FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with NSCLC that had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging, were excluded from the pivotal clinical study
Danish: Patienter med ikke-småcellet lungekræft, der havde tydelig tumorinfiltration i de store thorakale kar eller tydelig kavitation af lunge læsioner, set på billeddannelse, blev udelukket fra hovedstudiet IMpower150 efter adskillige tilfælde af dødelige lungeblødninger, som er en kendt risikofaktor ved behandling med bevacizumab.
English: The observed OS improvement was consistently demonstrated across subgroups of patients including those with brain metastases at baseline (HR of 0.54, 95% CI: 0.31, 0.94; median OS of 20.1
Danish: Den observerede forbedring i samlet overlevelse blev påvist på tværs af subgrupper, inklusive patienter med hjernemetastaser ved baseline (hazardratio 0,54; 95%
English: Meningoencephalitis requiring the use of corticosteroids occurred in 0.2% (6/3,178) of patients receiving atezolizumab and four patients discontinued atezolizumab.
Danish: Meningoencefalitis med behov for kortikosteroidbehandling sås hos 0,2% (6/3.178) af patienterne behandlet med atezolizumab og 4 patienter fik seponeret behandlingen med atezolizumab.
English: A phase III, double-blind, two-arm, multi-center, international, randomised, placebo-controlled study, IMpassion130, was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel, in patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.
Danish: Der er gennemført et randomiseret, dobbeltblindet, toarmet, internationalt, placebo-kontrolleret fase III-multicenterstudie (IMpassion130) med henblik på at evaluere effekt og sikkerhed af atezolizumab i kombination med nab-paclitaxel, hos patienter med inoperabel lokalt fremskredent eller metastatisk triplenegativ brystkræft, som ikke tidligere havde modtaget kemoterapi for metastatisk sygdom.
English: The management guidelines for these adverse reactions are described in sections 4.2 and 4.4.
Danish: Behandlingsretningslinjer for disse bivirkninger beskrives i pkt.
English: • a cancer that affects the lungs, called small cell lung cancer (SCLC).
Danish: · en kræftform, småcellet lungekræft, der rammer lungerne.
English: Guillain-Barré syndrome requiring the use of corticosteroids occurred in < 0.1% (2/3,178) of patients receiving atezolizumab monotherapy.
Danish: Guillain-Barré-syndrom med behov for kortikosteroidbehandling sås hos <0,1% (2/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
English: Secondary efficacy endpoints evaluated per investigator-assessed Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 are objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).
Danish: (Response Evaluation Criteria in Solid Tumors) er objektiv responsrate, progressionsfri overlevelse samt varighed af respons.
English: Nephritis occurred in < 0.1% (3/3,178) of patients who received atezolizumab.
Danish: Der er set nefritis hos < 0,1% (3/3.178) af patienterne, der fik atezolizumab.
English: Figure 2: Kaplan-Meier curve for overall survival in the ITT population (IMpower150)
Danish: Figur 2: Kaplan-Meier-kurve for samlet overlevelse i ITT-populationen (IMpower150)
English: Data for patients with brain metastases are too limited to draw conclusions on this population.
Danish: Data fra patienter med hjernemetastaser er for begrænsede til kunne drage en konklusion vedrørende denne population.
English: Median duration of PFS (months)
Danish: Medianvarighed af progressionfri overlevelse (måneder)
English: Atezolizumab was administered until loss of clinical benefit as assessed by investigator b
Danish: Placebo aAtezolizumab blev administeret indtil investigator vurderet mangel af klinisk effekt.
English: Common hypothyroidismg
Danish: Hypothyroidismeg
English: Includes reports of acne, acne pustular, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis bullous, dermatitis exfoliative generalised, drug eruption, eczema, eczema infected, erythema, erythema multiforme, erythema of eyelid, exfoliative rash, eyelid rash, fixed eruption, folliculitis, furuncle, generalised erythema, palmar-plantar erythrodysaesthesia syndrome, rash , rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash papulosquamous, rash pruritic, rash pustular, rash vesicular, seborrhoeic dermatitis, skin exfoliation, skin toxicity, skin ulcer, toxic epidermal necrolysis, toxic skin eruption.
Danish: w Inkluderer indberetninger om akne, pustuløs akne, dermatitis, akneiform dermatitis, allergisk dermatitis, bulløs dermatitis, generaliseret eksfoliativ dermatitis, lægemiddeleruption, eksem, betændt eksem, erythem, erythema multiforme, øjenlågserythem, eksfoliativt udslæt, øjenlågsudslæt, fast eruption, follikulitis, furunkel, generaliseret erytem, palmar-plantar erytrodysæstetisk syndrom, udslæt, erythematøst udslæt, generaliseret udslæt, makuløst udslæt, makulo-papuløst udslæt, papuløst udslæt, papuløst skællet udslæt, pruritisk udslæt,
English: A Phase I/III, randomised, multicentre, double-blind, placebo-controlled study, IMpower133, was conducted to evaluate the efficacy and safety of atezolizumab in combination with carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).
Danish: Der er gennemført et fase I/III, randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie, IMpower133, for at evaluere atezolizumabs effekt og sikkerhed i kombination med carboplatin og etoposid hos patienter med småcellet lungekræft i udvidet stadie, der ikke tidligere er behandlet med kemoterapi.
English: One patient required corticosteroids and discontinued atezolizumab.
Danish: En patient havde behov for kortikosteroider og fik seponeret behandlingen med atezolizumab.
English: No. of complete response (%) No. of partial response (%) No. of stable disease (%)
Danish: Antal respondenter (%) 95% konfidensinterval Antal med komplet respons (%) Antal med partial respons (%) Antal med stabil sygdom (%) Investigatorvurderet varighed af respons n=109
English: Baseline ECOG performance status was 0 (37%) or 1 (63%).
Danish: ECOG-status ved baseline var 0 (37%) eller 1 (63%).
English: Figure 13: Kaplan-Meier curve for progression-free survival (IMpower133)
Danish: Figur 13: Kaplan-Meier-kurve for progressionsfri overlevelse (IMpower133)
English: Both patients required corticosteroids and discontinued atezolizumab.
Danish: Begge patienter havde behov for kortikosteroider og fik seponeret behandlingen med atezolizumab.
English: The median age was 64 years (range 18 to
Danish: Medianalderen var 64 år (interval: 18 til 86 år).
English: • After dilution, one mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
Danish: 6.6), indeholder én ml opløsning ca. 3,2 mg atezolizumab for en dosis på 840 mg og 6,0 mg atezolizumab for en dosis på 1680 mg.
English: For the recommended dose of 840 mg: fourteen mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Til den anbefalede dosis på 840 mg: Træk 14 ml Tecentriq koncentrat fra hætteglasset, som fortyndes i en 250 ml polyvinylchlorid (PVC), polyolefin (PO), polyethylen (PE) eller polypropylen (PP) infusionspose indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning.
English: An updated analysis with a total of 200 deaths observed and a median survival follow-up of
Danish: Der er gennemført en opdateret analyse for samlet overlevelse med en medianopfølgning på 18 måneder.
English: Tecentriq in combination with nab-paclitaxel in 1L mTNBC The recommended dose of Tecentriq is 840 mg administered by intravenous infusion, followed by 100 mg/m2 nab-paclitaxel.
Danish: Anbefalet dosis af Tecentriq er 840 mg administreret som intravenøs infusion efterfulgt af 100 mg/m2 nab-paclitaxel.
English: Grade 2 or 3 Diarrhoea (increase of ≥ 4
Danish: Grad 2 eller 3 diarré (≥4 gange så mange afføringer/dag i forhold til baseline)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Tecentriq 1200 mg koncentrat til infusionsvæske, opløsning.
English: The median duration was 24 days (range 3 days to 12.0+ months; + denotes a censored value).
Danish: Medianvarighed var 24 dage (interval: 3 dage til 12,0+ måneder; + angiver en censureret værdi).
English: • Absence of tumour progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be readily managed and stabilised by protocol-allowed medical interventions prior to repeat dosing
Danish: Behandling med atezolizumab indtil ophør af klinisk effekt var tilladt og defineret ved følgende kriterier: · Ingen symptomer (inklusiv forværring af laboratorieværdier [f.eks. ny eller forværret hypercalcæmi]) på utvetydig tegn på sygdom · Ingen forværring af ECOG-performancestatus · Ingen tumorprogression ved kritiske anatomiske placeringer (fx leptomeningeal sygdom), der ikke umiddelbart kan behandles og stabiliseres ved hjælp af protokoltilladte medicinske interventioner inden dosering gentages · Evidens for klinisk effekt, efter investigators vurdering
English: NAME OF THE MEDICINAL PRODUCT Tecentriq 840 mg concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Tecentriq 840 mg koncentrat til infusionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT Tecentriq 1,200 mg concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Tecentriq 1200 mg koncentrat til infusionsvæske, opløsning.
English: For symptomatic adrenal insufficiency, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Danish: Ved symptomatisk binyrebarkinsufficiens bør behandling med atezolizumab afbrydes, og behandling med intravenøst kortikosteroid (1 til 2 mg/kg/dag methylprednisolon, eller ækvivalent produkt), igangsættes.
English: POPLAR (GO28753): Randomised phase II trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
Danish: POPLAR (GO28753): Randomiseret fase II-studie med patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft, tidligere behandlet med kemoterapi
English: Patients with ES-SCLC were treated with atezolizumab until disease progression.
Danish: Patienter med småcellet lungekræft i udvidet sygdomsstadie blev behandlet med atezolizumab indtil sygdomsprogression.
English: NSCLC patients (hazard ratio [HR] of 0.73, 95% CI: 0.60, 0.89; median OS of 15.6 vs. 11.2 months for atezolizumab and docetaxel, respectively) and squamous NSCLC patients (HR of 0.73, 95% CI: 0.54, 0.98; median OS of 8.9 vs. 7.7 months for atezolizumab and docetaxel, respectively).
Danish: Der sås en forbedring i samlet overlevelse i atezolizumab-gruppen sammenlignet med docetaxel, både hos patienter med ikke-planocellulær ikke-småcellet lungekræft (hazardratio 0,73; 95% konfidensinterval: 0,60; 0,89; median samlet overlevelse 15,6 versus 11,2 måneder for henholdsvis atezolizumab og docetaxel) og patienter med planocellulær ikke-småcellet lungekræft (hazardratio 0,73; 95% konfidensinterval: 0,54; 0,98; median samlet overlevelse 8,9 versus 7,7 måneder for henholdsvis atezolizumab og docetaxel).
English: For Grade 2 diarrhoea or colitis, if symptoms persist > 5 days or recur, treatment with 1 to 2 mg/kg/day prednisone or equivalent should be started.
Danish: Ved grad 2 diarré eller colitis påbegyndes behandling med 1 til 2 mg/kg/dag prednison eller ækvivalent produkt, hvis symptomerne vedvarer i >5 dage eller ved recidiv.
English: Hyperthyroidism occurred in 0.9% (30/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er set hyperthyroidisme hos 0,9% (30/3.178)) af de patienter, der har fået atezolizumab enkeltstofbehandling.
English: Treatment with atezolizumab could be continued when nab-paclitaxel was stopped due to unacceptable toxicity.
Danish: Hvis nabpaclitaxel blev seponeret på grund af uacceptabel toksicitet, kunne behandling med atezolizumab fortsættes.
English: A phase III, open-label, randomised study, GO29537 (IMpower130), was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel and carboplatin, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Danish: Der er gennemført et åbent, randomiseret, fase III-studie, GO29537 (IMpower130) for at evaluere effekt og sikkerhed af atezolizumab i kombination med nab-paclitaxel og carboplatin, hos kemoterapinaive patienter med metastatisk ikke-planocellulært ikke-småcellet lungekræft, der ikke tidligere er behandlet med kemoterapi.
English: Once symptoms improve, treatment with 1 to 2 mg/kg/day of prednisone or equivalent should follow.
Danish: Når symptomerne forbedres igangsættes behandling med 1 til 2 mg/kg/dag prednison, eller ækvivalent produkt.
English: Investigator-assessed DOR (RECIST 1.1)** ^
Danish: Investigator-vurderet objektiv responsrate (RECIST v1.1)**^
English: Uncommon myositisy Renal and urinary disorders Common proteinuriaz
Danish: Ikke almindelig Myositisy Nyrer og urinveje Almindelig
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 840 mg concentrate for solution for infusion atezolizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Tecentriq 840 mg koncentrat til infusionsvæske, opløsning.
English: A phase III, open-label, multicenter, international, randomised study, IMpower150, was conducted to evaluate the efficacy and safety of atezolizumab in combination with paclitaxel and carboplatin, with or without bevacizumab, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Danish: Et åbent, multicenter, internationalt, randomiseret, fase III-studie, IMpower150, blev gennemført for at evaluere virkning og sikkerhed af atezolizumab i kombination med paclitaxel and carboplatin, med eller uden bevacizumab, hos kemoterapinaive patienter med metastatisk ikke-planocellurlær ikkesmåcellet lungekræft.
English: Immune-related meningoencephalitis
Danish: Immunrelateret meningoencefalitis
English: Myasthenia gravis occurred in < 0.1% (1/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er set myasthenia gravis hos <0,1% (1/3.178) af patienterne der fik atezolizumab enkeltstofbehandling.
English: Hepatobiliary disorders Common
Danish: Myocarditisp Vaskulære sygdomme Almindelig
English: Patients with liver metastases did not show improved PFS or OS with atezolizumab, nab-paclitaxel and carboplatin, compared to nab-paclitaxel and carboplatin (HR of 0.93, 95% CI: 0.59, 1.47 for PFS and HR of 1.04,
Danish: Hos patienterne med levermetastaser sås der ikke forbedret progressionsfri overlevelse eller samlet overlevelse med atezolizumab, nab-paclitaxel og carboplatin sammenlignet med nab-paclitaxel og carboplatin (hazardratio: 0,93; 95% konfidensinterval: 0,59; 1,47 for progressionsfri overlevelse og hazardratio:1,04; 95% konfidensinterval: 0,63; 1,72 for samlet overlevelse).
English: • Description of the main signs and symptoms of the following safety concerns and reminder of the importance of notifying their treating physician immediately if symptoms occur, persist or worsen: Immune-Related Hepatitis Immune-Related Pneumonitis Immune-Related Colitis Immune-Related Pancreatitis
Danish: Beskrivelse af hovedsymptomerne af de efterfølgende sikkerhedsmæssige aspekter og påmindelse om, at kontakte den behandlende læge omgående hvis symptomerne fremkommer, er vedvarende eller forværres:
English: The confirmed ORRs per IRF-RECIST v1.1 were 28.0% (95% CI: 19.5, 37.9) in patients with PD-L1 expression ≥ 5%, 19.3% (95% CI: 14.2, 25.4) in patients with PD-L1 expression ≥ 1%, and 15.8% (95% CI: 11.9, 20.4) in all comers.
Danish: Den bekræftede objektiv responsrate, vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1, var 28,0% (95% konfidensinterval: 19,5; 37,9) hos patienter med PD-L1ekspression ≥5%, 19,3% (95% konfidensinterval: 14,2; 25,4) hos patienter med PD-L1-ekspression ≥1% og 15,8% (95% konfidensinterval: 11,9; 20,4) i ITT-populationen.
English: OAK (GO28915): Randomised phase III trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
Danish: OAK (GO28915): Randomiseret fase III-studie med patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft, tidligere behandlet med kemoterapi
English: Roche a/s c/o Icepharma hf
Danish: Roche a/s c/o Icepharma hf Sími: +354 540 8000
English: No dedicated studies of atezolizumab have been conducted in patients with renal impairment.
Danish: Der er ikke gennemført studier med atezolizumab specifikt hos patienter med nedsat leverfunktion.
English: Baseline ECOG performance status was 0 (35%) or 1 (65%).
Danish: ECOG-status ved baseline var 0 (35%) eller 1 (65%).
English: Figure 8: Kaplan-Meier curves for progression free survival (IMpower130)
Danish: Figur 8: Kaplan-Meier-kurver for progressionsfri overlevelse (IMpower130)
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne påvirkning var reversibel (se pkt.
English: Hypothyroidism occurred in 5.2% (164/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er konstateret hypothyroidisme hos 5,2% (164/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
English: Tecentriq in combination therapy
Danish: Tecentriq kombinationsbehandling
English: Baseline ECOG performance status was 0 (43%) or 1 (57%).
Danish: ECOG-status ved baseline var 0 (43%) eller 1 (57%).
English: and PFS by PD-L1 expression are summarised in Figures 7 and 9, respectively.
Danish: De eksploratoriske resultater for samlet overlevelse og progressionsfri overlevelse fordelt på PD-L1-eskpression er vist i henholdsvis figur 7 og 9.
English: • If you have any further questions, ask your doctor or nurse.
Danish: · Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: The rate of infusion should be reduced or treatment should be interrupted in patients with Grade 1 or 2 infusion-related reactions.
Danish: Ved infusionsrelaterede reaktioner af grad 1 eller 2, skal infusionshastigheden nedsættes eller behandlingen afbrydes.
English: Permanently discontinue Tecentriq
Danish: Afbryd behandling med Tecentriq
English: There was no evidence of efficacy in patients with asymptomatic brain metastases at baseline, although the number of patients treated was small; the median PFS was 2.2 months in the atezolizumab plus nab-paclitaxel arm (n=15) compared to 5.6 months in the placebo plus nabpaclitaxel arm (n=11) (HR 1.40; 95% CI 0.57, 3.44).
Danish: Median progressionsfri overlevelse var 2,2 måneder i atezolizumab og nab-paclitaxel-armen (n=15) sammenlignet med 5,6 måneder i placebo og nabpaclitaxel-armen (n=11).
English: Nervous system disorders Very Common peripheral neuropathyl , dizziness, headache
Danish: Perifer neuropatil, svimmelhed, hovedpine
English: Treatment with atezolizumab should be withheld for Grade 2 pneumonitis, and 1 to 2 mg/kg/day prednisone or equivalent should be started.
Danish: Behandling med atezolizumab bør afbrydes ved grad 2 pneumonitis, og behandling igangsættes med 1-2 mg/kg/dag prednison eller ækvivalent produkt.
English: Withhold Tecentriq Grade 4 or grade 3 recurrent myositis Permanently discontinue Tecentriq
Danish: Grad 4 eller grad 3 af recidiverende myositis
English: Patients were excluded if they had a history of autoimmune disease, administration of live, attenuated vaccine within 28 days prior to randomisation, administration of immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomisation, and active or untreated CNS metastases.
Danish: Patienter blev ekskluderede fra studiet, hvis de havde; autoimmun sygdom i anamnesen, fået administreret levende, svækket vaccine inden for 28 dage inden randomisering, fået administreret immunstimulerende midler inden for 4 uger eller systemiske immunsupprimerende midler inden for 2 uger inden randomisering eller aktive eller ubehandlede CNS-metastaser.
English: Patients were excluded if they had history of autoimmune disease, administration of a live, attenuated vaccine within 28 days prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to randomisation, active or untreated CNS metastases, clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging.
Danish: Følgende patienter blev ekskluderet fra studiet: Autoimmun sygdom i anamnesen, administration af levende, svækket vaccine inden for 28 dage inden inklusion, administration af systemisk immunstimulerende midler inden for 4 uger eller systemisk immunsupprimerende midler inden for 2 uger inden inklusion, aktiv eller ubehandlede hjernemetastaser og tydelig tumorinfiltration i de store thorakale kar eller tydelig kavitation af lunge læsioner, set ved billeddannelse.
English: The median duration was 1.4 months (range 0 day to 21.2+ months; + denotes a censored value).
Danish: Medianvarighed var 1,4 måneder (interval: 0 dage til 21,2+ måneder; + angiver censureret værdi).
English: Stratified hazard ratio
Danish: Stratificeret hazardratio konfidensinterval) p-værdi
English: A phase III, open-label, multi-center, international, randomised study, OAK, was conducted to evaluate the efficacy and safety of atezolizumab compared with docetaxel in patients with locally advanced or metastatic NSCLC who progressed during or following a platinum-containing regimen.
Danish: Et åbent, internationalt, randomiseret, fase III multicenter-studie, OAK, blev gennemført for at evaluere virkning og sikkerhed af atezolizumab sammenlignet med docetaxel hos patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft, som oplever progression under eller efter en platinholdig behandling.
English: Diabetes mellitus occurred in 0.3% (11/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er konstateret diabetes mellitus hos 0,3% (11/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
English: This is because the effect of Tecentriq in pregnant women is not known - it is possible that it could harm your unborn baby.
Danish: Der er en risiko for, at det kan skade det ufødte barn.
English: Figure 12: Kaplan-Meier curve for overall survival (IMpower133)
Danish: Figur 12: Kaplan-Meier-kurve for samlet overlevelse (IMpower133)
English: Secondary and exploratory endpoints Investigator-assessed PFS (RECIST v1.1)
Danish: Sekundære og eksploratoriske endepunkter Investigatorvurderet progressionfri overlevelse (RECIST v1.1)
English: Pneumonitis requiring the use of corticosteroids occurred in 1.6% (51/3,178) of patients receiving atezolizumab monotherapy.
Danish: Pneumonitis med behov for brug af kortikosteroider sås hos 1,6% (51/3.178) af de patienter, der fik atezolizumab.
English: Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter.
Danish: Tumoranalyser blev udført hver 6. uge i de første 48 uger efter 1. serie, dag 1 og herefter hver 9. uge.
English: PD-L1 testing for patients with UC or TNBC
Danish: PD-L1 test for patienter med urotelialt carcinom eller triplenegativ brystkræft
English: Treatment with atezolizumab may be resumed when serum amylase and lipase levels improve to ≤ Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Danish: Behandling med atezolizumab kan genoptages hvis serum-amylase og -lipase er forbedret til ≤ grad 1 inden for 12 uger, eller symptomerne på pancreatitis er forsvundet, og kortikosteroiddosis er reduceret til ≤10 mg/dag prednison eller ækvivalent produkt.