FrancophonIA/ELRC3.0 huggingface dataset:
English: OPDIVO can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting according to the following instructions: the final infusion concentration should range between 1 and 10 mg/mL.
Danish: OPDIVO kan gives som intravenøs administration enten: ufortyndet efter overførsel til en infusionsbeholder ved brug af en passende steril sprøjte; eller efter fortynding ifølge disse instruktioner: den færdige koncentration i infusionsvæsken bør være fra 1 til 10 mg/ml.
English: Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day
Danish: Grad 4 eller recidiverende grad 3; vedvarende grad 2 eller 3 på trods af behandlingsmodifikation; ikke muligt at reducere kortikosteroiddosis til 10 mg prednison dagligt eller en dosis ækvivalent hermed
English: The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal).
Danish: Den primære effektpopulation inkluderede de mellem- eller højrisikopatienter med mindst 1 eller flere af de 6 prognostiske risikofaktorer i International Metastatic RCC Database Consortium (IMDC) (mindre end et år fra diagnosetidspunktet for initial renalcellekarcinom til randomisering, Karnofsky Performance Status (KPS) < 80 %, hæmoglobin mindre end den nedre normalgrænse, korrigeret calcium større end 10 mg/dl, blodpladetal større end den øvre normalgrænse og absolut neutrofiltal større end den øvre normalgrænse).
English: Grade 3 diarrhoea or colitis - OPDIVO monotherapy
Danish: Grad 3 diarre eller colitis - OPDIVO-monoterapi
English: OPDIVO infusion is compatible with PVC and polyolefin containers, glass bottles, PVC infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Danish: OPDIVO-infusionsvæske er kompatibel med PVC- og polyolefin-beholdere, glasflasker, PVC-infusionssæt og in-line filtre af polyethersulfonmembraner med en porestørrelse på 0,2 μm til 1,2 μm.
English: p-value
Danish: p-værdib
English: Check with your doctor or nurse before you are given OPDIVO if: you have an autoimmune disease (a condition where the body attacks its own cells); you have melanoma of the eye; you were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine; you have been told that your cancer has spread to your brain; you have any history of inflammation of the lungs; you have been taken medicines to suppress your immune system.
Danish: Tal med lægen eller sygeplejersken, inden du får OPDIVO, hvis: du har en autoimmun sygdom (en tilstand, hvor kroppen angriber sine egne celler); du har melanom i øjet; du tidligere har fået ipilimumab, en anden medicin til behandling af melanom, og du fik alvorlige bivirkninger på grund af denne medicin; du har fået at vide, at kræften har spredt sig til hjernen; du tidligere har haft en betændelseslignende reaktion (inflammation) i lungerne; du har taget medicin, som hæmmer dit immunforsvar.
English: Forty-two percent of patients were BRAF V600 mutation positive while 45% were BRAF wild type and 13% BRAF were status unknown.
Danish: 42 % af patienterne var positive for BRAF-V600-mutation, og 45 % var BRAF-vildtype og ved 13 % af tilfældende var BRAF-status ukendt.
English: OPDIVO must not be administered as an intravenous push or bolus injection.
Danish: OPDIVO må ikke administreres som intravenøs bolus- eller push-injektion.
English: Number of Subjects at Risk Nivolumab
Danish: Antal forsøgspersoner i risikogruppe Nivolumab
English: Hypophysitis (1 Grade 1, 2 Grade 2, 5 Grade 3, and 1 Grade 4), hypopituitarism (4 Grade 2 and 1 Grade 3), adrenal insufficiency (including secondary adrenocortical insufficiency) (1 Grade 1, 9 Grade 2, and 5 Grade 3), diabetes mellitus (including Type 1 diabetes mellitus) (3 Grade 2 and 1 Grade 3), and diabetic ketoacidosis (2 Grade 3) were reported.
Danish: Der blev rapporteret hypofysitis (1 grad 1, 2 grad 2, 5 grad 3 og 1 grad 4), hypopituitarisme (4 grad 2 og 1 grad 3), binyrebarkinsufficiens (inklusive sekundær adrenokortikal insufficiens) (1 grad 1, 9 grad 2 og 5 grad 3), diabetes mellitus (inklusive type 1-diabetes mellitus) (3 grad 2 og 1 grad 3) og diabetisk ketoacidose (2 grad 3).
English: The frequency of adverse events in the cardiac disorders system organ class regardless of causality was higher in the nivolumab group than in the chemotherapy group in post-CTLA4/BRAF inhibitor metastatic melanoma population.
Danish: Hyppigheden af bivirkninger i systemorganklassen hjerte var, uanset kausalitet, højere i nivolumabgruppen end i kemoterapigruppen i post-CTLA4/BRAF-hæmmer-populationen af patienter med metastatisk melanom.
English: The co-primary efficacy outcome measures were confirmed ORR in the first 120 patients treated with nivolumab, as measured by independent radiology review committee (IRRC) using RECIST, version 1.1, and comparison of OS of nivolumab to chemotherapy.
Danish: De 2 primære effektparametre var bekræftet ORR målt hos de første 120 patienter behandlet med nivolumab, bedømt af en uafhængig radiologisk komite (independent radiology review committee, IRRC) ved hjælp af RECIST version 1.1, og sammenligning af samlet overlevelse (OS overall survival) med nivolumab og med kemoterapi.
English: Patients had an ECOG performance status score of 0 or 1 and were enrolled regardless of their tumour PD-L1 status.
Danish: Patienter havde en ECOG-performance-score på 0 eller 1 og deltog uanset deres PD-L1 tumorstatus.
English: In subjects with non-clear cell histology, at a minimum follow-up of approximately 16.7 months ORR and median duration of response were 13.6% and 10.2 months, respectively.
Danish: Hos forsøgspersoner med non-clear cellehistologi var ORR og medianvarighed for respons henholdsvis 13,6 % og 10,2 måneder efter en minimum opfølgningsperiode på ca. 16,7 måneder.
English: The majority of the patients had AJCC Stage IV disease (93%); 58% had M1c disease at study entry.
Danish: De fleste patienter havde AJCC-stadie IV sygdom (93 %); 58 % havde sygdomsstadie M1c ved inklusion i studiet.
English: OPDIVO infusion must not be administered as an intravenous push or bolus injection.
Danish: OPDIVO-infusion må ikke administreres som intravenøs bolus- eller push-injektion.
English: dacarbazine (n = 208)
Danish: dacarbazin (n = 208)
English: Of patients evaluable for the presence of antiipilimumab antibodies, the incidence of anti-ipilimumab antibodies ranged from 6.3 to 8.4% and neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
Danish: Af de patienter som var evaluerbare for tilstedeværelse af anti-ipilimumab-antistoffer, var forekomsten af anti-ipilimumab-antistoffer mellem 6,3 og 8,4 % og neutraliserende antistoffer mod ipilimumab var mellem 0 og 0,3 %
English: ≥ 5 prior lines of systemic therapy
Danish: ≥5 forudgående systemiske behandlinger
English: Quantifiable tumour PD-L1 expression was measured in 67% of patients in the nivolumab group and 82% of patients in the investigator's choice group.
Danish: Kvantificerbar PD-L1-tumorekspression blev målt hos 67 % af patienterne i nivolumab-gruppen og 82 % af patienterne i gruppen, der fik investigators valg.
English: Additional safety and descriptive efficacy data are available from study CA209374, an open-label Phase 3b/4 safety study of nivolumab monotherapy (treated with 240 mg every 2 weeks) for the treatment of patients with advanced or metastatic RCC (n = 142), including 44 patients with non-clear cell histology.
Danish: Yderligere sikkerhedsdata samt deskriptive data om effekt er tilgængelige fra CA209374-studiet, som er et åbent fase 3b/4-sikkerhedsstudie med nivolumab som monoterapi (behandling med 240 mg hver 2. uge) til behandling af patienter med fremskredent eller metastatisk RCC (n = 142), herunder 44 patienter med non-clear cellehistologi.
English: OPDIVO in combination with ipilimumab Melanoma
Danish: OPDIVO i kombination med ipilimumab Melanom
English: Additional efficacy measures included duration of response, PFS and OS.
Danish: Yderligere virkningsmål omfattede responsvarighed, PFS og OS.
English: Table 15: ORR based on response evaluable patients - total and by subgroup (CA209171) Results
Danish: Tabel 15: ORR baseret på patienter med evaluerbart respons - i alt og ud fra undergruppe (CA209171)
English: Abnormal liver function tests (increased amounts of the liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in your blood, higher blood levels of the waste product bilirubin)
Danish: Unormale prøveresultater for leverfunktionen (øget mængde af leverenzymerne aspartataminotransferase, alanin-aminotransferase eller alkalisk phosphatase i blodet, øget indhold af nedbrydningsproduktet bilirubin i blodet)
English: A total of 270 patients who received nivolumab 3 mg/kg administered intravenously over 60 minutes every 2 weeks with a minimum follow-up of 8.3 months were evaluable for efficacy.
Danish: I alt 270 patienter fik nivolumab 3 mg/kg administreret intravenøst over 60 minutter hver anden uge med en minimumsopfølgning på 8,3 måneder, var vurderbare angående virkning.
English: ≥ 1% to < 10%a ≥ 10% to < 50%a ≥ 50%a
Danish: ≥ 1 % til < 10 %a ≥ 10 % til < 50 %a ≥ 50 %a
English: Efficacy by tumour PD-L1 expression: Objective responses to nivolumab were observed regardless of tumour PD-L1 expression.
Danish: Effekt i forhold til PD-L1-tumorekspression: Objektivt respons på nivolumab blev observeret uanset PD-L1-tumorekspression.
English: Pericardial disorders is a composite term which includes pericarditis, pericardial effusion, cardiac tamponade, and Dressler's syndrome.
Danish: Sygdomme i perikardiet er en sammensat term, der omfatter perikarditis, perikardieeffusion, hjertetamponade og Dresslers syndrom.
English: Median age, years (range) Gender
Danish: Medianalder, år (interval) Køn
English: Dacarbazine
Danish: Dacarbazin
English: Not reached (0+-12.5+)
Danish: Ikke nået (0+-12,5+)
English: Metabolism and nutrition disorders Very common decreased appetite decreased appetite
Danish: Metabolisme og ernæring Meget almindelig appetitløshed appetitløshed
English: Results from post-hoc, exploratory analyses indicate that in patients with low (e.g. <1%) to no tumour PD-L1 expression, other patient characteristics (e.g. liver metastases, visceral metastases, baseline haemoglobin <10g/dL and ECOG performance status = 1) might contribute to the clinical outcome.
Danish: Resultater fra post hoc, eksplorative analyser indikerer, at hos patienter med lav (f.eks. <1 %) til ingen PD-L1-tumorekspression, andre patientkarakteristika (f.eks. levermetastaser, viscerale metastaser, baseline-hæmoglobin <10 g/dl og ECOG-performance-status = 1) kan bidrage til det kliniske resultat.
English: Patients ≥ 75 years of age represented 8% of all intermediate/poor risk patients in CA209214, and the combination of nivolumab and ipilimumab showed numerically less effect on OS (HR 0.97, 95% CI: 0.48, 1.95) in this subgroup versus the overall population.
Danish: Patienter ≥ 75 år udgjorde 8 % af alle mellem- eller højrisikopatienter i CA209214, og kombinationen af nivolumab og ipilimumab viste numerisk mindre effekt på OS (HR 0,97; 95 % CI: 0,48; 1,95), i denne undergruppe versus den samlede population.
English: You must use effective contraception while you are being treated with OPDIVO and for at least 5 months following the last dose of OPDIVO, if you are a woman who could become pregnant.
Danish: Du skal anvende sikker prævention, mens du er i behandling med OPDIVO og i mindst 5 måneder efter, du har fået den sidste dosis OPDIVO, hvis du er en kvinde i den fødedygtige alder. Fortæl det til lægen, hvis du bliver gravid, mens du bruger OPDIVO.
English: Grade 4 creatinine elevation
Danish: Grad 4 kreatininstigning
English: The primary efficacy outcome measure was ORR as determined by BICR.
Danish: Det primære effektparameter var ORR som fastlagt af BICR.
English: Fourty-nine (47.6%) responders had ongoing responses with a duration ranging from 0.0-27.6+ months.
Danish: 49 (47,6 %) responderende patienter havde vedvarende respons af en varighed på 0,0-27,6+ måneder.
English: Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors.
Danish: Der er efter markedsføringen rapporteret om afstødning af transplanterede solide organer hos patienter, der er behandlet med PD-1-hæmmere.
English: Patients should be monitored for signs and symptoms of nephritis or renal dysfunction.
Danish: Patienter bør monitoreres for tegn og symptomer på nefritis eller nedsat nyrefunktion.
English: B-symptoms were present in 22% (53/243) of the patients in CA209205 at baseline.
Danish: B-symptomer forekom ved baseline hos 22 % (53/243) af patienterne i CA209205.
English: 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes
Danish: 240 mg hver 2. uge over 30 minutter eller 480 mg hver 4. uge over 60 minutter
English: Any unused medicine or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør bortskaffes i henhold til lokale retningslinjer.
English: Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with rapidly progressing disease (see section 5.1).
Danish: Der skal tages hensyn til nivolumabs forsinkede virkning, før behandling initieres hos patienter med hurtigt progredierende sygdom (se pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/4 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 40 mg/4 ml
English: Patients with baseline performance score of 2 were included in study CA209171 (see section 5.1).
Danish: Patienter med en performance-score ved baseline på 2 blev inkluderet i CA209171studiet (se pkt.
English: Recommended doses and infusion times for intravenous administration of nivolumab in combination with ipilimumab
Danish: Anbefalede doser og infusionstider for intravenøs administration af nivolumab og ipilimumab i kombination
English: PFS results (with minimum follow up of 18 months) are shown in Figure 2 (all randomised population), Figure 3 (at the tumour PD-L1 5% cut off), and Figure 4 (at the tumour PD-L1 1% cut off).
Danish: PFS-resultater (opfølgningsperioden var minimum 18 måneder) er vist i figur 2 (hele populationen randomiseret), figur 3 (ved tumor-PD-L1 5 % cut-off) og figur 4 (ved tumor-PD-L1 1 % cut-off).
English: The median PFS was 3.7 months (95% CI: 1.9, 9.3).
Danish: Median-PFS var 3,7 måneder (95 % CI: 1,9; 9,3).
English: Time to resolution ranged from 0.4 to 155.4+ weeks.
Danish: Tid til resolution var fra 0,4 til 155,4+ uger.
English: The majority of patients were male (75%) and white (88%), all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups were represented, and 34% and 66% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
Danish: Størstedelen af patienterne var mænd (75 %) og kaukasiere (88 %), alle Memorial Sloan Kettering Cancer Center (MSKCC) risikogrupper var repræsenterede, og henholdsvis 34 % og 66 % af patienterne havde en KPS ved baseline på 70-80 % og 90-100 %.
English: • Relevant information (e.g., seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns: 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 o Potential risk of ‘Complications including acute graft-versus-host disease (GVHD) and transplant related mortality of allogeneic Haematopoietic Stem Cell Transplant (HSCT)
Danish: • Relevante oplysninger (f.eks. hvor alvorlig bivirkningen er, sværhedsgraden, hyppigheden, tid til opståen, reversibilitet) om følgende sikkerhedsproblemer: 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 o Potentiel risiko for 'Komplikationer, herunder akut graft-versus-host-sygdom (GVHD) og transplantationsrelateret mortalitet, ved allogen hæmatopoietisk stamcelletransplantation
English: Acid in the blood produced from diabetes (diabetic ketoacidosis) Blockage of bile ducts
Danish: Syreforgiftning i blodet som følge af sukkersyge (diabetisk ketoacidose) Blokerede galdegange
English: Not known hypoparathyroidismh hypoparathyroidismh
Danish: Ikke kendt hypoparatyroidismeh
English: The majority of patients were white (86%) and male (78%).
Danish: Hovedparten af patienterne var hvide (86 %) og mænd (78 %).
English: Thereafter it will be given as an infusion over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single-agent phase).
Danish: Herefter vil du få OPDIVO som en infusion over en periode på 30 eller 60 minutter hver 2. eller 4. uge, alt afhængig af den dosis du modtager (enkeltstoffasen).
English: Caution should be used when considering the use of nivolumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents.
Danish: Der skal udvises forsigtighed, hvis nivolumab-behandling overvejes hos patienter, der har oplevet en alvorlig eller livstruende hudrelateret bivirkning under tidligere behandling med andre immunstimulerende cancerlægemidler.
English: OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Danish: OPDIVO som monoterapi eller i kombination med ipilimumab er indiceret til behandling af fremskredent (inoperabelt eller metastatisk) melanom hos voksne.
English: Hypophysitis occurred in 4.0% (22/547) of patients.
Danish: Hypofysitis forekom hos 4,0 % (22/547) af patienterne.
English: ** nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in RCC.
Danish: ** nivolumab i kombination med ipilimumab for de første 4 doser, derefter efterfulgt af nivolumab som monoterapi ved RCC.
English: Resolution occurred in 76 patients (42.7%).
Danish: Resolution forekom hos 76 patienter (42,7 %).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Seventy-three percent of patients had cutaneous melanoma and 10% had mucosal melanoma.
Danish: 73 % af patienterne havde kutant melanom, og 10 % havde mukosalt melanom.
English: 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).
Danish: 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.).
English: Sunitinib (events: 209/422), median and 95.0% CI: 26.97 (22.08, 34.83)
Danish: Sunitinib (hændelser: 209/422), median og 95,0 % CI: 26,97 (22,08; 34,83)
English: 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.
Danish: 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.
English: Grade 4 hypothyroidism Grade 4 hyperthyroidism Grade 4 hypophysitis Grade 3 or 4 adrenal insufficiency Grade 4 diabetes
Danish: Grad 4 hypotyroidisme Grad 4 hypertyroidisme Grad 4 hypofysitis Grad 3 eller 4 binyrebarkinsufficiens Grad 4 diabetes
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The prescriber must discuss the risks of OPDIVO therapy with the patient.
Danish: Den ordinerende læge skal tale med patienten om de risici, der er forbundet med behandling med OPDIVO.
English: Preparing the infusion Take care to ensure aseptic handling when you prepare the infusion.
Danish: Klargøring af infusion Vær opmærksom på aseptisk håndtering, mens infusionen forberedes.
English: Additional prespecified subgroup analyses were conducted to evaluate the efficacy by tumour PD-L1 expression at predefined levels of 1%, 5%, and
Danish: Der blev udført yderligere præspecificerede undergruppeanalyser for at vurdere virkningen ud fra PD-L1-tumorekspression ved prædefinerede niveauer på 1 %, 5 % og 10 %.
English: PFS rate at 12 months and 95% CI: 18% (14, 23)
Danish: PFS-rater ved 12 måneder og 95 % CI: 18 % (14; 23)
English: 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).
Danish: 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).
English: Rate (95% CI) at 12 months “+” denotes a censored observation.
Danish: Rate (95 % CI) ved 12 måneder “+” betegner en censureret observation.
English: Most patients had ECOG performance score of 0 (64%) or 1 (34%).
Danish: De fleste patienter havde ECOG-performance-score 0 (64 %) eller 1 (34 %).
English: chemotherapy (n = 47)
Danish: kemoterapi (n = 47)