FrancophonIA/ELRC3.0 huggingface dataset:
English: The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease.
Danish: De centrale inklusionskriterier var metastatisk planocellulær NSCLC, uanset PD-L1-tumorekspressionsstatus, og ingen tidligere systemisk behandling for metastatisk sygdom.
English: PD-L1 expression was tested retrospectively by immunohistochemistry assay with the 22C3 anti-PD-L1 antibody; 84% of patients had PD-L1-positive melanoma (PD-L1 expression in ≥ 1% of tumour and tumour-associated immune cells relative to all viable tumour cells).
Danish: PD-L1ekspression blev testet retrospektivt ved en immunhistokemisk analyse med 22C3 anti-PD-L1-antistof; 84% af patienterne havde PD-L1-positivt melanom (PD-L1-ekspression hos ≥ 1% af tumor- og tumorassocierede immunceller i forhold til alle levedygtige tumorceller).
English: Urothelial Carcinoma
Danish: Urotelialt karcinom
English: Withhold until adverse reactions recover to Grades 0
Danish: Pauser behandlingen indtil bivirkningerne bedres til grad 0
English: Among patients with BRAF mutant tumours, 139 (46%) were previously treated with a BRAF inhibitor.
Danish: Blandt patienterne med BRAFmuteret tumor havde 139 (46%) tidligere været i behandling med en BRAF-hæmmer.
English: • a kind of cancer called classical Hodgkin lymphoma
Danish: • en bestemt type lymfeknudekræft kaldet klassisk Hodgkins lymfom
English: 15 mL Type I glass vial, with a grey bromobutyl stopper and an aluminium seal with an avocado coloured flip-off cap, containing 50 mg pembrolizumab.
Danish: 15 ml hætteglas (type I-glas) med en grå brombutylprop og en aluminiumshætte med et avocadofarvet flip-off-låg, der indeholder 50 mg pembrolizumab.
English: Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer
Danish: Baseret på Kaplan-Meier-estimater; inkluderer 43 patienter med respons på 6 måneder eller længere
English: Common pneumonitis pneumonitis pneumonitis
Danish: Almindelig pneumonitis pneumonitis pneumonitis l
English: % with duration ≥ 6 months
Danish: % med varighed ≥ 6 måneder
English: Patients received pembrolizumab 200 mg every 3 weeks (n=210; KEYNOTE-087) or 10 mg/kg every 2 weeks (n=31; KEYNOTE-013) until unacceptable toxicity or documented disease progression.
Danish: Patienterne fik pembrolizumab 200 mg hver 3. uge (n=210; KEYNOTE-087) eller 10 mg/kg hver 2. uge (n=31; KEYNOTE-013) indtil uacceptabel toksicitet eller dokumenteret sygdomsprogression.
English: Not reached (22, NA)
Danish: Ikke nået (22, NA)
English: KEYTRUDA contains the active substance pembrolizumab, which is a monoclonal antibody.
Danish: Keytruda indeholder det aktive stof pembrolizumab, som er et monoklonalt antistof.
English: Among patients with BRAF mutant tumours, 10 (50%) were previously treated with a BRAF inhibitor.
Danish: Blandt patienterne med BRAF-muteret tumor havde 10 (50%) tidligere været i behandling med en BRAF-hæmmer.
English: KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Danish: KEYTRUDA som monoterapi er indiceret til behandling af fremskredent (inoperabelt eller metastatisk) melanom hos voksne.
English: Common hyponatraemia, hypokalaemia, hypocalcaemia hyponatraemia, hypocalcaemia hypokalaemia, hyponatraemia, hypocalcaemia
Danish: Almindelig hyponatriæmi, hypokaliæmi, hypokalcæmi hyponatriæmi, hypokalcæmi hypokaliæmi, hyponatriæmi, hypokalcæmi
English: Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes, da det er kendt, at antistoffer kan udskilles i human mælk.
English: Patients should be monitored for suspected severe skin reactions and other causes should be excluded.
Danish: Patienterne skal monitoreres ved mistanke om alvorlige hudreaktioner, og andre årsager skal udelukkes.
English: KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.
Danish: KEYTRUDA, i kombination med carboplatin og enten paclitaxel eller nab-paclitaxel, er indiceret til førstelinjebehandling af metastatisk planocellulær NSCLC hos voksne.
English: Blood and lymphatic system disorders Very common anaemia anaemia, neutropaenia, thrombocytopaenia
Danish: Blod og lymfesystem Meget almindelig anæmi anæmi, neutropeni, trombocytopeni
English: If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 96 hours at 2ºC to 8ºC.
Danish: Hvis KEYTRUDA ikke anvendes straks, er der påvist kemisk og fysisk stabilitet i 96 timer ved 2 °C-8 °C.
English: Not reached (24, NA)
Danish: Ikke nået (24, NA)
English: Based on Kaplan-Meier estimates; includes 16 patients with responses of 6 months or longer
Danish: Baseret på Kaplan-Meier-estimater; inkluderer 16 patienter med respons på 6 måneder eller længere
English: A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity.
Danish: I alt 1.019 voksne patienter blev randomiseret i forholdet 1:1 til at få pembrolizumab 200 mg hver 3. uge (n=514) eller placebo (n=505) i en periode på op til 1 år indtil sygdomsrecidiv eller uacceptabel toksicitet.
English: No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab.
Danish: Der er ikke udført formelle farmakokinetiske lægemiddelinteraktionsstudier med pembrolizumab.
English: Each vial contains an excess fill of 0.25 ml (total content per vial 4.25 ml) to ensure the recovery of 4 ml of concentrate.
Danish: Hvert hætteglas indeholder et overskud på 0,25 ml (samlet indhold pr. hætteglas 4,25 ml) for at sikre, at der kan udtrækkes 4 ml koncentrat.
English: Incidences of Grades 3-5 adverse reactions in patients with NSCLC were 67% for pembrolizumab combination therapy and 66% for chemotherapy alone and in patients with HNSCC were 85% for pembrolizumab combination therapy and 84% for chemotherapy plus cetuximab.
Danish: Forekomsten af bivirkninger af grad 3-5 hos patienter med NSCLC var 67% for kombinationsbehandling med pembrolizumab og 66% for kemoterapi alene og forekomsten hos patienter med HNSCC var 85% for kombinationsbehandling med pembrolizumab og 84% for kemoterapi plus cetuximab.
English: PD-L1 testing for patients with NSCLC, urothelial carcinoma, or HNSCC Testing for PD-L1 tumour expression using a validated test is recommended for patients with NSCLC.
Danish: PD-L1-test af patienter med NSCLC, urotelialt karcinom eller HNSCC Det anbefales at teste for PD-L1-tumorekspression ved hjælp af en valideret test hos patienter med NSCLC.
English: In clinical studies in patients treated with pembrolizumab 2 mg/kg every three weeks, 200 mg every three weeks, or 10 mg/kg every two or three weeks as monotherapy, 36 (1.8%) of 2,034 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab, of which 9 (0.4%) patients had neutralising antibodies against pembrolizumab.
Danish: I kliniske studier med patienter, som blev behandlet med pembrolizumab 2 mg/kg hver 3. uge, 200 mg hver 3. uge eller 10 mg/kg hver 2. eller 3. uge som monoterapi, havde 36 (1,8%) ud af 2.034 evaluerbare patienter en positiv test for antistoffer mod pembrolizumab udviklet under behandlingen, hvoraf 9 (0,4%) patienter havde neutraliserende antistoffer mod pembrolizumab.
English: Patients in the placebo arm were offered pembrolizumab as a single agent at the time of disease progression.
Danish: Patienterne i placeboarmen blev tilbudt pembrolizumab som monoterapi på tidspunktet for sygdomsprogression.
English: If rechallenging with axitinib, dose reduction as per the axitinib SmPC may be considered.
Danish: Hvis behandlingen med axitinib genoptages, kan dosisreduktion i henhold til produktresuméet for axitinib overvejes.
English: Pembrolizumab is most commonly associated with immune-related adverse reactions.
Danish: Pembrolizumab er sædvanligvis associeret med immunrelaterede bivirkninger.
English: For patients ≥ 75 years, pembrolizumab combination therapy should be used with caution after careful consideration of the potential benefit/risk on an individual basis (see section 5.1).
Danish: Kombinationsbehandling med pembrolizumab skal anvendes med forsigtighed hos patienter ≥ 75 år efter grundig overvejelse af benefit/risk-forholdet på individuel basis (se pkt.
English: Hyperthyroidism resolved in 191 (78.3%) patients, 5 with sequelae.
Danish: Hypertyroidisme gik over hos 191 (78,3%) patienter, 5 med sequelae.
English: Pembrolizumab CL is approximately 23% lower (geometric mean, 195 mL/day [CV%: 40%]) after achieving maximal change at steady-state compared with the first dose (252 mL/day [CV%: 37%]); this decrease in CL with time is not considered clinically meaningful.
Danish: Pembrolizumabs clearance er cirka 23% lavere (geometrisk gennemsnit, 195 ml/dag [CV%: 40%]) efter at have opnået maksimal ændring ved steady state sammenlignet med den første dosis (252 ml/dag [CV%: 37%]).
English: There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1).
Danish: Der foreligger begrænsede data om KEYTRUDAs sikkerhed og virkning hos patienter med okulært melanom (se pkt.
English: The safety of pembrolizumab in combination with axitinib has been evaluated in a clinical study of 429 patients with advanced RCC receiving 200 mg pembrolizumab every 3 weeks and 5 mg axitinib twice daily.
Danish: Pembrolizumabs sikkerhed i kombination med axitinib er blevet vurderet i et klinisk studie med 429 patienter med fremskredent RCC, der fik 200 mg pembrolizumab hver 3. uge og 5 mg axitinib to gange dagligt.
English: If SJS or TEN is confirmed, pembrolizumab should be permanently discontinued (see section 4.2).
Danish: Hvis mistanken om SJS eller TEN bekræftes, skal pembrolizumab seponeres permanent (se pkt.
English: Disease characteristics were squamous (21%) and non-squamous (70%); M1 (91%); stable brain metastases (15%) and the incidence of mutations was EGFR (8%) or ALK (1%).
Danish: Sygdomskarakteristika var planocellulær (21%) og ikke-planocellulær (70%); M1-stadie (91%); stabile hjernemetastaser (15%), og forekomsten af mutationer var EGFR (8%) og ALK (1%).
English: Rare cases of SJS and TEN, some of them with fatal outcome, have been observed (see sections 4.2 and 4.4).
Danish: Der er observeret sjældne tilfælde af SJS og TEN, herunder tilfælde med dødelig udgang (se pkt.
English: Endpoint n=370
Danish: Endepunkt n=370
English: Common aspartate aminotransferase increased, alanine aminotransferase increased, hypercalcaemia, blood alkaline phosphatase increased, blood bilirubin increased, blood creatinine increased hypercalcaemia, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased
Danish: Almindelig forhøjet aspartataminotransferase, forhøjet alaninaminotransferase, hyperkalcæmi, forhøjet alkalisk fosfatase i blodet, forhøjet bilirubin i blodet, forhøjet kreatinin i blodet hyperkalcæmi, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet alkalisk fosfatase i blodet forhøjet alkalisk fosfatase i blodet, hyperkalcæmi, forhøjet bilirubin i blodet
English: A total of 65 NSCLC patients aged ≥ 75 years were enrolled in study KEYNOTE-407 (34 in the pembrolizumab combination and 31 in the control).
Danish: I alt 65 NSCLC-patienter i alderen ≥ 75 år blev inkluderet i KEYNOTE-407-studiet (34 i kombinationsbehandlingen med pembrolizumab og 31 i kontrolgruppen).
English: PD-L1 expression was tested retrospectively by immunohistochemistry assay with the 22C3 anti-PD-L1 antibody.
Danish: PD-L1-ekspression blev testet retrospektivt ved en immunhistokemisk analyse med 22C3 anti-PD-L1-antistof.
English: The following additional clinically significant, immune-related adverse reactions have been reported in clinical trials or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barré syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis and encephalitis (see sections 4.2 and 4.8).
Danish: Følgende yderligere klinisk signifikante, immunrelaterede bivirkninger er rapporteret i kliniske studier eller efter markedsføring: uveitis, artritis, myositis, myokarditis, pankreatitis, Guillain-Barrés syndrom, myastenisk syndrom, hæmolytisk anæmi, sarkoidose og encephalitis (se pkt.
English: Results for patients previously treated with ipilimumab (n=84) and naïve to treatment with ipilimumab (n=52) who received 10 mg/kg of pembrolizumab every 3 weeks were similar to those seen in patients who received 2 mg/kg of pembrolizumab every 3 weeks.
Danish: Resultaterne for ipilimumab-erfarne patienter (n=84) og for ipilimumab-naive patienter (n=52), som fik 10 mg/kg pembrolizumab hver 3. uge, var sammenlignelige med resultaterne for patienter, som fik 2 mg/kg pembrolizumab hver 3. uge.
English: % with duration ≥ 6 months % with duration ≥ 9 months
Danish: % med varighed ≥ 6 måneder % med varighed ≥ 9 måneder
English: Table 3 summarises key efficacy measures in patients naïve to treatment with ipilimumab at the final analysis performed after a minimum of 21 months of follow-up.
Danish: I tabel 3 opsummeres de centrale effektresultater hos ipilimumab-naive patienter efter den endelige analyse, som er blevet udført efter en opfølgningstid på mindst 21 måneder.
English: The diluted solution may be stored for up to 96 hours in a refrigerator (2°C - 8°C).
Danish: Den fortyndede infusionsvæske kan opbevares op til 96 timer i køleskab (2 °C - 8 °C).
English: Patients on chemotherapy who experienced independently verified progression of disease after the first scheduled disease assessment were able to crossover and receive 2 mg/kg or 10 mg/kg of pembrolizumab every 3 weeks in a double-blind fashion.
Danish: De patienter, som fik kemoterapi og oplevede uafhængigt verificeret sygdomsprogression efter den første planlagte sygdomsvurdering, kunne overkrydses til at få 2 mg/kg eller 10 mg/kg pembrolizumab hver 3. uge i et dobbeltblindet design.
English: The efficacy of pembrolizumab in combination with carboplatin and either paclitaxel or nabpaclitaxel was investigated in Study KEYNOTE-407, a randomised, double-blind, multicentre, placebo-controlled study.
Danish: Pembrolizumabs virkning i kombination med carboplatin og enten paclitaxel eller nab-paclitaxel blev undersøgt i KEYNOTE-407, et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie.
English: Pembrolizumab should be withheld for Grade ≥ 3 until recovery to Grade ≤ 1 hyperthyroidism.
Danish: Pembrolizumab skal pauseres ved ≥ grad 3-hypertyroidisme indtil bedring til ≤ grad 1.
English: Nervous system disorders Very common headache dizziness, headache, neuropathy peripheral, dysgeusia headache, dysgeusia
Danish: Nervesystemet Meget almindelig hovedpine svimmelhed, hovedpine, perifer neuropati, dysgeusi hovedpine, dysgeusi
English: - The recommended dose of KEYTRUDA is either 200 mg every 3 weeks or 400 mg every
Danish: - Den anbefalede dosis af Keytruda er enten 200 mg hver 3. uge eller 400 mg hver 6. uge.
English: In patients with NSCLC, pneumonitis occurred in 8.1% with a history of prior thoracic radiation.
Danish: Hos patienter med NSCLC forekom pneumonitis hos 8,1% af patienterne, der tidligere havde fået torakal strålebehandling.
English: PD-L1 negative
Danish: PD-L1-negativ
English: Endocrinopathies
Danish: Endokrinopatier
English: Metabolism and nutrition disorders Very common decreased appetite hypokalaemia, decreased appetite decreased appetite
Danish: Metabolisme og ernæring Meget almindelig appetitløshed hypokaliæmi, appetitløshed appetitløshed
English: type 1 diabetes mellitus (diabetic ketoacidosis) g. Guillain-Barré syndrome (axonal neuropathy and demyelinating polyneuropathy) h. myasthenic syndrome (myasthenia gravis, including exacerbation) i.
Danish: Guillain-Barrés syndrom (axonal neuropati og demyeliniserende polyneuropati) h. myastenisk syndrom (myasthenia gravis, inklusive eksacerbation) i.
English: Patients received pembrolizumab at a dose of 200 mg every 3 weeks until unacceptable toxicity or disease progression.
Danish: Patienterne fik pembrolizumab i doser på 200 mg hver 3. uge, indtil uacceptabel toksicitet eller sygdomsprogression.
English: % with duration ≥ 6-months Time to Response Median in months (range) PFS*
Danish: % med varighed ≥ 6 måneder Tid til respons Median i måneder (interval) PFS*
English: The median area under the concentration time curve at steady state over 3 weeks (AUC0-3weeks) was 794 mcg∙day/mL at a dose of 2 mg/kg every 3 weeks and 1,053 mcg∙day/mL at a dose of 200 mg every 3 weeks.
Danish: Det mediane areal under kurven for koncentration over tid ved steady state over 3 uger (AUC0-3uger) var 794 μg∙dag/ml ved en dosis på 2 mg/kg hver 3. uge og 1.053 μg∙dag/ml ved en dosis på 200 mg hver 3. uge.
English: All patients with BRAF mutant tumours were previously treated with a BRAF inhibitor.
Danish: Alle patienter med BRAF-muteret tumor havde tidligere været i behandling med en BRAF-hæmmer.
English: Sixty-one percent of patients had received Auto-SCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 36% of patients had prior radiation therapy.
Danish: 61% af patienterne havde gennemgået ASCT, 38% var uegnede til transplantation; 17% havde ikke tidligere fået brentuximab vedotin; og 36% af patienterne havde tidligere fået strålebehandling.
English: Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT) Allogeneic HSCT after treatment with pembrolizumab Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with classical Hodgkin lymphoma undergoing allogeneic HSCT after previous exposure to pembrolizumab.
Danish: Komplikationer ved allogen hæmatopoietisk stamcelletransplantation (HSCT) Allogen HSCT efter behandling med pembrolizumab Tilfælde af graft versus host-sygdom (GVHD) og hepatisk veno-okklusiv sygdom (VOD) er observeret hos patienter med klassisk Hodgkins lymfom, der gennemgår allogen HSCT efter tidligere eksponering for pembrolizumab.
English: What KEYTRUDA looks like and contents of the pack KEYTRUDA is a white to off-white lyophilised powder.
Danish: Udseende og pakningsstørrelser Keytruda er et hvidt til offwhite frysetørret pulver.
English: Number at Risk
Danish: Antal i risikogruppe
English: • Aseptically add 2.3 mL of water for injections to yield a 25 mg/mL (pH 5.2-5.8) solution of KEYTRUDA.
Danish: • Tilføj 2,3 ml vand til injektionsvæsker aseptisk for at få en opløsning af KEYTRUDA på 25 mg/ml (pH: 5,2-5,8).
English: Best overall response ORR % (95% CI)
Danish: Bedste samlede respons ORR % (95% CI)
English: Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8).
Danish: Tilfælde af Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN) er rapporteret hos patienter, der fik pembrolizumab (se pkt.
English: The trial demonstrated a statistically significant improvement in OS for all patients randomised to pembrolizumab in combination with chemotherapy compared to standard treatment (HR 0.72; 95% CI 0.60-0.87) and in patients whose tumours expressed PD-L1 CPS ≥ 1 randomised to pembrolizumab monotherapy compared to standard treatment.
Danish: Studiet viste en statistisk signifikant forbedring i OS for alle patienter, som var randomiseret til pembrolizumab i kombination med kemoterapi sammenlignet med standardbehandling (HR: 0,72; 95% CI 0,60-0,87), og hos patienter, hvis tumorer udtrykte PD-L1 CPS ≥ 1, som var randomiseret til pembrolizumab som monoterapi sammenlignet med standardbehandling.
English: For Grade 4 haematological toxicity, only in patients with cHL, KEYTRUDA should be withheld until adverse reactions recover to Grades 0-1.
Danish: Ved grad 4 hæmatologisk toksicitet, kun hos patienter med cHL, skal KEYTRUDA pauseres, indtil bivirkningerne bedres til grad 0-1.
English: A statistically significant improvement in RFS for patients randomised to the pembrolizumab arm compared with placebo was demonstrated in the overall population across resected stage III melanoma per AJCC 7
Danish: Der blev påvist en statistisk signifikant forbedring i RFS for patienter randomiseret til armen med pembrolizumab sammenlignet med placebo i den samlede population på tværs af resekteret stadie III-melanom i henhold til AJCC, 7. udgave.
English: Sixtynine (44.8%) patients had 1 or more Grades 3 to 5 adverse reactions of which 6 (3.9%) patients had 1 or more adverse reactions that resulted in death.
Danish: 69 (44,8%) patienter havde 1 eller flere bivirkninger af grad 3 til 5, hvoraf 6 (3,9%) patienter havde 1 eller flere bivirkninger med dødelig udgang.
English: After preparation of infusion
Danish: Efter klargøring af infusionsvæsken
English: Patients with HNSCC or previously untreated urothelial carcinoma should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).
Danish: Patienter med HNSCC eller tidligere ubehandlet urotelialt karcinom skal udvælges til behandling på basis af PD-L1-tumorekspression, som er bekræftet af en valideret test (se pkt.
English: Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8).
Danish: Type 1-diabetes mellitus, herunder diabetisk ketoacidose, er rapporteret hos patienter, der fik pembrolizumab (se pkt.
English: Dose delay or discontinuation (see also section 4.4)
Danish: Pausering eller seponering af behandling (se også pkt.
English: In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2.
Danish: Hos patienter med HNSCC, som blev behandlet med pembrolizumab i kombination med platinbaseret kemoterapi og 5-FU (n=276), var forekomsten af hypotyroidisme 15,2%, hvoraf alle var af grad 1 eller 2.
English: Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered.
Danish: Baseret på bivirkningens sværhedsgrad skal behandlingen med pembrolizumab pauseres og kortikosteroider administreres.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4).
Danish: Systemiske kortikosteroider og andre immunsuppressiva kan dog anvendes til at behandle immunrelaterede bivirkninger efter initiering af pembrolizumab (se pkt.
English: The median time to onset of colitis was 4.3 months (range 7 days to 24.3 months).
Danish: Den mediane tid til indtræden af colitis var 4,3 måneder (interval: 7 dage til 24,3 måneder).
English: Of 23 patients with cHL who proceeded to allogeneic HSCT after treatment with pembrolizumab, 6 patients (26%) developed GVHD, one of which was fatal, and 2 patients (9%) developed severe hepatic VOD after reduced-intensity conditioning, one of which was fatal.
Danish: Komplikationer ved allogen HSCT ved klassisk Hodgkins lymfom Ud af 23 patienter med cHL, som gik videre til allogen HSCT efter behandling med pembrolizumab, udviklede 6 patienter (26%) GVHD, hvoraf en døde, og 2 patienter (9%) fik svær hepatisk VOD efter konditionering med reduceret intensitet, hvoraf en døde.
English: * Based on the stratified Cox proportional hazard model Based on stratified Log rank test Based on method by Miettinen and Nurminen Based on Kaplan-Meier estimation NA = not available
Danish: * Baseret på den stratificerede Cox proportional hazard-model Baseret på stratificeret log rank-test Baseret på Miettinen- og Nurminen-metoden Baseret på Kaplan-Meier-estimering NA = Foreligger ikke
English: The efficacy and safety of pembrolizumab in patients with tumours that do not express PD-L1 have not been established.
Danish: Pembrolizumabs virkning og sikkerhed hos patienter, hvis tumorer ikke udtrykker PD-L1, er ikke klarlagt.