FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks were ineligible.
Danish: Patienter med autoimmun sygdom, der havde krævet systemisk behandling inden for de seneste 2 år; lidelser, som krævede behandling med immunsuppressiva; eller patienter, som havde fået mere end 30 Gy torakal strålebehandling inden for de forudgående 26 uger, blev ekskluderet fra studiet.
English: OS HR (95% CI)
Danish: HR (95% CI)
English: Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P204: A Phase III, Randomised, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma - Final Study Report
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P204: Et randomiseret, åbent klinisk fase III-studie, der sammenligner pembrolizumab med brentuximab vedotin hos forsøgspersoner med recidiverende eller refraktært klassisk Hodgkins lymfom - Endelig studierapport
English: Figure 14: Kaplan-Meier curve for overall survival for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Danish: Figur 14: Kaplan-Meier-kurve for samlet overlevelse for pembrolizumab som monoterapi i KEYNOTE-048 med PD-L1-ekspression (CPS ≥ 1)
English: Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P087, A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects with Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL) - Final Study Report
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P087: Et klinisk fase II-studie af MK-3475 (pembrolizumab) hos forsøgspersoner med recidiverende eller refraktært (R/R) klassisk Hodgkins lymfom (cHL) - Endelig studierapport
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen.
Danish: KEYTRUDA som monoterapi er indiceret til behandling af lokalt fremskredent eller metastatisk NSCLC hos voksne efter tidligere behandling med minimum én kemoterapi, og hvis tumorer udtrykker PD-L1 med TPS ≥ 1%.
English: Hypophysitis occurred in 36 (0.6%) patients, including Grade 2, 3 or 4 cases in 13 (0.2%), 19 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Danish: Hypofysitis forekom hos 36 (0,6%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 13 (0,2%), 19 (0,3%) og 1 (< 0,1%) patienter.
English: Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade ≥ 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2).
Danish: Kortikosteroider skal administreres (initialdosis 0,5-1 mg/kg/dag [ved bivirkninger af grad 2] eller 1-2 mg/kg/dag [ved bivirkninger ≥ grad 3] prednison eller ækvivalent hermed efterfulgt af langsom udtrapning), og på basis af sværhedsgraden af leverenzymstigningen skal behandlingen med pembrolizumab pauseres eller seponeres (se pkt.
English: PFS Hazard ratio* (95% CI) OS Hazard ratio* (95% CI) ORR %
Danish: HR* for PFS (95% CI) HR* for OS (95% CI) ORR %
English: KEYTRUDA has not been studied in patients with moderate or severe hepatic impairment (see sections 4.4 and 5.2).
Danish: KEYTRUDA er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: • KEYTRUDA 200 mg every 3 weeks, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every
Danish: • KEYTRUDA 200 mg hver 3. uge, carboplatin AUC 5 mg/ml/min hver 3. uge eller cisplatin
English: ‡ % (95% CI) Complete response % Partial response % p-Value Response duration Median in months (range)
Danish: ‡ % (95% CI) Komplet respons % Partielt respons % p-værdi Responsvarighed Median i måneder (interval)
English: Nephritis led to discontinuation of pembrolizumab in 10 (0.2%) patients.
Danish: Nefritis medførte seponering af pembrolizumab hos 10 (0,2%) patienter.
English: • Cetuximab 400 mg/m 2 load then 250 mg/m 2 once weekly, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m 2 every 3 weeks, and 5-FU 1,000 mg/m 2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU)
Danish: 5 mg/ml/min hver 3. uge eller cisplatin 100 mg/m 2 hver 3. uge, og 5-FU 1.000 mg/m 2/dag kontinuerligt i 4 dage hver 3. uge (maksimalt 6 serier med platinbaseret behandling og 5-FU)
English: Common hyperthyroidism hypothyroidism, hyperthyroidism hypophysitis d,
Danish: Almindelig hypertyroidisme hypotyroidisme, hypertyroidisme hypofysitis d, tyroiditis e, binyrebarkinsufficiens
English: Adrenal insufficiency led to discontinuation of pembrolizumab in 4 (0.1%) patients.
Danish: Binyrebarkinsufficiens medførte seponering af pembrolizumab hos 4 (0,1%) patienter.
English: The median duration was 1.9 months (range 1 day to 25.3+ months).
Danish: Medianvarigheden var 1,9 måneder (interval: 1 dag til 25,3+ måneder).
English: 12-month OS rate, % (95% CI)
Danish: OS-rate i måned 12, % (95% CI)
English: vomiting (26%), headache (22%), abdominal pain (21%), anaemia (21%) and constipation (20%).
Danish: De hyppigste bivirkninger (rapporteret hos mindst 20% af de pædiatriske patienter) var pyreksi (31%), opkastning (26%), hovedpine (22%), abdominalsmerter (21%), anæmi (21%) og obstipation (20%).
English: ORR % * Hazard ratio (pembrolizumab combination therapy compared to chemotherapy) based on the stratified Cox proportional hazard model
Danish: ORR % * Hazard ratio (pembrolizumab kombinationsbehandling sammenlignet med kemoterapi) baseret på den stratificerede Cox proportional hazard-model
English: Pembrolizumab 10 mg/kg every 3 weeks n=181
Danish: Pembrolizumab 10 mg/kg hver 3. uge n=181
English: Table 26: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 1 to < 20)
Danish: Tabel 26: Effektresultater for pembrolizumab plus kemoterapi og pembrolizumab som monoterapi ud fra PD-L1-ekspression i KEYNOTE 048 (CPS ≥ 1 til < 20)
English: Number of responders Median in months (range)
Danish: Responsvarighed Median i måneder (interval)
English: Pembrolizumab 2 mg/kg every 3 weeks n=180
Danish: Pembrolizumab 2 mg/kg hver 3. uge n=180
English: • Pembrolizumab 200 mg and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles, and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks.
Danish: og paclitaxel 200 mg/m2 på dag 1 i hver 21-dages serie i 4 serier eller nab-paclitaxel 100 mg/m2 på dag 1, 8 og 15 i hver 21-dages serie i 4 serier, efterfulgt af pembrolizumab 200 mg hver 3. uge.
English: An analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 20 [pembrolizumab plus chemotherapy: n=126 (49%) vs. standard treatment: n=110 (43%) and pembrolizumab monotherapy: n=133 (52%) vs. standard treatment: n=122 (48%)] (see Table 25).
Danish: Der blev udført en analyse i KEYNOTE-048 hos patienter, hvis tumorer udtrykte PD-L1 CPS ≥ 20 [pembrolizumab plus kemoterapi: n=126 (49%) versus standardbehandling: n=110 (43%) og pembrolizumab som monoterapi: n=133 (52%) versus standardbehandling: n=122 (48%)] (se tabel 25).
English: Table 23: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PDL1 expression (CPS ≥ 1)
Danish: Tabel 23: Effektresultater for pembrolizumab plus kemoterapi i KEYNOTE-048 med PD-L1ekspression (CPS ≥ 1)
English: Among KEYNOTE-013 patients, the baseline characteristics were median age 32 years (7% age 65 or older), 58% male, 94% White; and 45% and 55% had an ECOG performance status 0 and 1, respectively.
Danish: Hos patienterne i KEYNOTE-013 var baseline-karakteristika: medianalder 32 år (7% ≥ 65 år), 58% mænd, 94% kaukasere; og 45% og 55% havde henholdsvis ECOG-performance-status 0 og 1.
English: Figure 17: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Danish: Figur 17: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-426 (intent to treat-population)*
English: Pembrolizumab + Platinum Chemotherapy + 5-FU n=242
Danish: Pembrolizumab + platinbaseret kemoterapi + 5-FU n=242
English: Median in months (95% CI) 6-month OS rate 12-month OS rate
Danish: Median i måneder (95% CI) 6-måneders OS-rate 12-måneders OS-rate
English: The efficacy of pembrolizumab was investigated in KEYNOTE-048, a multicentre, randomized, open-label, active-controlled study in patients with histologically confirmed metastatic or recurrent HNSCC of the oral cavity, pharynx or larynx, who had not previously received systemic therapy for recurrent or metastatic disease and who were considered incurable by local therapies.
Danish: KEYNOTE-048: Kontrolleret studie af monoterapi og kombinationsbehandling hos behandlingsnaive HNSCC-patienter i behandling for recidiverende eller metastatisk sygdom Pembrolizumabs virkning blev undersøgt i KEYNOTE-048, et randomiseret, åbent, aktivt kontrolleret multicenterstudie hos patienter med histologisk bekræftet metastatisk eller recidiverende HNSCC i mundhulen, svælget (farynx) eller struben (larynx), som ikke tidligere havde fået systemisk behandling for recidiverende eller metastatisk sygdom, og som blev anset for at være uhelbredeligt med lokal behandling.
English: Reconstituted KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution.
Danish: Det rekonstituerede KEYTRUDA-koncentrat er en klar til let opaliserende og farveløs til lysegul opløsning.
English: Figure 7: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-189 (intent to treat population)
Danish: Figur 7: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-189 (intent to treat-population)
English: Median in months (95% CI) 6-month PFS rate 12-month PFS rate
Danish: Median i måneder (95% CI) 6-måneders PFS-rate 12-måneders PFS-rate
English: Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P407: A Randomised, Double-Blind, Phase III Study of Carboplatin - Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects - Final Study Report
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P407: Et randomiseret, dobbeltblindet fase III-studie af carboplatin - paclitaxel/nabpaclitaxel-kemoterapi med eller uden pembrolizumab (MK-3475) som førstelinjebehandling hos forsøgspersoner med metastatisk planocellulær ikkesmåcellet lungecancer - Endelig studierapport
English: Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator.
Danish: Behandlingen kunne fortsætte efter progression, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel.
English: Pembrolizumab
Danish: Pembrolizumab Placebo
English: Figure 8: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-189 (intent to treat population)
Danish: Figur 8: Kaplan-Meier-kurve for progressionsfri overlevelse i hver behandlingsarm i KEYNOTE-189 (intent to treat-population)
English: KEYTRUDA 50 mg powder for concentrate for solution for infusion pembrolizumab
Danish: Keytruda 50 mg pulver til koncentrat til infusionsvæske, opløsning pembrolizumab
English: In a subgroup analysis, a reduced survival benefit of pembrolizumab compared to chemotherapy was observed in the small number of patients who were never-smokers; however, due to the small number of patients, no definitive conclusions can be drawn from these data.
Danish: I en subgruppeanalyse viste pembrolizumab en reduceret fordel med hensyn til overlevelse sammenlignet med kemoterapi hos de få patienter, som aldrig havde røget.
English: Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1).
Danish: Sekundære resultatmål var OS og ORR (baseret på BICR-vurdering i henhold til RECIST 1.1).
English: Pembrolizumab + Platinum Chemotherapy + 5-FU n=126
Danish: Pembrolizumab + platinbaseret kemoterapi + 5-FU n=126
English: Chemotherapy
Danish: Kemoterapi
English: Figure 16: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Danish: Figur 16: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-426 (intent to treat-population)*
English: Pembrolizumab 10 mg/kg every 2 weeks n=31
Danish: Pembrolizumab 10 mg/kg hver 2. uge n=31
English: Pembrolizumab + Platinum Chemotherapy + 5-FU n=116
Danish: Pembrolizumab + platinbaseret kemoterapi + 5-FU n=116
English: KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Danish: KEYTRUDA 25 mg/ml koncentrat til infusionsvæske, opløsning.
English: Based on patients with a best overall response as confirmed complete or partial response Based on Miettinen and Nurminen method stratified by PD-L1 status, platinum chemotherapy and smoking status
Danish: Baseret på Miettinen- og Nurminen-metoden stratificeret ud fra PD-L1-status, platinbaseret kemoterapi og rygestatus
English: Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator.
Danish: Behandlingen kunne fortsætte efter sygdomsprogression, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel.
English: Hepatitis occurred in 50 (0.8%) patients, including Grade 2, 3 or 4 cases in 8 (0.1%), 31 (0.5%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Danish: Hepatitis forekom hos 50 (0,8%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 8 (0,1%), 31 (0,5%) og 8 (0,1%) patienter.
English: #) of patients with duration ≥ 6 months Number (%
Danish: Antal (% #) patienter med varighed ≥ 6 måneder Antal (% #) patienter med varighed ≥ 12 måneder
English: Safety data of pembrolizumab in the adjuvant melanoma setting in patients ≥ 75 years are limited.
Danish: Der er begrænsede data vedrørende sikkerhed fra patienter ≥ 75 år, som har fået adjuverende behandling for melanom.
English: Table 25: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 20)
Danish: Tabel 25: Effektresultater for pembrolizumab plus kemoterapi og pembrolizumab som monoterapi ud fra PD-L1-ekspression i KEYNOTE 048 (CPS ≥ 20)
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80.
Danish: Hjælpestoffer: L-histidin, L-histidin-hydrochloridmonohydrat, saccharose, polysorbat 80.
English: 2Q 2021
Danish: 2. kvartal 2021
English: Objective response rate ORR % (95% CI) Complete Remission Partial Remission Response duration Median in months (range)
Danish: Objektiv responsrate ORR % (95% CI) Komplet remission Partiel remission Responssvarighed Median i måneder (interval)
English: Administration of pembrolizumab and axitinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator.
Danish: Administration af pembrolizumab og axitinib var tilladt efter sygdomsprogression i henhold til RECIST, hvis patienten var klinisk stabil, og investigator mente, at patienten havde en klinisk fordel.
English: pneumonitis (interstitial lung disease) m. abdominal pain (abdominal discomfort, abdominal pain upper and abdominal pain lower) n. colitis (colitis microscopic, enterocolitis, enterocolitis haemorrhagic, and autoimmune colitis) o. pancreatitis (autoimmune pancreatitis and pancreatitis acute) p. hepatitis (autoimmune hepatitis, immune-mediated hepatitis and drug induced liver injury) q. rash (rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash)
Danish: pneumonitis (interstitiel lungesygdom) m. abdominalsmerter (abdominalgener, øvre abdominalsmerter og nedre abdominalsmerter) n. colitis (mikroskopisk colitis, enterocolitis, hæmoragisk enterocolitis og autoimmun colitis) o. pankreatitis (autoimmun pankreatitis og akut pankreatitis) p. hepatitis (autoimmun hepatitis, immunmedieret hepatitis og lægemiddelinduceret leverskade) q. udslæt (erytematøst udslæt, follikulært udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt, pruritisk udslæt, vesikuløst udslæt og genitalt udslæt)
English: Median in months (95% CI) Overall response rate ORR % (95% CI) Complete response % Partial response % Response duration Median in months (range)
Danish: Median i måneder (95% CI) Bedste samlede respons ORR % (95% CI) Komplet respons % Partielt respons % Responsvarighed Median i måneder (interval)
English: - a decreased number of white blood cells (eosinophils) - inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat,
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer) - nedsat antal hvide blodlegemer (eosinofiler) - inflammation i hjertemusklen, som kan vise sig som kortåndethed, uregelmæssig hjerterytme,
English: Based on the stratified Cox proportional hazard model Based on stratified log-rank test Assessed by BICR using RECIST 1.1 Based on patients with a best overall response as confirmed complete or partial response Based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region Based on Kaplan-Meier estimation NA = not available
Danish: Baseret på patienter med en bedste samlet respons, der er bekræftet komplet eller partielt respons Baseret på Miettinen og Nurminen-metoden stratificeret ud fra IMDC-risikogruppe og geografisk område Baseret på estimering i henhold til Kaplan-Meier
English: Adrenal insufficiency occurred in 46 (0.8%) patients, including Grade 2, 3 or 4 cases in 19 (0.3%), 20 (0.3%) and 3 (0.1%) patients, respectively, receiving pembrolizumab.
Danish: Binyrebarkinsufficiens forekom hos 46 (0,8%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 19 (0,3%), 20 (0,3%) og 3 (0,1%) patienter.
English: Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8).
Danish: Alvorlige immunrelaterede hudreaktioner er rapporteret hos patienter, der fik pembrolizumab (se pkt.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC18
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80, water for injections.
Danish: Hjælpestoffer: L-histidin, L-histidin-hydrochloridmonohydrat, saccharose, polysorbat 80, vand til injektionsvæsker.
English: 3Q 2021
Danish: 3. kvartal 2021
English: EU/1/15/1024/001 (1 vial)
Danish: EU/1/15/1024/001 (1 hætteglas)
English: Nephritis occurred in 22 (0.4%) patients, including Grade 2, 3 or 4 cases in 5 (0.1%), 14 (0.2%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab as monotherapy.
Danish: Nefritis forekom hos 22 (0,4%) patienter, som fik pembrolizumab som monoterapi, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 5 (0,1%), 14 (0,2%) og 1 (< 0,1%) patienter.
English: Pembrolizumab 10 mg/kg every 3 weeks
Danish: Pembrolizumab 10 mg/kg hver 3. uge
English: Pembrolizumab 200 mg every 3 weeks n=154
Danish: Pembrolizumab 200 mg hver 3. uge n=154
English: NOTE: for RCC patients treated with pembrolizumab in combination with axitinib with liver enzyme elevations, see dosing guidelines following this table.
Danish: denne tabel for RCCpatienter i behandling med pembrolizumab i kombination med axitinib og med forhøjede leverenzymer.
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis (see section 4.2).
Danish: Kortikosteroider skal administreres ved bivirkninger ≥ grad 2 (initialdosis 1-2 mg/kg/dag prednison eller ækvivalent hermed efterfulgt af langsom udtrapning); pembrolizumab skal pauseres ved grad 2-pneumonitis og seponeres permanent ved grad 3-, grad 4- eller tilbagevendende grad 2-pneumonitis (se pkt.
English: The primary efficacy outcome measures were OS and PFS (assessed by BICR according to RECIST 1.1).
Danish: De primære resultatmål var OS og PFS (BICR-vurdering i henhold til RECIST 1.1).
English: * Assessed by BICR using RECIST 1.1
Danish: * BICR-vurdering i henhold til RECIST version 1.1
English: KEYTRUDA has not been studied in patients with severe renal impairment (see sections 4.4 and 5.2).
Danish: KEYTRUDA er ikke undersøgt hos patienter med svært nedsat nyrefunktion (se pkt.
English: (n=99), or cetuximab 400 mg/m2 loading dose and then 250 mg/m2 once weekly (n=71).
Danish: • Cetuximab 400 mg/m2 støddosis og herefter 250 mg/m2 en gang ugentligt, carboplatin AUC
English: Objective response rate ORR % (95% CI) Complete response % Partial response % Response Duration Median in months (range)
Danish: Objektiv responsrate ORR % (95% CI) Komplet respons % Partielt respons % Responsvarighed Median i måneder (interval)
English: OS rate at 24 months HR (95% CI)
Danish: PFS-rate i måned 24 (95% CI)
English: Pembrolizumab 10 mg/kg every 2 weeks n=279
Danish: Pembrolizumab 10 mg/kg hver 2. uge n=279
English: EU/1/15/1024/002 (1 vial)
Danish: EU/1/15/1024/002 (1 hætteglas)
English: Number at Risk Pembrolizumab + Chemo:
Danish: Antal i risikogruppe Pembrolizumab + kemo: Standard:
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper) and, based on severity of creatinine elevations, pembrolizumab should be withheld for Grade 2, and permanently discontinued for Grade 3 or Grade 4 nephritis (see section 4.2).
Danish: Kortikosteroider skal administreres ved bivirkninger ≥ grad 2 (initialdosis 1-2 mg/kg/dag prednison eller ækvivalent hermed efterfulgt af langsom udtrapning), og på basis af sværhedsgraden af kreatininstigningen skal behandlingen med pembrolizumab pauseres ved grad 2-nefritis og seponeres permanent ved grad 3- eller 4-nefritis (se pkt.
English: Treatment arm PFS rate at 12 months PFS rate at 18 months HR (95% CI) p-value Pembrolizumab + Axitinib 60%
Danish: Behandlingsarm PFS-rate i måned 12 PFS-rate i måned 18 HR (95% CI) p-værdi Pembrolizumab + Axitinib 60%