FrancophonIA/ELRC3.0 huggingface dataset:
English: OS and PFS were estimated using Kaplan-Meier method.
Danish: OS og PFS blev estimeret ved brug af Kaplan-Meier-metoden.
English: Treatment with nivolumab may increase the risk of rejection in solid organ transplant recipients.
Danish: Behandling med nivolumab kan øge risikoen for afstødning af transplanterede solide organer.
English: This observation was maintained with the OS results with a minimum followup of 36 months.
Danish: Denne observation blev bevaret for OSresultaterne med en opfølgningsperiode på minimum 36 måneder.
English: Rare cases of SJS and TEN some of them with fatal outcome have been observed.
Danish: Der er observeret sjældne tilfælde af SJS og TEN, hvoraf nogle havde dødelig udgang.
English: (95% CI)c nivolumab investigator's choice nivolumab investigator's choice nivolumab investigator's choice
Danish: (95 % CI)c nivolumab investigators valg nivolumab investigators valg nivolumab investigators valg
English: Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.
Danish: Lægen vil overvåge dig nøje for tegn på komplikationer, hvis du gennemgår en allogen stamcelletransplantation.
English: OPDIVO infusion must be completed within 24 hours of preparation.
Danish: Administration af OPDIVO-infusion skal være afsluttet inden for 24 timer efter klargøring.
English: OS results at an additional analysis undertaken at a minimum follow-up of 36 months show outcomes consistent with the original analysis.
Danish: OS-resultaterne fra en yderligere analyse, foretaget efter en opfølgningsperiode på minimum 36 måneder, viste resultater i overensstemmelse med den oprindelige analyse.
English: Randomisation was stratified by tumour PD-L1 status and M stage (M0/M1a/M1b versus M1c).
Danish: Randomiseringen blev stratificeret i forhold til PD-L1-tumorstatus og M-stadie (M0/M1a/M1b versus M1c).
English: Study CA209017 included a limited number of patients ≥ 75 years (11 in the nivolumab group and 18 in the docetaxel group).
Danish: Studie CA209017 inkluderede et begrænset antal patienter ≥ 75 år (11 i nivolumab-gruppen og 18 i docetaxel-gruppen).
English: Common dehydration dehydration
Danish: Almindelig dehydrering dehydrering
English: Hepatic veno-occlusive disease occurred in one patient, who died of GVHD and multi-organ failure.
Danish: Hepatisk veno-okklusiv sygdom indtrådte hos én patient, som døde af GVHD og multiorgansvigt.
English: It contains the active substance nivolumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Danish: OPDIVO indeholder det aktive stof nivolumab, som er et monoklonalt antistof, en type protein, der er designet til at genkende og binde sig til et bestemt målstof i kroppen.
English: • Grade 4 or recurrent Grade 3 adverse reactions;
Danish: • Grad 4 eller tilbagevendende grad 3 bivirkninger;
English: Thirty-one percent had progressive disease reported as the best response to their most recent prior regimen and 45% received nivolumab within 3 months of completing their most recent prior regimen.
Danish: Hos 31 % blev fremskreden sygdom rapporteret som det bedste respons på den seneste tidligere behandling, og 45 % fik nivolumab inden for 3 måneder efter afslutning af deres seneste tidligere behandling.
English: Prior to launch of OPDIVO in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Forud for markedsføring af OPDIVO i hvert enkelt medlemsland skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om indholdet og udformningen af uddannelsesmaterialet, inklusive kommunikationsmedier, distributionsmetoder og andre aspekter af programmet.
English: The active substance is nivolumab.
Danish: Aktivt stof: Nivolumab.
English: Safety and efficacy in elderly patients
Danish: Sikkerhed og virkning hos ældre
English: An additional line of TKI therapy was allowed for patients with known EGFR mutation or ALK translocation.
Danish: Supplerende TKI-behandling var tilladt for patienter med kendt EGFR-mutation eller ALK-translokation.
English: Median PFSa (months)
Danish: Median-PFSa (måneder)
English: Non-Small Cell Lung Cancer
Danish: Ikke-småcellet lungecancer
English: 31st March 2019
Danish: 31. marts 2019
English: Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Danish: Klargøring af lægemidlet skal foretages af uddannet personale i overensstemmelse med god praksis, især med henblik på aseptik.
English: An updated OS analysis was performed when all patients had a minimum follow-up of 24 months (see figure 11).
Danish: En opdateret analyse af OS blev foretaget da alle patienter havde en opfølgningsperiode på minimum 24 måneder (se figur 11).
English: However, the role of this biomarker (tumour PD-L1 expression) has not been fully elucidated.
Danish: Imidlertid er denne biomarkørs (PD-L1-tumorekspression) rolle ikke fuldt belyst.
English: Transfer the concentrate into a sterile, evacuated glass bottle or intravenous container (PVC or polyolefin).
Danish: Overfør koncentratet til en steril, tom glasflaske eller intravenøs beholder (PVC eller polyolefin).
English: Complete response (CR) Partial response (PR) Stable disease (SD)
Danish: Komplet respons (CR) Partielt respons (PR) Stabil sygdom (SD)
English: After 28 months of follow-up, median OS was not reached in either of the nivolumab containing arms regardless of BRAF status.
Danish: Efter en opfølgningsperiode på 28 måneder blev median-OS ikke nået i nogle af nivolumab-armene uanset BRAF-status.
English: Systemic immunosuppression
Danish: Systemisk immunsuppression
English: More patients in the nivolumab arm had poor prognostic factors (elevated LDH and brain metastases) than in the chemotherapy arm.
Danish: Flere patienter i nivolumabarmen havde dårlige prognostiske faktorer (forhøjet LDH og hjernemetastaser) end i kemoterapiarmen.
English: Hypersensitivity/Infusion Reaction a at least 40 mg daily prednisone equivalents b frequency is based on the number of patients who experienced the immune-related adverse reaction
Danish: Overfølsomhed/infusionsreaktion a mindst ækvivalent med 40 mg prednison dagligt b hyppigheden er baseret på antal patienter, der fik de immunrelaterede bivirkninger
English: At the time of this final ORR analysis, results from 120 nivolumab-treated patients and 47 chemotherapy-treated patients who had a minimum of 6 months of follow-up were analysed.
Danish: Ved tidspunktet for den afsluttende ORR-analyse analyserede man resultaterne fra 120 nivolumab-behandlede patienter og 47 kemoterapi-behandlede patienter, som havde en opfølgningsperiode på mindst 6 måneder.
English: Determined for subjects with CR or PR NE = non-estimable
Danish: Bestemt for patienter med CR eller PR NE = ikke estimerbar
English: The primary endpoint was recurrence-free survival (RFS).
Danish: Det primære endepunkt var overlevelse uden tilbagefald (recurrence-free survival, RFS).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via: det nationale rapporteringssystem anført i Appendiks V.
English: Patients treated with OPDIVO must be given the patient alert card and be informed about the risks of OPDIVO (see also package leaflet).
Danish: Patienter, der behandles med OPDIVO, skal have udleveret patient-informationskortet og informeres om de risici, der er forbundet med OPDIVO-behandling (se også indlægssedlen).
English: Randomisation was stratified by prior cetuximab treatment.
Danish: Randomiseringen blev stratificeret i forhold til tidligere cetuximab-behandling.
English: The final OS analysis occurred when all patients had a minimum follow-up of 28 months.
Danish: Den endelige analyse af OS blev foretaget da alle patienter havde en opfølgningsperiode på minimum 28 måneder.
English: The remaining offspring of nivolumab-treated females survived to scheduled termination, with no treatment-related clinical signs, alterations to normal development, organ-weight effects, or gross and microscopic pathology changes.
Danish: De resterende afkom af nivolumab-behandlede hunaber overlevede til planlagt termin uden behandlingsrelaterede kliniske tegn, ændringer i normal udvikling, effekt på organvægt eller betydningsfulde eller mikroskopiske patologiske ændringer.
English: OPDIVO alone or in combination with ipilimumab may cause changes in the results of tests carried out by your doctor.
Danish: OPDIVO alene eller i kombination med ipilimumab kan ændre resultaterne af de prøver, som lægen tager.
English: Life-threatening cases have been reported in completed or ongoing clinical studies.
Danish: Der er rapporteret livstruende tilfælde i afsluttede eller igangværende kliniske studier.
English: The safety and efficacy of OPDIVO in children below 18 years of age have not been established.
Danish: OPDIVOs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Hyperacute GVHD, defined as acute GVHD occurring within 14 days after stem cell infusion, was reported in three patients (6%).
Danish: Hyperakut GVHD, defineret som akut GVHD, der indtræder i løbet af 14 dage efter stamcelleinfusion, blev rapporteret hos tre patienter (6 %).
English: Uncommon tubulointerstitial nephritis tubulointerstitial nephritis
Danish: Ikke almindelig tubulointerstitiel nefritis tubulointerstitiel nefritis
English: The Kaplan-Meier curves for OS (with a minimum follow-up of 24 months) in intermediate/poor risk patients are shown in Figure 11.
Danish: Kaplan-Meier-kurverne for OS (med en minimum opfølgningsperiode på 24 måneder) hos mellemeller højrisikopatienter er vist i figur 11.
English: Based on modelling of dose/exposure efficacy and safety relationships, there are no clinically significant differences in efficacy and safety between a nivolumab dose of 240 mg every 2 weeks or 3 mg/kg every 2 weeks.
Danish: En modellering af forholdet mellem dosis/eksponering i relation til effekt og sikkerhed viser ingen klinisk signifikante forskelle i effekt og sikkerhed mellem en dosis på 240 mg nivolumab hver 2. uge eller 3 mg/kg nivolumab hver 2. uge.
English: The primary efficacy outcome measures were OS, ORR and PFS as determined by a Blinded Independent Central Review (BICR) in intermediate/poor risk patients.
Danish: De primære effektparametre var OS, ORR og PFS som bestemt ved Blinded Independent Central Review (BICR) hos mellem- eller højrisikopatienter.
English: The following side effects have been reported with nivolumab alone:
Danish: Følgende bivirkninger er blevet rapporteret med nivolumab alene:
English: These include:
Danish: Disse kan være:
English: With a minimum follow-up of 11.4 months, the trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with investigator's choice.
Danish: Med en opfølgningsperiode på minimum 11,4 måneder blev viste studiet en statistisk signifikant forbedring i OS hos de patienter, der blev randomiseret til nivolumab, sammenlignet med investigators valg.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne listet efter faldende alvorlighed.
English: Patients that received more than 2 prior lines of chemotherapy with liver metastases were excluded.
Danish: Patienter, der havde fået mere end 2 tidligere linjer kemoterapi og havde levermetastaser blev ekskluderet.
English: During administration of the second phase of treatment (nivolumab monotherapy) following combination treatment, permanently discontinue treatment if Grade 3 diarrhoea or colitis occurs.
Danish: Under administration i anden fase af behandlingen (nivolumab-monoterapi) efter kombinationsbehandling skal behandlingen seponeres permanent, hvis der opstår grad 3 diarre eller colitis.
English: Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with nivolumab or nivolumab in combination with ipilimumab may occur at any time during or after discontinuation of therapy.
Danish: Patienten bør monitoreres løbende (som minimum i op til 5 måneder efter den sidste dosis), da bivirkninger ved nivolumab eller nivolumab i kombination med ipilimumab kan opstå på et hvilket som helst tidspunkt under eller efter seponering af behandlingen.
English: Efficacy results for the intermediate/poor risk patients from the primary analysis (minimum follow-up 17.5 months) are shown in Table 19.
Danish: Effektresultater hos mellem- eller højrisikopatienter fra den primære analyse (med en minimum opfølgningperiode på 17,5 måneder) er vist i tabel 19.
English: Patient Alert Card
Danish: Patient-informationskort
English: Sixty-four percent of patients had no prior clinical benefit (CR/PR or SD) on ipilimumab.
Danish: 64 % af patienterne havde ingen klinisk gavn (CR/PR eller SD) af tidligere behandling med ipilimumab.
English: At a minimum follow-up of 9 months, investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3, 35.4).
Danish: Ved en minimumsopfølgning på 9 måneder var investigatorvurderet bekræftet ORR 24,4 % (95 % CI : 15,3, 35,4).
English: Non-corticosteroid immunosuppressive therapy should be added if there is worsening or no improvement despite corticosteroid use.
Danish: Non-kortikosteroid immunsuppressiv behandling bør tilføjes, hvis der opstår forværring, eller der ikke sker bedring, på trods af anvendelse af kortikosteroider.
English: This analysis showed that not only tumour cell PD-L1 expression but also TAIC PD-L1 expression appeared to be associated with benefit from nivolumab relative to investigator's choice (see Table 25).
Danish: Denne analyse viste, at ikke kun PD-L1-tumorcelleekspression men også PD-L1-TAIC-ekspression syntes at være forbundet med en fordel ved nivolumab i forhold til investigators valg (se tabel 25).
English: More than one vial of OPDIVO concentrate may be needed to give the total dose for the patient.
Danish: Mere end 1 hætteglas OPDIVO-koncentrat kan være nødvendigt for at give patienten den totale dosis.
English: It is to be administered as an intravenous infusion over a period of 30 or 60 minutes depending on the dose (see Tables 1, 2 and 3).
Danish: Det skal administreres som intravenøs infusion over 30 eller 60 minutter afhængigt af dosis (se tabel 1, 2 og 3).
English: The PFS was measured by RECIST, version 1.1.
Danish: PFS blev målt ved RECIST, version 1.1.
English: The safety and tolerability of nivolumab were investigated in a phase 1, open-label dose-escalation study in various tumour types, including malignant melanoma.
Danish: Nivolumabs sikkerhed og tolerabilitet blev undersøgt i et åbent fase 1-dosiseskaleringsstudie med forskellige tumortyper, herunder malignt melanom.
English: Patients on controlled sodium diet
Danish: Patienter på natriumkontrolleret diæt
English: The MAH shall ensure that in each Member State where OPDIVO is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use OPDIVO have access to/are provided with the following educational package:
Danish: I alle de medlemslande, hvor OPDIVO markedsføres, skal indehaveren af markedsføringstilladelsen sikre, at al plejepersonale og patienter/omsorgspersoner, som forventes at udskrive og anvende OPDIVO, har adgang til/har modtaget følgende uddannelsespakke:
English: • The patient alert card shall contain the following key messages:
Danish: • Patient-informationskortet skal indeholde følgende hovedelementer:
English: OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Kun til engangsbrug.
English: Assessment according to discrete PD-L1 expression intervals were not included in the prespecified analyses due to the small sample sizes within the intervals.
Danish: Vurdering ud fra diskrete PD-L1-ekspressionsintervaller blev ikke inkluderet i de præspecificerede analyser på grund af den lille populationsstørrelse i undergrupperne.
English: Confidence interval for ORR calculated using the Clopper-Pearson method.
Danish: Konfidensinterval for ORR er beregnet ved brug af Clopper-Pearson-metoden.
English: The ORR and PFS were assessed by IRRC per RECIST version 1.1.
Danish: ORR og PFS blev vurderet ved IRRC pr. RECIST version 1.1.
English: Updated analysis (24-month follow-up)
Danish: Opdateret analyse (opfølgning efter 24 måneder)
English: The PRO data should be interpreted in the context of the open-label study design and therefore taken cautiously.
Danish: PRO-dataene bør tolkes i lyset af det åbne studiedesign og derfor tages med forbehold.
English: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Danish: Stevens-Johnsons syndrom (SJS) eller toksisk epidermal nekrolyse (TEN)
English: Treatment with nivolumab may increase the risk of severe GVHD and death in patients who have had prior allogeneic HSCT, mainly in those with prior history of GVHD.
Danish: Behandling med nivolumab kan øge risikoen for alvorlig GVHD og død hos patienter, der tidligere har gennemgået allogen HSCT, først og fremmest hos dem, der tidligere har oplevet GVHD.
English: Your doctor will continue giving you OPDIVO for as long as you keep benefitting from it or until you no longer tolerate the treatment.
Danish: Lægen vil fortsætte med at give dig OPDIVO, så længe du har gavn af det, eller indtil du ikke længere tåler behandlingen.
English: Factors associated with early deaths were ECOG performance status, fast progressive disease on prior platinum therapy and high tumour burden.
Danish: Faktorer associeret med tidlig død omfattede ECOG-performance-score, hurtigt progredierende sygdom på tidligere platinbehandling og høj tumorbyrde.
English: Tumour assessments were continued after treatment discontinuation in patients who discontinued treatment for reasons other than progression.
Danish: Tumorvurderinger blev fortsat efter afbrydelse af behandling hos patienter, som afbrød behandling på grund af andre årsager end progression.
English: Patient-reported outcomes (PROs) were assessed using the EORTC QLQ-C30, EORTC QLQ-H&N35, and 3-level EQ-5D.
Danish: Patientrapporterede resultater (patient-reported outcomes - PRO) blev vurderet ved hjælp af EORTC QLQ-C30, EORTC QLQ-H&N35 og 3-niveaus EQ-5D.
English: The metabolic pathway of nivolumab has not been characterised.
Danish: Nivolumabs metaboliseringsvej er ikke fuldt belyst.
English: While both arms of the study received active therapy, the QoL data should be interpreted in the context of the open-label study design and therefore cautiously taken.
Danish: Da begge studiearme fik aktiv behandling, bør data for QoL tolkes i lyset af studiets åbne design og med forsigtighed.
English: The majority of patients (72%) were treated with one prior anti-angiogenic therapy.
Danish: Størstedelen af patienterne (72 %) havde tidligere fået en anti-angiogenese-behandling.
English: In terms of ORR, increasing PD-L1 expression was associated with larger ORR.
Danish: Stigende PD-L1-ekspression var associeret med højere ORR.
English: Complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with OPDIVO.
Danish: Komplikationer ved stamcelletransplantation, hvor der anvendes stamceller fra en donor (allogen transplantation) efter behandling med OPDIVO.
English: Additional outcome measures included duration and timing of response.
Danish: Yderligere effektparametre omfattede responsvarighed og tid til respons.
English: Results are shown in Table 21.
Danish: Resultaterne er angivet i tabel 21.
English: Rare (may affect up to 1 in 1000 people) Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis)
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer) Alvorlig og muligvis dødelig afskalning af huden (toksisk epidermal nekrolyse)
English: Incidence rates per 100 person-years of exposure were 9.3 vs. 0; serious cardiac events were reported by 4.9% patients in the nivolumab group vs. 0 in the investigator´s choice group.
Danish: Incidensen pr. 100 patientårs eksponering var 9,3 versus 0; alvorlige kardielle bivirkninger blev rapporteret hos 4,9 % af patienterne i nivolumabgruppen versus 0 i den gruppe, der fik investigators valg af behandling.
English: • patients with prior autoimmune disease, and any condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications,
Danish: • patienter med tidligere autoimmun sygdom, og andre tilstande der kræver systemisk behandling med enten kortikosteroider (≥ 10 mg prednisolon dagligt eller tilsvarende) eller andre immunosuppresive lægemidler,
English: Renal Cell Carcinoma (RCC)
Danish: Renalcellekarcinom (RCC)
English: If dosing is resumed after a delay, either the combination treatment or OPDIVO monotherapy could be resumed based on the evaluation of the individual patient.
Danish: Hvis dosering genoptages efter at have været udsat, bør enten kombinationsbehandling eller OPDIVO-monoterapi genoptages baseret på en vurdering af den enkelte patient.
English: Cases of Vogt-Koyanagi-Harada syndrome and hypoparathyroidism have been reported postmarketing (see section 4.8).
Danish: Tilfælde af Vogt-Koyanagi-Harada syndrom og hypoparatyroidisme er blevet rapporteret efter markedsføring (se pkt.
English: A higher proportion of patients experienced death within the first 3 months in the nivolumab arm (59/292, 20.2%) as compared to the docetaxel arm (44/290, 15.2%).
Danish: En højere andel af patienterne døde inden for de første 3 måneder i nivolumab-armen (59/292; 20,2 %) sammenlignet med docetaxel-armen (44/290; 15,2 %).
English: Nivolumab treatment resulted in rapid resolution of B-symptoms in 88.7% (47/53) of the patients, with a median time to resolution of 1.9 months.
Danish: Behandling med nivolumab resulterede i hurtig resolution af B-symptomer hos 88,7 % (47/53) af patienterne med en mediantid til resolution på 1,9 måneder.
English: following nivolumab therapy' o Potential risk of ‘Risk of GVHD with nivolumab after allogeneic HSCT'
Danish: (HSCT) efter behandling med nivolumab' o Potentiel risiko for 'Risiko for GVHD med nivolumab efter allogen HSCT'
English: Grade 3 or 4 myocarditis
Danish: Grad 3 eller 4 myocarditis
English: Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant related complications should be made case-by-case (see section 4.8).
Danish: Indtil yderligere data bliver tilgængelige, skal de potentielle fordele ved HSCT og den potentielt øgede risiko for transplantationsrelaterede komplikationer vurderes nøje for hver enkelt patient (se pkt.
English: Grade 2 or 3 creatinine elevation
Danish: Grad 2 eller 3 kreatininstigning
English: • Persistent Grade 2 or 3 adverse reactions despite management.
Danish: • Vedvarende grad 2 eller 3 bivirkninger trods behandling.
English: Phase 3b/4 safety study (CA209374)
Danish: Fase 3b/4-sikkerhedsstudie (CA209374)
English: • Contact details of the OPDIVO prescriber
Danish: • Kontaktoplysninger på den læge, der har ordineret OPDIVO
English: Be aware of important symptoms of inflammation.
Danish: Vær opmærksom på vigtige symptomer på inflammation (betændelseslignende reaktion).
English: ECOG performance scores were 0 for 61% of patients and 1 for 39% of patients.
Danish: ECOG-performance-score var 0 hos 61 % af patienterne, og 1 hos 39 % af patienterne.
English: Patients with investigator-assessed primary site of oropharyngeal cancer were tested for HPV (determined by p16 immunohistochemistry [IHC]).
Danish: Patienter med investigatorvurderet orofaryngeal primærtumor blev testet for HPV (bestemt ved p16immunhistokemi [IHC]).
English: Stevens-Johnson syndrome, vitiligo, erythema multiforme, alopecia, psoriasis
Danish: Stevens-Johnsons syndrom, vitiligo, erythema multiforme, alopeci, psoriasis