FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 67 patients in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab at the time of disease progression and 18 additional patients received a checkpoint inhibitor as subsequent therapy.
Danish: I alt 67 patienter i placebo plus kemoterapiarmen krydsede over til pembrolizumab som monoterapi på tidspunktet for sygdomsprogression, og yderligere 18 patienter fik en checkpoint-hæmmer som efterfølgende behandling.
English: Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either trial.
Danish: Patienter med aktiv, ikke-infektiøs pneumonitis, allogen transplantation inden for de seneste 5 år (eller > 5 år, men med GVHD), aktiv autoimmun sygdom eller en lidelse, som nødvendiggjorde behandling med immunsuppressiva, var uegnede til at deltage i begge
English: Adrenal insufficiency Symptomatic hypophysitis Type 1 diabetes associated with Grade ≥ 3 hyperglycaemia (glucose > 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis Hyperthyroidism Grade ≥ 3
Danish: Binyrebarkinsufficiens Symptomatisk hypofysitis Type 1-diabetes associeret med hyperglykæmi grad ≥ 3 (glucose > 250 mg/dl eller > 13,9 mmol/l) eller associeret med ketoacidose Hypertyroidisme grad ≥ 3
English: In the Hodgkin lymphoma population, the ORR was 50.0%, 2 patients (11.1%) had a complete response and 7 patients (38.9%) had a partial response.
Danish: I populationen med Hodgkins lymfom var ORR 50,0%, 2 patienter (11,1%) havde komplet respons og 7 patienter (38,9%) havde partielt respons.
English: Overall, 20 cHL patients ≥ 65 years were treated with pembrolizumab in studies KEYNOTE-087 and KEYNOTE-013.
Danish: Alt i alt blev 20 cHL-patienter ≥ 65 år behandlet med pembrolizumab i studierne KEYNOTE-087 og KEYNOTE-013.
English: Exposure to pembrolizumab as expressed by peak concentration (Cmax) or area under the plasma concentration time curve (AUC) increased dose proportionally within the dose range for efficacy.
Danish: Eksponeringen for pembrolizumab udtrykt ved peak-koncentration (Cmax) eller areal under kurven for plasmakoncentration over tid (AUC) steg dosisproportionalt inden for det terapeutiske dosisinterval.
English: Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel.
Danish: 35% havde PD-L1tumorekspression TPS < 1% [negativ]; 19% var østasiatere og 60% fik paclitaxel.
English: A prolonged time to deterioration in EORTC QLQ-C30 global health status/QoL was observed for patients treated with pembrolizumab compared to investigator's choice chemotherapy (HR 0.70; 95% CI 0.55-0.90).
Danish: I EORTC QLQC30 global helbredstilstand/QoL sås en forlængelse af tiden til forværring hos patienter, der var blevet behandlet med pembrolizumab sammenlignet med investigators valg af kemoterapi (HR 0,70; 95% CI 0,55-0,90).
English: Patients with active infections were excluded from clinical trials and were required to have their infection treated prior to receiving pembrolizumab.
Danish: Patienter med aktive infektioner blev ekskluderet fra kliniske studier, og det var en forudsætning, at infektionen blev behandlet, inden de kunne få pembrolizumab.
English: Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Pembrolizumab er et humaniseret monoklonalt anti-programmed cell death-1 (PD-1)-antistof (IgG4/kappa-isotype med en stabiliserende forandring af sekvensen i Fc-regionen), som er fremstillet ved rekombinant dna-teknologi i ovarieceller fra kinesiske hamstre.
English: Data from patients ≥ 65 years are too limited to draw conclusions on cHL population (see section 5.1).
Danish: Data fra patienter ≥ 65 år med cHL er for begrænsede til at kunne drage konklusioner (se pkt.
English: Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
Danish: Hypotyroidisme kan substitutionsbehandles uden afbrydelse af behandlingen og uden kortikosteroider.
English: It is unknown whether pembrolizumab is secreted in human milk.
Danish: Det er ukendt, om pembrolizumab udskilles i human mælk.
English: PD-L1 Expression Pembrolizumab
Danish: PD-L1-ekspression Pembrolizumab
English: More frequent monitoring of liver enzymes as compared to when the medicines are used in monotherapy may be considered.
Danish: Det kan overvejes at udføre hyppigere monitorering af leverenzymer i forhold til, når lægemidlerne anvendes som monoterapi.
English: The 23 patients had a median follow-up from subsequent allogeneic HSCT of 5.1 months (range: 0-26.2 months).
Danish: De 23 patienter havde en median opfølgningstid fra efterfølgende allogen HSCT på 5,1 måneder (interval: 0-26,2 måneder).
English: Response: Best objective response as confirmed complete response or partial response Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)
Danish: Respons: Bedste objektive respons, der er bekræftet komplet eller partielt respons Baseret på Miettinen og Nurminen-metoden stratificeret ud fra ECOG (0 versus 1), HPV-status (positiv versus negativ) og PD-L1-status (markant positiv versus ikke markant positiv)
English: Table 29 summarises the efficacy measures by IMDC risk category from the pre-specified interim analysis.
Danish: I tabel 29 opsummeres effektresultater ud fra IMDC-risikokategori fra den præspecificerede interimanalyse.
English: There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development.
Danish: Der sås ingen tegn på ændret farmakokinetisk profil eller sikkerhedsprofil i forbindelse med anti-pembrolizumab binding eller dannelse af neutraliserende antistoffer mod pembrolizumab.
English: The primary efficacy outcome measures were progression free survival (PFS; as assessed by Integrated Radiology and Oncology Assessment [IRO] review using Response Evaluation Criteria in Solid Tumours [RECIST], version 1.1) and overall survival (OS).
Danish: De primære resultatmål var progressionsfri overlevelse (PFS, baseret på IRO-vurdering [Integrated Radiology and Oncology Assessment] i henhold til RECIST version 1.1 [Response Evaluation Criteria in Solid Tumors]) og samlet overlevelse (OS).
English: Subjects whose tumours express PD-L1 CPS < 10 already enrolled into the pembrolizumab monotherapy arm can continue treatment.
Danish: Forsøgspersoner, hvis tumorer udtrykker PD-L1 CPS < 10 og som allerede er indrulleret i armen med pembrolizumab som monoterapi, kan fortsætte behandlingen.
English: Patients with active infections occurring during treatment with pembrolizumab were managed with appropriate medical therapy.
Danish: Patienter, hvor aktive infektioner indtrådte under behandlingen med pembrolizumab, blev behandlet med passende medicinsk behandling.
English: The safety and efficacy of KEYTRUDA in children below 18 years of age have not yet been established.
Danish: KEYTRUDAs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Twenty-one percent had received 2 prior systemic regimens in the metastatic setting.
Danish: 21% havde tidligere fået 2 systemiske regimer til behandling af metastaser.
English: • a kind of lung cancer called non-small cell lung cancer
Danish: • en bestemt type lungekræft kaldet ikke-småcellet lungekræft
English: If you stop receiving KEYTRUDA
Danish: Hvis du holder op med at få Keytruda
English: Pneumonitis occurred more frequently in patients with a history of prior thoracic radiation (8.1%) than in patients who did not receive prior thoracic radiation (3.4%).
Danish: Pneumonitis forekom hyppigere hos patienter, der tidligere havde fået torakal strålebehandling (8,1%) end hos patienter, der ikke tidligere havde fået torakal strålebehandling (3,4%).
English: The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions (see section 4.4).
Danish: De alvorligste bivirkninger var immunrelaterede bivirkninger og alvorlige infusionsreaktioner (se pkt.
English: PD-L1 negative n=428
Danish: PD-L1-negativ n=428
English: Disease characteristics were: 21% HPV positive and 95% had Stage IV disease (Stage IVa 21%, Stage IVb 6%, and Stage IVc 69%).
Danish: Sygdomskarakteristika var: 21% HPV-positive og 95% havde sygdom i stadie IV (stadie IVa 21%, stadie IVb 6% og stadie IVc 69%).
English: Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS ≥ 1%), investigator's choice of paclitaxel or nabpaclitaxel, and geographic region (East Asia vs. non-East Asia).
Danish: Randomiseringen blev stratificeret ud fra PD-L1tumorekspression (TPS < 1% [negativ] versus TPS ≥ 1%), investigators valg af paclitaxel eller nabpaclitaxel og geografisk område (Østasien versus ikke Østasien).
English: Overall Survival (%)
Danish: Samlet overlevelse (%)
English: Tables 23 and 24 summarise key efficacy results for pembrolizumab in patients whose tumours expressed PD-L1 with a CPS ≥ 1 in KEYNOTE-048 at the final analysis performed at a median follow-up of 13 months for pembrolizumab in combination with chemotherapy and at a median follow-up of 11.5 months for pembrolizumab monotherapy.
Danish: I tabel 23 og 24 opsummeres de centrale effektresultater for pembrolizumab hos patienter, hvis tumorer udtrykte PD-L1 med CPS ≥ 1 i KEYNOTE-048 ved den endelige analyse udført med en median opfølgningstid på 13 måneder for pembrolizumab i kombination med kemoterapi og med en median opfølgningstid på 11,5 måneder for pembrolizumab som monoterapi.
English: Infections and infestations Common pneumonia pneumonia pneumonia
Danish: Infektioner og parasitære sygdomme Almindelig pneumoni pneumoni pneumoni
English: Among patients who were evaluable for PD-L1 expression (98%), 82% were PD-L1 positive and 18% were PD-L1 negative.
Danish: Hos de patienter, som var evaluerbare for PD-L1-ekspression (98%), var 82% PD-L1-positive, og 18% var PD-L1-negative.
English: Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN
Danish: Grad 2 med aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) > 3-5 gange ULN eller totalbilirubin > 1,5-3 gange ULN
English: OS rate at 24 months
Danish: OS-rate i måned 24
English: Of the patients randomised to the chemotherapy arm, 55% crossed over and subsequently received treatment with pembrolizumab.
Danish: 55% af de patienter, som var randomiseret til kemoterapi-armen, krydsede over og fik efterfølgende behandling med pembrolizumab.
English: Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded.
Danish: Patienterne skal monitoreres for ændringer i leverfunktionen (ved behandlingsstart, periodevist i løbet af behandlingen og som indiceret på basis af den kliniske vurdering) og for symptomer på hepatitis, og andre årsager skal udelukkes.
English: KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1.
Danish: KEYTRUDA, som monoterapi eller som kombinationsbehandling, skal seponeres permanent ved grad 4 eller tilbagevendende grad 3 immunrelaterede bivirkninger, medmindre det er specificeret anderledes i tabel 1.
English: KEYTRUDA potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to 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.
Danish: KEYTRUDA aktiverer T-cellemedieret respons, herunder anti-tumorrespons, ved at blokere PD-1-bindingen til PD-L1 og PD-L2, som er udtrykt i antigenpræsenterende celler, og som kan udtrykkes af tumorer eller andre celler i tumorens mikromiljø.
English: - Your doctor will give you KEYTRUDA through an infusion into your vein (IV) for about
Danish: - Lægen vil give dig Keytruda som en infusion i en vene (intravenøst) over en periode på ca.
English: All but two patients were white.
Danish: Alle på nær to patienter var kaukasere.
English: Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour.
Danish: 45% havde en ECOG-performance-status på 1, 40% havde forhøjet LDH, og 23% havde en BRAF-muteret tumor.
English: Not reached (1.4+, 18.2+)
Danish: Ikke nået (1,4+; 18,2+)
English: The study demonstrated statistically significant improvements in OS and ORR for patients randomised to pembrolizumab as compared to chemotherapy.
Danish: Studiet viste statistisk signifikante forbedringer i OS og ORR for patienter, der var randomiseret til pembrolizumab sammenlignet med kemoterapi.
English: % ongoing
Danish: % igangværende respons
English: Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded.
Danish: Patienterne skal monitoreres for ændringer i nyrefunktionen, og andre årsager til nedsat nyrefunktion skal udelukkes.
English: 18.9 (11, not available)
Danish: 18,9 (11, foreligger ikke)
English: Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab.
Danish: Immunrelaterede bivirkninger, inklusive svære og dødelige tilfælde, er forekommet hos patienter, der fik pembrolizumab.
English: Hypothyroidism may be managed with replacement therapy without treatment interruption.
Danish: Hypotyroidisme kan behandles med substitution uden afbrydelse af behandlingen.
English: th edition classification, a total of 82 subjects were classified as stage IIIA; 42 in the pembrolizumab arm and 40 in the placebo arm; with a total of 13 RFS events; 6 in the pembrolizumab arm and 7 in the placebo arm.
Danish: I henhold til AJCC-stadieklassificering, 8. udgave, blev i alt 82 forsøgspersoner klassificeret som stadie IIIA; 42 i armen med pembrolizumab og 40 i placebo-armen; med i alt 13 RFS-hændelser; 6 i armen med pembrolizumab og 7 i placebo-armen.
English: Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents.
Danish: Der skal udvises forsigtighed, hvis pembrolizumab-behandling overvejes hos en patient, der har oplevet en alvorlig eller livstruende hudreaktion under tidligere behandling med andre immunstimulerende cancerlægemidler.
English: There was no statistically significant difference between pembrolizumab and chemotherapy in the final OS analysis that was not adjusted for the potentially confounding effects of crossover.
Danish: Der var ingen statistisk signifikant forskel mellem pembrolizumab og kemoterapi i den endelige OS-analyse, som ikke var korrigeret for den potentielt konfunderende effekt af overkrydsningen.
English: The Kaplan-Meier curves for OS and PFS based on an additional four months of follow up are shown in Figures 16 and 17.
Danish: Kaplan-Meier-kurverne for OS og PFS baseret på yderligere fire måneders opfølgning er vist i figur 16 og 17.
English: A decision should be made whether to discontinue breast-feeding or to discontinue pembrolizumab, taking into account the benefit of breast-feeding for the child and the benefit of pembrolizumab therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med pembrolizumab skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele ved pembrolizumab-behandlingen for moderen.
English: In urothelial cancer, a higher number of deaths within 2 months was observed in pembrolizumab compared to chemotherapy (see section 5.1).
Danish: Ved urotelial cancer sås et højere antal dødsfald indenfor 2 måneder med pembrolizumab sammenlignet med kemoterapi (se pkt.
English: Table 29: Efficacy Results in KEYNOTE-426 by IMDC Risk Category
Danish: Tabel 29: Effektresultater i KEYNOTE-426 ud fra IMDC-risikokategori
English: Pembrolizumab is catabolised through non-specific pathways; metabolism does not contribute to its clearance.
Danish: Pembrolizumab nedbrydes via non-specifikke metaboliseringsveje; metaboliseringen bidrager ikke til pembrolizumabs clearance.
English: There was no statistically significant difference between pembrolizumab and chemotherapy with respect to PFS.
Danish: Der var ingen statistisk signifikant forskel mellem pembrolizumab og kemoterapi med hensyn til PFS.
English: What you need to know before you are given KEYTRUDA
Danish: Det skal du vide, før du får Keytruda
English: Forty-five percent had no prior therapies for advanced melanoma.
Danish: 45% havde ikke tidligere fået behandling for fremskredent melanom.
English: Not reached (NA, NA)
Danish: Ikke nået (NA; NA)
English: KEYTRUDA works by helping your immune system fight your cancer.
Danish: Keytruda styrker immunsystemets evne til at bekæmpe kræft.
English: Randomization was stratified by tumour PD-L1 expression (TPS ≥ 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1).
Danish: Randomiseringen blev stratificeret ud fra PD-L1tumorekspression (TPS ≥ 50% eller < 50%), HPV-status (positiv eller negativ) og ECOG-PS (0 versus 1).
English: Number of patients OS
Danish: Antal patienter
English: Response: Best objective response as confirmed complete response or partial response
Danish: Respons: Bedste objektive respons, der er bekræftet komplet eller partielt respons
English: Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab.
Danish: Patienter med EGFR-aktiverende mutationer eller ALK-translokation havde også sygdomsprogression, mens de var i godkendt behandling for disse mutationer inden behandling med pembrolizumab.
English: Two patients (< 0.1%) discontinued pembrolizumab due to hypothyroidism.
Danish: 2 patienter (< 0,1%) seponerede pembrolizumab som følge af hypotyroidisme.
English: Translucent to white proteinaceous particles may be seen in diluted solution.
Danish: Gennemsigtige til hvide proteinholdige partikler kan forekomme i den fortyndede infusionsvæske.
English: Data about efficacy and safety of pembrolizumab in combination with platinum chemotherapy are limited in this patient population.
Danish: Data vedrørende pembrolizumabs virkning og sikkerhed i kombination med platinbaseret kemoterapi er begrænset i denne patientpopulation.
English: The majority of adverse reactions reported for monotherapy were of Grade 1 or 2 severity.
Danish: Størstedelen af de rapporterede bivirkninger ved monoterapi var af sværhedsgrad 1 eller 2.
English: Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar.
Danish: Efter administration af pembrolizumab 200 mg hver 3. uge til patienter med cHL var den observerede mediane Cmin ved steady state op til 40% højere end den, som blev observeret ved andre tumortyper, der blev behandlet med samme dosis.
English: Psychiatric disorders Common insomnia insomnia insomnia
Danish: Psykiske forstyrrelser Almindelig insomni insomni insomni
English: Based on best response of stable disease or better Based on Kaplan-Meier estimates; includes 84 patients with response of 6 months or longer
Danish: Baseret på bedst respons for stabil sygdom eller bedre Baseret på Kaplan-Meier-estimering; omfatter 84 patienter med 6 måneders respons eller længere
English: Grade ≥ 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN
Danish: Grad ≥ 3 med ASAT eller ALAT > 5 gange ULN eller total-bilirubin > 3 gange ULN
English: Insulin should be administered for type 1 diabetes, and pembrolizumab should be withheld in cases of Grade 3 hyperglycaemia until metabolic control is achieved (see section 4.2).
Danish: Insulin skal administreres ved type 1-diabetes, og behandlingen med pembrolizumab skal pauseres i tilfælde af grad 3-hyperglykæmi, indtil der er opnået metabolisk kontrol (se pkt.
English: Table 22: ORR and OS by PD-L1 Expression
Danish: Tabel 22: ORR og OS ved PD-L1-ekspression
English: Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens.
Danish: 76% af patienterne havde tidligere fået cisplatin, 23% havde tidligere fået carboplatin, og 1% var blevet behandlet med andre platinbaserede regimer.
English: Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative.
Danish: Blandt de patienter, som var evaluerbare for PD-L1-ekspression (79%), var 69% (n=294) PD-L1-positive, og 31% (n=134) var PD-L1-negative.
English: Immune system disorders Common infusion related reaction infusion related reaction a infusion related reaction
Danish: Immunsystemet Almindelig infusionsreaktioner infusionsreaktioner infusionsreaktioner
English: See Table 28 for p-Value for inferential test of OS based on the pre-specified interim analysis, where statistical significance has been reached.
Danish: Se tabel 28 for p-værdien for inferentiel test af OS baseret på den præspecificerede interimanalyse, hvor der er nået statistisk signifikans.
English: Median follow-up time of 10.1 months Median follow-up time of 52.8 months Assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria by PET CT scans Based on patients (n=145) with a response by independent review Based on patients (n=18) with a response by independent review Based on Kaplan-Meier estimation; includes 31 patients with responses of 6 months or longer Based on Kaplan-Meier estimation; includes 9 patients with responses of 6 months or longer Based on Kaplan-Meier estimation; includes 7 patients with responses of 12 months or longer
Danish: Median opfølgningstid på 10,1 måneder Median opfølgningstid på 52,8 måneder BICR-vurdering (blinded independent central review) i henhold til IWG (International Working Group)kriterierne, revideret i 2007, ud fra PET/CT-scanninger Baseret på patienter (n=145) med et respons ud fra uafhængig vurdering Baseret på patienter (n=18) med et respons ud fra uafhængig vurdering Baseret på Kaplan-Meier-estimering; inkluderer 31 patienter med respons på 6 måneder eller længere Baseret på Kaplan-Meier-estimering; inkluderer 9 patienter med respons på 6 måneder eller længere Baseret på Kaplan-Meier-estimering; inkluderer 7 patienter med respons på 12 måneder eller længere
English: Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment.
Danish: Svære endokrinopatier, herunder binyrebarkinsufficiens, hypofysitis, type 1-diabetes mellitus, diabetisk ketoacidose, hypotyroidisme og hypertyroidisme er observeret i forbindelse med pembrolizumabbehandling.
English: Patients with ECOG performance status score ≥ 2 were excluded from the clinical trials of melanoma, NSCLC, cHL, and HNSCC (see sections 4.4 and 5.1).
Danish: Patienter med ECOG-performance-status ≥ 2 blev ekskluderet fra de kliniske studier med melanom, NSCLC, cHL og HNSCC (se pkt.
English: Uncommon amylase increased blood bilirubin increased, amylase increased amylase increased
Danish: Ikke almindelig forhøjet amylase forhøjet bilirubin i blodet, forhøjet amylase forhøjet amylase
English: * Based on the stratified Cox proportional hazard model NR = not reached
Danish: * Baseret på den stratificerede Cox proportional hazard-model NR = Ikke nået
English: PD-L1 positive
Danish: PD-L1-positiv