FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: Uncommon tubulointerstitial nephritis, renal failure (including acute kidney injury)a,c General disorders and administration site conditions Very common fatigue
Danish: Ikke almindelig tubulointerstitiel nefritis, nyresvigt (inklusive akut nyreskade)a,c Almene symptomer og reaktioner på administrationsstedet Meget almindelig træthed
English: Please refer to the package leaflet of ipilimumab in order to understand the use of this medicine.
Danish: Du skal læse indlægssedlen for ipilimumab, så du kender dette lægemiddel.
English: No dose adjustment is required for elderly patients (≥ 65 years) (see section 5.2).
Danish: Dosisjustering er ikke nødvendig til ældre patienter (≥ 65 år) (se pkt.
English: OPDIVO contains sodium
Danish: OPDIVO indeholder natrium
English: “+” Denotes a censored observation.
Danish: “+” Betegner en censureret observation.
English: Uncommon psoriasis
Danish: Ikke almindelig psoriasis
English: 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).
Danish: 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).
English: Rate (95% CI) At 6 months At 12 months Progression-free survival Events
Danish: Hyppighed (95 % CI) Ved 6 måneder Ved 12 måneder Progressionsfri overlevelse Hændelser
English: Table 1: Recommended dose and infusion time for intravenous administration of nivolumab monotherapy
Danish: Tabel 1: Anbefalet dosis og infusionstid for intravenøs administration af nivolumab som monoterapi
English: Baseline characteristics were balanced between the two groups.
Danish: Baseline-karakteristika var velbalancerede mellem de to grupper.
English: Prior platinum-based therapy was administered in either the adjuvant, neo-adjuvant, primary, recurrent, or metastatic setting.
Danish: Den tidligere platinbaserede behandling blev administreret som adjuverende eller neoadjuverende behandling og til primær, recidiverende eller metastatiske sygdom.
English: Common musculoskeletal paing arthritis, muscle spasms, muscular weakness
Danish: Almindelig muskuloskeletale smerterg artritis, muskelkramper, muskelsvaghed
English: Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to increase foetal loss.
Danish: I murine drægtighedsmodeller er blokering af PD-L1-signalering vist at ødelægge tolerancen for fosteret og øge fosterdødeligheden.
English: Once a diagnosis of myocarditis is established, nivolumab or nivolumab in combination with ipilimumab should be withheld or permanently discontinued (see section 4.2).
Danish: Så snart diagnosen myocarditis er fastslået, skal nivolumab eller nivolumab i kombination med ipilimumab udsættes eller seponeres permanent (se pkt.
English: Inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis and Stevens-Johnson syndrome).
Danish: Betændelseslignende reaktion (inflammation) i huden, som kan medføre alvorlige hudreaktioner (kendt som toksisk epidermal nekrolyse og Stevens-Johnsons syndrom).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia).
Danish: Ingen af bivirkningerne blev af investigatorerne anset for at være relateret til nivolumab på nær arytmi (artrieflimren, takykardi og ventrikulær arytmi).
English: 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.
Danish: 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.
English: Updated analysis Minimum follow-up: 24.2 months
Danish: Opdateret analyse Minimum opfølgning: 24,2 måneder
English: Hazard ratioa 95% CI p-value p<0.0001
Danish: 95 % CI p-værdi p<0.0001
English: 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%).
Danish: 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 %).
English: Hazard ratio 95% CI p-value Median (95% CI) “+” denotes a censored observation.
Danish: 95 % CI p-værdi Median (95 % CI) “+” betegner en censureret observation.
English: • 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
Danish: • 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
English: Signs and symptoms of severe skin reaction may include rash, itching, and peeling of the skin (possibly fatal).
Danish: Tegn og symptomer på en alvorlig hudreaktion kan være udslæt, kløe og afskalning af huden (kan være dødelig).
English: Confirmed objective response (95% CI)
Danish: Bekræftet objektiv respons (95 % CI)
English: 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
Danish: 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
English: Figure 5 Overall survival (CA209067) - Minimum follow-up of 36 months
Danish: Figur 5 Samlet overlevelse (CA209067) - Opfølgningsperiode på minimum 36 måneder
English: 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.
Danish: 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.
English: All prescribers of OPDIVO must be familiar with the Physician Information and Management Guidelines.
Danish: Alle læger, der ordinerer OPDIVO, skal være fortrolig med behandlingsguiden.
English: The co-primary outcome measures were progression-free survival and OS. ORR and the duration of response were also assessed.
Danish: De 2 primære effektparametre var progressionsfri overlevelse og OS. ORR og responsvarighed blev også vurderet.
English: 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.
Danish: Randomisering blev stratificeret efter PD-L1ekspression (≥ 5 % versus < 5 % tumorcellemembran-ekspression), BRAF-status og M-stadie ifølge American Joint Committee on Cancer (AJCC) stadieklassificering.
English: Grade 5 cases were reported in < 0.1% (2/2578) of patients in these studies.
Danish: Grad 5 tilfælde blev rapporteret hos < 0,1 % (2/2.578) af patienterne i disse studier.
English: Recommended treatment modifications for OPDIVO or OPDIVO in combination with ipilimumab
Danish: Anbefalede modifikationer for OPDIVO og OPDIVO i kombination med ipilimumab
English: This helps increase their activity against the melanoma, lung, kidney, lymphoid, head and neck or bladder cancer cells.
Danish: Dette medvirker til at øge T-cellernes aktivitet mod kræftceller ved melanom, lungekræft, nyrekræft, lymfekræft, hoved-halskræft eller blærekræft.
English: Post-marketing event (also see section 4.4).
Danish: Bivirkning efter markedsføring (se også pkt.
English: OPDIVO concentrate is a clear to opalescent, colourless to pale yellow liquid.
Danish: OPDIVO-koncentrat er en klar til opaliserende, farveløs til lysegul væske.
English: 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.
Danish: 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.
English: In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Danish: In-line filtre af polyethersulfonmembraner med en porestørrelse på 0,2 μm til 1,2 μm.
English: 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.
Danish: 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.
English: Progression Free Survival per Investigator (Months) Number of Subjects at Risk Nivolumab + Ipilimumab
Danish: Progressionsfri overlevelse i henhold til investigator (måneder) Antal forsøgspersoner i risikogruppe Nivolumab + ipilimumab
English: Twenty-two percent of patients had tumours that tested BRAF mutation positive and 50% of patients had tumours that were considered PD-L1 positive.
Danish: 22 % af patienterne havde tumorer, der blev testet BRAF-mutationpositive, og 50 % af patienterne havde tumorer, der blev kategoriseret som PD-L1-positive.
English: 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.
Danish: 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.
English: Renal and urinary disorders Common renal failure (including acute kidney injury)a,c renal failure (including acute kidney injury)c
Danish: Nyrer og urinveje Almindelig nyresvigt (inklusive akut nyreskade)a,c nyresvigt (inklusive akut nyreskade)c
English: 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.
Danish: 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.
English: In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.
Danish: I modeller med syngene mus resulterede blokering af PD-1-aktivitet i nedsat tumorvækst.
English: 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.
Danish: 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.
English: 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.
Danish: 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 %.
English: 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.
Danish: 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.
English: Treatment of advanced melanoma
Danish: Behandling af fremskredent melanom
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Sixty-one percent of patients had M1c stage disease at study entry.
Danish: 61 % af patienterne havde sygdomsstadie M1c ved inklusion i studiet.
English: Nivolumab or nivolumab in combination with ipilimumab is associated with immune-related adverse reactions.
Danish: Nivolumab eller nivolumab i kombination med ipilimumab er associeret med immunrelaterede bivirkninger.
English: 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.
Danish: 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.
English: Grade 2 cases were reported in 2.2% (10/448) of patients.
Danish: Grad 2 tilfælde blev rapporteret hos 2,2 % (10/448) af patienterne.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: In 49 evaluated patients from two cHL studies who underwent allogeneic HSCT after discontinuing nivolumab monotherapy, Grade 3 or 4 acute GVHD was reported in 13/49 patients (26.5%).
Danish: I to studier hos patienter med klassisk HL, som gennemgik allogen HSCT efter seponering af monoterapi med nivolumab, blev der blandt 49 evaluerede patienter rapporteret akut GVHD af grad 3 eller 4 hos 13 (26,5 %).
English: Table 21: Efficacy results in patients with relapsed/refractory classical Hodgkin lymphoma
Danish: Tabel 21: Effektresultater hos patienter med recidiverende/refraktært klassisk Hodgkins lymfom
English: Figure 2: Progression-free survival (CA209067)
Danish: Figur 2: Progressionsfri overlevelse (CA209067)
English: Immune system disorders Common infusion related reaction, hypersensitivity infusion-related reaction, hypersensitivity
Danish: Immunsystemet Almindelig infusionsrelateret reaktion, overfølsomhed infusionsrelateret reaktion, overfølsomhed
English: Sixty-four percent of patients were men and 98% were white.
Danish: 64 % af patienterne var mænd, og 98 % var kaukasiere.
English: The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 "OPDIVO contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Danish: Øvrige indholdsstoffer: Natriumcitratdihydrat, natriumchlorid (se afsnit 2 ”OPDIVO indeholder natrium”), mannitol (E421), diethylentriaminpentaeddikesyre, polysorbat 80, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: Of the 1008 treated patients, 103 (10%) had ocular/uveal melanoma, 66 (7%) had an ECOG performance score of 2, 165 (16%) had asymptomatic treated and untreated CNS metastases, 13 (1.3%) had treated leptomeningeal metastases, 25 (2%) had autoimmune disease, and 84 (8%) had Grade 3-4 immune-related AEs with prior anti-CTLA-4 therapy.
Danish: Af de 1.008 behandlede patienter havde 103 (10 %) okulært/uvealt melanom, 66 (7 %) havde en ECOG-performance-score på 2, 165 (16 %) havde asymptomatiske behandlede og ubehandlede CNS-metastaser, 13 (1,3 %) havde behandlede leptomeningeale metastaser, 25 (2 %) havde autoimmun sygdom, og 84 (8 %) havde grad 3-4 immunrelaterede bivirkninger med tidligere anti-CTLA-4-behandling.
English: The study included adult patients who had progressed on or after ipilimumab and if BRAF V600 mutation positive had also progressed on or after BRAF kinase inhibitor therapy.
Danish: Studiet inkluderede voksne patienter, hvis sygdom havde progredieret under eller efter behandling med ipilimumab, og som, hvis positiv for BRAF-V600-mutation, også havde progredieret under eller efter behandling med BRAF-kinasehæmmer.
English: Discard the vial if the solution is cloudy, is discoloured, or contains particulate matter other than a few translucentto-white particles.
Danish: Kasser hætteglasset, hvis koncentratet er grumset, misfarvet eller indeholder andre partikler end nogle få delvist gennemsigtige eller hvidlige partikler.
English: Patients who had not received prior systemic anticancer therapy for unresectable or metastatic melanoma were enrolled.
Danish: Patienter, som ikke tidligere havde fået systemisk cancerbehandling for inoperabelt eller metastatisk melanom, blev indrulleret i studiet.
English: Grade 2 adrenal insufficiency Grade 3 diabetes
Danish: Grad 2 binyrebarkinsufficiens Grad 3 diabetes
English: Do not use OPDIVO after the expiry date which is stated on the carton and on the vial label after EXP.
Danish: Brug ikke OPDIVO efter den udløbsdato, der står på æsken og etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Thirty-two percent of patients had BRAF mutation-positive melanoma; 26.5% of patients had PD-L1 ≥ 5% tumour cell membrane expression.
Danish: 32 % af patienterne havde BRAF-mutationpositivt melanom; 26,5 % af patienterne havde PD-L1 ≥ 5 % tumorcellemembranekspression.