FrancophonIA/ELRC3.0 huggingface dataset:
English: Four percent of patients had a history of brain metastasis, and 37% of patients had a baseline LDH level greater than ULN at study entry.
Danish: 4 % af patienterne havde hjernemetastaser i anamnesen, og 37 % af patienterne havde et laktatdehydrogenase (LDH)-niveau ved baseline, der var højere end ULN ved inklusion i studiet.
English: The infusion must be administered through a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2-1.2 μm.
Danish: Infusionen skal administreres gennem et sterilt, pyrogenfrit, minimalt proteinbindende in-line filter med en porestørrelse på 0,2-1,2 μm.
English: When OPDIVO is given in combination with ipilimumab, you will be given an infusion over a period of 30 minutes, every 3 weeks for the first 4 doses (combination phase).
Danish: Hvis du får OPDIVO sammen med ipilimumab, vil du få de første 4 doser som en infusion over en periode på 30 minutter med 3 ugers mellemrum (kombinationsfasen).
English: OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1).
Danish: OPDIVO som monoterapi er indiceret til adjuverende behandling af voksne med melanom, med lymfeknudeinvolvering eller metastatisk sygdom, som har fået foretaget komplet resektion (se pkt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OPDIVO 10 mg/mL sterile concentrate nivolumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) OPDIVO 10 mg/ml sterilt koncentrat nivolumab administreres i.v.
English: Grade 2 cases were reported in 2.4% (13/547) of patients.
Danish: Grad 2 tilfælde blev rapporteret hos 2,4 % (13/547) af patienterne.
English: The primary efficacy outcome measure was ORR as determined by an IRRC.
Danish: Det primære effektparameter var ORR, bedømt af en IRRC.
English: - - -*- - - - Nivolumab+ipilimumab (events: 161/314), median and 95% CI: 11.50 (8.90, 22.18).
Danish: - - -*- - - - Nivolumab+ipilimumab (hændelser:161/314), median og 95 % CI: 11,50 (8,90; 22,18).
English: c p-value is compared to alpha 0.002 in order to achieve statistical significance.
Danish: c p-værdi blev sammenlignet med en alfa-værdi på 0,002 for at opnå statistisk signifikans.
English: Other medicines and OPDIVO
Danish: Brug af anden medicin sammen med OPDIVO
English: Sodium chloride
Danish: Natriumcitratdihydrat Natriumchlorid
English: Hazard ratioa 99.8% CI p-valueb, c
Danish: 99,8 % CI p-værdib, c
English: Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, and spinal pain.
Danish: Muskuloskeletale smerter er en sammensat term, der omfatter rygsmerter, knoglesmerter, muskuloskeletale brystsmerter, muskuloskeletale gener, myalgi, nakkesmerter, smerter i arme og ben og smerter i rygsøjlen.
English: Resolution occurred in 63 patients (72.4%) with a median time to resolution of 6.1 weeks (range: 0.1+-96.7+); + denotes a censored observation.
Danish: Resolution forekom hos 63 patienter (72,4 %) med en mediantid til resolution på 6,1 uger (0,1+-96,7+); + betegner en censureret observation.
English: Nivolumab monotherapy:
Danish: Nivolumab-monoterapi:
English: The diagnosis of myocarditis requires a high index of suspicion.
Danish: Myocarditis skal i særdeleshed vurderes som en mulig diagnose.
English: f p-value is compared to alpha 0.001 in order to achieve statistical significance.
Danish: f p-værdi blev sammenlignet med en alfa-værdi på 0,001 for at opnå statistisk signifikans.
English: Inflammation or problems with your kidneys.
Danish: Betændelseslignende reaktion i nyrerne eller problemer med nyrerne.
English: Grade 3 thyroid disorders were reported in < 0.1% (2/2578) of patients.
Danish: Grad 3 thyroidearelaterede bivirkninger blev rapporteret hos < 0,1 % (2/2.578) af patienterne.
English: Among all randomised patients, the ORR was 27.2% (95% CI: 22.0, 32.9) in the nivolumab group and 9.8% (95% CI: 5.3, 16.1) in the chemotherapy group.
Danish: Blandt alle randomiserede patienter var ORR 27,2 % (95 % CI: 22,0, 32,9) i nivolumabgruppen og 9,8 % (95 % CI: 5,3, 16,1) i kemoterapigruppen.
English: Inflammation of the brain
Danish: Betændelse i hjernen
English: Table 23: Efficacy results (CA209141)
Danish: Tabel 23: Effektresultater (CA209141)
English: Tumour assessments were conducted every 12 weeks for the first 2 years then every 6 months thereafter.
Danish: Tumorvurdering blev udført hver 12. uge, for de første 2 år, dernæst hver 6. måned.
English: When OPDIVO is given in combination with ipilimumab, you will first be given OPDIVO followed by ipilimumab.
Danish: Hvis du får OPDIVO i kombination med ipilimumab, vil du få OPDIVO først og derefter ipilimumab.
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction.
Danish: Nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent i tilfælde af enhver recidiverende alvorlig immunrelateret bivirkning og enhver livstruende immunrelateret bivirkning.
English: Permanently discontinue treatment (see section 4.4)
Danish: Behandlingen seponeres permanent Behandlingen seponeres permanent (se pkt.
English: ECOG performance status score was 0 (73%) or 1 (27%).
Danish: ECOG-performance-score var 0 (73 %) eller 1 (27 %).
English: CA209238
Danish: CA209238-studiet
English: Baseline ECOG performance status was 0 (54%) or 1 (46%).
Danish: Baseline ECOG-performance-status var 0 (54 %) eller 1 (46 %).
English: When OPDIVO is given on its own, the recommended dose is either 240 mg given every 2 weeks or 480 mg given every 4 weeks depending on indication.
Danish: Når OPDIVO gives alene, er den anbefalede dosis enten 240 mg hver 2. uge eller 480 mg hver 4. uge, alt afhængig af indikationen.
English: CA209205 is an ongoing Phase 2, open-label, multi-cohort, single-arm study of nivolumab in cHL.
Danish: CA209205 er et igangværende åbent, enkelt-armet fase 2-studie af nivolumab ved klassisk HL med flere kohorter.
English: For tumour PD-L1 expression < 1%, the median OS was 34.7 months for the nivolumab in combination with ipilimumab, and was 32.2 months in the sunitinib arm (HR = 0.70; 95% CI: 0.54, 0.92).
Danish: For PD-L1-tumorekspression < 1 % var median-OS 34,7 måneder for nivolumab i kombination med ipilimumab, og den var 32,2 måneder for sunitinib-armen (HR = 0,70; 95 % CI: 0,54; 0,92).
English: OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).
Danish: OPDIVO i kombination med ipilimumab er indiceret til førstelinjebehandling af voksne patienter med fremskredent renalcellekarcinom i mellem- eller højrisikogruppen (se pkt.
English: Table 19: Efficacy results in intermediate/poor risk patients (CA209214)
Danish: Tabel 19: Effektresultater hos mellem- eller højrisikopatienter (CA209214)
English: To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other methods / assays, and associated cut offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1 (on tumour- and tumour associated immune cells), PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, Tumour mutational burden) as predictive of nivolumab adjuvant therapy efficacy.
Danish: Yderligere at undersøge værdien af biomarkører ud over PD-L1ekspressionsstatus ved tumorcellemembran-niveau ved immunhistokemisk (IHC) analyse (f.eks. andre metoder/analyser og relaterede cut-offs, som kan vise sig at være mere følsomme og specifikke til at forudse respons på behandlingen baseret på PD-L1 (på tumor- og tumerassocierede immunceller), PD-L2, tumorinfiltrerende lymfocytter med måling af CD8+T-densitet, RNA-signatur, tumormutationsbyrde), som prædiktive for effektiviteten af nivolumab som adjuverende behandling.
English: Randomised phase 2 study of nivolumab in combination with ipilimumab and ipilimumab (CA209069)
Danish: Randomiseret fase 2-studie med nivolumab i kombination med ipilimumab og ipilimumab (CA209069)
English: Grade 4 diarrhoea or colitis
Danish: Grad 4 diarre eller colitis
English: Investigator assessed ORR was 61% (95% CI: 48.9, 72.4) in the combination arm (n = 72) versus 11% (95% CI: 3.0, 25.4) for the ipilimumab arm (n = 37).
Danish: Investigatorvurderet ORR var 61 % (95 % CI: 48,9; 72,4) i kombinationsarmen (n = 72) versus 11 % (95 % CI: 3,0; 25,4) i ipilimumab-armen (n = 37).
English: Pain in the joints (arthralgia), pain in the muscles and bones (musculoskeletal pain) Feeling tired or weak, fever
Danish: Ledsmerter (artralgi), smerter i muskler og knogler (muskuloskeletale smerter) Træthed eller svaghedsfølelse, feber
English: The number of prior systemic regimen received was 1 for 27% of patients, 2 for 51% of patients, and > 2 for 21% of patients.
Danish: 27 % af patienterne havde tidligere fået et systemisk behandlingsregime, 51 % af patienterne havde fået 2 og 21 % af patienterne havde tidligere fået mere end 2 systemiske regimer.
English: Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PDL1 positive (tumour membrane expression cut off of 1%, 5% or 10%).
Danish: Bedre overlevelse blev observeret, uanset om patienterne havde tumorer, som var kategoriseret som PD-L1-negative eller PD-L1-positive (tumormembran-ekspression cut-off-niveau på 1 %, 5 % eller 10 %).
English: OS benefit was observed regardless of tumour PD-L1 expression level.
Danish: OS-fordel blev observeret uanset PD-L1-tumorekspressionsniveau.
English: The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication (see section 4.2).
Danish: Den ordinerede dosis for patienten er 240 mg eller 480 mg uanset kropsvægt, alt afhængig af indikation (se pkt.
English: Ocular/ Uveal melanoma
Danish: Okulært/ uvealt melanom
English: At 24 months, the OS rate was 66.5 (95% CI 61.8-70.9) for nivolumab in combination with ipilimumab and 52.9 (95% CI 47.9- 57.7) for sunitinib.
Danish: Ved 24 måneder var OS-raten 66,5 (95 % CI 61,8-70,9) for nivolumab i kombination med ipilimumab og 52,9 (95 % CI 47,9-57,7) for sunitinib.
English: A temporary inflammation of the nerves that causes pain, weakness, and paralysis in the extremities (Guillain- Barré syndrome), loss of the protective sheath around nerves (demyelination), a condition in which the muscles become weak and tire easily (myasthenic syndrome)
Danish: Midlertidig betændelseslignende reaktion i nerverne, der medfører smerter, svaghed og lammelse af arme og ben (Guillain-Barré syndrom), tab af den beskyttende skede rundt om nerverne (demyelinisering), en tilstand, hvor musklerne bliver svage og hurtigere bliver trætte (myastenisk syndrom)
English: In the absence of data for patients who had been receiving systemic immunosuppressants prior to study entry, and for patients with active brain or leptomeningeal metastases, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Danish: Da der ikke foreligger tilstrækkelige data for patienter, som havde fået systemiske immunsuppressiva før studieinklusion, og for patienter med aktive hjernemetastaser eller leptomeningeale metastaser, bør nivolumab anvendes med forsigtighed hos disse populationer og kun efter omhyggelig afvejning af de potentielle fordele/risici for hver enkelt patient.
English: The median age was 55 years (range: 18-86), 58% were men, and 95% were white.
Danish: Medianalderen var 55 år (18-86) 58 % var mænd og 95 % var hvide.
English: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.
Danish: Nivolumab er et humant immunglobulin G4 (IgG4) monoklonalt antistof (HuMAb), som bindes til programmeret celledød-1- (PD-1) receptor og blokerer dets interaktion med liganderne PD-L1 og PD-L2. PD-1-receptoren er en negativ regulator af T-celleaktivitet, som er vist at være medvirkende til at kontrollere T-celleimmunresponset.
English: Tumour assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks for the first year and then every 12 weeks thereafter.
Danish: Tumorvurdering ifølge Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, blev udført 9 uger efter randomisering og fortsatte hver 6. uge i det første år og herefter hver 12. uge.
English: Study CA209172 was a single-arm, open label study of nivolumab monotherapy in patients with stage III (unresectable) or stage IV metastatic melanoma after prior treatment containing an antiCTLA-4 monoclonal antibody.
Danish: CA209172-studiet var et åbent enkeltarmsstudie med nivolumab som monoterapi til patienter med stadie III (inoperabelt) eller stadie IV metastatisk melanom efter tidligere behandling indeholdende et anti-CTLA-4 monoklonalt antistof.
English: Grade 3-4 irAEs with Anti-CTLA-4
Danish: Grad 3-4 immunrelaterede bivirkninger med antiCTLA-4
English: Grade 2 and Grade 3 hypophysitis (including lymphocytic hypophysitis) occurred in 5.8% (26/448) and 2.0% (9/448) of patients, respectively.
Danish: Grad 2 og grad 3 hypofysitis (inklusive lymfatisk hypofysitis) forekom hos henholdsvis 5,8 % (26/448) og 2,0 % (9/448) af patienterne.
English: 24 mL of concentrate in a 25 mL vial (Type I glass) with a stopper (coated butyl rubber) and a red matte flip-off seal (aluminium).
Danish: 24 ml koncentrat i et 25 ml hætteglas (type I-glas) med en prop (coated butylgummi) og et rødt mat flip-off låg (aluminium).
English: Study CA209171 was a single-arm, open label study of nivolumab monotherapy in patients with previously treated advanced or metastatic squamous NSCLC.
Danish: CA209171-studiet var et åbent enkeltarmsstudie med nivolumab som monoterapi til patienter med tidligere behandlet fremskreden eller metastatisk planocellulær NSCLC.
English: Abnormal kidney function tests (increased amounts of creatinine in your blood) High (hyperglycaemia) or low (hypoglycaemia) sugar levels in the blood A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot) An increased level of the enzyme that breaks down fats and of the enzyme that breaks down starch Increased or decreased amount of calcium or potassium Increased or decreased blood levels of magnesium or sodium Decrease in body weight
Danish: Nedsat antal røde blodlegemer (som transporterer ilt), hvide blodlegemer (som er vigtige for at kunne bekæmpe infektioner) eller blodplader (der hjælper blodet med at størkne) Øget mængde af enzymet, der nedbryder fedtstoffer, og af enzymet, der nedbryder stivelse Forhøjet eller nedsat mængde calcium eller kalium i blodet Forhøjet eller nedsat mængde magnesium eller natrium i blodet Vægttab
English: The first tumour assessments were conducted 9 weeks after the start of treatment and continued thereafter until disease progression or treatment discontinuation.
Danish: De første tumorvurderinger blev udført 9 uger efter behandlingsstart og fortsatte derefter indtil sygdomsprogression eller seponering.
English: Urothelial Carcinoma Open-label phase 2 study (CA209275)
Danish: Urothelialt karcinom CA209275 - et åbent fase 2 studie
English: Common increased total bilirubin, hypoglycaemia, hypermagnesaemia, hypernatraemia, weight decreased a
Danish: Almindelig forhøjet total-bilirubin, hypoglykæmi, hypermagnesiæmi, hypernatriæmi, vægttab a
English: Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT) in classical Hodgkin Lymphoma
Danish: Komplikationer ved allogen hæmatopoietisk stamcelletransplantation (HSCT) ved klassisk Hodgkins lymfom
English: The majority of patients were white (93%) and male (76%).
Danish: Størstedelen af patienterne var kaukasiere (93 %) og mænd (76 %).
English: ≥ 1% to < 10%a
Danish: ≥ 1 % til < 10 %a
English: In subgroup analyses, survival benefit compared to docetaxel was not shown for patients who were never-smokers or whose tumours harboured EGFR activating mutations; however, due to the small numbers of patients, no definitive conclusions can be drawn from these data.
Danish: I analyser af undergrupperne blev der ikke observeret bedre overlevelse sammenlignet med docetaxel for patienter, som aldrig havde røget, eller hvis tumorer indeholdt aktiverende EGFR-mutationer.
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 288 pharmDx assay.
Danish: PD-L1-tumorekspression blev bestemt ved hjælp af PD-L1 IHC 288 pharmDx-analysen.
English: Nivolumab or nivolumab in combination with ipilimumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Danish: Nivolumab eller nivolumab i kombination med ipilimumab skal udsættes ved grad 3 udslæt og seponeres ved grad 4 udslæt.
English: In patients treated with nivolumab monotherapy, the incidence of diarrhoea, colitis, or frequent bowel movements was 13.1% (339/2578).
Danish: Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af diarre, colitis eller hyppig afføring13,1 % (339/2.578).
English: The magnitude of OS benefit was consistent for ≥ 1%, ≥ 5% or ≥ 10% tumour PD-L1 expression levels (see Table 24).
Danish: Omfanget af OS-fordelen var konsistent for PD-L1tumorekspressionsniveauerne ≥ 1 %, ≥ 5 % og ≥ 10 % (se tabel 24).
English: NE: non-estimable
Danish: NE: ikke estimerbar
English: Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PD-L1 positive (tumour membrane expression cut off of 5% or 10%).
Danish: Bedre overlevelse blev observeret, uanset om patienterne havde tumorer, som var kategoriseret som PD-L1-negative eller PD-L1-positive (tumormembranekspression cut-off-niveau på 5 % eller 10 %).
English: The first tumour assessments were conducted 8 weeks after the start of treatment and continued every 8 weeks thereafter up to 48 weeks, then every 12 weeks until disease progression or treatment discontinuation, whichever occurred later.
Danish: Den første tumorvurdring blev foretaget 8 uger efter påbegyndt behandling og fortsatte hver 8. uge derefter op til 48 uger, derefter hver 12. uge indtil sygdomsprogression eller afbrydelse af behandling, hvad end indtraf sidst.
English: OPDIVO may be given in combination with ipilimumab.
Danish: Du får muligvis OPDIVO sammen med ipilimumab.
English: Upon improvement, nivolumab monotherapy may be resumed after corticosteroid taper.
Danish: Når der indtræder bedring, kan nivolumabmonoterapi genoptages efter nedtrapning af kortikosteroid.
English: In patients with tumour PD-L1 expression <1%, ORR per IRRC was 13.0% (n=69; 95% CI: 6.1, 23.3) and 12.0% (n=25; 95% CI: 2.5, 31.2), respectively.
Danish: Hos patienter med PD-L1tumorekspression <1 % var ORR pr. IRRC henholdsvis 13,0 % (n=69 ; 95 % CI : 6,1, 23,3) og 12,0 % (n=25 ; 95 % CI : 2,5, 31,2).
English: The observed OS benefit was consistently demonstrated across subgroups of patients including baseline ECOG performance status, M stage, history of brain metastases, and baseline LDH level.
Danish: Den observerede OS-fordel blev vist konsistent på tværs af forskellige undergrupper af patienter, inklusive ECOG-performance-score ved baseline, M-stadie, tidligere hjernemetastaser og LDH-niveau ved baseline.
English: No Grade 3-5 cases were reported.
Danish: Ingen grad 3-5 tilfælde blev rapporteret.
English: Patients with baseline performance score of 2, treated leptomeningeal metastases, ocular/uveal melanoma, autoimmune disease and patients who have had a Grade 3-4 adverse reaction that was related to prior anti-CTLA-4 therapy were included in study CA209172 (see section 5.1).
Danish: Patienter med en performance-score ved baseline på 2, behandlede leptomeningeale metastaser, okulært/uvealt melanom eller autoimmun sygdom og patienter, som havde haft en grad 3-4 bivirkning, der var relateret til tidligere anti-CTLA-4-behandling, blev inkluderet i CA209172-studiet (se pkt.
English: Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Danish: Der skal anvendes et infusionssæt og et sterilt, pyrogenfrit, minimalt proteinbindende in-line filter (porestørrelse 0,2 μm til 1,2 μm).
English: Figure 11: Kaplan-Meier curves of OS in intermediate/poor risk patients (CA209214)
Danish: Figur 11: Kaplan-Meier-kurverne for OS hos mellem- eller højrisikopatienter (CA209214)
English: (61 nivolumab, 47 investigator's choice)
Danish: (61 nivolumab, 47 investigators valg)
English: Objective response, n (%); (95% CI) Complete remission (CR), n (%); (95% CI) Partial remission (PR), n (%); (95% CI) Stable disease, n (%) Duration of response (months)b Median (95% CI)
Danish: Objektiv respons, n (%); (95 % CI) Komplet remission (CR), n (%); (95 % CI) Delvis remission (PR), n (%); (95 % CI) Stabil sygdom, n (%) Responsvarighed (måneder)b
English: OPDIVO should not be infused concomitantly in the same intravenous line with other medicinal products.
Danish: OPDIVO må ikke infunderes samtidigt med andre lægemidler i samme infusionsslange.
English: The study included patients (18 years or older) who had disease progression during or following platinum-containing chemotherapy for advanced or metastatic disease or had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Danish: Studiet inkluderede patienter (18 år og ældre), som havde sygdomsprogression under eller efter platinholdig kemoterapi for fremskreden eller metastatisk sygdom eller havde sygdomsprogression inden for 12 måneder efter neoadjuvant eller adjuvant behandling med platinholdig kemoterapi.
English: Diabetes mellitus including Type 1 diabetes mellitus (3 Grade 2, 2 Grade 3, and 3
Danish: Diabetes mellitus inklusive Type 1 diabetes mellitus (3 grad 2, 2 grad 3 og 3 grad 4) og diabetisk ketoacidose (1 grad 4) blev rapporteret.
English: Classical Hodgkin lymphoma
Danish: Klassisk Hodgkins Lymfom
English: Decreased function of the parathyroid gland
Danish: Nedsat funktion af biskjoldbruskkirtlerne
English: - Adjuvant treatment of melanoma (monotherapy): study
Danish: Adjuverende behandling af melanom (monoterapi):
English: For tumour PD-L1 expression, 34% of patients had PD-L1 expression ≥ 5% and 62% had < 5% as determined by clinical trial assay.
Danish: 34 % af patienterne havde PD-L1-tumorekspression ≥ 5 % og 62 % havde < 5 %, bestemt ved en klinisk studieanalyse.
English: NE = non-estimable
Danish: NE= ikke estimerbar
English: The ORRs in the BRAF mutation-positive subgroup were 17% (95% CI: 8.4, 29.0) for nivolumab and 11% (95% CI: 2.4, 29.2) for chemotherapy, and in the BRAF wild-type subgroup were 30% (95% CI: 24.0, 36.7) and 9% (95% CI: 4.6, 16.7), respectively.
Danish: ORR i den BRAF mutationspositive undergruppe var 17 % (95 % CI: 8,4, 29,0) for nivolumab og 11 % (95 % CI: 2,4, 29,2) for kemoterapi og i BRAF vildtype undergruppen var det henholdsvis 30 % (95 % CI: 24,0, 36,7) og 9 % (95 % CI: 4,6, 16,7)
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening diabetes.
Danish: Nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent i tilfælde af livstruende diabetes.
English: OPDIVO 10 mg/mL concentrate for solution for infusion nivolumab
Danish: OPDIVO 10 mg/ml koncentrat til infusionsvæske, opløsning nivolumab
English: OS in favourable risk patients receiving nivolumab plus ipilimumab compared to sunitinib had a hazard ratio of 1.13 (95% CI: 0.64, 1.99; p = 0.6710).
Danish: OS hos lav-risikopatienterne, der fik nivolumab plus ipilimumab, havde en hazard ratio på 1,13 (95 % CI: 0,64; 1,99; p = 0,6710) sammenlignet med sunitinib.
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 28-8 pharmDx assay.
Danish: PD-L1-tumorekspression blev bestemt ved hjælp af PD-L1 IHC 28-8 pharmDx-analyse.