FrancophonIA/ELRC3.0 huggingface dataset:
English: KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2.
Danish: KEYTRUDA er et humaniseret monoklonalt antistof, der binder til programmed cell death-1 (PD-1)receptoren og blokerer dets interaktion med liganderne PD-L1 og PD-L2. PD-1-receptoren er en negativ regulator af T-celleaktivering, som er påvist at være involveret i kontrollen af T-cellemedieret immunrespons.
English: The median follow-up time was 12.8 months (range: 0.1 to 21.5 months).
Danish: Den mediane opfølgningstid var 12,8 måneder (interval: 0,1 til 21,5 måneder).
English: Severe infusion-related reactions, including hypersensitivity and anaphylaxis, have been reported in patients receiving pembrolizumab (see section 4.8).
Danish: Alvorlige infusionsreaktioner, herunder overfølsomhed og anafylaksi, er rapporteret hos patienter, der fik pembrolizumab (se pkt.
English: • a kind of cancer called bladder cancer (urothelial carcinoma)
Danish: • en bestemt type blærekræft kaldet urotelialt karcinom
English: No clinically important differences in the clearance of pembrolizumab were found between patients with mild hepatic impairment and normal hepatic function.
Danish: Der blev ikke påvist klinisk betydningsfulde forskelle i pembrolizumabs clearance mellem patienter med let nedsat leverfunktion og patienter med normal leverfunktion.
English: Number (%) of patients with event 6-month OS rate
Danish: Antal (%) patienter med hændelse 6-måneders OS-rate 12-måneders OS-rate
English: #) of patients with duration ≥ 6 months
Danish: #) patienter med varighed ≥ 6 måneder
English: • From a microbiological point of view, the reconstituted or diluted solution should be used immediately.
Danish: • Ud fra en mikrobiologisk synsvinkel skal det rekonstituerede koncentrat eller den fortyndede infusionsvæske anvendes straks.
English: The median time to onset of severe skin reactions was 3.3 months (range 3 days to 19.4 months).
Danish: Den mediane tid til indtræden af alvorlige hudreaktioner var 3,3 måneder (interval: 3 dage til 19,4 måneder).
English: Figure 11: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-010 (patients with PD-L1 expression tumour proportion score  1%, intent to treat population)
Danish: Figur 11: Kaplan-Meier-kurve for samlet overlevelse i hver behandlingsarm i KEYNOTE-010 (patienter med PD-L1-ekspression TPS  1%, intent to treat-population)
English: KEYTRUDA 200 mg every 3 weeks n=514
Danish: KEYTRUDA 200 mg hver 3. uge n=514
English: Based on patients with a best overall response as confirmed complete or partial response
Danish: Baseret på patienter med en bedste samlet respons, der er bekræftet komplet respons eller partielt respons
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
Danish: KEYTRUDA som monoterapi er indiceret til behandling af lokalt fremskredent eller metastatisk urotelialt karcinom hos voksne, som er uegnede til cisplatinbaseret kemoterapi, og hvis tumorer udtrykker PD-L1 med en kombineret positiv score (CPS) ≥ 10 (se pkt.
English: Allogeneic HSCT prior to treatment with pembrolizumab In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab.
Danish: Hos patienter, der tidligere har gennemgået allogen HSCT, er der rapporteret akut GVHD, inklusive GVHD med dødelig udgang, efter behandling med pembrolizumab.
English: Standard Treatment* n=133
Danish: Standardbehandling* n=133
English: Renal and urinary disorders Common nephritis z, acute kidney injury acute kidney injury, nephritis
Danish: Nyrer og urinveje Almindelig nefritis z, akut nyreskade akut nyreskade, nefritis
English: The median duration was 1.8 months (range 4 days to 29.2+ months).
Danish: Medianvarigheden var 1,8 måneder (interval: 4 dage til 29,2+ måneder).
English: Assessment of tumour status was performed at Week 6 and Week 12, followed by every 9 weeks thereafter.
Danish: Vurdering af tumorstatus blev foretaget i uge 6 og uge 12 og efterfølgende hver 9. uge derefter.
English: Data for the following immune-related adverse reactions are based on patients who received pembrolizumab across four doses (2 mg/kg every 3 weeks, 10 mg/kg every 2 or 3 weeks, or 200 mg every 3 weeks) in clinical studies (see section 5.1).
Danish: Dataene for følgende immunrelaterede bivirkninger er baseret på patienter, som har fået pembrolizumab i kliniske studier (4 doseringsregimer: 2 mg/kg hver 3. uge, 10 mg/kg hver 2. eller 3. uge eller 200 mg hver 3. uge) (se pkt.
English: KEYNOTE-024: Controlled trial of NSCLC patients naïve to treatment The safety and efficacy of pembrolizumab were investigated in KEYNOTE-024, a multicentre, controlled study for the treatment of previously untreated metastatic NSCLC.
Danish: KEYNOTE-024: Kontrolleret studie med behandlingsnaive NSCLC-patienter Pembrolizumabs sikkerhed og virkning blev undersøgt i KEYNOTE-024, et kontrolleret multicenterstudie hos tidligere ubehandlede patienter med metastatisk NSCLC.
English: Corticosteroids to treat adrenal insufficiency and other hormone replacement should be administered as clinically indicated, and pembrolizumab should be withheld for adrenal insufficiency or symptomatic hypophysitis until the event is controlled with hormone replacement.
Danish: Behandlingen med pembrolizumab skal pauseres ved binyrebarkinsufficiens eller symptomatisk hypofysitis, indtil bivirkningen er kontrolleret med hormonsubstitutionsbehandling.
English: KEYNOTE-040: Controlled trial in HNSCC patients previously treated with platinum-containing chemotherapy
Danish: KEYNOTE-040: Kontrolleret studie med HNSCC-patienter, som tidligere har været behandlet med platinbaseret kemoterapi
English: From a microbiological point of view, the product, once diluted, should be used immediately.
Danish: Ud fra en mikrobiologisk synsvinkel skal lægemidlet anvendes straks efter fortynding.
English: Pembrolizumab has not been studied in patients with moderate or severe hepatic impairment (see section 4.2).
Danish: Pembrolizumab er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: From a microbiological point of view, the reconstituted or diluted solution should be used immediately.
Danish: Ud fra en mikrobiologisk synsvinkel skal det rekonstituerede koncentrat eller den fortyndede infusionsvæske anvendes straks.
English: Breast-feeding - If you are breast-feeding, tell your doctor.
Danish: Amning - Fortæl det til lægen, hvis du ammer.
English: If you have any of the following conditions, call or see your doctor right away.
Danish: Kontakt straks lægen, hvis du får en eller flere af følgende tilstande.
English: Pembrolizumab Monotherapy n=124
Danish: Pembrolizumabmonoterapi n=124
English: Subgroup analyses by enrollment were performed in KEYNOTE-426 in patients with PD-L1 CPS ≥ 1 [pembrolizumab/axitinib combination: n=243 (56%) vs. sunitinib: n=254 (59%)]; CPS < 1 [pembrolizumab/axitinib combination: n=167 (39%) vs. sunitinib: n=158 (37%)], and in patients with IMDC risk categories of favourable [pembrolizumab/axitinib combination: n=138 (32%) vs. sunitinib: n=131 (31%)]; intermediate [pembrolizumab/axitinib combination: n=238 (55%) vs. sunitinib: n=246 (57%)]; and poor [pembrolizumab/axitinib combination: n=56 (13%) vs. sunitinib: n=52 (12%)].
Danish: Der blev udført subgruppeanalyser ud fra inklusion i KEYNOTE-426 hos patienter med PD-L1 CPS ≥ 1 [pembrolizumab/axitinib-kombinationen: n=243 (56%) versus sunitinib: n=254 (59%)]; CPS < 1 [pembrolizumab/axitinib-kombinationen: n=167 (39%) versus sunitinib: n=158 (37%)], og hos patienter med IMDC-risikokategorierne lav risiko [pembrolizumab/axitinib-kombinationen: n=138 (32%) versus sunitinib: n=131 (31%)]; middel risiko [pembrolizumab/axitinib-kombinationen: n=238 (55%) versus sunitinib: n=246 (57%)]; og høj risiko [pembrolizumab/axitinib-kombinationen: n=56 (13%) versus sunitinib: n=52 (12%)].
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).
Danish: KEYTRUDA som monoterapi er indiceret til behandling af lokalt fremskredent eller metastatisk urotelialt karcinom hos voksne, som tidligere har fået platinbaseret kemoterapi (se pkt.
English: Blockade of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss.
Danish: I dyremodeller med drægtige mus er det blevet påvist, at blokering af PD-L1-signalet kan påvirke tolerancen for fostret og medføre et stigende antal fostertab.
English: Adrenal insufficiency resolved in 16 patients, 4 with sequelae.
Danish: Binyrebarkinsufficiens gik over hos 16 patienter, 4 med sequelae.
English: Severe skin reactions led to discontinuation of pembrolizumab in 9 (0.2%) patients.
Danish: Alvorlige hudreaktioner medførte seponering af pembrolizumab hos 9 (0,2%) patienter.
English: Disease-specific precautions
Danish: Sygdomsspecifikke forholdsregler
English: KEYTRUDA, or if corticosteroid dosing cannot be reduced to ≤ 10 mg prednisone or equivalent per day within 12 weeks, KEYTRUDA should be permanently discontinued.
Danish: * Hvis behandlingsrelateret toksicitet ikke bedres til grad 0-1 inden for 12 uger efter den sidste dosis KEYTRUDA, eller hvis kortikosteroiddoseringen ikke kan reduceres til ≤ 10 mg prednison eller tilsvarende pr. dag inden for 12 uger, skal KEYTRUDA seponeres permanent.
English: The safety and efficacy of pembrolizumab were investigated in KEYNOTE-052, a multicentre, openlabel study for the treatment of locally advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy.
Danish: Pembrolizumabs sikkerhed og virkning blev undersøgt i KEYNOTE-052, et åbent, multicenterstudie til behandling af lokalt fremskredent eller metastatisk urotelialt karcinom hos patienter, som var uegnede til behandling med cisplatinbaseret kemoterapi.
English: No dose adjustment is needed for patients with mild hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion.
English: Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases.
Danish: 63% havde melanom i M1c-stadiet, og 2% af patienterne havde hjernemetastaser i anamnesen.
English: What KEYTRUDA looks like and contents of the pack KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 - 5.8.
Danish: Keytruda er en klar til let opaliserende, farveløs til lysegul opløsning med pH 5,2 - 5,8.
English: Table 27: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS ≥ 50% who were previously treated with platinum chemotherapy in KEYNOTE-040
Danish: Tabel 27: Effekt af pembrolizumab 200 mg hver 3. uge hos HNSCC-patienter med TPS ≥ 50%, som tidligere har været behandlet med platinbaseret kemoterapi i KEYNOTE-040
English: The median time to onset of hypophysitis was 5.9 months (range 1 day to 17.7 months).
Danish: Den mediane tid til indtræden af hypofysitis var 5,9 måneder (interval: 1 dag til 17,7 måneder).
English: Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006
Danish: Tabel 7: Effektresultater ud fra BRAF-mutationsstatus i KEYNOTE-006
English: KEYNOTE-001: Open label study in melanoma patients naïve and previously treated with ipilimumab The safety and efficacy of pembrolizumab for patients with advanced melanoma were investigated in an uncontrolled, open-label study, KEYNOTE-001.
Danish: KEYNOTE-001: Åbent studie med ipilimumab-naive og ipilimumab-erfarne melanom-patienter Pembrolizumabs sikkerhed og virkning blev undersøgt hos patienter med fremskredent melanom i et ikke-kontrolleret, åbent studie, KEYNOTE-001.
English: Duration of Response Median duration of response in months (range) % with duration ≥ 6 months
Danish: Responsvarighed Median responsvarighed i måneder (interval) % med varighed ≥ 6 måneder
English: Table 6: Efficacy results by BRAF mutation status in KEYNOTE-002
Danish: Tabel 6: Effektresultater ud fra BRAF-mutationsstatus i KEYNOTE-002
English: Objective Response Rate* ORR %, (95% CI) Disease Control Rate Complete Response Partial Response Stable Disease Response Duration Median in months (range)
Danish: Objektiv responsrate* ORR %, (95% CI) Sygdomskontrolrate Komplet respons Partielt respons Stabil sygdom Responsvarighed Median i måneder (interval)
English: Pembrolizumab 2 mg/kg every 3 weeks in patients naïve to treatment with ipilimumab n=51
Danish: Pembrolizumab 2 mg/kg hver 3. uge hos ipilimumab-naive patienter n=51
English: Assessed by BICR using RECIST 1.1
Danish: BICR-vurdering i henhold til RECIST 1.1
English: Median in months (95% CI)
Danish: Median i måneder (95% CI)
English: p-Value Median in months (95% CI) Rate (%) at 6 months (95% CI) Overall response rate ORR% (95% CI) p-Value Complete response Partial response Stable disease Response duration Median in months (range)
Danish: † (95% CI) p-værdi Median i måneder (95% CI) 6-måneders rate (%) (95% CI) Samlet responsrate ORR% (95% CI) p-værdi Komplet respons Partielt respons Stabil sygdom Responsvarighed Median i måneder (interval)
English: The median duration was 0.9 months (range 1 day to 8.7+ months).
Danish: Medianvarigheden var 0,9 måneder (interval: 1 dag til 8,7+ måneder).
English: • Pembrolizumab 200 mg with pemetrexed 500 mg/m2 and investigator's choice of cisplatin
Danish: • Placebo med pemetrexed 500 mg/m2 og investigators valg af cisplatin 75 mg/m2 eller carboplatin
English: IIIC ≥ 4 positive lymph nodes) and geographic region (North America, European countries, Australia and other countries as designated).
Danish: Randomiseringen blev stratificeret ud fra stadie (IIIA versus IIIB versus IIIC 1-3 positive lymfeknuder versus IIIC ≥ 4 positive lymfeknuder) i henhold til American Joint Committee on Cancer (AJCC), 7. udgave, og geografisk område (Nordamerika, de europæiske lande, Australien og andre udvalgte lande).
English: Endpoint Pembrolizumab combination therapy
Danish: Pembrolizumab kombinationsbehandling
English: Patients were randomised (2:1) to receive one of the following regimens:
Danish: Patienterne blev randomiseret i forholdet 2:1 til behandling med et af følgende regimer:
English: Table 14: Efficacy results by PD-L1 Expression in KEYNOTE-189
Danish: Tabel 14: Effektresultater ud fra PD-L1-ekspression i KEYNOTE-189
English: Pembrolizumab Monotherapy n=133
Danish: Pembrolizumabmonoterapi n=133
English: Gastrointestinal disorders Very common diarrhoea, abdominal pain m, nausea, vomiting, constipation diarrhoea, nausea, vomiting, constipation, abdominal pain diarrhoea, abdominal pain m, nausea, vomiting, constipation
Danish: Mave-tarm-kanalen Meget almindelig diarré, abdominalsmerter kvalme, opkastning, obstipation diarré, kvalme, opkastning, obstipation, abdominalsmerter diarré, abdominalsmerter m,
English: • The Patient Alert Card
Danish: • Patientinformationskortet
English: KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinumcontaining chemotherapy (see section 5.1).
Danish: KEYTRUDA som monoterapi er indiceret til behandling af recidiverende eller metastatisk HNSCC hos voksne, hvis tumorer udtrykker PD-L1 med TPS ≥ 50% og med sygdomsprogression under eller efter platinbaseret kemoterapi (se pkt.
English: Table 8: Efficacy results by PD-L1 expression in KEYNOTE-002
Danish: Tabel 8: Effektresultater ud fra PD-L1-ekspression i KEYNOTE-002
English: Hypophysitis has also been reported in patients receiving pembrolizumab.
Danish: Hypofysitis er også rapporteret hos patienter, der fik pembrolizumab (se pkt.
English: Standard Treatment* n=125
Danish: Standardbehandling* n=125
English: * Based on the stratified Cox proportional hazard model Based on stratified log-rank test
Danish: * Baseret på den stratificerede Cox proportional hazard-model Baseret på stratificeret log rank-test
English: The study excluded patients with autoimmune disease or a medical condition that required immunosuppression.
Danish: Studiet ekskluderede patienter med autoimmun sygdom og patienter, som fik immunsuppressiv behandling.
English: KEYNOTE-407: Controlled trial of combination therapy in squamous NSCLC patients naïve to treatment
Danish: KEYNOTE-407: Kontrolleret studie af kombinationsbehandling hos behandlingsnaive patienter med planocellulær NSCLC
English: Treatment with pembrolizumab or placebo continued until RECIST 1.1-defined progression of disease as determined by blinded independent central review (BICR), unacceptable toxicity, or a maximum of 24 months.
Danish: Behandling med pembrolizumab eller placebo fortsatte indtil sygdomsprogression i henhold til RECIST 1.1 baseret på BICR-vurdering, uacceptabel toksicitet eller i højst 24 måneder.
English: severe skin reactions (dermatitis bullous, dermatitis exfoliative, erythema multiforme, exfoliative rash, pemphigus, skin necrosis, toxic skin eruption and Grade ≥ 3 of the following: acute febrile neutrophilic dermatosis, contusion, decubitus ulcer, dermatitis psoriasiform, drug eruption, jaundice, pemphigoid, pruritus, pruritus generalised, rash, rash erythematous, rash generalised, rash maculo-papular, rash pruritic, rash pustular and skin lesion)
Danish: alvorlige hudreaktioner (bulløs dermatit, eksfoliativ dermatitis, erythema multiforme, eksfoliativt udslæt, pemphigus, hudnekrose, toksisk hududslæt samt ≥ grad 3 af følgende: akut febril neutrofil dermatose, kontusion, liggesår, psoriasiform dermatitis, lægemiddeludslæt, gulsot, pemfigoid, pruritus, generaliseret pruritus, udslæt, erytematøst udslæt, generaliseret udslæt, makulopapuløst udslæt, pruritisk udslæt, pustuløst udslæt og hudlæsion)
English: • Placebo 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/m on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by placebo every 3 weeks.
Danish: • Placebo og carboplatin AUC 6 mg/ml/min på dag 1 i hver 21-dages serie i 4 serier 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
English: The study excluded patients with autoimmune disease, a medical condition that required immunosuppression and patients with more than 2 prior lines of systemic chemotherapy for metastatic urothelial cancer.
Danish: Patienter med autoimmun sygdom, en medicinsk tilstand som krævede behandling med immunsuppressiva, og patienter som tidligere havde fået mere end 2 omgange systemisk kemoterapi mod metastatisk urotelial cancer blev ekskluderet fra studiet.
English: Hyperthyroidism occurred in 244 (4.1%) patients, including Grade 2 or 3 cases in 64 (1.1%) and 7 (0.1%) patients, respectively, receiving pembrolizumab.
Danish: Hypertyroidisme forekom hos 244 (4,1%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2 eller 3 hos henholdsvis 64 (1,1%) og 7 (0,1%) patienter.
English: Among the 305 patients in KEYNOTE-024, baseline characteristics were: median age 65 years (54% age 65 or older); 61% male; 82% White, 15% Asian; and ECOG performance status 0 and 1 in 35% and 65%, respectively.
Danish: Hos de 305 patienter i KEYNOTE-024 var baseline-karakteristika: medianalder 65 år (54% ≥ 65 år), 61% mænd, 82% kaukasere, 15% asiater og ECOG-performance-status 0 og 1 hos henholdsvis 35% og 65%.
English: Standard Treatment* n=122
Danish: Standardbehandling* n=122
English: Complete response % Partial response % Response duration Median in months (range)
Danish: Komplet respons % Partielt respons % Responsvarighed Median i måneder (interval)
English: An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n= 176 (65%)] or ≥ 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n= 90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 20).
Danish: Der blev udført en analyse i KEYNOTE-045 hos patienter, der havde PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) versus kemoterapi: n=176 (65%)] eller ≥ 10 [pembrolizumab: n=74 (27%) versus kemoterapi: n=90 (33%)] i både pembrolizumab- og kemoterapi-armene (se tabel 20).
English: Hepatitis led to discontinuation of pembrolizumab in 19 (0.3%) patients.
Danish: Hepatitis medførte seponering af pembrolizumab hos 19 (0,3%) patienter.
English: a. infusion-related reaction (drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction, hypersensitivity and cytokine release syndrome) b. hypothyroidism (myxoedema) c. adrenal insufficiency (Addison's disease, adrenocortical insufficiency acute, secondary adrenocortical insufficiency) d. hypophysitis (hypopituitarism) e. thyroiditis (autoimmune thyroiditis and thyroid disorder) f.
Danish: a. infusionsreaktion (lægemiddeloverfølsomhed, anafylaktisk reaktion, anafylaktoid reaktion, overfølsomhed og cytokinfrigivelsessyndrom) b. hypotyroidisme (myksødem) c.
English: Hypothyroidism occurred in 645 (11.0%) patients, including Grade 2 or 3 cases in 475 (8.1%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Danish: Hypotyroidisme forekom hos 645 (11,0%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2 eller 3 hos henholdsvis 475 (8,1%) og 8 (0,1%) patienter.
English: Table 9: Efficacy results by PD-L1 expression in KEYNOTE-006
Danish: Tabel 9: Effektresultater ud fra PD-L1-ekspression i KEYNOTE-006
English: Table 12: Efficacy results in KEYNOTE-024
Danish: Tabel 12: Effektresultater i KEYNOTE-024
English: Hypophysitis led to discontinuation of pembrolizumab in 8 (0.1%) patients.
Danish: Hypofysitis medførte seponering af pembrolizumab hos 8 (0,1%) patienter.
English: Pembrolizumab 200 mg every 3 weeks
Danish: Pembrolizumab 200 mg hver 3. uge
English: Table 3: Efficacy results in KEYNOTE-006
Danish: Tabel 3: Effektresultater i KEYNOTE-006
English: Immune-related severe skin reactions occurred in 89 (1.5%) patients, including Grade 2, 3 or 5 cases in 10 (0.2%), 65 (1.1%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Danish: Alvorlige immunrelaterede hudreaktioner forekom hos 89 (1,5%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 5 hos henholdsvis 10 (0,2%), 65 (1,1%) og 1 (< 0,1%) patienter.
English: Table 16: Efficacy results by PD-L1 Expression in KEYNOTE-407
Danish: Tabel 16: Effektresultater ud fra PD-L1-ekspression i KEYNOTE-407
English: RFS analysis.
Danish: -analysen.
English: Colitis occurred in 107 (1.8%) patients, including Grade 2, 3 or 4 cases in 31 (0.5%), 62 (1.1%) and 3 (< 0.1%) patients, respectively, receiving pembrolizumab.
Danish: Colitis forekom hos 107 (1,8%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 31 (0,5%), 62 (1,1%) og 3 (< 0,1%) patienter.
English: patches of skin that have lost colour - inflammation of the sheath that surrounds tendons - increased level of amylase, an enzyme that breaks down starch; increased bilirubin in the blood
Danish: pletvise farveændringer i huden (hvide pletter) - forhøjet indhold af amylase, et enzym, som nedbryder stivelse.
English: Table 4: Efficacy results in KEYNOTE-002
Danish: Tabel 4: Effektresultater i KEYNOTE-002