FrancophonIA/ELRC3.0 huggingface dataset:
English: In the non-squamous NSCLC study (CA209057), the safety profile in patients with baseline renal or hepatic impairment was comparable to that in the overall population.
Danish: I det ikke-planocellulære NSCLC-studie (CA209057) var sikkerhedsprofilen hos patienter med nedsat nyre- eller leverfunktion ved baseline sammenlignelig med den, der blev set for den samlede population.
English: The 49 patients had a median follow-up from subsequent allogeneic HSCT of 5.6 months (range: 0-19 months).
Danish: De 49 patienter havde en medianopfølgningsperiode efter allogen HSCT på 5,6 måneder (0-19 måneder).
English: Preliminary results from the follow-up of patients with cHL undergoing allogeneic HSCT after previous exposure to nivolumab showed a higher than expected number of cases of acute graft-versus-host disease (GVHD) and transplant related mortality (TRM).
Danish: Foreløbige resultater fra opfølgningen af patienter med klassisk HL, der gennemgår allogen HSCT efter tidligere eksponering for nivolumab, viste et højere antal tilfælde af akut graft-versus-hostsygdom (GVHD) og transplantationsrelateret mortalitet (TRM) end forventet.
English: Special populations Paediatric population
Danish: Særlige populationer Pædiatrisk population
English: ORRs were higher for the combination of nivolumab and ipilimumab relative to nivolumab monotherapy across tumour PD-L1 expression levels (Table 12) after 28 months of follow-up, with a best overall response of complete response correlating to an improved survival rate.
Danish: ORR var højere med kombinationen af nivolumab og ipilimumab i forhold til nivolumab-monoterapi på tværs af PD-L1-tumorekspressionsniveauer (tabel 12) efter en opfølgningsperiode på 28 måneder, hvor et bedste samlede respons i form af et komplet respons var korreleret til en forbedret overlevelsesrate.
English: Problems with your lungs such as breathing difficulties or cough.
Danish: Problemer med lungerne som f.eks. vejrtrækningsbesvær eller hoste.
English: The primary efficacy outcome measure was OS.
Danish: Det primære effektparameter var OS.
English: 30th September 2021
Danish: 30. september 2021
English: If diagnosis of corticosteroidrefractory immune-related colitis is confirmed addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered.
Danish: Hvis diagnosen kortikosteroid-refraktær immunrelateret colitis er bekræftet, bør en tilføjelse af et alternativt immunsuppressivum til kortikosteroidbehandlingen, eller udskiftning af kortikosteroidbehandlingen, overvejes.
English: Other forms of interaction
Danish: Andre typer interaktion
English: Open-label phase 1 dose-escalation study (MDX1106-03)
Danish: Åbent fase 1-dosiseskaleringsstudie (MDX1106-03)
English: Nivolumab with ipilimumab was continued beyond progression in 29% of patients.
Danish: Nivolumab med ipilimumab-behandling blev fortsat efter progression hos 29 % af patienterne.
English: From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately.
Danish: Efter åbning Ud fra en mikrobiologisk betragtning bør lægemidlet infunderes eller fortyndes og infunderes umiddelbart efter åbning.
English: The median time to onset of objective response was 3.5 months (range: 1.4-24.8 months) after the start of nivolumab treatment.
Danish: Mediantiden til objektivt respons var 3,5 måneder (1,4-24,8 måneder) efter påbegyndelse af nivolumab-behandling.
English: The educational programme is aimed at increasing the awareness about the potential immune mediated adverse events associated with OPDIVO use, how to manage them and to enhance the awareness of patients or their caregivers on the signs and symptoms relevant to the early recognition/identification of those adverse events.
Danish: Uddannelsesmaterialet har til formål at øge opmærksomheden omkring de potentielle immunmedierede bivirkninger, der er forbundet med OPDIVO, hvordan de behandles, og at gøre patienterne eller omsorgspersonerne opmærksomme på de tegn og symptomer, der er relevante for tidlig opdagelse/identifikation af disse bivirkninger.
English: Responses were assessed per RECIST 1.1 for 588/1008 (58.3%) of patients who continued treatment through week 12 and had a follow-up scan at week 12.
Danish: Respons blev vurderet i henhold til RECIST 1.1 for 588/1.008 (58,3 %) af de patienter, der fortsatte behandlingen til og med uge 12, og som havde en opfølgende scanning i uge 12.
English: Updated analysis Minimum follow-up: 62.7 months a Post-hoc analysis; results should be interpreted with caution as the subgroup samples sizes are small and, at the time of the analysis, the PD-L1 IHC 28-8 pharmDx assay was not analytically validated at the 10% or 50% expression levels.
Danish: Opdateret analyse Minimum opfølgning: 24,2 måneder a Post-hoc-analyse; Resultaterne skal fortolkes med forsigtighed, da populationsstørrelsen i undergrupperne er lille, og da PD-L1 IHC 28-8 pharmDx-analysen ikke var blevet valideret analytisk ved 10 % og 50 % ekspressionsniveauerne på analysetidspunktet.
English: CA209214 also randomised 249 favourable risk patients as per IMDC criteria to nivolumab plus ipilimumab (n = 125) or to sunitinib (n = 124).
Danish: CA209214 randomiserede også 249 lav-risikopatienter ifølge IMDC-kriterierne til nivolumab plus ipilimumab (n = 125) eller til sunitinib (n = 124).
English: The rate of disease-related symptom improvement, as measured by LCSS, was similar between the nivolumab group (18.5%) and the docetaxel group (21.2%).
Danish: Hyppigheden af bedring i sygdomsrelaterede symptomer, målt med LCSS, var sammenlignelig i nivolumab gruppen (18,5 %) og docetaxel-gruppen (21,2 %).
English: Factors associated with early deaths were poorer prognostic factors and/or more aggressive disease combined with low or no tumour PD-L1 expression (see section 5.1).
Danish: Faktorerne associeret med tidlig død var dårlige prognostiske faktorer og/eller mere aggressiv sygdom kombineret med lav eller ingen PD-L1-tumor ekspression (se pkt 5.1).
English: Non-Small Cell Lung Cancer (NSCLC)
Danish: Ikke-småcellet lungecancer (NSCLC)
English: 30th June 2021
Danish: 30. juni 2021
English: The median duration of response is 18.0 months (6.6, NE) for the 22 responders to nivolumab who had failed to achieve response with prior brentuximab vedotin treatment.
Danish: Medianresponsvarighed er 18,0 måneder (6,6; NE) for de 22 nivolumabresponderende patienter, som ikke havde responderet på tidligere behandling med brentuximab vedotin.
English: Not reached (2.9-20.5+)
Danish: Ikke nået (2,9-20,5+)
English: Before you are given OPDIVO, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids, since these medicines may interfere with the effect of OPDIVO.
Danish: Fortæl det til lægen, inden du får OPDIVO, hvis du tager medicin, der hæmmer immunsystemet, som f.eks. kortikosteroider, da denne type medicin kan påvirke OPDIVOs virkning.
English: The value of biomarkers to predict the efficacy of nivolumab and/or nivolumab + ipilimumab combination therapy should be further explored, specifically:
Danish: Betydningen af biomarkører til at forudsige virkningen af nivolumab og/eller nivolumab + ipilimumab-kombinationsterapi bør undersøges nærmere, især: 1.
English: Additionally, based on these relationships, there were no clinically significant differences between a nivolumab dose of 480 mg every 4 weeks or 3 mg/kg every 2 weeks in adjuvant treatment of melanoma, advanced melanoma and advanced RCC.
Danish: Endvidere er der, baseret på disse forhold, ikke fundet klinisk signifikante forskelle mellem en dosis på 480 mg nivolumab hver 4. uge eller 3 mg/kg nivolumab hver 2. uge ved adjuverende behandling af melanom, fremskredent melanom og fremskredent renalcellekarcinom.
English: The median duration of response was not reached (range: 4.4-16.6+ months).
Danish: Medianresponsvarigheden blev ikke nået (4,4-16,6+måneder).
English: In this patient population, objective response was reported in 33 patients (31%) with a median duration of response of 22.9 months (95% CI: 17.0, NR).
Danish: I denne patientpopulation blev der rapporteret om objektivt respons hos 33 patienter (31 %) med en medianresponsvarighed på 22,9 måneder (95 % CI: 17,0; NR).
English: Comparable to the overall population, median duration of response was increased with nivolumab vs. docetaxel for patients with no PD-L1 expression (18.3 months vs. 5.6 months) and for patients with PD-L1 expression (16.0 months vs. 5.6 months).
Danish: Sammenlignet med den samlede population, var den mediane responsvarighed længere med nivolumab versus docetaxel hos patienter uden PD-L1-ekspression (18,3 måneder versus 5,6 måneder) og hos patienter med PD-L1-ekspression (16,0 måneder versus 5,6 måneder).
English: Grade 3 or 4 elevation in AST, ALT, or total bilirubin
Danish: Grad 3 eller 4 forhøjelse af ASAT, ALAT eller total-bilirubin
English: The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with everolimus at the prespecified interim analysis when 398 events were observed (70% of the planned number of events for final analysis) (Table 18 and Figure 10).
Danish: Studiet viste en statistisk signifikant forbedret OS for patienter, der blev randomiseret til nivolumab, sammenlignet med everolimus ved den planlagte interimanalyse efter 398 observerede hændelser (70 % af det planlagte antal hændelser til endelig analyse) (tabel 18 og figur 10).
English: Permanently discontinue treatment
Danish: Behandlingen seponeres permanent
English: Over 15 weeks of follow-up, patients treated with nivolumab exhibited stable PROs, while those assigned to investigator's choice therapy exhibited significant declines in functioning (e.g., physical, role, social) and health status as well as increased symptomatology (e.g., fatigue, dyspnoea, appetite loss, pain, sensory problems, social contact problems).
Danish: I en opfølgningsperiode på 15 uger udviste de patienter, der blev behandlet med nivolumab, stabile PRO, hvorimod de patienter, der fik tildelt behandling efter investigators valg, udviste signifikante fald i funktionsevner (f.eks. fysisk, fysisk betingede begrænsninger, socialt) og helbredsstatus og øget symptomatologi (f.eks. træthed, dyspnø, manglende appetit, smerter, føleproblemer og problemer med social kontakt).
English: Rapid onset of GVHD has been reported with nivolumab use before and after allogeneic HSCT (see section 4.4).
Danish: Hurtigt opstået GVHD er rapporteret i forbindelse med brug af nivolumab før og efter allogen HSCT (se pkt.
English: Computed using Kaplan-Meier method.
Danish: Beregnet ved brug af Kaplan-Meier-metoden.
English: It is recommended to continue treatment with nivolumab or nivolumab in combination with ipilimumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Danish: Det anbefales at fortsætte behandlingen med nivolumab eller nivolumab og ipilimumab i kombination hos klinisk stabile patienter, der indledningsvist udviser tegn på sygdomsprogression, indtil sygdomsprogression er bekræftet.
English: Due to the small numbers of patients in the subgroups, and exploratory nature of the analysis, no definitive conclusions can be drawn from these data.
Danish: På grund af det lille antal patienter i undergrupperne og analysens eksplorative natur kan der ikke drages nogen definitive konklusioner ud fra disse data.
English: Quality of life (QoL) with nivolumab remained stable and close to baseline values during treatment, as assessed by valid and reliable scales like the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D utility index and visual analog scale (VAS).
Danish: Livskvalitet (QoL) forblev stabil under behandlingen med nivolumab og tæt på baseline-værdierne, der blev vurderet ved validerede og pålidelige skalaer, såsom the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 og EQ-5D utility index og visual analog scale (VAS).
English: Efficacy results based on investigator-assessed ORR are presented in Table 15 below.
Danish: Effektresultater baseret på investigatorvurderet ORR kan ses i tabel 15 nedenfor.
English: OPDIVO must be stored in a refrigerator (2°C to 8°C).
Danish: OPDIVO skal opbevares i køleskab (2°C til 8°C).
English: OPDIVO as monotherapy
Danish: OPDIVO som monoterapi
English: More than one vial of OPDIVO may be necessary to obtain the required dose.
Danish: Det kan være nødvendigt at anvende mere end et hætteglas OPDIVO for at opnå den nødvendige dosis.
English: Median OSa (months)
Danish: Median-OSa (måneder)
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies and for hyperglycaemia and changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
Danish: Patienten skal monitoreres for kliniske tegn og symptomer på endokrinopatier, hyperglykæmi og ændringer i thyroideafunktionen (i begyndelsen af behandlingen, regelmæssigt under behandlingen og som indiceret baseret på klinisk evaluering).
English: A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, solid tumour type, tumour size, and hepatic impairment.
Danish: En farmakokinetisk populationsanalyse tydede ikke på nogen forskel i nivolumabs CL på basis af alder, køn, race, type af solid tumor, tumorstørrelse og nedsat leverfunktion.
English: Cardiac and pulmonary adverse events including pulmonary embolism have also been reported with combination therapy.
Danish: Kardielle og pulmonale bivirkninger, herunder lungeemboli, er også rapporteret med kombinationsbehandling.
English: The overall safety profile of nivolumab 3 mg/kg for the adjuvant treatment of melanoma (n = 452) was consistent with that established across tumour types for nivolumab monotherapy.
Danish: Den overordnede sikkerhedsprofil for nivolumab 3 mg/kg til adjuverende behandling af melanom (n = 452) var i overensstemmelse med den, der er etableret på tværs af tumortyper for nivolumabmonoterapi.
English: Hypersensitivity/Infusion Reaction
Danish: Overfølsomhed/infusionsreaktion
English: Table 7 presents the percentage for immune-related adverse reactions who were permanently discontinued from treatment by dosing regimen.
Danish: Tabel 7 viser procentdelen af immunrelatererede bivirkninger, hvor behandling blev seponeret permanent ud fra dosisregime.
English: Efficacy assessments included investigator-assessed ORR, retrospectively evaluated by an IRRC, and duration of response.
Danish: Effektparametrene omfattede investigatorvurderet ORR, retrospektivt evalueret af en IRRC, og responsvarighed.
English: If you stop using OPDIVO
Danish: Hvis du holder op med at få OPDIVO
English: The unopened vial can be stored at controlled room temperature up to 25°C with room light for up to 48 hours.
Danish: Det uåbnede hætteglas kan opbevares ved stuetemperaturer på op til 25°C og rumbelysning i op til 48 timer.
English: How to use OPDIVO 4.
Danish: Sådan skal du bruge OPDIVO 4.
English: Inspect the OPDIVO concentrate for particulate matter or discoloration.
Danish: Kontroller OPDIVO-koncentratet for partikler eller misfarvning.
English: The frequency of cardiac adverse events was lower in the nivolumab group than in the dacarbazine group in the metastatic melanoma without prior treatment population.
Danish: Hyppigheden af kardielle bivirkninger var lavere i nivolumabgruppen end i dacarbazingruppen i populationen med metastatisk melanom uden tidligere behandling.
English: Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immunerelated colitis.
Danish: Der er rapporteret om infektion med/reaktivering af cytomegalovirus (CMV) hos patienter med kortikosteroid-refraktær immunrelateret colitis.
English: Nivolumab CL in cHL patients was approximately 32% lower relative to NSCLC.
Danish: Nivolumabs CL hos patienter med klassisk HL var cirka 32 % lavere i forhold til NSCLC.
English: The benefit of treatment with nivolumab versus the risk of possible organ rejection should be considered in these patients.
Danish: Fordelene ved behandling med nivolumab skal afvejes mod risikoen for mulig organafstødning hos disse patienter.
English: ORR (95% CI) by tumour PD-L1 expression n=210
Danish: ORR (95 % CI) i forhold til PD-L1-tumorekspression n = 210
English: The median age was 60 years (range: 23-88).
Danish: Medianalderen var 60 år (23-88).
English: The safety of re-initiating nivolumab or nivolumab in combination with ipilimumab therapy in patients previously experiencing immune-related myocarditis is not known.
Danish: Sikkerheden ved at genoptage behandlingen med nivolumab eller nivolumab i kombination med ipilimumab hos patienter, der tidligere har haft immunrelateret myocarditis, kendes ikke.
English: OPDIVO or OPDIVO in combination with ipilimumab should be permanently discontinued for:
Danish: OPDIVO eller OPDIVO i kombination med ipilimumab skal seponeres permanent ved:
English: It includes 243 patients who had ASCT; Cohort A included 63 (26%) patients who were brentuximab vedotin naïve; Cohort B included 80 (33%) patients who had received brentuximab vedotin after ASCT failure; and Cohort C included 100 (41%) patients who had received brentuximab vedotin before and/or after ASCT out of which 33 (14%) patients received brentuximab vedotin only prior to ASCT.
Danish: Det omfatter 243 patienter der har ASCT: Kohorte A omfattede 63 (26 %) patienter som var brentuximab vedotin-naive; Kohorte B omfattede 80 (33 %) patienter, som havde fået brentuximab vedotin efter ASCT-svigt; og Kohorte C omfattede 100 (41 %) patienter som havde fået brentuximab vedotin før og/eller efter ACST hvoraf 33 (14 %) patienter kun fik brentuximab vedotin før ACST.
English: Problems with your heart such as a change in the rhythm or rate of the heartbeat or an abnormal heart rhythm.
Danish: Problemer med hjertet som f.eks. ændringer i rytmen eller hastigheden af hjerteslag eller en unormal hjerterytme.
English: Not known aseptic meningitish
Danish: Ikke kendt aseptisk meningitish
English: Chronic diseases associated with a build-up of inflammatory cells in various organs and tissues, most commonly the lungs (sarcoidosis)
Danish: Kroniske sygdomme forbundet med ophobning af betændelsesceller i forskellige organer og væv, oftest i lungerne (sarkoidose)
English: The median duration of time from initial diagnosis to randomisation was 2.6 years in both the nivolumab and everolimus groups.
Danish: Mediantiden fra initial diagnosticering til randomisering var 2,6 år i både nivolumab-gruppen og everolimus-gruppen.
English: Table 9: Best overall response, time and duration of response (CA209037)
Danish: Tabel 9: Bedste samlet respons, tid til respons og responsvarighed (CA209037)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours, malignant neoplasms of lymphoid tissue and malignant neoplasms of the central nervous system (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med nivolumab i alle undergrupper af den pædiatriske population ved behandling af maligne solide tumorer, maligne neoplasmer i lymfevæv og maligne neoplasmer i centralnervesystemet (se pkt.
English: Grade 2 myocarditis
Danish: Grad 2 myocarditis
English: If a patient develops signs and symptoms of myotoxicity, close monitoring should be implemented, and the patient referred to a specialist for assessment and treatment without delay.
Danish: Hvis en patient udvikler symptomer på myotoksicitet, skal patienten nøje overvåges og straks henvises til en specialist for vurdering og behandling.
English: The volume of OPDIVO concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the OPDIVO concentrate strength is 10 mg/mL).
Danish: Volumen (ml) af OPDIVO-koncentrat til klargøring af dosis = den totale dosis i mg, divideret med 10 (styrken af OPDIVO-koncentratet er 10 mg/ml).
English: Patients were to have ECOG performance status score of 0 or 1.
Danish: Patienterne skulle have ECOG-performance-score 0 eller 1.
English: What you need to know before you use OPDIVO 3.
Danish: Det skal du vide, før du begynder at bruge OPDIVO 3.
English: Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion.
Danish: PD-1s interaktion med liganderne PD-L1 og PD-L2, der udtrykkes i antigenpræsenterende celler og muligvis af tumorer eller andre celler i tumors mikromiljø, medfører hæmning af T-celleproliferation og cytokinudskillelse.
English: Both nivolumab-containing arms demonstrated greater objective response rates than ipilimumab regardless of PD-L1 expression levels.
Danish: Begge nivolumab-arme viste større objektive responsrater end ipilimumab uanset PDL1-ekspressionsniveau.
English: P-value is derived from a log-rank test stratified by prior cetuximab; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0227.
Danish: P-værdi er udledt af en log-rank-test stratificeret efter tidligere cetuximab-behandling; grænsen for det tilsvarende O'Brien-Fleming-signifikansniveau for effekt er 0,0227.
English: Uncommon intestinal perforationa, gastritis, duodenitis gastritis
Danish: Ikke almindelig intestinal perforationa, gastritis, duodenitis gastritis
English: Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease.
Danish: Lægen skal tage hensyn til nivolumabs forsinkede virkning, før behandling initieres hos patienter med dårlige prognostiske udsigter og/eller aggressiv sygdom.
English: Immune-related myocarditis
Danish: Immunrelateret myocarditis
English: Immune-related adverse reaction requiring high-dose corticosteroidsa,b
Danish: Immunrelateret bivirkning, der krævede behandling med højdosis-kortikosteroidera,b
English: Grade 2 elevation in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin
Danish: Grad 2 forhøjelse af aspartataminotransferase (ASAT), alaninaminotransferase (ALAT) eller total-bilirubin
English: Nivolumab in combination with ipilimumab:
Danish: Nivolumab i kombination med ipilimumab:
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Danish: Der blev ikke rapporteret om nogen generel forskel på sikkerheden mellem ældre (≥ 65 år) og yngre patienter (< 65 år).
English: Longer follow-up data from Cohort B (minimum 20.5 months) and efficacy of Cohort C from CA209205 are presented below in Table 22.
Danish: Data fra den længere opfølgningsperiode fra kohorte B (minimum 20,5 måneder) og effekt i kohorte C fra CA209205 er vist i nedenstående tabel 22.
English: 240 mg every 2 weeks over 30 minutes
Danish: 240 mg hver 2. uge over 30 minutter
English: Treatment with OPDIVO, either as a monotherapy or in combination with ipilimumab, should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Danish: Behandling med OPDIVO, enten som monoterapi eller i kombination med ipilimumab, bør fortsættes, så længe der observeres en klinisk gavnlig effekt, eller indtil patienten ikke længere tolererer behandlingen.
English: Of the 306 previously treated patients enrolled in the study, 107 had melanoma and received nivolumab at a dose of 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 10 mg/kg for a maximum of 2 years.
Danish: Af de 306 tidligere behandlede patienter, der deltog i studiet, havde 107 melanom og fik nivolumab i en dosis på 0,1 mg/kg, 0,3 mg/kg, 1 mg/kg, 3 mg/kg eller 10 mg/kg i højst 2 år.