FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients treated with pembrolizumab in combination with chemotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 26.7% for neutrophils decreased, 23.9% for lymphocytes decreased, 19.1% for haemoglobin decreased, 17.9% for leucocytes decreased, 12.2% for platelets decreased, 10.2% for sodium decreased, 8.9% for phosphate decreased, 7.4% for glucose increased, 6.5% for potassium decreased, 3.3 for creatinine increased, 3.1% for ALT increased, 3.1% for AST increased, 3.1% for calcium decreased, 3.0% for potassium increased, 2.9% for albumin decreased, 2.3% for calcium increased, 1.2% for alkaline phosphatase increased, 0.8% for glucose decreased, 0.7% for bilirubin increased, and 0.3% for sodium increased.
Danish: Hos patienter, der blev behandlet med pembrolizumab i kombination med kemoterapi, var andelen af patienter, som oplevede et skift fra baseline til unormal laboratorieværdi af grad 3 eller 4, følgende: 26,7% med nedsat neutrofiltal; 23,9% med nedsat lymfocyttal; 19,1% med nedsat hæmoglobin; 17,9% med nedsat leukocyttal; 12,2% med nedsat trombocyttal; 10,2% med nedsat natrium; 8,9% med nedsat fosfat; 7,4% med forhøjet glucose; 6,5% med nedsat kalium; 3,3% med forhøjet kreatinin; 3,1% med forhøjet ALAT; 3,1% med forhøjet ASAT; 3,1% med nedsat kalcium; 3,0% med forhøjet kalium; 2,9% med nedsat albumin; 2,3% med forhøjet kalcium; 1,2% med forhøjet alkalisk fosfatase; 0,8% med nedsat glucose; 0,7% med forhøjet bilirubin og 0,3% med forhøjet natrium.
English: Table 10: Efficacy results in KEYNOTE-054
Danish: Tabel 10: Effektresultater i KEYNOTE-054
English: Grades 3 or 4 myocarditis Grades 3 or 4 encephalitis Grades 3 or 4 Guillain-Barré syndrome
Danish: Grad 3 eller 4 Guillain-Barrés syndrom
English: In 1 month and 6 month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs; however, many animals in these studies were not sexually mature.
Danish: Toksicitetsstudier af 1 måned og 6 måneders varighed med gentagne doser viste ingen væsentlig indvirkning på forplantningsorganerne hos han- og hunaber (se pkt.
English: Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P426: A Phase III Randomised, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC)
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport for studie P426: Et randomiseret, åbent fase III-studie, der vurderer pembrolizumabs (MK-3475) virkning og sikkerhed i kombination med axitinib versus sunitinib som monoterapi som førstelinjebehandling for lokalt fremskredent eller metastatisk renalcellekarcinom (mRCC)
English: An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS < 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or ≥ 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 14).
Danish: Der blev udført en analyse i KEYNOTE-189 hos patienter, som havde PD-L1 TPS < 1% [pembrolizumab-kombination: n=127 (31%) versus kemoterapi: n=63 (31%)], TPS 1-49% [pembrolizumab-kombination: n=128 (31%) versus kemoterapi: n=58 (28%)] eller TPS ≥ 50% [pembrolizumab-kombination: n=132 (32%) versus kemoterapi: n=70 (34%)] (se tabel 14).
English: • Placebo with pemetrexed 500 mg/m 2 and investigator's choice of cisplatin 75 mg/m or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m intravenously every 3 weeks (n=206)
Danish: • Pembrolizumab 200 mg med pemetrexed 500 mg/m2 og investigators valg af cisplatin 75 mg/m eller carboplatin AUC 5 mg/ml/min intravenøst hver 3. uge i 4 serier efterfulgt af pembrolizumab 200 mg og pemetrexed 500 mg/m2 intravenøst hver 3. uge (n=410).
English: Use of pembrolizumab for first-line treatment of patients with HNSCC In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see section 4.8).
Danish: Brug af pembrolizumab til førstelinjebehandling af patienter med HNSCC Generelt forekommer bivirkninger hyppigere ved kombinationsbehandling med pembrolizumab end ved pembrolizumab som monoterapi eller kemoterapi alene, hvilket afspejler bidrag fra hver af de individuelle behandlinger (se pkt.
English: An analysis was performed in KEYNOTE-407 in patients who had PD-L1 TPS < 1% [pembrolizumab plus chemotherapy arm: n=95 (34%) vs. placebo plus chemotherapy arm: n=99 (35%)], TPS 1% to 49% [pembrolizumab plus chemotherapy arm: n=103 (37%) vs. placebo plus chemotherapy arm: n=104 (37%)] or TPS ≥ 50% [pembrolizumab plus chemotherapy arm: n=73 (26%) vs. placebo plus chemotherapy arm: n=73 (26%)] (see Table 16).
Danish: Der blev udført en analyse i KEYNOTE-407 hos patienter, som havde PD-L1 TPS < 1% [pembrolizumab plus kemoterapiarmen: n=95 (34%) versus placebo plus kemoterapiarmen: n=99 (35%)], TPS 1% til 49% [pembrolizumab plus kemoterapiarmen: n=103 (37%) versus placebo plus kemoterapiarmen: n=104 (37%)] eller TPS ≥ 50% [pembrolizumab plus kemoterapiarmen: n=73 (26%) versus placebo plus kemoterapiarmen: n=73 (26%)] (se tabel 16).
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Danish: 4.1, 4.4, 4.8 og 5.1).
English: In patients treated with pembrolizumab monotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 10.9% for lymphocytes decreased, 8.2% for sodium decreased, 6.3% for haemoglobin decreased, 5.2% for phosphate decreased, 4.8% for glucose increased, 2.8% for AST increased, 2.7% for alkaline phosphatase increased, 2.7% for ALT increased, 2.2% for potassium decreased, 1.8% for calcium increased, 1.8% for neutrophils decreased, 1.8% for potassium increased, 1.7% for bilirubin increased, 1.7% for platelets decreased, 1.6% for albumin decreased, 1.5% for calcium decreased, 1.3% for creatinine increased, 0.8% for leucocytes decreased, 0.7% for magnesium increased, 0.6% for glucose decreased, 0.2% for magnesium decreased, and 0.2% for sodium increased.
Danish: Hos patienter, der blev behandlet med pembrolizumab som monoterapi, var andelen af patienter, som oplevede et skift fra baseline til en grad 3 eller 4 unormal laboratorieværdi, følgende: 10,9% med nedsat lymfocyttal; 8,2% med nedsat natrium; 6,3% med nedsat hæmoglobin; 5,2% med nedsat fosfat; 4,8% med forhøjet glucose; 2,8% med forhøjet ASAT; 2,7% med forhøjet alkalisk fosfatase; 2,7% med forhøjet ALAT; 2,2% med nedsat kalium; 1,8% med forhøjet kalcium; 1,8% med nedsat neutrofiltal; 1,8% med forhøjet kalium; 1,7% med forhøjet bilirubin; 1,7% med nedsat trombocyttal; 1,6% med nedsat albumin; 1,5% med nedsat kalcium; 1,3% med forhøjet kreatinin; 0,8% med nedsat leukocyttal; 0,7% med forhøjet magnesium; 0,6% med nedsat glucose; 0,2% med nedsat magnesium og 0,2% med forhøjet natrium.
English: Assessment of tumour status was performed at 12 weeks, then every 6 weeks through week 48, followed by every 12 weeks thereafter.
Danish: Der blev foretaget vurdering af tumorstatus i uge 12, herefter hver 6. uge til og med uge 48 og derefter hver 12. uge.
English: Table 5: Efficacy results in KEYNOTE-001
Danish: Tabel 5: Effektresultater i KEYNOTE-001
English: Pembrolizumab 2 mg/kg every 3 weeks in patients previously treated with ipilimumab n=89
Danish: Pembrolizumab 2 mg/kg hver 3. uge hos ipilimumab-erfarne patienter n=89
English: Very common fatigue, asthenia, oedema aa pyrexia fatigue, asthenia, pyrexia, oedema aa fatigue, asthenia, pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig træthed, asteni, ødem aa pyreksi træthed, asteni, pyreksi, ødem aa træthed, asteni, pyreksi
English: Ipilimumab 3 mg/kg every 3 weeks n=278
Danish: Ipilimumab 3 mg/kg hver 3. uge n=278
English: Standard Treatment* n=235
Danish: Standardbehandling* n=235
English: Number of events (%) Median in months (95% CI)
Danish: Antal hændelser (%) Median i måneder (95% CI)
English: 129 patients included: median age 62 years (40% age 65 or older); 81% male; 78% White, 11% Asian, and 2% Black; 23% and 77% with an ECOG performance status 0 or 1, respectively; and 19% with HPV positive tumours.
Danish: Baseline-karakteristika for disse 129 patienter inkluderede: medianalder 62 år (40% i alderen 65 år eller ældre); 81% mænd; 78% kaukasere, 11% asiater og 2% negroide; henholdsvis 23% og 77% havde ECOG-performance-status på 0 eller 1; og 19% havde HPV-positive tumorer.
English: Standard Treatment* n=255
Danish: Standardbehandling* n=255
English: Post-authorization efficacy study (PAES) the MAH should submit the final study report of RFS/DMFS and OS data for study KN054: a Phase III Clinical Trial of Pembrolizumab (MK-3475 in Subjects with complete resection of highrisk Stage III melanoma - Final Study Report
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal indsende den endelige studierapport med RFS/DMFS- og OS-data for studie KN054: Et klinisk fase III-studie af pembrolizumab (MK-3475) hos forsøgspersoner med komplet resektion af højrisiko stadie III-melanom - Endelig studierapport
English: The median duration was 1.1 months (range 1 day to 20.9+ months).
Danish: Medianvarigheden var 1,1 måneder (interval: 1 dag til 20,9+ måneder).
English: Animal fertility studies have not been conducted with pembrolizumab.
Danish: Der er ikke udført fertilitetsstudier med pembrolizumab hos dyr.
English: Animal reproduction studies have not been conducted with pembrolizumab.
Danish: Der har ikke været udført reproduktionsstudier med pembrolizumab hos dyr.
English: Secondary outcome measures were ORR (as assessed by BICR using RECIST v1.1) and duration of response.
Danish: De sekundære resultatmål var ORR (baseret på BICR i henhold til RECIST version 1.1) og responsvarighed.
English: Pembrolizumab 2 mg/kg every 3 weeks Pembrolizumab 10 mg/kg every 3 weeks Chemotherapy
Danish: Pembrolizumab 2 mg/kg hver 3. uge Pembrolizumab 10 mg/kg hver 3. uge Kemoterapi
English: powder for concentrate for solution for infusion 1 vial
Danish: pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas
English: Pneumonitis occurred in 253 (4.3%) patients, including Grade 2, 3, 4 or 5 cases in 106 (1.8%), 69 (1.2%), 13 (0.2%) and 9 (0.2%) patients, respectively, receiving pembrolizumab.
Danish: Pneumonitis forekom hos 253 (4,3%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3, 4 eller 5 hos henholdsvis 106 (1,8%), 69 (1,2%), 13 (0,2%) og 9 (0,2%) patienter.
English: Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1.
Danish: De sekundære resultatmål var ORR og responsvarighed baseret på BICR-vurdering i henhold til RECIST 1.1.
English: erythema, dry skin severe skin reactions s, dermatitis acneiform, dermatitis, dry skin, alopecia, eczema, erythema
Danish: akneiform dermatitis, dermatitis, tør hud, alopeci, eksem, erytem
English: arthralgia musculoskeletal pain v,
Danish: artralgi muskuloskeletale smerter v, artralgi, ekstremitetssmerter
English: KEYTRUDA 25 mg/mL concentrate for solution for infusion pembrolizumab
Danish: Keytruda 25 mg/ml koncentrat til infusionsvæske, opløsning pembrolizumab
English: Do not store any unused portion of the infusion solution for reuse.
Danish: Eventuelt resterende infusionsvæske må ikke gemmes til senere brug.
English: % ongoing at 18 months * Hazard ratio (pembrolizumab compared to ipilimumab) based on the stratified Cox proportional hazard model
Danish: % igangværende i måned 18 * Hazard ratio (pembrolizumab sammenlignet med ipilimumab) baseret på den stratificerede Cox proportional hazard-model
English: The primary efficacy outcome measures were OS and PFS as assessed by blinded independent central review (BICR) using RECIST 1.1.
Danish: De primære resultatmål var OS og PFS baseret på BICR (blinded independent central review)-vurdering i henhold til RECIST 1.1.
English: What KEYTRUDA is and what it is used for What you need to know before you are given KEYTRUDA How you are given KEYTRUDA Possible side effects
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Keytruda Sådan får du Keytruda Bivirkninger
English: Grades 3 or 4, or recurrent Grade 2 Permanently discontinue
Danish: Grad 3 eller 4 eller tilbagevendende grad 2
English: Assessment of tumour status was performed at Week 9 and then every 6 weeks for the first year, followed by every 9 weeks through 24 months.
Danish: Vurdering af tumorstatus blev foretaget i uge 9 og herefter hver 6. uge i løbet af det første år, og efterfølgende hver 9. uge til og med måned 24.
English: Very common dyspnoea, cough dyspnoea, cough dyspnoea, cough, dysphonia
Danish: Luftveje, thorax og mediastinum Meget almindelig dyspnø, hoste dyspnø, hoste dyspnø, hoste, dysfoni
English: KEYNOTE-045: Controlled trial in urothelial carcinoma patients who have received prior platinumcontaining chemotherapy
Danish: KEYNOTE-045: Kontrolleret studie med patienter med urotelialt karcinom, som tidligere har fået platinbaseret kemoterapi
English: The median duration was 1.6 months (range 1 day to 27.3+ months).
Danish: Medianvarigheden var 1,6 måneder (interval: 1 dag til 27,3+ måneder).
English: Use of pembrolizumab for first-line treatment of patients with NSCLC In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see sections 4.2 and 4.8).
Danish: Brug af pembrolizumab til førstelinjebehandling af patienter med NSCLC Generelt forekommer bivirkninger hyppigere ved kombinationsbehandling med pembrolizumab end ved pembrolizumab som monoterapi eller kemoterapi alene, hvilket afspejler bidrag fra hver af de individuelle behandlinger (se pkt.
English: Table 19: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma previously treated with chemotherapy in KEYNOTE-045
Danish: Tabel 19: Respons på pembrolizumab 200 mg hver 3. uge hos patienter med urotelialt karcinom, der tidligere var blevet behandlet med kemoterapi i KEYNOTE-045
English: Number (%) of patients with event Median in months (95% CI)
Danish: Antal (%) patienter med hændelse Median i måneder (95% CI)
English: Use of pembrolizumab in combination with axitinib for first-line treatment of patients with RCC When pembrolizumab is given with axitinib, higher than expected frequencies of Grades 3 and 4 ALT and AST elevations have been reported in patients with advanced RCC (see section 4.8).
Danish: Brug af pembrolizumab i kombination med axitinib til førstelinjebehandling af RCC-patienter Ved administration af pembrolizumab i kombination med axitinib er der hos patienter med fremskredent RCC blevet rapporteret en højere end forventet forekomst af grad 3 og 4 forhøjelser af ALAT og ASAT (se pkt.
English: Table 21: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma ineligible for cisplatin-containing chemotherapy in KEYNOTE-052
Danish: Tabel 21: Respons på pembrolizumab 200 mg hver 3. uge hos patienter med urotelialt karcinom, der var uegnede til behandling med cisplatinbaseret kemoterapi i KEYNOTE-052
English: PFS HR (95% CI)
Danish: HR for PFS (95% CI)
English: Pembrolizumab 10 mg/kg every 2 weeks Pembrolizumab 10 mg/kg every 3 weeks ipilimumab
Danish: Pembrolizumab 10 mg/kg hver 2. uge Pembrolizumab 10 mg/kg hver 3. uge ipilimumab
English: Patients were randomized 1:1:1 to one of the following treatment arms:
Danish: Patienterne blev randomiseret i forholdet 1:1:1 til en af følgende behandlingsarme:
English: Eye disorders Common dry eye dry eye dry eye
Danish: Øjne Almindelig øjentørhed øjentørhed øjentørhed
English: Median in months (95% CI) 12-month OS rate
Danish: Median i måneder (95% CI) 12-måneders OS-rate
English: Pembrolizumab 2mg/kg every 3 weeks (n=44)
Danish: Pembrolizumab 2 mg/kg hver 3. uge (n=44)
English: Pembrolizumab + Pemetrexed + Platinum Chemotherapy n=410
Danish: Pembrolizumab + pemetrexed + platinbaseret kemoterapi n=410
English: 754 patients included: median age of 61 years (range: 20 to 94); 36% age 65 or older; 82% male; 74% White and 19% Asian; 61% ECOG performance status of 1; and 77% former/current smokers.
Danish: Karakteristika ved baseline for disse 754 patienter inkluderede: medianalder på 61 år (interval: 20 til 94); 36% i alderen 65 eller ældre; 82% mænd; 74% kaukasere og 19% asiatere; 61% med ECOG-performance-status 1; og 77% tidligere/nuværende rygere.
English: The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 17.7 months).
Danish: Den mediane tid til indtræden af binyrebarkinsufficiens var 5,4 måneder (interval: 1 dag til 17,7 måneder).
English: PFS rate at 18 months HR (95% CI)
Danish: PFS-rate i måned 18 HR (95% CI)
English: KEYNOTE-006: Controlled trial in melanoma patients naïve to treatment with ipilimumab The safety and efficacy of pembrolizumab were investigated in KEYNOTE-006, a multicentre, controlled, Phase III study for the treatment of advanced melanoma in patients who were naïve to ipilimumab.
Danish: KEYNOTE-006: Kontrolleret studie med ipilimumab-naive melanom-patienter Pembrolizumabs sikkerhed og virkning blev undersøgt i KEYNOTE-006, et kontrolleret fase IIImulticenterstudie af behandling af fremskredent melanom hos patienter, der ikke tidligere havde været behandlet med ipilimumab.
English: An exploratory subgroup analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 1 to < 20 [pembrolizumab plus chemotherapy: n=116 (45%) vs. standard treatment: n=125 (49%) and pembrolizumab monotherapy: n=124 (48%) vs. standard treatment: n=133 (52%)] (see Table 26).
Danish: Der blev udført en eksploratorisk subgruppeanalyse i KEYNOTE-048 hos patienter, hvis tumorer udtrykte PD-L1 CPS ≥ 1 til < 20 [pembrolizumab plus kemoterapi: n=116 (45%) versus standardbehandling: n=125 (49%) og pembrolizumab som monoterapi: n=124 (48%) versus standardbehandling: n=133 (52%)] (se tabel 26).
English: Hyperthyroidism led to discontinuation of pembrolizumab in 3 (0.1%) patients.
Danish: Hypertyroidisme medførte seponering af pembrolizumab hos 3 (0,1%) patienter.
English: Number of events (%) Median in months (95% CI) Hazard ratio* (95% CI) p-Value
Danish: Antal hændelser (%) Median i måneder (95% CI) HR* (95% CI) p-værdi
English: musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis) w. myositis (myalgia, myopathy, polymyalgia rheumatica and rhabdomyolysis) x. arthritis (joint swelling, polyarthritis and joint effusion) y. tenosynovitis (tendonitis, synovitis and tendon pain) z. nephritis (nephritis autoimmune, tubulointerstitial nephritis and renal failure, renal failure acute, or acute kidney injury with evidence of nephritis, nephrotic syndrome) aa. oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema and lip oedema, face oedema, localised oedema and periorbital oedema)
Danish: vitiligo (depigmentering af huden, hypopigmentering af huden og hypopigmentering af øjenlåget) u. likenoid keratose (lichen planus og lichen sclerosus) v. muskuloskeletale smerter (muskuloskeletale gener, rygsmerter, muskuloskeletal stivhed, muskuloskeletale brystsmerter og torticollis) w. myositis (myalgi, myopati, polymyalgia rheumatica og rabdomyolyse) x. artritis (hævede led, polyartritis og ledeffusion) y. tenosynovitis (tendinitis, synovitis og senesmerter) z. nefritis (autoimmun nefritis, tubulointerstitiel nefritis og nyresvigt, akut nyresvigt eller akut nyreskade med tegn på nefritis, nefrotisk syndrom) aa. ødem (perifert ødem, generaliseret ødem, overhydrering, væskeretention, øjenlågsødem og læbeødem, ansigtsødem, lokaliseret ødem og periorbitalt ødem)
English: One vial of 4 mL contains 100 mg of pembrolizumab.
Danish: Et hætteglas med 4 ml indeholder 100 mg pembrolizumab.
English: Patients were randomised (1:1) to receive either KEYTRUDA 200 mg every 3 weeks (n=270) or investigator's choice of any of the following chemotherapy regimens all given intravenously every 3 weeks (n=272): paclitaxel 175 mg/m
Danish: Patienterne blev randomiseret (1:1) til at få KEYTRUDA 200 mg hver 3. uge (n=270) eller investigators valg af en hvilken som helst af følgende kemoterapi-regimer, der alle gives intravenøst hver 3. uge (n=272): paclitaxel 175 mg/m2 (n=84), docetaxel 75 mg/m2 (n=84) eller vinflunin 320 mg/m2 (n=87).
English: Figure 13: Kaplan-Meier curve for overall survival for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Danish: Figur 13: Kaplan-Meier-kurve for samlet overlevelse for pembrolizumab plus kemoterapi i KEYNOTE-048 med PD-L1-ekspression (CPS ≥ 1)
English: Treatment arm OS rate at 24 months OS rate at 36 months HR (95% CI)
Danish: Behandlingsarm OS-rate i måned 24 OS-rate i måned 36 HR (95% CI)
English: Post-authorisation efficacy study (PAES): The MAH should provide the study report for study P361: A Phase III Randomised, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma - Study Report
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES): Indehaveren af markedsføringstilladelsen skal sørge for studierapporten for studie P361: Et randomiseret kontrolleret klinisk fase III-studie af pembrolizumab med eller uden platinbaseret kombineret kemoterapi versus kemoterapi hos forsøgspersoner med fremskredent eller metastatisk urotelialt karcinom - Studierapport
English: Figure 15: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-040 patients with PD-L1 expression (TPS ≥ 50%)
Danish: Figur 15: Kaplan-Meier-kurve for samlet overlevelse for hver behandlingsarm hos patienter med PD-L1-ekspression (TPS ≥ 50%) i KEYNOTE-040
English: KEYTRUDA 50 mg powder for concentrate for solution for infusion.
Danish: KEYTRUDA 50 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Among KEYNOTE-087 patients, the baseline characteristics were median age 35 years (9% age 65 or older); 54% male; 88% White; and 49% and 51% had an ECOG performance status 0 and 1, respectively.
Danish: Hos patienterne i KEYNOTE-087 var baseline-karakteristika: medianalder 35 år (9% ≥ 65 år); 54% mænd; 88% kaukasere; og henholdsvis 49% og 51% havde ECOG-performance-status 0 og 1.
English: Assessment of tumour status was performed at 9 weeks, then every 6 weeks through week 52, followed by every 9 weeks through 24 months.
Danish: Vurdering af tumorstatus blev foretaget i uge 9, herefter hver 6. uge til og med uge 52, og efterfølgende hver 9. uge til og med måned 24.
English: Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction (see sections 4.2 and 4.8).
Danish: Behandlingen med pembrolizumab skal seponeres permanent ved en hvilken som helst immunrelateret bivirkning af grad 3, som recidiverer, og ved alle immunrelaterede bivirkninger af grad 4 (se pkt.
English: One vial of 4 mL of concentrate contains 100 mg of pembrolizumab.
Danish: Et hætteglas med 4 ml koncentrat indeholder 100 mg pembrolizumab.
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)