FrancophonIA/ELRC3.0 huggingface dataset:
English: A group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome) An inflammatory disorder (most likely of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome) Inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial disorders)
Danish: Afstødning af et transplanteret fast organ (solidt organ) En gruppe af stofskiftekomplikationer, som sker efter kræftbehandling, karakteriseret ved høje blodniveauer af kalium og phosphat, og lave blodniveauer af calcium (tumorlysesyndrom) En betændelsessygdom (højst sandsynligt af autoimmun oprindelse), der påvirker øjnene, huden og membranerne i ørerne, hjernen og rygmarven (Vogt-Koyanagi-Harada syndrom) Betændelseslignende reaktion i sækken der ligger omkring hjertet og ophobning af væske omkring hjertet (sygdomme i perikardiet)
English: The first tumour assessments were conducted 4 weeks after the start of treatment and continued thereafter until disease progression or treatment discontinuation.
Danish: De første tumorvurderinger blev udført 4 uger efter behandlingsstart og fortsatte derefter indtil sygdomsprogression eller seponering.
English: In patients treated with nivolumab monotherapy, the incidence of pneumonitis, including interstitial lung disease and lung infiltration, was 3.4% (87/2578).
Danish: Hos patienter, der blev behandlet med nivolumab-monoterapi, var hyppigheden af pneumonitis, herunder interstitiel lungesygdom og lungeinfiltration, 3,4 % (87/2.578).
English: 51 (64%) M 29 (36%) F
Danish: 51 (64 %)M / 29 (36 %)K
English: with Stage IIIB/C or Stage IV American Joint Committee on Cancer (AJCC), 7th edition, histologically confirmed melanoma that is completely surgically resected.
Danish: Studiet inkluderede voksne patienter, som havde en ECOG-performance-status score på 0 eller 1, med stadie IIIB/C eller stadie IV American Join Committee on Cancer (AJCC), 7. udgave, histologisk bekræftet melanom som var komplet kirurgisk resekteret.
English: The benefit of treatment with nivolumab versus the possible risk should be considered in these patients (see section 4.8).
Danish: Hos disse patienter bør fordelen ved behandling med nivolumab vurderes mod den potentielle risiko (se pkt.
English: In patients treated with nivolumab monotherapy, the incidence of thyroid disorders, including hypothyroidism or hyperthyroidism, was 9.6% (248/2578).
Danish: Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af thyroidearelaterede bivirkninger, herunder hypotyroidisme og hypertyroidisme, 9,6 % (248/2.578).
English: For Grade 2 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab should be withheld.
Danish: Ved grad 2 diarre eller colitis udsættes nivolumab eller nivolumab i kombination med ipilimumab.
English: Uncommon spondyloarthropathy, Sjogren's syndrome, arthritis, myopathy, myositis (including polymyositis)a,e, rhabdomyolysisa,f polymyalgia rheumatica, myositis (including polymyositis), rhabdomyolysis
Danish: Ikke almindelig spondylartropati, Sjögrens syndrom, artritis, myopati, myositis (inklusive polymyositis)a,e, rabdomyolysea,f polymyalgia rheumatica, myositis (inklusive polymyositis), rabdomyolyse
English: Withhold dose(s) until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Danish: Dosis/doser udsættes, indtil symptomerne forsvinder, radiografiske anormaliteter bedres, og behandling med kortikosteroid er afsluttet
English: The median OS was 17.3 months (95% CI: 12.5, 37.8), and the estimated OS rates were 42% (95% CI: 32, 51) at 3 years, 35% (95% CI: 26, 44) at 4 years, and 34% (95% CI: 25, 43) at 5 years (minimum follow-up of 45 months).
Danish: Median-OS var 17,3 måneder (95 % CI: 12,5; 37,8), og estimerede OS-rater var 42 % (95 % CI: 32; 51) ved år 3, 35 % (95 % CI: 23, 44) ved år 4 og 34 % (95 % CI: 25, 43) ved år 5 (minimumsopfølgning på 45 måneder).
English: A total of 906 patients were randomised to receive either nivolumab 3 mg/kg (n = 453) administered every 2 weeks or ipilimumab 10 mg/kg (n = 453) administered every 3 weeks for 4 doses then every 12 weeks beginning at week 24 for up to 1 year.
Danish: Samlet modtog 906 randomiserede patienter enten 3 mg/kg nivolumab (n = 453) administreret hver 2. uge, eller ipilimumab 10 mg/kg (n = 453), administretet hver 3. uge for 4 doser, derefter hver 12. uge, med start i uge 24 i op til 1 år.
English: A total of 405 patients were randomised to receive either nivolumab (n = 272) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or chemotherapy (n = 133) which consisted of the investigator's choice of either dacarbazine (1000 mg/m2 every 3 weeks) or carboplatin (AUC 6 every 3 weeks) and paclitaxel (175 mg/m2 every 3 weeks).
Danish: I alt 405 patienter blev randomiseret til enten nivolumab (n = 272) 3 mg/kg hver 2. uge indgivet intravenøst over en periode på 60 minutter eller kemoterapi (n = 133), som bestod af investigators valg af enten dacarbazin (1000 mg/m2 hver 3. uge) eller carboplatin (AUC 6 hver 3. uge) og paclitaxel (175 mg/m2 hver 3. uge).
English: Relative to nivolumab monotherapy, an increase in PFS for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.
Danish: I forhold til nivolumab-monoterapi er forbedring af PFS for kombinationen nivolumab og ipilimumab udelukkende dokumenteret hos patienter med lav PD-L1-tumorekspression.
English: In patients with tumour PD-L1 expression ≥1%, ORR was 33.5% for nivolumab (n=179; 95% CI: 26.7, 40.9) and 13.5% for chemotherapy (n=74; 95% CI: 6.7, 23.5).
Danish: Hos patienter med PD-L1-tumorekspression ≥1 % var ORR 33,5 % for nivolumab (n=179; 95 % CI: 26,7, 40,9) og 13,5 % for kemoterapi (n=74; 95 % CI: 6,7, 23,5).
English: Patients with active autoimmune disease, ocular melanoma, active brain or leptomeningeal metastases or a known history of prior ipilimumab-related high-grade (Grade 4 per CTCAE v4.0) adverse reactions, except for resolved nausea, fatigue, infusion reactions, or endocrinopathies, were excluded from the study.
Danish: Patienter med aktiv autoimmun sygdom, okulært melanom, aktive hjerne- eller leptomeningeale metastaser eller ipilimumab-relatererede bivirkninger af høj sværhedsgrad (grad 4 efter CTCAE v4.0), med undtagelse af ophørt kvalme, træthed, infusionsreaktioner eller endokrinopatier, i anamnesen, blev udelukket fra studiet.
English: Clinical activity was observed regardless of tumour PD-L1 expression status.
Danish: Der blev observeret klinisk aktivitet uanset tumor-PD-L1-ekpressionsstatus.
English: Nivolumab+ipilimumab vs nivolumab (descriptive analysis) - HR (95% CI): 0.85 (0.68, 1.07)
Danish: Nivolumab+ipilimumab versus nivolumab (deskriptiv analyse) - HR (95 % CI): 0,85 (0,68; 1,07)
English: Secondary efficacy assessments included investigator-assessed ORR and PFS.
Danish: Sekundære effektparametre omfattede investigatorvurderet ORR og PFS.
English: Rate (95% CI) at 18 months
Danish: Rate (95 % CI) ved 18 måneder
English: Uncommon arrhythmia (including ventricular arrhythmia)a,d, atrial fibrillation, myocarditisa,f arrhythmia (including ventricular arrhythmia), myocarditisc
Danish: Ikke almindelig arytmi (herunder ventrikulær arytmi)a,d, atrieflimren, myocarditisa,f arytmi (herunder ventrikulær arytmi), myocarditisc
English: Objective response (95% CI) Odds ratio (vs. ipilimumab) (99.5% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Duration of response Median (range), months
Danish: Objektivt respons (95 % CI) Oddsratio (versus ipilimumab) (99,5 % CI) Komplet respons (CR) Partielt respons (PR) Stabil sygdom (SD) Responsvarighed Median (interval), måneder
English: Very common increased AST, increased ALT, increased total bilirubin, increased alkaline phosphatase, increased lipase, increased amylase, increased creatinine, hyperglycaemiac, hypoglycaemia, lymphopaenia, leucopoenia, neutropaenia, thrombocytopaenia, anaemiak, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia increased AST, increased ALT, increased total bilirubin, increased alkaline phosphatase, increased lipase, increased amylase, increased creatinine, hyperglycaemiac, hypoglycaemia, lymphopaenia, leucopoenia, neutropaeniac, thrombocytopaenia, anaemiak, hypercalcaemia, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia
Danish: Ikke almindelig brystsmerter Undersøgelserb Meget almindelig forhøjet ASAT, forhøjet ALAT, forhøjet total-bilirubin, forhøjet alkalisk phosphatase, forhøjet lipase, forhøjet amylase, forhøjet kreatinin, hyperglykæmic, hypoglykæmi, lymfopeni, leukopeni, neutropeni, trombocytopeni, anæmik, hypocalcæmi, hyperkaliæmi, hypokaliæmi, hypomagnesiæmi, hyponatriæmi forhøjet ASAT, forhøjet ALAT, forhøjet total-bilirubin, forhøjet alkalisk phosphatase, forhøjet lipase, forhøjet amylase, forhøjet kreatinin, hyperglykæmic, hypoglykæmi, lymfopeni, leukopeni, neutropenic, trombocytopeni, anæmik, hypercalcæmi, hypocalcæmi, hyperkaliæmi, hypokaliæmi, hypomagnesiæmi, hyponatriæmi
English: The study included patients (18 years or older) who have experienced disease progression during or after 1 or 2 prior anti-angiogenic therapy regimens and no more than 3 total prior systemic treatment regimens.
Danish: Studiet inkluderede patienter (18 år eller ældre), som havde oplevet sygdomsprogression under eller efter 1 eller 2 tidligere anti-angiogenese-behandlingsregimer og højst 3 tidligere systemiske behandlingsforløb.
English: The estimated 2 and 3 year OS rates were 68% (95% CI: 56, 78) and 61% (95% CI: 49, 71), respectively, for the combination (n = 73) and 53% (95% CI: 36, 68) and 44% (95% CI: 28, 60), respectively, for ipilimumab (n = 37).
Danish: De estimerede OS-rater var henholdsvis 68 % (95 % CI: 56; 78) og 61 % (95 % CI: 49; 71) for kombinationen (n = 73) og henholdsvis 53 % (95 % CI: 36; 68) og 44 % (95 % CI: 28; 60) for ipilimumab alene (n = 37).
English: 61 (64%) M 34 (36%) F
Danish: 61 (64 %)M / 34 (36 %)K
English: Objective response, n (%); (95% CI) Complete remission (CR), n (%); (95% CI) Partial remission (PR), n (%); (95% CI)
Danish: Objektiv respons, n (%); (95 % CI) Komplet remission (CR), n (%); (95 % CI)
English: Number of Subjects at Risk Nivolumab + Ipilimumab
Danish: Antal patienter i risiko Nivolumab + Ipilimumab
English: Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. docetaxel) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (53% vs. 55%), ≥ 5% (41% vs. 38%), or ≥ 10% (37% vs. 35%).
Danish: Niveauet for PD-L1-tumorekspression var ens i de to behandlingsgrupper (nivolumab versus docetaxel) ved hvert af de prædefinerede PDL1-tumorekspressionsniveauer på ≥1 % (53 % versus 55 %), ≥5 % (41 % versus 38 %) og ≥10 % (37 % versus 35 %).
English: ──Δ─── Nivolumab (events: 50/210), median and 95% CI: N.A. - - -- - - Dacarbazine (events: 96/208), median and 95% CI: 10.84 (9.33, 12.09)
Danish: ──Δ─── Nivolumab (hændelser: 50/210), median og 95 % CI: N.A. = ikke tilgængelig - - -- - - Dacarbazin (hændelser: 96/208), median og 95 % CI: 10,84 (9,33; 12,09)
English: The recommended dose is 3 mg/kg nivolumab in combination with 1 mg/kg ipilimumab administered intravenously every 3 weeks for the first 4 doses.
Danish: Den anbefalede dosis er 3 mg/kg nivolumab i kombination med 1 mg/kg ipilimumab administreret intravenøst hver 3. uge for de første 4 doser.
English: ──Δ─── Nivolumab 3 mg/kg (events: 86/135), median and 95% CI: 9.23 (7.33, 13.27) - - -- - - Docetaxel (events: 113/137), median and 95% CI: 6.01 (5.13, 7.33)
Danish: ──Δ─── Nivolumab 3 mg/kg (hændelser: 86/135), median og 95 % CI: 9,23 (7,33; 13,27) - - -- - -Docetaxel (hændelser: 113/137), median og 95 % CI: 6,01 (5,13; 7,33)
English: Patients should be monitored for cardiac and pulmonary adverse reactions continuously, as well as for clinical signs, symptoms, and laboratory abnormalities indicative of electrolyte disturbances and dehydration prior to and periodically during treatment.
Danish: Før og regelmæssigt under behandlingen bør patienten monitoreres for kliniske tegn, symptomer og abnorme laboratorieværdier, som kan være tegn på elektrolytforstyrrelser og dehydrering.
English: Withhold dose(s) until creatinine returns to baseline and management with corticosteroids is complete
Danish: Dosis/doser udsættes, indtil kreatinin vender tilbage til baseline, og behandling med kortikosteroid er afsluttet
English: Complications of allogeneic HSCT in classical Hodgkin Lymphoma
Danish: Komplikationer ved allogen HSCT ved klassisk Hodgkins lymfom
English: The recommended dose is 1 mg/kg nivolumab in combination with 3 mg/kg ipilimumab administered intravenously every 3 weeks for the first 4 doses.
Danish: Den anbefalede dosis er 1 mg/kg nivolumab i kombination med 3 mg/kg ipilimumab administreret intravenøst hver 3. uge for de første 4 doser.
English: Grade 3 cases were reported in 1.6% (41/2578) of patients.
Danish: Grad 3 tilfælde blev rapporteret hos 1,6 % (41/2.578) af patienterne.
English: In patients treated with nivolumab monotherapy, the incidence of liver function test abnormalities was 6.7% (173/2578).
Danish: Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af abnorme leverfunktionstests 6,7 % (173/2.578).
English: Non-squamous NSCLC
Danish: Ikke-planocellulær NSCLC
English: Ipilimumab 3 mg/kg over 90 minutes
Danish: Ipilimumab 3 mg/kg over 90 minutter
English: PFS rate at 12 months and 95% CI: 42% (36, 47) - - -- - - Ipilimumab (events: 245/315), median and 95% CI: 2.89 (2.79, 3.42).
Danish: PFS-rater ved 12 måneder og 95 % CI: 42 % (36; 47) - - -- - - Ipilimumab (hændelser: 245/315), median og 95 % CI: 2,89 (2,79; 3,42).
English: Treatment after disease progression was permitted for patients who had a clinical benefit and did not have substantial adverse effects with the study drug, as determined by the investigator.
Danish: Behandling efter sygdomsprogression var tilladt hos patienter, som efter investigators afgørelse oplevede kliniske fordele og ikke fik betydelige bivirkninger af studiemedicinen.
English: Allergic reaction, reactions related to the infusion of the medicine Underactive thyroid gland (which can cause tiredness or weight gain), overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) Decreased appetite
Danish: Allergisk reaktion, reaktioner i forbindelse med infusion af medicinen Nedsat funktion af skjoldbruskkirtlen (som kan medføre træthed eller vægtstigning), øget funktion af skjoldbruskkirtlen (som kan medføre hurtig hjerterytme [puls], svedudbrud og vægttab)
English: Patients were enrolled regardless of their tumour PD-L1 or human papilloma virus (HPV) status.
Danish: Patienterne blev indrulleret i studiet uanset PD-L1-tumorstatus og papillomavirus (HPV)-status.
English: After 28 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to nivolumab in combination with ipilimumab had an ORR of 67.6% (95% CI: 57.7, 76.6; n = 102) and 54.7% (95% CI: 47.8, 61.5; n = 212), while those in the nivolumab monotherapy arm had an ORR of 36.7% (95% CI: 27.2, 47.1; n = 98) and 48.2% (95% CI: 41.4, 55.0; n = 218), respectively.
Danish: Efter en opfølgningsperiode på 28 måneder havde BRAF[V600]mutationspositive patienter og patienter med BRAF-vildtype, som blev randomiseret til nivolumab i kombination med ipilimumab, en ORR på henholdsvis 67,6 % (95 % CI: 57,7; 76,6; n = 102) og 54,7 % (95 % CI: 47,8; 61,5; n = 212), mens de patienter, der blev randomiseret til nivolumabmonoterapi, havde en ORR på henholdsvis 36,7 % (95 % CI: 27,2; 47,1; n = 98) og 48,2 % (95 % CI: 41,4; 55,0; n = 218).
English: Grade 2 diarrhoea or colitis
Danish: Grad 2 diarre eller colitis
English: The primary OS analysis was not adjusted to account for subsequent therapies, with 54 (40.6%) patients in the chemotherapy arm subsequently receiving an anti-PD1 treatment.
Danish: 54 (40,6 %) af patienterne i kemoterapiarmen fik efterfølgende en anti-PD1-behandling.
English: Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80
Danish: Diethylentriaminpentaeddikesyre Polysorbat 80
English: Infections and infestations Common pneumonia, upper respiratory tract infection pneumonia, upper respiratory tract infection, conjunctivitis
Danish: Infektioner og parasitære sygdomme Almindelig pneumoni, infektion i øvre luftveje pneumoni, infektion i øvre luftveje, konjunktivitis
English: In patients treated with nivolumab monotherapy, the incidence of rash was 26.4% (680/2578).
Danish: Hos patienter, som blev behandlet med nivolumab-monoterapi, var hyppigheden af udslæt 26,4 % (680/2.578).
English: Table 13: Efficacy results (CA209238)
Danish: Tabel 13: Effektresultater (CA209238)
English: Each mL of concentrate contains 10 mg of nivolumab.
Danish: Hver ml koncentrat indeholder 10 mg nivolumab.
English: Overall survival could be accompanied by an improvement over time in disease related symptoms and non-disease specific QoL as assessed using valid and reliable scales in the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) and the EuroQoL EQ-5D.
Danish: Samlet overlevelse kunne der også være bedring over tid af sygdomsrelaterede symptomer og ikke-sygdomsspecifik QoL, som blev vurderet ved brug af valide og pålidelige skalaer i Functional
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening hyperthyroidism or hypothyroidism.
Danish: Nivolumab eller nivolumab i kombination med ipilimumab skal seponeres permanent i tilfælde af livstruende hypertyroidisme eller hypotyroidisme.
English: Randomised phase 3 study of nivolumab in combination with ipilimumab vs. sunitinib (CA209214)
Danish: Randomiseret fase 3-studie med nivolumab i kombination med ipilimumab versus sunitinib (CA209214)
English: CA209205 Cohort Cb
Danish: CA209205 kohorte Cb
English: Overall survival Median (95% CI) months
Danish: Samlet overlevelse Median (95 % CI) måneder
English: Inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools), vomiting, nausea, stomach pain
Danish: Betændelseslignende reaktion i tarmene (colitis), diarre (vandig, løs eller blød afføring), opkastning, kvalme, mavesmerter
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer) Infektioner i de øvre luftveje
English: Gently mix the infusion by manual rotation.
Danish: Blandes forsigtigt ved at bevæge beholderen manuelt.
English: NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL sterile concentrate nivolumab
Danish: OPDIVO 10 mg/ml sterilt koncentrat nivolumab
English: Because of the small size of this subgroup, no definitive conclusions can be drawn from these data.
Danish: På grund af den lille sub-population kan der ikke drages nogen endelige konklusioner på baggrund af disse data.
English: In the absence of data, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Danish: Ved fravær af data bør nivolumab bruges med forsigtighed hos disse populationer, og under grundig hensynstagen til de potentielle fordele/risici på individuel basis.
English: Withhold dose(s) until symptoms resolve and management with corticosteroids (if needed for symptoms of acute inflammation) is complete.
Danish: Dosis/doser udsættes, indtil symptomerne forsvinder, og eventuel behandling med kortikosteroid (for symptomer på akut inflammation) er afsluttet.
English: Inflammation of the liver (hepatitis)
Danish: Leverbetændelse (hepatitis)
English: Disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjogren's syndrome), aching muscles, muscle tenderness or weakness, not caused by exercise (myopathy), inflammation of the muscles (myositis), stiffness in muscles and joints, muscle spasm (rhabdomyolysis)
Danish: Sygdom hvor immunsystemet angriber kirtlerne der laver væsker til kroppen, f.eks. tåre og spyt (Sjögrens syndrom), muskelsmerter, ømme eller svage muskler, som ikke skyldes fysisk aktivitet (myopati), betændelseslignende reaktion i musklerne (myositis), stivhed i muskler og led, muskelkramper (rabdomyolyse)
English: No Grade 5 cases were reported in these studies.
Danish: Ingen grad 5 tilfælde blev rapporteret i disse studier.
English: Randomised phase 3 study vs. dacarbazine (CA209066)
Danish: Randomiseret fase 3-studie versus dacarbazin (CA209066)
English: Tumour PD-L1 expression n nivolumab + ipilimumab Median OS (95% CI)
Danish: Tumor PD-L1ekspression n nivolumab + ipilimumab Median-OS (95 % CI)
English: 0.5% with nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks and 4.6% with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks.
Danish: Forekomsten af neutraliserende antistoffer mod nivolumab var 0,5 % med 3 mg/kg nivolumab og 1 mg/kg ipilimumab hver 3. uge og 4,6 % med 1 mg/kg nivolumab og 3 mg/kg ipilimumab hver 3. uge.
English: PFS rate at 12 months and 95% CI: 49% (44, 55) ──Δ─── Nivolumab (events: 183/316), median and 95% CI: 6.87 (4.34, 9.46).
Danish: PFS-rater ved 12 måneder og 95 % CI: 49 % (44; 55) ──Δ─── Nivolumab (hændelser: 183/316), median og 95 % CI: 6,87 (4,34; 9,46).
English: Based on the severity of the adverse reaction, nivolumab or nivolumab in combination with ipilimumab should be withheld and corticosteroids administered.
Danish: Afhængigt af bivirkningens sværhedsgrad bør nivolumab eller nivolumab i kombination med ipilimumab udsættes og kortikosteroid administreres.
English: Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).
Danish: I forhold til nivolumab-monoterapi er forbedring af progressionsfri overlevelse (PFS) og samlet overlevelse (OS) med kombinationen nivolumab og ipilimumab udelukkende dokumenteret hos patienter med lav PD-L1-tumorekspression (se pkt.
English: When OPDIVO is given in combination with ipilimumab for the treatment of advanced kidney cancer, the recommended dose of OPDIVO is 3 mg of nivolumab per kilogram of your body weight for the first 4 doses (combination phase).
Danish: Hvis OPDIVO gives sammen med ipilimumab til behandling af fremskreden nyrekræft, er den anbefalede dosis OPDIVO 3 mg nivolumab pr. kilogram kropsvægt for de første 4 doser
English: OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
Danish: OPDIVO er som monoterapi indiceret til behandling af fremskredent renalcellekarcinom hos voksne efter tidligere behandling.
English: For additional information on the safety profile of ipilimumab monotherapy, please refer to the ipilimumab SmPC.
Danish: Se produktresuméet for ipilumumab for yderligere information om sikkerhedsprofilen for ipilimumab-monoterapi.
English: Tumour assessments were conducted 12 weeks after randomisation then every 6 weeks for the first year, and every 12 weeks thereafter.
Danish: Tumorvurdering blev udført 12 uger efter randomisering, dernæst hver 6. uge i det første år, og derefter hver 12. uge.
English: Not known pericardial disordersj Vascular disorders Common hypertension hypertension
Danish: Ikke kendt sygdomme i perikardietj Vaskulære sygdomme Almindelig hypertension hypertension
English: Hazard ratio 98.52% CI p-value
Danish: 98,52 % CI p-værdi
English: Upon improvement, nivolumab or nivolumab in combination with ipilimumab may be resumed after corticosteroid taper.
Danish: Når der indtræder bedring, kan nivolumab eller nivolumab i kombination med ipilimumab genoptages efter nedtrapning af kortikosteroid.
English: Recurrence-Free Survival (Months)
Danish: Overlevelse uden tilbagefald (måneder)
English: OPDIVO infusion should not be infused at the same time in the same intravenous line with other agents.
Danish: OPDIVO-infusion må ikke infunderes samtidig med andre lægemidler i samme infusionsslange.