natgillin/translations-raw huggingface dataset:
OPDIVO som monoterapi er indiceret til behandling af voksne patienter med recidiverende eller refraktært klassisk Hodgkins lymfom efter autolog stamcelletransplantation (ASCT) og behandling med brentuximab vedotin.
OPDIVO as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
Ved mistanke om myocarditis skal høj dosis steroider (prednison 1 til 2 mg/kg/dag eller methylprednisolon 1 til 2 mg/kg/dag) omgående initieres, og en kardiologisk konsultation med en diagnostisk undersøgelse i henhold til de gældende kliniske retningslinjer skal hurtigt udføres.
If myocarditis is suspected, prompt initiation of a high dose of steroids (prednisone 1 to 2 mg/kg/day or methylprednisolone 1 to 2 mg/kg/day) and prompt cardiology consultation with diagnostic workup according to current clinical guidelines should be initiated.
73 % af patienterne havde kutant melanom, og 10 % havde mukosalt melanom.
Seventy-three percent of patients had cutaneous melanoma and 10% had mucosal melanoma.
Hos de 128 patienter, hvor nivolumab i kombination med ipilimumab blev seponeret på grund af bivirkninger efter en opfølgningsperiode på 18 måneder, var median-PFS 16,7 måneder (95 % CI: 10,2; N.A.).
Among 128 patients who discontinued nivolumab in combination with ipilimumab due to adverse reaction after 18 months of follow-up, median PFS was 16.7 months (95% CI: 10.2, NA).
Sunitinib (hændelser: 209/422), median og 95,0 % CI: 26,97 (22,08; 34,83)
Sunitinib (events: 209/422), median and 95.0% CI: 26.97 (22.08, 34.83)
Tegn og symptomer på hepatitis kan være unormale prøveresultater for leverfunktionen, gulfarvning af øjnene eller huden (gulsot), smerter i den højre side af maven eller træthed.
Signs and symptoms of hepatitis may include abnormal liver function tests, eye or skin yellowing (jaundice), pain on the right side of your stomach area, or tiredness.
Grad 4 hypotyroidisme Grad 4 hypertyroidisme Grad 4 hypofysitis Grad 3 eller 4 binyrebarkinsufficiens Grad 4 diabetes
Grade 4 hypothyroidism Grade 4 hyperthyroidism Grade 4 hypophysitis Grade 3 or 4 adrenal insufficiency Grade 4 diabetes
Indehaveren af markedsføringstilladelsen skal indsende de endelige OS-data for CA209238-studiet : Et randomiseret, dobbeltblindt fase 3-studie med OPDIVO versus Yervoy hos patienter, som har fået foretaget komplet resektion af melanom i stadie IIIb/c eller stadie IV.
The MAH should submit the final OS data for study CA209238: A Phase 3, randomised double-blind study of OPDIVO versus Yervoy in patients who have undergone complete resection of Stage IIIb/c or Stage IV melanoma.
For monoterapifasen, bør den første dosis nivolumab administreres; 3 uger efter den sidste dosis af nivolumab og ipilimumab i kombination, hvis der anvendes 240 mg hver 2. uge; eller 6 uger efter den sidste dosis af nivolumab og ipilimumab i kombination, hvis der anvendes 480 mg hver 4. uge.
For the monotherapy phase, the first dose of nivolumab should be administered; 3 weeks after the last dose of the combination of nivolumab and ipilimumab if using 240 mg every 2 weeks; or 6 weeks after the last dose of the combination of nivolumab and ipilimumab if using 480 mg every 4 weeks.
Den ordinerende læge skal tale med patienten om de risici, der er forbundet med behandling med OPDIVO.
The prescriber must discuss the risks of OPDIVO therapy with the patient.
Klargøring af infusion Vær opmærksom på aseptisk håndtering, mens infusionen forberedes.
Preparing the infusion Take care to ensure aseptic handling when you prepare the infusion.
Der blev udført yderligere præspecificerede undergruppeanalyser for at vurdere virkningen ud fra PD-L1-tumorekspression ved prædefinerede niveauer på 1 %, 5 % og 10 %.
Additional prespecified subgroup analyses were conducted to evaluate the efficacy by tumour PD-L1 expression at predefined levels of 1%, 5%, and
PFS-rater ved 12 måneder og 95 % CI: 18 % (14; 23)
PFS rate at 12 months and 95% CI: 18% (14, 23)
OS-resultater fra denne opfølgende analyse er vist i Figur 5 (hele den randomiserede population), Figur 6 (ved tumor-PD-L1 1 % cut-off) og tabel 11 (ved tumor-PD-L1 5 % cut-off).
OS results from this follow-up analysis are shown in Figure 5 (all randomised), Figure 6 (at the tumour PD-L1 1% cut off), and Table 11 (at the tumour PD-L1 5% cut off).
Rate (95 % CI) ved 12 måneder “+” betegner en censureret observation.
Rate (95% CI) at 12 months “+” denotes a censored observation.
De fleste patienter havde ECOG-performance-score 0 (64 %) eller 1 (34 %).
Most patients had ECOG performance score of 0 (64%) or 1 (34%).
kemoterapi (n = 47)
chemotherapy (n = 47)
Før behandling med kombinationen indledes, bør lægen omhyggeligt vurdere den enkelte patient og tumorkarakteristika, samtidig med at fordele og toksicitet ved kombinationen i forhold til nivolumab-monoterapi tages i betragtning (se pkt.
Before initiating treatment with the combination, physicians are advised to carefully evaluate the individual patient and tumour characteristics, taking into consideration the observed benefits and the toxicity of the combination relative to nivolumab monotherapy (see sections 4.8 and 5.1).
Når det blev administreret i kombination med ipilimumab øgedes nivolumabs CL med 20 % ved tilstedeværelse af anti-nivolumab-antistoffer og ipilimumabs CL øgedes med 5,7 % ved tilstedeværelse af anti-ipilimumab-antistoffer.
When administered in combination with ipilimumab, the CL of nivolumab increased by 20% in the presence of anti-nivolumab antibodies and the CL of ipilimumab increased by 5.7% in the presence of anti-ipilimumab antibodies.
Ikke almindelig tubulointerstitiel nefritis, nyresvigt (inklusive akut nyreskade)a,c Almene symptomer og reaktioner på administrationsstedet Meget almindelig træthed
Uncommon tubulointerstitial nephritis, renal failure (including acute kidney injury)a,c General disorders and administration site conditions Very common fatigue
Du skal læse indlægssedlen for ipilimumab, så du kender dette lægemiddel.
Please refer to the package leaflet of ipilimumab in order to understand the use of this medicine.
Dosisjustering er ikke nødvendig til ældre patienter (≥ 65 år) (se pkt.
No dose adjustment is required for elderly patients (≥ 65 years) (see section 5.2).
OPDIVO indeholder natrium
OPDIVO contains sodium
“+” Betegner en censureret observation.
“+” Denotes a censored observation.
Ikke almindelig psoriasis
Uncommon psoriasis
Symptomer omfatter overdreven tørst, kraftigt øget urinproduktion, øget appetit med vægttab, træthed, sløvhed, svaghedsfølelse, nedtrykthed, irritabilitet og generel utilpashed eller diabetisk ketoacidose (syrestoffer i blodet som følge af diabetes).
Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
Hyppighed (95 % CI) Ved 6 måneder Ved 12 måneder Progressionsfri overlevelse Hændelser
Rate (95% CI) At 6 months At 12 months Progression-free survival Events
Tabel 1: Anbefalet dosis og infusionstid for intravenøs administration af nivolumab som monoterapi
Table 1: Recommended dose and infusion time for intravenous administration of nivolumab monotherapy
Baseline-karakteristika var velbalancerede mellem de to grupper.
Baseline characteristics were balanced between the two groups.
Den tidligere platinbaserede behandling blev administreret som adjuverende eller neoadjuverende behandling og til primær, recidiverende eller metastatiske sygdom.
Prior platinum-based therapy was administered in either the adjuvant, neo-adjuvant, primary, recurrent, or metastatic setting.
Almindelig muskuloskeletale smerterg artritis, muskelkramper, muskelsvaghed
Common musculoskeletal paing arthritis, muscle spasms, muscular weakness
I murine drægtighedsmodeller er blokering af PD-L1-signalering vist at ødelægge tolerancen for fosteret og øge fosterdødeligheden.
Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to increase foetal loss.
Så snart diagnosen myocarditis er fastslået, skal nivolumab eller nivolumab i kombination med ipilimumab udsættes eller seponeres permanent (se pkt.
Once a diagnosis of myocarditis is established, nivolumab or nivolumab in combination with ipilimumab should be withheld or permanently discontinued (see section 4.2).
Betændelseslignende reaktion (inflammation) i huden, som kan medføre alvorlige hudreaktioner (kendt som toksisk epidermal nekrolyse og Stevens-Johnsons syndrom).
Inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis and Stevens-Johnson syndrome).
Mediantiden fra initial diagnosticering til randomisering var 0,4 år i både gruppen med nivolumab 3 mg/kg i kombination med ipilimumab 1 mg/kg og i sunitinibgruppen.
The median duration of time from initial diagnosis to randomisation was 0.4 years in both the nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg and sunitinib groups.
Resultater fra eksplorative, multivariate analyser viser, andre patient- og tumorkarakteristika (ECOG-performance-score, Mstadie, LDH ved baseline, BRAF-mutationsstatus, PD-L1-status og køn) som kan være medvirkende til overlevelsesudfaldet.
Results from exploratory multivariate analyses identified patient and tumour characteristics (ECOG performance status, M stage, baseline LDH, BRAF mutation status, PD-L1 status, and gender) which might contribute to the survival outcome.
Ud af de 382 patienter i denne gruppe, som fortsatte behandlingen i enkeltstoffasen, fik 144 (38 %) mindst én grad 3 eller 4 bivirkning i løbet af enkeltstoffasen.
Among the 382 patients in this group who continued treatment in the single-agent phase, 144 (38%) experienced at least one Grade 3 or 4 adverse reaction during the single-agent phase.
Ingen af bivirkningerne blev af investigatorerne anset for at være relateret til nivolumab på nær arytmi (artrieflimren, takykardi og ventrikulær arytmi).
All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia).
Af de 2.022 patienter, som blev behandlet med nivolumab-monoterapi 3 mg/kg hver 2. uge og undersøgt for antistoffer mod lægemidlet, blev 231 patienter (11,4 %) testet positive for behandlingsrelaterede antistoffer, heraf blev 15 patienter (0,7 %) testet positive for neutraliserende antistoffer.
Of the 2022 patients who were treated with nivolumab monotherapy 3 mg/kg every 2 weeks and evaluable for the presence of anti-product-antibodies, 231 patients (11.4%) tested positive for treatment-emergent anti-product-antibodies with fifteen patients (0.7 %) testing positive for neutralising antibodies.
Opdateret analyse Minimum opfølgning: 24,2 måneder
Updated analysis Minimum follow-up: 24.2 months
95 % CI p-værdi p<0.0001
Hazard ratioa 95% CI p-value p<0.0001
Forbedringen af OS var sammenlignelig mellem nivolumab i kombination med ipilimumab og nivolumab som monoterapi hos patienter med høj PD-L1-tumorekspression (PD-L1 ≥ 1 %).
The improvement in OS was similar between nivolumab in combination with ipilimumab and nivolumab monotherapy in patients with high tumour PD-L1 expression (PD-L1 ≥ 1%).
95 % CI p-værdi Median (95 % CI) “+” betegner en censureret observation.
Hazard ratio 95% CI p-value Median (95% CI) “+” denotes a censored observation.
• At behandling med OPDIVO kan øge risikoen for: o Immunrelateret pneumonitis o Immunrelateret colitis o Immunrelateret hepatitis o Immunrelateret nefritis og nedsat nyrefunktion o Immunrelaterede endokrinopatier o Immunrelaterede hudreaktioner o Andre immunrelaterede bivirkninger
• That OPDIVO treatment may increase the risk of: o Immune-related pneumonitis o Immune-related colitis o Immune-related hepatitis o Immune-related nephritis and renal dysfunction o Immune-related endocrinopathies o Immune-related skin adverse reactions o Other immune-related ARs
Tegn og symptomer på en alvorlig hudreaktion kan være udslæt, kløe og afskalning af huden (kan være dødelig).
Signs and symptoms of severe skin reaction may include rash, itching, and peeling of the skin (possibly fatal).
Bekræftet objektiv respons (95 % CI)
Confirmed objective response (95% CI)
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Fald i antallet af nogle hvide blodceller Diarre (vandig, løs eller blød afføring), kvalme Hududslæt, undertiden med blærer, kløe Træthed eller svaghedsfølelse
Very common (may affect more than 1 in 10 people) Decrease in some white blood cells Diarrhoea (watery, loose or soft stools), nausea Skin rash sometimes with blisters, itching Feeling tired or weak
Figur 5 Samlet overlevelse (CA209067) - Opfølgningsperiode på minimum 36 måneder
Figure 5 Overall survival (CA209067) - Minimum follow-up of 36 months
Ud af de 147 patienter i denne gruppe, som fortsatte behandlingen i enkeltstoffasen, fik 47 (32 %) mindst én grad 3 eller 4 bivirkning i løbet af enkeltstoffasen.
Among the 147 patients in this group who continued treatment in the single-agent phase, 47 (32%) experienced at least one Grade 3 or 4 adverse reaction during the single-agent phase.
Alle læger, der ordinerer OPDIVO, skal være fortrolig med behandlingsguiden.
All prescribers of OPDIVO must be familiar with the Physician Information and Management Guidelines.
De 2 primære effektparametre var progressionsfri overlevelse og OS. ORR og responsvarighed blev også vurderet.
The co-primary outcome measures were progression-free survival and OS. ORR and the duration of response were also assessed.
Randomisering blev stratificeret efter PD-L1ekspression (≥ 5 % versus < 5 % tumorcellemembran-ekspression), BRAF-status og M-stadie ifølge American Joint Committee on Cancer (AJCC) stadieklassificering.
Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system.
Grad 5 tilfælde blev rapporteret hos < 0,1 % (2/2.578) af patienterne i disse studier.
Grade 5 cases were reported in < 0.1% (2/2578) of patients in these studies.
Anbefalede modifikationer for OPDIVO og OPDIVO i kombination med ipilimumab
Recommended treatment modifications for OPDIVO or OPDIVO in combination with ipilimumab
Dette medvirker til at øge T-cellernes aktivitet mod kræftceller ved melanom, lungekræft, nyrekræft, lymfekræft, hoved-halskræft eller blærekræft.
This helps increase their activity against the melanoma, lung, kidney, lymphoid, head and neck or bladder cancer cells.
Bivirkning efter markedsføring (se også pkt.
Post-marketing event (also see section 4.4).
OPDIVO-koncentrat er en klar til opaliserende, farveløs til lysegul væske.
OPDIVO concentrate is a clear to opalescent, colourless to pale yellow liquid.
Patienter med tidligere autoimmun sygdom, og alle tilstande der kræver systemisk behandling med enten kortikosteroider (≥ 10 mg prednisolon dagligt eller tilsvarende) eller andre immunosuppresive lægemidler, såvel som patienter der tidligere har modtaget behandling for melanom (undtagen patienter der har modtaget kirurgisk indgreb, adjuverende strålebehandling efter neurokirurgisk resektion for læsioner i centralnervesystemet og tidligere adjuverende interferon færdigbehandlet ≥ 6 måneder inden randomisering) og patienter der tidligere er behandlet med anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 eller anti-CTLA-4 antistof (inklusive ipilimumab eller andre antistoffer eller lægemidler specifikt rettet mod T-celle-costimulation eller checkpoint pathways), blev ekskluderet fra studiet.
Patients with prior autoimmune disease, and any condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications, as well as patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥6 months prior to randomisation) prior therapy with, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways), were excluded from the study.
In-line filtre af polyethersulfonmembraner med en porestørrelse på 0,2 μm til 1,2 μm.
In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
OPDIVO er en medicin, der anvendes til behandling af: fremskredent melanom (en bestemt type hudkræft, modermærkekræft) hos voksne melanom efter komplet resektion hos voksne (behandling efter en operation kaldes adjuverende behandling) fremskreden ikke små-cellet lungekræft (en bestemt type lungekræft) hos voksne fremskredent renalcellekarcinom (fremskreden nyrekræft) hos voksne klassisk Hodgkins lymfom, som er vendt tilbage, eller som ikke har reageret på tidligere behandlinger, herunder autolog stamcelletransplantation (transplantation af dine egne bloddannende celler) hos voksne fremskreden hoved-halskræft hos voksne.
OPDIVO is a medicine used to treat: advanced melanoma (a type of skin cancer) in adults melanoma after complete resection in adults (treatment after surgery is called adjuvant therapy) advanced non-small cell lung cancer (a type of lung cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults classical Hodgkin lymphoma that has come back after or has not responded to previous therapies, including an autologous stem-cell transplant (a transplant of your own blood-producing cells) in adults advanced cancer of the head and neck in adults advanced urothelial carcinoma (bladder and urinary tract cancer) in adults.
Progressionsfri overlevelse i henhold til investigator (måneder) Antal forsøgspersoner i risikogruppe Nivolumab + ipilimumab
Progression Free Survival per Investigator (Months) Number of Subjects at Risk Nivolumab + Ipilimumab
22 % af patienterne havde tumorer, der blev testet BRAF-mutationpositive, og 50 % af patienterne havde tumorer, der blev kategoriseret som PD-L1-positive.
Twenty-two percent of patients had tumours that tested BRAF mutation positive and 50% of patients had tumours that were considered PD-L1 positive.
Den mediane behandlingsvarighed var 5,5 måneder (0-29,6+ måneder) hos nivolumab-behandlede patienter og 3,7 måneder (6 dage-25,7+ måneder) hos everolimus-behandlede patienter.
The median duration of treatment was 5.5 months (range: 0- 29.6+ months) in nivolumab-treated patients and was 3.7 months (range: 6 days-25.7+ months) in everolimus-treated patients.
Nyrer og urinveje Almindelig nyresvigt (inklusive akut nyreskade)a,c nyresvigt (inklusive akut nyreskade)c
Renal and urinary disorders Common renal failure (including acute kidney injury)a,c renal failure (including acute kidney injury)c
Når du først er i behandling med OPDIVO, kan lægen imidlertid godt give dig kortikosteroider for at dæmpe de bivirkninger, du kan få under behandlingen.
However, once you are treated with OPDIVO, your doctor may give you corticosteroids to reduce any possible side effects that you may have during your treatment and this will not impact the effect of the medicine.
I modeller med syngene mus resulterede blokering af PD-1-aktivitet i nedsat tumorvækst.
In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.
Patienter i nivolumab-gruppen med PD-L1-tumorekspression ved alle prædefinerede ekspressionsniveauer viste større sandsynlighed for forbedret overlevelse sammenlignet med patienter i gruppen med investigators valg.
Patients with tumour PD-L1 expression by all predefined expression levels in the nivolumab group demonstrated greater likelihood of improved survival compared to investigator's choice.
Størstedelen af patienterne var mænd (73 %) og kaukasiere (87 %), og henholdsvis 31 % og 69 % af patienterne havde en KPS ved baseline på 70 til 80 % og 90 til 100 %.
The majority of patients were male (73%) and white (87%), and 31% and 69% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
OPDIVO i kombination med ipilimumab: Når nivolumab 1 mg/kg blev administreret i kombination med ipilimumab 3 mg/kg, øgedes nivolumabs CL med 29 % og ipilimumabs CL øgedes med 9 %, hvilket ikke blev anset for klinisk relevant.
OPDIVO in combination with ipilimumab: When nivolumab 1 mg/kg was administered in combination with ipilimumab 3 mg/kg, the CL of nivolumab was increased by 29% and the CL of ipilimumab was increased by 9%, which was not considered clinically relevant.
Behandling af fremskredent melanom
Treatment of advanced melanoma
Omvendt, hvis patienter skal skifte fra 480 mg hver 4. uge til 240 mg hver 2. uge, bør den første dosis med 240 mg administreres fire uger efter den sidste dosis med 480 mg.
Conversely, if patients need to be switched from the 480 mg every 4 weeks schedule to the 240 mg every 2 weeks schedule, the first 240 mg dose should be administered four weeks after the last 480 mg dose.
ECOGperformance-scoren ved baseline var 0 (20 %) eller 1 (78 %), 77 % var tidligere/nuværende rygere, 90 % havde sygdom på stadium IV, 66 % havde to eller flere læsioner, henholdsvis 45 %, 34 % og 20 % havde fået 1, 2 eller 3 eller flere tidligere systemiske behandlinger, og 25 % havde positiv HPV16-status.
Baseline ECOG performance status score was 0 (20%) or 1 (78%), 77% were former/current smokers, 90% had Stage IV disease, 66% had two or more lesions, 45%, 34% and 20% received 1, 2, or 3 or more prior lines of systemic therapy, respectively, and 25% were HPV-16 status positive.
61 % af patienterne havde sygdomsstadie M1c ved inklusion i studiet.
Sixty-one percent of patients had M1c stage disease at study entry.
Nivolumab eller nivolumab i kombination med ipilimumab er associeret med immunrelaterede bivirkninger.
Nivolumab or nivolumab in combination with ipilimumab is associated with immune-related adverse reactions.
I kliniske studier blev der på tværs af doser og tumortyper rapporteret følgende immunrelaterede bivirkninger hos færre end 1 % af de patienter, der blev behandlet med nivolumab-monoterapi eller nivolumab i kombination med ipilimumab: pancreatitis, uveitis, demyelinisering, autoimmun neuropati (herunder facial og nervus abducens parese), Guillain-Barré syndrom, myasthenia gravis, myastenisk syndrom, aseptisk meningitis, encephalitis, gastritis, sarkoidose, duodenitis, myositis, myocarditis og rhabdomyolyse.
The following immune-related adverse reactions were reported in less than 1% of patients treated with nivolumab monotherapy or nivolumab in combination with ipilimumab in clinical trials across doses and tumour types: pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, myasthenia gravis, myasthenic syndrome, aseptic meningitis, encephalitis, gastritis, sarcoidosis, duodenitis, myositis, myocarditis, and rhabdomyolysis.
Grad 2 tilfælde blev rapporteret hos 2,2 % (10/448) af patienterne.
Grade 2 cases were reported in 2.2% (10/448) of patients.
Eftersom monoklonale antistoffer ikke metaboliseres af CYP-enzymer eller andre lægemiddelmetaboliserende enzymer, forventes det ikke, at nivolumabs farmakokinetik vil blive påvirket af samtidigt administrerede lægemidlers hæmning eller induktion af disse enzymer.
As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of nivolumab.
Data fra de 80 patienter fra CA209205 kohorte B og fra de 15 patienter fra CA209039, som fik forudgående behandling med brentuximab vedotin efter ASCT, blev puljet.
Data from the 80 patients from CA209205 Cohort B and from the 15 patients from CA209039 who received prior brentuximab vedotin treatment following ASCT were integrated.