FrancophonIA/ELRC3.0 huggingface dataset:
English: Figure 10: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407
Danish: Figur 10: Kaplan-Meier-kurve for progressionsfri overlevelse i KEYNOTE-407
English: Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded.
Danish: Mistanke om pneumonitis skal bekræftes ved en billeddiagnostisk udredning af patienterne, og andre årsager skal udelukkes.
English: KEYTRUDA as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
Danish: KEYTRUDA som monoterapi er indiceret til behandling af recidiverende eller refraktært klassisk Hodgkins lymfom (cHL) hos voksne, som har oplevet svigt af autolog stamcelletransplantation (ASCT) og svigt af behandling med brentuximab vedotin (BV), eller som er uegnede til transplantation og har oplevet svigt af behandling med BV.
English: For the IMDC risk category, the OS hazard ratio for the favourable risk group was 0.94 (95% CI 0.43, 2.07), for the intermediate risk group the OS hazard ratio was 0.52 (95% CI 0.36, 0.75), and for the poor risk group the OS hazard ratio was 0.50 (95% CI 0.29, 0.87).
Danish: For IMDC-risikokategorien: HR for OS for risikogruppen med lav risiko var 0,94 (95% CI: 0,43; 2,07), HR for OS for risikogruppen med middel risiko var 0,52 (95% CI: 0,36; 0,75) og HR for OS for risikogruppen med høj risiko var 0,50 (95% CI: 0,29; 0,87).
English: Chemotherapy (n=137)
Danish: Kemoterapi (n=137)
English: In KEYNOTE-051, 154 paediatric patients (60 children aged 6 months to less than 12 years and 94 adolescents aged 12 years to 18 years) with advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumours or lymphoma were administered pembrolizumab 2 mg/kg every 3 weeks.
Danish: I KEYNOTE-051 blev pembrolizumab 2 mg/kg hver 3. uge administreret til 154 pædiatriske patienter (60 børn i alderen 6 måneder til under 12 år og 94 unge i alderen 12 år til 18 år) med fremskredent melanom eller PD-L1-positive fremskredne, recidiverende eller refraktære solide tumorer eller lymfomer.
English: Number at Risk Pembrolizumab:
Danish: Antal i risikogruppe Pembrolizumab:
English: Eighty-two percent had M1c stage, 73% had at least two and 32% of patients had three or more prior systemic therapies for advanced melanoma.
Danish: 82% havde melanom i M1c-stadiet, 73% af patienterne havde forudgående fået mindst to, og 32% af patienterne havde fået tre eller flere systemiske behandlingsregimer for fremskredent melanom.
English: Table 13: Efficacy results in KEYNOTE-189
Danish: Tabel 13: Effektresultater i KEYNOTE-189
English: Of the 51 patients receiving 2 mg/kg of pembrolizumab who were naïve to treatment with ipilimumab, 63% were male, 35% were ≥ 65 years of age and the median age was 60 years (range 35-80).
Danish: Af de 51 patienter, som fik 2 mg/kg pembrolizumab, og som ikke tidligere havde været behandlet med ipilimumab, var 63% mænd, 35% var ≥ 65 år, og medianalderen var 60 år (interval: 35-80).
English: In patients with non-squamous NSCLC treated with pembrolizumab in combination with pemetrexed and platinum chemotherapy (n=488), the incidence of nephritis was 1.4% (all Grades) with 0.8% Grade 3 and 0.4% Grade 4.
Danish: Hos patienter med ikkeplanocellulær NSCLC, som fik pembrolizumab i kombination med pemetrexed og platinbaseret kemoterapi (n=488), var forekomsten af nefritis 1,4% (alle grader) med 0,8% af grad 3 og 0,4% af grad 4.
English: • Prior to reconstitution, the vial of lyophilised powder can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
Danish: • Før rekonstitution kan hætteglasset med frysetørret pulver (lyofilisat) opbevares uden for køleskab (ved temperaturer på eller under 25 °C) i op til 24 timer.
English: Secondary efficacy outcome measures were overall response rate (ORR) and response duration.
Danish: De sekundære resultatmål var samlet responsrate (ORR) og responsvarighed.
English: Of the 834 patients, 60% were male, 44% were ≥ 65 years (median age was 62 years [range 18-89]) and 98% were white.
Danish: Ud af 834 patienter var 60% mænd, 44% var ≥ 65 år (medianalder 62 år [interval: 18-89]), og 98% var kaukasere.
English: Eighty-one percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy.
Danish: 81% var refraktære over for mindst en forudgående behandling, inklusive 35%, som var refraktære over for førstelinjebehandling.
English: Eighty-four percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy.
Danish: 84% var refraktære over for mindst en forudgående behandling, inklusive 35%, som var refraktære over for førstelinjebehandling.
English: The Kaplan-Meier curves for OS and PFS are shown in Figures 9 and 10.
Danish: Kaplan-Meier-kurver for OS og PFS er vist i figur 9 og 10.
English: The efficacy of pembrolizumab was evaluated in KEYNOTE-054, a multicentre, randomised, doubleblind, placebo-controlled trial in patients with completely resected stage IIIA (> 1 mm lymph node metastasis), IIIB or IIIC melanoma.
Danish: Pembrolizumabs virkning blev vurderet i KEYNOTE-054, et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie hos patienter med komplet resekteret stadie IIIA- (> 1 mm lymfeknudemetastaser), IIIB- eller IIIC-melanom.
English: Figure 9: Kaplan-Meier Curve for Overall Survival in KEYNOTE-407
Danish: Figur 9: Kaplan-Meier-kurve for samlet overlevelse i KEYNOTE-407
English: The management guidelines for these adverse reactions are described in section 4.4.
Danish: Vejledning til håndtering af disse bivirkninger findes i pkt.
English: Key eligibility criteria were metastatic non-squamous NSCLC, no prior systemic treatment for metastatic NSCLC, and no EGFR or ALK genomic tumour aberrations.
Danish: De centrale inklusionskriterier var metastatisk ikke-planocellulær NSCLC, ingen tidligere systemisk behandling for metastatisk NSCLC og ingen EGFR- eller ALK-mutationer i tumor.
English: Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel).
Danish: Patienterne blev randomiseret i forholdet 1:1:1 til at få pembrolizumab i en dosis på 2 (n=180) eller 10 mg/kg (n=181) hver 3. uge eller kemoterapi (n=179; inkluderede dacarbazin, temozolomid, carboplatin, paclitaxel eller carboplatin+paclitaxel).
English: Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2.
Danish: Kaplan-Meierkurver for OS og PFS, som er baseret på den endelige analyse, er vist i figur 1 og 2.
English: Uncommon neutropaenia, leukopaenia, eosinophilia lymphopaenia, eosinophilia
Danish: Ikke almindelig neutropeni, leukopeni, eosinofili lymfopeni, eosinofili
English: The pharmacokinetics of pembrolizumab was studied in 2,993 patients with metastatic or unresectable melanoma, NSCLC, or carcinoma who received doses in the range of 1 to 10 mg/kg every 2 weeks, 2 to 10 mg/kg every 3 weeks, or 200 mg every 3 weeks.
Danish: Pembrolizumabs farmakokinetik blev undersøgt hos 2.993 patienter med metastatisk eller inoperabelt melanom, NSCLC eller karcinom, som har fået doser i intervallet 1 til 10 mg/kg hver 2. uge, 2 til 10 mg/kg hver 3. uge eller 200 mg hver 3. uge.
English: Patients should be treated with KEYTRUDA until disease progression or unacceptable toxicity.
Danish: Patienterne skal behandles med KEYTRUDA indtil sygdomsprogression eller uacceptabel toksicitet.
English: The Kaplan-Meier curves for OS and PFS are shown in Figures 7 and 8.
Danish: Kaplan-Meier-kurver for OS og PFS er vist i figur 7 og 8.
English: The median follow-up time was 10.5 months (range: 0.2 to 20.4 months).
Danish: Den mediane opfølgningstid var 10,5 måneder (interval: 0,2 til 20,4 måneder).
English: BRAF mutant with prior BRAF treatment
Danish: BRAF-mutation med forudgående BRAFbehandling
English: Uncommon lichenoid keratosis u, psoriasis, dermatitis, papule, hair colour changes psoriasis, dermatitis acneiform, dermatitis, vitiligo t, eczema hair colour changes, lichenoid keratosis, papule, psoriasis, vitiligo
Danish: Ikke almindelig likenoid keratose u, psoriasis, dermatitis, papel, ændret hårfarve psoriasis, akneiform dermatitis, dermatitis, vitiligo t, eksem ændret hårfarve, likenoid keratose, papel, psoriasis, vitiligo
English: Patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible for the study.
Danish: Patienter med nasofaryngealt karcinom, aktiv autoimmun sygdom, der havde krævet systemisk behandling inden for 2 år efter behandling, eller lidelser, som krævede behandling med immunsuppressiva, var uegnede til studiet.
English: The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function.
Danish: Effekten af nedsat nyrefunktion på pembrolizumabs clearance blev vurderet ud fra farmakokinetiske populationsanalyser, hvor patienter med let eller moderat nedsat nyrefunktion blev sammenlignet med patienter med normal nyrefunktion.
English: The safety of pembrolizumab in combination with chemotherapy has been evaluated in 1,067 patients with NSCLC or HNSCC receiving 200 mg, 2 mg/kg or 10 mg/kg pembrolizumab every 3 weeks, in clinical studies.
Danish: Pembrolizumabs sikkerhed i kombination med kemoterapi er blevet vurderet hos 1.067 patienter med NSCLC eller HNSCC, der fik 200 mg, 2 mg/kg eller 10 mg/kg pembrolizumab hver 3. uge, i kliniske studier.
English: A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were BRAF wild type (n=414; 77%) or BRAF mutant with prior BRAF treatment (n=126; 23%) as summarised in Table 6.
Danish: Der blev udført en subgruppeanalyse som en del af den endelige analyse i KEYNOTE-002 hos patienter, som havde BRAF vildtype (n=414; 77%) eller BRAF-mutation med forudgående BRAF-behandling (n=126; 23%) som opsummeret i tabel 6.
English: The recommended dose of KEYTRUDA as monotherapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.
Danish: Den anbefalede dosis af KEYTRUDA som monoterapi er enten 200 mg hver 3. uge eller 400 mg hver 6. uge administreret som intravenøs infusion over 30 minutter.
English: KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
Danish: KEYTRUDA som monoterapi eller i kombination med platinbaseret kemoterapi og 5-fluorouracil (5-FU) er indiceret til førstelinjebehandling af metastatisk eller inoperabelt recidiverende planocellulært hovedhals karcinom (HNSCC) hos voksne, hvis tumorer udtrykker PD-L1 med CPS ≥ 1 (se pkt.
English: th edition identifies a patient population with a better prognosis compared to stage IIIA according to AJCC 7
Danish: Stadie IIIA-melanom i henhold til AJCC, 8. udgave, identificerer en patientpopulation med en bedre prognose sammenlignet med stadie IIIA i henhold til AJCC, 7. udgave.
English: Nephritis resolved in 13 patients, 3 with sequelae.
Danish: Nefritis gik over hos 13 patienter, 3 med sequelae.
English: The following side effects have been reported in clinical trials with pembrolizumab in combination with chemotherapy:
Danish: Følgende bivirkninger er indberettet i kliniske studier med pembrolizumab i kombination med kemoterapi:
English: Among the 882 patients in KEYNOTE-048, 754 (85%) had tumours that expressed PD-L1 with a CPS ≥ 1 based on the PD-L1 IHC 22C3 pharmDx
Danish: Blandt de 882 patienter i KEYNOTE-048, havde 754 (85%) tumorer, som udtrykte PD-L1 med CPS ≥ 1 baseret på PD-L1 IHC 22C3 pharmDx™-analysen.
English: Uncommon hepatitis hepatitis
Danish: Ikke almindelig hepatitis hepatitis
English: The 12-month OS rate was 89.5% (95% CI 86.2, 92.1) for pembrolizumab in combination with axitinib and 78.8% (95% CI 74.7, 82.4) for sunitinib.
Danish: OS-raten i måned 12 var 89,5% (95% CI: 86,2; 92,1) for pembrolizumab i kombination med axitinib og 78,8% (95% CI: 74,7; 82,4) for sunitinib.
English: The median duration was 2.6 months (range 6 days to 12.0 months).
Danish: Medianvarigheden var 2,6 måneder (interval: 6 dage til 12,0 måneder).
English: Hypophysitis resolved in 17 patients, 8 with sequelae.
Danish: Hypofysitis gik over hos 17 patienter, 8 med sequelae.
English: Skin and subcutaneous tissue disorders Very common rash q, pruritus rash q, alopecia, pruritus palmar-plantar erythrodysaesthesia syndrome, rash q,
Danish: Hud og subkutane væv Meget almindelig udslæt q, pruritus udslæt q, alopeci, pruritus palmoplantar erytrodysæstesisyndrom (hånd-fod-syndrom), udslæt q, pruritus
English: ORR difference, % (95% CI)
Danish: ORR-forskel, % (95% CI)
English: The safety of pembrolizumab as monotherapy has been evaluated in 5,884 patients with advanced melanoma, resected Stage III melanoma (adjuvant therapy), NSCLC, cHL, urothelial carcinoma, or HNSCC across four doses (2 mg/kg every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg every 2 or 3 weeks) in clinical studies.
Danish: Pembrolizumabs sikkerhed som monoterapi er blevet vurderet hos 5.884 patienter med fremskredent melanom, resekteret stadie III-melanom (adjuverende behandling), NSCLC, cHL, urotelialt karcinom eller HNSCC ved 4 doser (2 mg/kg hver 3. uge, 200 mg hver 3. uge eller 10 mg/kg hver 2. eller 3. uge) i kliniske studier.
English: For liver enzyme elevations, in patients with RCC being treated with KEYTRUDA in combination with axitinib:
Danish: Ved forhøjede leverenzymer hos RCC-patienter, der behandles med KEYTRUDA i kombination med axitinib:
English: In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3.
Danish: Hos patienter med HNSCC, som blev behandlet med pembrolizumab som monoterapi (n=909), var forekomsten af hypotyroidisme 16,1% (alle grader) med 0,3% af grad 3.
English: Elevated liver enzymes when pembrolizumab is combined with axitinib in RCC In a clinical study of previously untreated patients with RCC receiving pembrolizumab in combination with axitinib, a higher than expected incidence of Grades 3 and 4 ALT increased (20%) and AST increased (13%) were observed.
Danish: Forhøjede leverenzymer, når pembrolizumab anvendes i kombination med axitinib ved RCC I et klinisk studie af tidligere ubehandlede RCC-patienter, der fik pembrolizumab i kombination med axitinib, blev der observeret en højere end forventet forekomst af grad 3 og 4 forhøjelser af ALAT (20%) og ASAT (13%).
English: Pneumonitis led to discontinuation of pembrolizumab in 98 (1.7%) patients.
Danish: Pneumonitis medførte seponering af pembrolizumab hos 98 (1,7%) patienter.
English: The median time to onset of pneumonitis was 3.3 months (range 2 days to 26.8 months).
Danish: Den mediane tid til indtræden af pneumonitis var 3,3 måneder (interval: 2 dage til 26,8 måneder).
English: Common influenza like illness, chills chills, influenza-like illness oedema aa
Danish: Almindelig influenzalignende sygdom, kuldegysninger kuldegysninger, influenzalignende sygdom ødem aa
English: Of the 540 patients, 61% were male, 43% were ≥ 65 years (median age was 62 years [range 15-89]) and 98% were white.
Danish: Ud af 540 patienter var 61% mænd, 43% var ≥ 65 år (medianalderen var 62 år [interval: 15-89]), og 98% var kaukasere.
English: The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively.
Danish: Baseline-karakteristika for denne population inkluderede: medianalder 63 år (42% i alderen 65 år eller ældre); 61% mænd; 72% kaukasere og 21% asiater og henholdsvis 34% og 66% med ECOGperformance-status 0 og 1.
English: Colitis resolved in 84 patients, 2 with sequelae.
Danish: Colitis gik over hos 84 patienter, 2 med sequelae.
English: Table 17: Response to pembrolizumab 2 or 10 mg/kg every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010
Danish: Tabel 17: Respons på pembrolizumab 2 eller 10 mg/kg hver 3. uge hos tidligere behandlede patienter med NSCLC i KEYNOTE-010
English: • Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
Danish: • Før fortynding kan hætteglasset med koncentrat opbevares uden for køleskab (ved temperaturer på eller under 25 °C) i op til 24 timer.
English: Table 9 summarizes efficacy results by PD-L1 expression.
Danish: I tabel 9 opsummeres effektresultaterne ud fra PD-L1-ekspression.
English: Chemotherapy (n=42)
Danish: Kemoterapi (n=42)
English: The median duration was not reached (range 2 days to 32.6+ months).
Danish: Medianvarigheden blev ikke nået (interval: 2 dage til 32,6+ måneder).
English: The median duration was 3.3 months (range 3 days to 18.1+ months).
Danish: Medianvarigheden var 3,3 måneder (interval: 3 dage til 18,1+ måneder).
English: Common dizziness, neuropathy peripheral, lethargy, dysgeusia lethargy dizziness, lethargy, neuropathy peripheral
Danish: Almindelig svimmelhed, perifer neuropati, letargi, dysgeusi letargi svimmelhed, letargi, perifer neuropati
English: Table 8 summarises efficacy results by PD-L1 expression.
Danish: I tabel 8 opsummeres effektresultaterne ud fra PD-L1-ekspression.
English: Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract.
Danish: 81% havde en primær tumor i den nederste del af urinvejene, og 19% havde en primær tumor i de øvre urinveje.
English: Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion:
Danish: Patienterne blev randomiseret i forholdet 1:1 til en af følgende behandlingsarme med intravenøs infusion:
English: Standard Treatment* n=110
Danish: Standardbehandling* n=110
English: Patients were stratified by PD-L1 expression (TPS ≥ 50%), HPV status and ECOG performance status and then randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=247) or one of three standard treatments (n=248): methotrexate 40 mg/m2 once weekly (n=64), docetaxel 75 mg/m2 once every 3 weeks
Danish: Patienterne blev stratificeret ud fra PD-L1-tumorekspression (TPS ≥ 50%), HPV-status og ECOG-performance-status og blev herefter randomiseret i forholdet 1:1 til at få enten pembrolizumab 200 mg hver 3. uge (n=247) eller en af tre standardbehandlinger (n=248): methotrexat 40 mg/m2 en gang ugentligt (n=64), docetaxel 75 mg/m2 en gang hver 3. uge (n=99) eller cetuximab 400 mg/m 2 støddosis og herefter 250 mg/m 2 en gang ugentligt (n=71).
English: The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months).
Danish: Den mediane tid til indtræden af forhøjet ALAT var 2,3 måneder (interval: 7 dage til 19,8 måneder).
English: Standard Treatment* n=65
Danish: Standardbehandling* n=65
English: Fatigue has been reported following administration of pembrolizumab (see section 4.8).
Danish: Træthed er rapporteret efter administration af pembrolizumab (se pkt.
English: A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were BRAF wild type (n=525; 63%), BRAF mutant without prior BRAF treatment (n=163; 20%) and BRAF mutant with prior BRAF treatment (n=139; 17%) as summarised in Table 7.
Danish: Der blev udført en subgruppeanalyse som en del af den endelige analyse i KEYNOTE-006 hos patienter, som var enten BRAF vildtype (n=525; 63%), BRAF-mutation uden forudgående BRAF-behandling (n=163; 20%) eller BRAF-mutation med forudgående BRAF-behandling (n=139; 17%) som opsummeret i tabel 7.
English: Objective Response Rate* ORR %, (95% CI) OS
Danish: Objektiv responsrate* ORR %, (95% CI) OS
English: KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection (see section 5.1).
Danish: KEYTRUDA som monoterapi er indiceret til adjuverende behandling af voksne med stadie III-melanom og lymfeknudeinvolvering, som har fået foretaget komplet resektion (se pkt.
English: Before you get KEYTRUDA, tell your doctor if you: - have an autoimmune disease (a condition where the body attacks its own cells) - have pneumonia or inflammation of your lungs (called pneumonitis) - were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine - had an allergic reaction to other monoclonal antibody therapies - have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV) - have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) - have liver damage - have kidney damage - have had a solid organ transplant or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic)
Danish: (pneumonitis) - hvis du tidligere har fået ipilimumab, der er et andet lægemiddel til behandling af melanom, og har oplevet alvorlige bivirkninger på grund af dette lægemiddel - hvis du har haft en allergisk reaktion ved behandling med andre monoklonale antistoffer - hvis du har eller har haft en kronisk virusinfektion i leveren, herunder hepatitis B (hbv) eller hepatitis C (hcv) - hvis du har hiv- (human immundefekt virus) infektion eller aids (erhvervet immundefekt syndrom) - hvis du har leverskader - hvis du har nyreskader - hvis du har gennemgået en transplantation af et fast organ eller en knoglemarvstransplantation
English: Table 11: Efficacy results by PD-L1 expression and BRAF mutation status in KEYNOTE-054
Danish: Tabel 11: Effektresultater ud fra PD-L1-ekspression og BRAF-mutationsstatus i KEYNOTE-054
English: Among the 495 patients in KEYNOTE-040, 129 (26%) had tumours that expressed PD-L1 with a TPS ≥ 50% based on the PD-L1 IHC 22C3 pharmDx
Danish: Blandt de 495 patienter i KEYNOTE-040 havde 129 (26%) tumorer, der udtrykte PD-L1 med TPS ≥ 50% baseret på PD-L1 IHC 22C3 pharmDx
English: Chemotherapy n=151
Danish: Kemoterapi n=151
English: In patients with NSCLC whose tumours have high PD-L1 expression, the risk of adverse reactions with combination therapy relative to pembrolizumab monotherapy should be considered and the benefit/risk ratio of the combined therapy evaluated on an individual basis (see sections 4.1, 4.4, 4.8 and 5.1).
Danish: Hos patienter med NSCLC, hvis tumorer har høj PD-L1-ekspression, skal risikoen for bivirkninger med kombinationsbehandling i forhold til pembrolizumab monoterapi overvejes og benefit/risk-forholdet for den kombinerede behandling vurderes på individuel basis (se pkt.
English: Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline.
Danish: Hos de 616 patienter i KEYNOTE-189 var baseline-karakteristika: medianalder 64 år (49% i alderen 65 år eller ældre); 59% mænd; 94% kaukasere og 3% asiater; henholdsvis 43% og 56% med ECOGperformance-status 0 eller 1; 31% PD-L1-negative (TPS < 1%); og 18% med behandlede eller ikke behandlede hjernemetastaser ved baseline.
English: Table 28: Efficacy Results in KEYNOTE-426
Danish: Tabel 28: Effektresultater i KEYNOTE-426
English: Secondary efficacy outcome measures were ORR and response duration.
Danish: Sekundære resultatmål var ORR og responsvarighed.
English: Common colitis n, dry mouth colitis n, dry mouth colitis n, dry mouth
Danish: Almindelig colitis n, mundtørhed colitis n, mundtørhed colitis n, mundtørhed