics
Danish: Histologisk bekræftet CD30-udtrykkende sygdom Sygdomskarakteristika
English: There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with hepatic impairment, where total bilirubin is > 1.5 times the upper limit of normal (ULN) (unless due to Gilbert syndrome), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are > 3 times the ULN, or > 5 times the ULN if their elevation may be reasonably ascribed to the presence of HL in the liver.
Danish: Der er ingen erfaringer fra kliniske forsøg med ADCETRIS i kombination med kemoterapi hos patienter med nedsat leverfunktion, hvor total bilirubin er > 1,5 gange den øvre grænse for normal (ULN) (medmindre det skyldes Gilberts syndrom), eller hvor aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) er > 3 gange ULN eller > 5 gange ULN, hvis denne forhøjelse med rimelighed kan tilskrives tilstedeværelse af HL i leveren.
English: There were no formal drug-drug interaction studies with brentuximab vedotin and bleomycin(B).
Danish: Der er ikke udført formelle studier af lægemiddelinteraktion med brentuximab vedotin og bleomycin (B).
English: Among patients who experienced peripheral neuropathy, the median follow up time from end of treatment until last evaluation was approximately 91 weeks.
Danish: Blandt de patienter, der oplevede perifer neuropati, var den mediane opfølgningstid fra afslutning af behandlingen til sidste evaluering cirka 91 uger.
English: In nonclinical studies, thymus depletion has been observed (see section 5.3).
Danish: I ikke-kliniske studier er der observeret thymus-depletion (se pkt.
English: Consider G-CSF or GMCSF in subsequent cycles for patients who develop Grade 3 or Grade 4 neutropenia.
Danish: Overvej G-CSF eller GM-CSF i efterfølgende behandlingsserier for patienter, der udvikler neutropeni i Grad 3 eller Grad 4.
English: The primary objective was to evaluate the effect of brentuximab vedotin on cardiac ventricular re-polarization and the predefined primary analysis was the change in QTc from baseline to multiple time points in Cycle 1.
Danish: Det primære mål var at evaluere effekten af brentuximab vedotin på hjerteventrikel-repolarisering, og den forud definerede primære analyse var ændringen i QTc fra baseline til flere tidspunkter i behandlingsserie 1.
English: Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest and results in apoptotic death of the CD30-expressing tumour cell.
Danish: Binding af MMAE til tubulin splitter mikrotubulus-netværket i cellen, inducerer cellecyklusstop og resulterer i den CD30-udtrykkende tumorcelles apoptotiske død.
English: There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with renal impairment, where serum creatinine is ≥ 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance is ≤ 40 mL/minute.
Danish: Der er ingen erfaringer fra kliniske forsøg med ADCETRIS i kombination med kemoterapi hos patienter med nedsat nyrefunktion, hvor serumkreatinin er ≥ 2,0 mg/dl og/eller kreatininclearance eller beregnet kreatininclearance er ≤ 40 ml/minut.
English: In clinical trials, serious infections and opportunistic infections occurred in 10% of patients, sepsis or septic shock occurred in < 1% of the patients.
Danish: I kliniske forsøg forekom alvorlige infektioner og opportunistiske infektioner hos 10% af patienterne, og sepsis eller septisk shock forekom hos < 1 % af patienterne.
English: Response assessments were performed at cycles 2, 4, 7, 10, 13 and 16 with PET at cycles 4 and 7.
Danish: Der blev gennemført respons-vurderinger efter behandlingsserie 2, 4, 7, 10, 13 og 16 med PET-scanning i behandlingsserie 4 og 7.
English: Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Danish: Derfor tilrådes mænd, der behandles med dette lægemiddel, at få nedfrosset og opbevaret spermprøver før behandlingen.
English: No effect was observed in patients with mild or moderate renal impairment.
Danish: Der blev ikke observeret nogen effekt hos patienter med let eller moderat nedsat nyrefunktion.
English: Other secondary efficacy endpoints including CR rate and ORR at the end of randomisation regimen, CR rate at the end of first-line therapy, and the rate of PET negativity at the end of Cycle 2, duration of response (DOR), duration of complete remission (DOCR), disease-free survival (DFS,) and event-free survival (EFS) all trended in favour of ADCETRIS + AVD in both the ITT and Stage IV population.
Danish: Andre sekundære endepunkter for effekt, herunder CR-rate og ORR ved afslutning af randomiseringsregimet, CR-rate ved afslutning af førstelinjebehandling, PET-negativitetsrate ved afslutning af behandlingsserie 2, varighed af respons (DOR), varighed af komplet remission (DOCR), sygdomsfri overlevelse (DFS) samt hændelsesfri overlevelse (EFS), viste alle en tendens til fordel for ADCETRIS + AVD i både ITT- og stadie IV-populationerne.
English: Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; see neuropathy: motor; neuropathy: sensory; and neuropathic pain.
Danish: Graduering baseret på National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; se neuropati: motorisk; neuropati: sensorisk; og neuropatiske smerter.
English: CD30 positivity was defined as ≥10% target lymphoid cells demonstrating membrane, cytoplasmic, and/or Golgi staining pattern based on an immunohistochemistry assay (Ventana anti-CD30 [Ber-H2]).
Danish: CD30-positivitet blev defineret som ≥ 10 % lymfoide targetceller, som udviste membran-, cytoplasma- og/eller Golgifarvningsmønster på baggrund af en immunhistokemisk analyse (Ventana anti-CD30 [Ber-H2]).
English: Each vial contains approximately 13.2 mg of sodium.
Danish: Hvert hætteglas indeholder 13,2 mg natrium.
English: The CD30-targeted mechanism of action of brentuximab vedotin, the consistent expression of CD30 throughout the classical HL, sALCL and CD30+ CTCL disease and therapeutic spectrums and clinical evidence in CD30-positive malignancies following multiple lines of treatment provide a biologic rationale for its use in patients with relapsed and refractory classical HL, sALCL with or without prior ASCT and CD30+ CTCL after at least 1 prior systemic therapy.
Danish: Brentuximab vedotins CD30 målrettede virkningsmekanisme kombineret med den konsekvente udtrykning af CD30 gennem hele den klassiske HL, sALCL og CD30+ CTCL sygdom og terapeutiske spektre og klinisk bevis i CD30positive maligne tilstande efter flere behandlingsforløb giver et biologisk rationale for dets anvendelse i patienter med recidiverende og refraktær klassisk HL, sALCL med eller uden forudgående ASCT og CD30+ CTCL efter mindst 1 forudgående systemisk behandling.
English: If neutropenia develops, refer to Table 1: Dosing recommendations for neutropenia (see section 4.2).
Danish: Hvis der forekommer neutropeni, se Tabel 1: Doseringsanbefalinger ved neutropeni (se pkt.
English: Patients should be monitored during and after infusion (see section 4.4).
Danish: Patienterne skal monitoreres under og efter infusion (se pkt.
English: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence.
Danish: Omfanget af behandlingens effekt ved andre undertyper af CD30+ CTCL end Mycosis Fungoides (MF) og primært kutant anaplastisk storcellelymfom (pcALCL) er ikke klart på grund af manglende højniveau-evidens.
English: ADCETRIS dosing should be permanently discontinued if a diagnosis of PML is confirmed.
Danish: Doseringen af ADCETRIS skal seponeres permanent, hvis diagnosen PML bekræftes.
English: 2.4 vials a.
Danish: 2,4 hætteglas a.
English: Nevertheless, ADCETRIS should be used with caution in other CD30+ CTCL patients after careful consideration of the potential benefit-risk on an individual basis (see section 5.1).
Danish: Ikke desto mindre skal ADCETRIS bruges med forsigtighed hos andre CD30+ CTCL patienter efter omhyggelig overvejelse af det mulige risk/benefit-forhold for den enkelte patient (se pkt.
English: Management of TLS may include aggressive hydration, monitoring of renal function, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
Danish: Behandling af TLS kan omfatte aggressiv hydrering, monitorering af nyrefunktion, korrektion af elektrolytanomalier, anti-hyperurikæmibehandling og støttebehandling.
English: For safety information of chemotherapy agents given in combination with ADCETRIS (doxorubicin, vinblastine and dacarbazine) for newly diagnosed patients with HL, refer to their summary of product characteristics.
Danish: For oplysninger om sikkerheden af kemoterapeutika, der gives i kombination med ADCETRIS (doxorubicin, vinblastin og dacarbazin) til nyligt diagnosticerede patienter med HL, henvises til deres produktresuméer.
English: In nonclinical studies, lymphoid depletion and reduced thymic weight were observed, consistent with the pharmacologic disruption of microtubules caused by MMAE derived from brentuximab vedotin.
Danish: I ikke-kliniske studier observeredes lymfoid depletion og nedsat thymusvægt i overensstemmelse med den farmakologiske nedbrydning af mikrotubuli forårsaget af MMAE deriveret fra brentuximab vedotin.
English: These data indicate the absence of clinically relevant QT prolongation due to brentuximab vedotin administered at a dose of 1.8 mg/kg every 3 weeks in patients with CD30-expressing malignancies.
Danish: Disse data indikerer fravær af klinisk relevant QT-forlængelse som følge af brentuximab vedotin administreret ved en dosis på 1,8 mg/kg hver 3. uge hos patienter med maligniteter, der udtrykker CD30.
English: Patients experiencing hepatotoxicity may require a delay, change in dose or discontinuation of ADCETRIS.
Danish: Patienter, der oplever levertoksicitet, kan få behov for forsinkelse i dosis, dosisændring eller ophør af behandling med ADCETRIS.
English: What Adcetris is and what it is used for What you need to know before you are given Adcetris How Adcetris will be given Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du begynder at få Adcetris Sådan indgives Adcetris Bivirkninger
English: b risk factors, n (%)
Danish: b risikofaktorer, n (%)
English: Per IRF, the ORR was 51% (95% CI [36%, 66%]) for the patients who had received > 1 prior cancer-related treatment and 45% (95% CI [17%, 77%]) for the patients who had received 1 prior cancer-related treatment.
Danish: IRF-vurdering var ORR 51 % (95 % CI [36 %, 66 %]) for de patienter, som tidligere havde fået > 1 cancerrelateret behandling, og 45 % (95 % CI [17 %, 77 %]) for de patienter, som tidligere havde fået 1 cancerrelateret behandling.
English: The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om lægemidlet, og produktresuméet vil om nødvendigt blive ajourført.
English: Across the study, a total of 16 patients with r/r HL and 17 patients with r/r sALCL, of whom 10 were in first relapse, were treated with 1.8 mg/kg of ADCETRIS.
Danish: For hele studiet betragtet, blev i alt 16 patienter med r/r HL og 17 patienter med r/r sALCL, hvoraf 10 var i første recidiv, behandlet med ADCETRIS 1,8 mg/kg.
English: Severity of peripheral sensory or motor neuropathy (signs and symptoms [abbreviated description of CTCAE
Danish: Sværhedsgrad af perifer sensorisk eller motorisk neuropati (tegn og symptomer [forkortet beskrivelse af CTCAE
English: CR was 59% (34 of 58 patients in the ITT set) and tumour reduction (of any degree) was achieved in 97% of patients.
Danish: CR var 59 % (34 af 58 patienter i ITT-gruppen) og tumorreduktion (af alle grader) blev opnået hos 97 % af patienterne.
English: MMAE is the major metabolite of brentuximab vedotin.
Danish: MMAE er den vigtigste metabolit af brentuximab vedotin.
English: Nonclinical data suggest that the biological activity of brentuximab vedotin results from a multi-step process.
Danish: Ikke-kliniske data tyder på, at brentuximab vedotins biologiske aktivitet er følgen af en flertrins proces.
English: The median duration of response was 9.2 and 9.4 months in patients who achieved OR (CR+PR) and CR, respectively.
Danish: Den mediane responsvarighed var hhv. 9,2 og 9,4 måneder hos patienter, som opnåede OR (CR+PR) og CR.
English: Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV.
Danish: Forslag til evaluering af PML omfatter neurologikonsultation, gadolinium-forstærket MR-scanning af hjernen og cerebrospinalvæskeanalyse for JCV DNA via polymerasekædereaktion eller en hjernebiopsi med JCV-evidens.
English: a per IRF at 2 Year (%)
Danish: IRF efter 2 år (%)
English: ADC accumulation (as assessed by AUC14D between Cycle 1 and Cycle 3) was 1.27-fold.
Danish: ADC-akkumulering (som vurderet af AUC14D mellem behandlingsserie 1 og behandlingsserie 3) var 1,27 gange.
English: Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; see Neutrophils/granulocytes; LLN = lower limit of normal b.
Danish: Graduering baseret på National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; se Neutrofiler/granulocytter; Lower Limit of normal (LLN) = nederste grænse af normalområdet b.
English: Patients ≥ 65 years old n (%) Gender, n (%)
Danish: Patienter ≥ 65 år, n (%) Køn, n (%)
English: Disease control rate (CR + PR + SD) Duration of response
Danish: Sygdomskontrolrate (CR + PR + SD) Responsvarighed
English: ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Danish: ADCETRIS er indiceret til behandling af voksne patienter med recidiverende eller refraktært systemisk anaplastisk storcellet lymfom (sALCL).
English: Objective Response Rate lasting at least 4 months (ORR4) per IRF n (%)
Danish: Objektiv responsrate varende mindst 4 måneder (ORR4) iht.