FrancophonIA/ELRC3.0 huggingface dataset:
English: Atezolizumab was administered as a fixed dose of 1,200 mg by intravenous infusion every 3 weeks.
Danish: Atezolizumab blev administreret i en fast dosis på 1200 mg ved intravenøs infusion hver 3. uge.
English: Treatment may be resumed when symptoms are controlled by antithyroid medicinal product and thyroid function is improving
Danish: Behandlingen kan genoptages, når symptomerne er under kontrol med antityroide midler, og thyroideafunktionen er i bedring.
English: Includes reports of oropharyngeal pain, oropharyngeal discomfort, throat irritation.
Danish: Inkluderer indberetninger om orofaryngeale smerter, orofaryngealt ubehag, svælgirritation.
English: For ES-SCLC and for first-line NSCLC, in patients given Tecentriq in combination with carboplatin and nab-paclitaxel, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity.
Danish: Ved småcellet lungekræft i udvidet sygdomsstadie og førstelinjebehandling af ikke-småcellet lungekræft, der behandles med Tecentriq i kombination med carboplatin og nab-placlitaxel, anbefales det, at patienterne behandles med Tecentriq indtil sygdomsprogression eller indtil der opstår toksicitet, der ikke kan behandles.
English: No developmental and reproductive studies were conducted with atezolizumab.
Danish: Der er ikke gennemført udviklings- og reproduktionsstudier med atezolizumab.
English: Treatment with atezolizumab should be withheld if Grade 2 event (ALT or AST > 3 to 5 x ULN or blood bilirubin > 1.5 to 3 x ULN) persists for more than 5 to 7 days, and 1 to 2 mg/kg/day of prednisone or equivalent should be started.
Danish: Behandling med atezolizumab bør afbrydes hvis grad 2 hændelse (ALAT eller ASAT >3-5 gange øvre referencegrænse eller blod-bilirubin >1,5 til 3 gange øvre referencegrænse) vedvarer i mere end 5 til 7 dage og behandling med 1 til 2 mg/kg/dag prednison eller ækvivalent produkt skal igangsættes.
English: Patient alert card
Danish: Patientkort
English: After dilution, one mL of solution should contain approximately 6.0 mg of Tecentriq (1680 mg/278 mL).
Danish: Efter fortynding, vil 1 ml opløsning indeholde ca. 6,0 mg Tecentriq (1680 mg/278 ml).
English: Arm B (Placebo + carboplatin + etoposide)
Danish: Arm B (Placebo + carboplatin + etoposid)
English: • The other ingredients are L-histidine, glacial acetic acid, sucrose, polysorbate 20 and water for injections.
Danish: · Øvrige indholdsstoffer er L-histidin; eddikesyre, koncentreret; saccharose; polysorbat 20 og vand til injektionsvæsker.
English: No reproductive and development toxicity studies have been conducted with atezolizumab; however, based on the 26-week repeat dose toxicity study, atezolizumab had an effect on menstrual cycles at an estimated AUC approximately 6 times the AUC in patients receiving the recommended dose and was reversible (see section 5.3).
Danish: I et 26-ugers toksicitetsstudie med gentagne doser påvirkede atezolizumab dog menstruationscyklus ved et estimeret AUC ca. 6 gange højere end det AUC, der ses hos patienter behandlet med den anbefalede dosis.
English: Immune-Related Endocrinopathies (Type 1 Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Adrenal Insufficiency and Hypophysitis) Immune-Related Neuropathies (Guillain-Barre Syndrome, Myasthenic Syndrome / Myasthenia Gravis) Immune-Related Meningoencephalitis Immune-Related Myocarditis Immune-Related Nephritis Immune-Related Myositis Infusion-Related Reactions
Danish: hyperthyroidisme, binyrebarkinsufficiens og hypofysitis) - Immunrelaterede neuropatier (Guillain-Barre syndrom, myastenisk syndrom/myasthenia gravis) - Immunrelateret meningoencefalitis - Immunrelateret myocarditis - Immunrelateret nefritis - Immunrelateret myositis - Infusionsrelaterede reaktioner
English: It is used if: the lung cancer has spread to other parts of the body (extensive-stage) you have not received any prior chemotherapy for extensive-stage SCLC.
Danish: Det anvendes til denne kræftform: hvis lungekræften har spredt sig til andre dele af kroppen (udvidet sygdomsstadie) hvis du ikke tidligere har fået kemoterapi for småcellet lungekræft i udvidet sygdomsstadie
English: Table 9: Summary of efficacy from IMpower130 in the primary analysis (ITT-WT population) Efficacy endpoints
Danish: Tabel 9: Opsummering af effekt i den primære analyse af ITT-WT-populationen (IMpower130) Effekt-endepunkter
English: The effect of severe renal impairment on the pharmacokinetics of atezolizumab is unknown.
Danish: Det vides ikke om svært nedsat nyrefunktion påvirker atezolizumabs farmakokinetik.
English: Tumour specimens were evaluated prospectively for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC).
Danish: Tumorbiopsier blev evalueret prospektivt for PD-L1-ekspression på tumorceller(TC) og tumorinfiltrerende immunceller (IC).
English: Patients should be monitored for signs and symptoms of colitis.
Danish: Patienterne bør monitoreres for symptomer på colitis.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 20 mL vial of concentrate contains 1,200 mg atezolizumab After dilution, 1 mL of solution contains approximately 4.4 mg of atezolizumab
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 20 ml koncentrat indeholder 1200 mg atezolizumab Efter fortynding indeholder 1 ml opløsning ca. 4,4 mg atezolizumab.
English: Tumour assessments were conducted every 9 weeks for the first 54 weeks, and every 12 weeks thereafter.
Danish: Der blev udført tumorvurdering hver 9. uge i de første 54 uger og herefter hver 12. uge.
English: v Includes reports of ascites, autoimmune hepatitis, hepatocellular injury, hepatitis, hepatitis acute, hepatotoxicity, liver disorder, drug-induced liver injury, hepatic failure, hepatic steatosis, hepatic lesion, oesophageal varices haemorrhage, varices oesophageal.
Danish: v Inkluderer indberetninger om ascites, autoimmun hepatitis, hepatocellulær skade, hepatitis, akut hepatitis, hepatotoksicitet, leversygdom, lægemiddelinduceret leverskade, leversvigt, hepatisk steatose, hepatisk læsion, blødning fra øsofagusvaricer, øsofageale varicer.
English: Pancreatitis, including amylase increased and lipase increased, occurred in 0.6% (18/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er set pancreatitis, inklusiv stigning i amylase og lipase, hos 0,6% (18/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
English: No dedicated studies of atezolizumab have been conducted in elderly patients.
Danish: Der er ikke gennemført studier med atezolizumab specifikt hos ældre patienter.
English: 1-year OS rate (%)
Danish: Samlet overlevelses-rate ved 1 år (%)
English: Per final analysis for PFS, ORR, DOR and first interim analysis for OS at clinical cut off 17th April 2018
Danish: Ved endelig analyse af progressionsfri overlevelse, objektiv responsrate, varighed af respons og første interim analyse for samlet overlevelse ved klinisk cut-off 17. april 2018 4.
English: Treatment with atezolizumab should be permanently discontinued for Grade 4 hypophysitis.
Danish: Behandling med atezolizumab skal seponeres permanent ved grad 4 hypofysitis.
English: Patients were treated until loss of clinical benefit as assessed by the investigator.
Danish: Patienterne blev behandlet indtil investigator vurderede, at der ikke længere var klinisk gavn af behandlingen.
English: Patients with locally advanced or metastatic UC who are ineligible for cisplatin therapy were treated with atezolizumab until disease progression.
Danish: Patienter med lokalt fremskredent eller metastatisk urotelialt carcinom, hvor cisplatin-behandling ikke er egnet, blev behandlet med atezolizumab indtil sygdomsprogression.
English: You will be given Tecentriq by a doctor experienced in cancer treatment in a hospital or clinic.
Danish: Tecentriq vil blive givet på et hospital eller på en klinik, af en læge med erfaring i behandling af kræftsygdomme.
English: Elderly Based on a population pharmacokinetic analysis, no dose adjustment of Tecentriq is required in patients ≥ 65 years of age (see sections 4.8 and 5.1).
Danish: Baseret på en farmakokinetisk populationsanalyse er dosisjustering af Tecentriq ikke nødvendig hos patienter i aldersgruppen ≥ 65 år (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 20 mL vial of concentrate contains 1,200 mg atezolizumab*.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et 20 ml hætteglas med koncentrat indeholder 1200 mg atezolizumab* Efter fortynding (se pkt.
English: Common abdominal pain, colitiss, dysphagia, oropharyngeal paint stomatitis, dysgeusia
Danish: Abdominalsmerter, colitiss, dysfagi, orofaryngeale smertert
English: • Stop your treatment with Tecentriq.
Danish: Afbryd behandling med Tecentriq.
English: For each 21-day cycle, Tecentriq, nab-paclitaxel, and carboplatin are administered on day 1.
Danish: Tecentriq, nab-paclitaxel og carboplatin administreres på dag 1 af hver serie på 21 dage.
English: 2,759 patients across multiple tumour types.
Danish: Atezolizumabs sikkerhed i kombination med andre lægemidler er vurderet hos 2.759 patienter på tværs af flere tumortyper.
English: Table 8: Intravenous treatment regimens (IMpower130) Treatment
Danish: Tabel 8: Intravenøse behandlingsregimer (IMpower130)
English: This means the lung cancer has: spread to other parts of the body come back after previous treatment.
Danish: Det anvendes når denne lunge kræftform er fremskreden, dvs: når kræften har spredt sig til andre dele af kroppen når kræften er vendt tilbage efter tidligere behandling
English: Hypophysitis occurred in 0.8% (3/393) of patients who received atezolizumab with bevacizumab, paclitaxel, and carboplatin.
Danish: Der er set hypofysitis hos 0,8% (3/393) af patienter behandlet med atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin.
English: The median time to onset was 15 days (range: 0 day to 12.5 months).
Danish: Mediantid til hændelsen var 15 dage (interval: 0 dage til 12,5 måneder).
English: The median time to onset was 5.2 months (range: 5.1 to 5.3 months).
Danish: Mediantid til hændelse var 5,2 måneder (interval: 5,1 til 5,3 måneder).
English: After dilution, one mL of solution should contain approximately 3.2 mg of Tecentriq (840 mg/264 mL).
Danish: Efter fortynding, vil 1 ml opløsning indeholde ca. 3,2 mg Tecentriq (840 mg/264 ml).
English: No. of events (%)
Danish: Antal hændelser (%)
English: Figure 7: Forest plot of overall survival by PD-L1 expression (IMpower130)
Danish: Figur 7: Forest-plot over samlet overlevelse fordelt på PD-L1-ekspression (IMpower130)
English: Refer to the full prescribing information for the combination product (see also section 5.1).
Danish: Se også produktresuméet for kombinationsproduktet (se pkt.
English: How Tecentriq is given
Danish: Hvordan gives Tecentriq?
English: Per second interim analysis for OS and exploratory PFS analysis at clinical cut off January 2
Danish: Ved anden interim analyse for samlet overlevelse og eksploratorisk progressionsfri overlvelse analyse ved klinisk cut-off 2. januar 2019.
English: Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Danish: Baseret på en farmakokinetisk populationsanalyse er dosisjustering ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (se pkt.
English: Other medicines and Tecentriq
Danish: Brug af anden medicin sammen med Tecentriq
English: Tumour assessments were performed every 8 weeks (± 1 week) for the first 12 months after Cycle 1, day 1 and every 12 weeks (± 1 week) thereafter.
Danish: Der blev udført tumoranalyse efter 1. serie 1. dag hver 8. uge (± 1 uge) i de første 12 måneder og herefter hver 12. uge (± 1 uge).
English: 22 months showed a median OS of 12.6 months in patients treated with atezolizumab, vs. 9.7 months in patients treated with docetaxel (HR of 0.69, 95% CI: 0.52, 0.92).
Danish: En opdateret analyse med i alt 200 dødsfald og en median overlevelsesopfølgning på 22 måneder viste en median samlet overlevelse på 12,6 måneder hos patienter behandlet med atezolizumab versus 9,7 måneder hos patienter behandlet med docetaxel (hazardratio på 0,69; 95% konfidensinterval: 0,52; 0,92).
English: b Includes reports of pneumonia, bronchitis, lung infection, lower respiratory tract infection, infective exacerbation of COPD, infectious pleural effusion, tracheobronchitis, atypical pneumonia, lung abscess, pyopneumothorax.
Danish: b Inkluderer indberetninger om pneumoni, bronkitis, lungeinfektion, nedre luftvejsinfektion, infektiøs forværring af KOL, infektiøs pleuraeffusion, tracheobronkitis, atypisk pneumoni, lungebyld, pyopneumothorax.
English: Infusion-related reactions have been observed with atezolizumab (see section 4.8).
Danish: Der er observeret infusionsrelaterede reaktioner med atezolizumab (se pkt.
English: Tlf: +47 - 22 78 90 00
Danish: Roche Norge AS Tlf: +47 - 22 78 90 00
English: and 0.82 for OS while in patients who had not received prior (neo)adjuvant treatment (n=127), the hazard ratio for PFS was 0.44 and 0.53 for OS.
Danish: For patienterne, der ikke tidligere havde fået (neo)adjuverende behandling (n=127), var hazardratio for progressionsfri overlevelse 0,44 og 0,53 for samlet overlevelse.
English: Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab
Danish: Tecentriq 1200 mg koncentrat til infusionsvæske, opløsning atezolizumab
English: Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy.
Danish: Tecentriq er som enkeltstofbehandling indiceret til behandling af voksne patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter forudgående kemoterapi.
English: The median time to onset was 5.4 months (range: 0.7 to 11.0 months).
Danish: Mediantid til hændelse var 5,4 måneder (interval: 0,7 til 11,0 måneder).
English: First-line treatment of non-small cell lung cancer
Danish: Førstelinjebehandling af ikke-småcellet lungekræft
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må medicinrester ikke smides i afløbet, toilettet eller skraldespanden.
English: Includes reports of musculoskeletal pain and myalgia.
Danish: Inkluderer indberetninger om smerter i bevægeapparatet, myalgi.
English: The median time to onset was 5.5 months (range: 3 days to 19 months).
Danish: Mediantid til hændelse var 5,5 måneder (interval: 3 dage til 19 måneder).
English: For intravenous use after dilution.
Danish: Til intravenøst brug efter fortynding
English: The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq followed by bevacizumab, is administered by intravenous infusion every three weeks.
Danish: Induktionsfasen efterfølges af en vedligeholdelsesfase uden kemoterapi, hvor 1200 mg Tecentriq efterfulgt af bevacizumab, administreres som intravenøs infusion hver 3. uge.
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Danish: Patienterne bør monitoreres for kliniske symptomer på endokrinopatier.
English: Figure 9: Forest plot of progression free survival by PD-L1 expression (IMpower130)
Danish: Figur 9: Forest-plot over progressionsfri overlevelse fordelt på PD-L1-ekspression (IMpower130)
English: Patients should be monitored for signs and symptoms of hepatitis.
Danish: Patienter bør monitoreres for symptomer på hepatitis.
English: Based on the severity of the adverse reaction, atezolizumab should be withheld and corticosteroids administered.
Danish: Afhængigt af sværhedsgraden af bivirkningen, skal behandling med atezolizumab afbrydes og kortikosteroidbehandling initieres.
English: Table 2: Summary of adverse reactions occurring in patients treated with atezolizumab Atezolizumab monotherapy
Danish: Tabel 2: Skema over indberettede bivirkninger hos patienter behandlet med atezolizumab Atezolizumab enkeltstofbehandling
English: The median age was 63 years (range: 31 to 90), and 60% of patients were male.
Danish: Medianalderen var 63 år (interval: 31 til 90), og 60% af patienterne var mænd.
English: The study met its co-primary endpoints in Cohort 2, demonstrating statistically significant ORRs per IRF-assessed RECIST v1.1 and investigator-assessed mRECIST
Danish: Studiet opfyldte de co-primære endepunkter i kohorte 2 og viste statistisk signifikant objektiv responsrate, vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1 og investigatorvurderet mRECIST, sammenlignet med en præspecificeret historisk kontrol-responsrate på
English: Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 myocarditis.
Danish: Behandling med atezolizumab bør seponeres permanent ved grad 3 eller 4 myocarditis.
English: If symptoms improve to ≤ Grade 1, taper corticosteroids as clinically indicated.
Danish: Hvis symptomerne forbedres til ≤ grad 1 skal behandlingen med kortikosteroid nedtrappes som klinisk indiceret.
English: Patients should be monitored for signs and symptoms of myocarditis.
Danish: Patienterne bør monitoreres omhyggeligt for symptomer tydende på myocarditis.
English: Paclitaxel was administered 175 mg/m2 by intravenous infusion over 3 hours on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Danish: Paclitaxel blev administreret i en dosis på 175 mg/m2 ved intravenøs infusion over 3 timer på dag 1 af hver 3-ugers cyklus indtil sygdomsprogression eller uacceptabel toksicitet.
English: Hepatitis led to discontinuation of atezolizumab in 6 (< 0.2%) patients.
Danish: Hepatitis medførte seponering af atezolizumab hos 6 (<0,2%) af patienterne.
English: 31 July 2021
Danish: Indsendelse af studieresultater: 31. juli 2021
English: Patients with PD-L1 expression <1% did not show improved OS when atezolizumab was added to nab-paclitaxel (HR of 0.97, 95% CI 0.78, 1.20).
Danish: Patienter med PD-L1-ekspression <1% viste ikke forbedret samlet overlevelse ved tilføjelse af atezolizumab til nab-paclitaxel (Hazardratio: 0,97 (95% konfidensinterval: 0,78; 1,20).
English: Tecentriq is a concentrate for solution for infusion.
Danish: Tecentriq er et koncentrat til infusionsvæske, opløsning.
English: A phase II, multi-centre, international, randomised, open-label, controlled study, POPLAR, was conducted in patients with locally advanced or metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression.
Danish: Der er gennemført et fase II, internationalt, randomiseret, ublindet, kontrolleret multicenterstudie, POPLAR, med patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft, der havde oplevet progression under eller efter platinholdig behandling, uanset PD-L1-ekspression.
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in EGFR+ patients with NSCLC who have progressed on erlotinib+bevacizumab
Danish: Brug af atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin hos EGFR+ patienter med ikke-småcellet lungekræft, som har progredieret under behandling med erlotinib+bevacizumab
English: In patients who had received prior (neo) adjuvant treatment (n=242), the hazard ratio for PFS was 0.79
Danish: For patienterne, der tidligere havde fået (neo)adjuverende behandling (n=242), var harzardratio for progressionsfri overlevelse 0,79, og 0,82 for samlet overlevelse.
English: Paclitaxel and carboplatin are administered until completion of 4 or 6 cycles, or progressive disease, or unacceptable toxicity whichever occurs first d.
Danish: c Paclitaxel og carboplatin administeres indtil 4 eller 6 serier er afsluttet, eller progressiv sygdom, uacceptabel toksicitet, hvad end der forekommer først.
English: LIST OF EXCIPIENTS Excipients: L-histidine, glacial acetic acid, sucrose, polysorbate 20, water for injections
Danish: Hjælpestoffer: L-histidin, eddikesyre, koncentreret, saccharose, polysorbat 20, vand til injektionsvæsker
English: a Atezolizumab is administered until loss of clinical benefit as assessed by the investigator b
Danish: Atezolizumab administeres indtil investigator-vurderet ophør af klinisk effekt b
English: The median age was 64 years (range: 33 to 85), and 61% of patients were male.
Danish: Medianalderen var 64 år (interval: 33 til 85), og 61% af patienterne var mænd.
English: Treatment with atezolizumab must be permanently discontinued for Grade 3 or Grade 4 events (ALT or AST > 5.0 x ULN or blood bilirubin > 3 x ULN).
Danish: Behandling med atezolizumab skal seponeres permanent ved grad 3 eller grad 4 bivirkninger (ALAT eller ASAT >5,0 gange øvre referencegrænse eller blod-bilirubin >3 gange øvre referencegrænse).
English: Patients with locally advanced or metastatic UC who are ineligible for cisplatin therapy and locally advanced unresectable or metastatic TNBC were treated with atezolizumab until disease progression.
Danish: Patienter med lokalt fremskredent eller metastatisk urotelialt carcinom, hvor cisplatin-behandling ikke er egnet, eller lokalt fremskredent inoperabel eller metastatisk triplenegativ brystkræft blev behandlet med atezolizumab indtil sygdomsprogression.
English: Figure 5: Forest plot of progression free survival by PD-L1 expression in the ITT population, Arm B vs. C (IMpower150)
Danish: Figur 5: Forest-plot over progressionsfri overlevelse fordelt på PD-L1-ekspressionen i ITT-populationen, arm B versus C (IMpower150)
English: (creatinine level > 1.5 to 3.0 x baseline or > 1.5 to 3.0 x ULN)
Danish: Grad 2: (kreatininniveau >1,5-3,0 gange baseline eller >1,5-3,0 gange øvre referencegrænse)
English: Patients should be monitored for signs and symptoms of pneumonitis.
Danish: Patienterne bør monitoreres for symptomer på pneumonitis.
English: Data for patients ≥ 75 years of age are too limited to draw conclusions on this population.
Danish: Data for patienter ≥ 75 år er for begrænsede til at kunne drage konklusioner vedrørende denne population.
English: 1 to 2 mg/kg/day of prednisone or equivalent should be started.
Danish: 1-2 mg/kg/dag prednison eller ækvivalent produkt.
English: Uncommon Guillain-Barré syndromem, meningoencephalitisn
Danish: Ikke almindelig Guillain-Barré-syndromm, meningoencefalitisn
English: j Includes reports of adrenal insufficiency and primary adrenal insufficiency.
Danish: j Inkluderer indberetninger om binyrebarkinsufficiens, primær binyrebarkinsufficiens.
English: For Grade 2 or Grade 3 hypophysitis, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started, and hormone replacement should be initiated as needed.
Danish: Ved grad 2 eller grad 3 hypofysitis skal atezolizumab afbrydes og behandling med intravenøst kortikosteroid (1 til 2 mg/kg/dag methylprednisolon eller ækvivalent produkt) samt hormonsubstitution efter behov påbegyndes.
English: Treatment with atezolizumab should be withheld for ≥ Grade 3 serum amylase or lipase levels increased (> 2 x ULN), or Grade 2 or 3 pancreatitis, and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Danish: Behandling med atezolizumab bør afbrydes ved ≥ grad 3 stigning i serum-amylase eller -lipase (> 2 gange øvre referencegrænse) eller grad 2 eller 3 pancreatitis, og behandling igangsættes med intravenøse kortikosteroider (1 til 2 mg/kg/dag methylprednisolon eller ækvivalent produkt).
English: Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).
Danish: Tecentriq er i kombination med nab-paclitaxel og carboplatin indiceret til førstelinjebehandling af voksne patienter med metastatisk ikke-planocellulært, ikke-småcellet lungekræft, som ikke har EGFR mutation eller ALK-positiv ikke-småcellet lungekræft (se pkt.
English: Most patients were male (81%), and the majority of patients were White (91%).
Danish: De fleste patienter var mænd (81%), og størstedelen af patienterne var af kaukasisk etnicitet (91%).
English: The median duration was 8.0 months (range 18 days to 8.3+ months; + denotes a censored value).
Danish: Medianvarighed var 8,0 måneder (interval: 18 dage til 8,3+ måneder; + angiver en censureret værdi).