FrancophonIA/ELRC3.0 huggingface dataset:
English: In Cohort 2, the co-primary efficacy endpoints were confirmed ORR as assessed by an IRF using RECIST v1.1 and investigator-assessed ORR according to Modified RECIST (mRECIST) criteria.
Danish: I kohorte 2 var de co-primære effekt-endepunkter bekræftet objektiv responsrate, vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1 og investigatorvurderet objektiv responsrate i overensstemmelse med mRECIST-kriterierne (Modificeret RECIST).
English: Hypophysitis
Danish: Hypofysitisk
English: Induction (Four or Six 21-day cycles)
Danish: Induktion (fire eller seks 21-dages cyklus)
English: Hrvatska Roche d.o.o.
Danish: Roche d.o.o.
English: Skin and subcutaneous tissue disorders Very Common rashw, pruritus rashw, pruritus
Danish: Hud og subkutane væv Meget almindelig Udslætw, pruritus
English: Treatment with insulin should be initiated for type 1 diabetes mellitus.
Danish: Ved type 1 diabetes mellitus initieres behandling med insulin.
English: Withhold Tecentriq
Danish: Om Tecentriq
English: Approximately three-quarters of patients had non-squamous histology (74%), 10% had known EGFR mutation, 0.2% had known ALK rearrangements, 10% had CNS metastases at baseline, and most patients were current or previous smokers (82%).
Danish: Ca. ¾ af patienterne havde ikke-planocellulær histologi (74%), 10% havde kendt EGFR-mutation, 0,2% havde kendte ALK-rearrangementer, 10% havde CNS-metastaser ved baseline, og de fleste patienter var aktive rygere eller tidligere rygere (82%).
English: z Includes reports of proteinuria, protein urine present, haemoglobinurea, nephrotic syndrome.
Danish: z Inkluderer indberetninger om proteinuri, protein i urinen, hæmoglobinuri, nefrotisk syndrom.
English: No. of deaths (%)
Danish: Antal dødsfald (%)
English: Uncommon hyperthyroidismh, diabetes mellitusi, adrenal insufficiencyj
Danish: Ikke almindelig Hyperthyroidismeh, diabetes mellitusi, binyrebarkinsufficiensj
English: Once the infusion is prepared it should be administered immediately (see section 6.3).
Danish: Infusionen anvendes straks efter fortynding (se pkt.
English: Only a few patients had severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2; n=8) (see section 4.2).
Danish: Kun få patienter havde svær nedsat nyrefunktion (estimeret glomerulær filtrationshastighed (eGFR) 15-29 ml/min/1,73 m2; n=8) (se pkt.
English: ORR was 15.3% vs. 14.7% and median DOR was 18.6 months vs. 7.2 months for atezolizumab vs. docetaxel, respectively.
Danish: Den objektive responsrate var 15,3% versus 14,7% og medianvarighed af respons var 18,6 versus 7,2 måneder for henholdsvis atezolizumab og docetaxel.
English: Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel, and carboplatin before initiating treatment (see section 4.8).
Danish: Risici ved brug af kombinationsbehandlingen med de 4 lægemidler atezolizumab, bevacizumab, paclitaxel og carboplatin, bør nøje overvejes af lægen før behandlingen påbegyndes (se pkt.
English: The median age was 64 years (range: 26 to 90 years) with 10% of patients ≥75 years of age.
Danish: Medianalderen var 64 år (interval: 26 til 90 år), og 10% af patienterne var ≥75 år.
English: The median time to onset was 7.7 months (range: 5.0 to 8.8 months).
Danish: Mediantid til hændelse var 7,7 måneder (interval: 5,0 til 8,8 måneder).
English: Atezolizumab should be permanently discontinued in patients with Grade 3 or 4 infusion-related reactions.
Danish: Atezolizumab bør seponeres permanent hos patienter med infusionsrelaterede reaktioner af grad 3 eller 4.
English: e Includes reports of white blood cell count decreased and leukopenia.
Danish: Inkluderer indberetninger om fald i antal hvide blodceller, leukopeni f
English: The most common adverse reactions (≥ 20%) were nausea (37.4%), fatigue (36.4%), neutropenia (33.7%), anaemia (33.2%), diarrhoea (29.5%), rash (28.5%), constipation (27.0%), peripheral neuropathy (26.8%), decreased appetite (24.6%), thrombocytopenia (21.2%) and cough (20.1%).
Danish: De mest almindelige bivirkninger (≥ 20%) var kvalme (37,4%), træthed (36,4%), neutropeni (33,7%), anæmi (33,2%), diarré (29,5%), udslæt (28,5%), forstoppelse (27,0%), perifer neuropati (26,8%), nedsat appetit (24,6%), trombocytopeni (21,2%) og hoste (20,1%).
English: • Keep this leaflet.
Danish: · Gem indlægssedlen.
English: • Keep the vial in the outer carton in order to protect from light.
Danish: · Opbevar hætteglasset i æsken for at beskytte mod lys.
English: A statistically significant improvement in OS was observed with atezolizumab in combination with carboplatin and etoposide compared to the control arm (HR of 0.70, 95% CI: 0.54, 0.91; median OS of 12.3 months vs. 10.3 months).
Danish: Der blev observeret en statistisk signifikant forbedring i samlet overlevelse ved behandling med atezolizumab i kombination med carboplatin og eptoposid sammenlignet med kontrolarmen (Hazardratio: 0,70, 95 % konfidensinterval: 0,54; 0,91; median samlet overlevelse var 12,3 måneder vs. 10,3 måneder).
English: Table 6: Summary of updated efficacy in the ITT population (IMpower150) Efficacy endpoint
Danish: Tabel 6: Opsummering af opdateret effekt i ITT-populationen (IMpower150) Effekt endepunkt
English: • Guide for healthcare professionals
Danish: · Uddannelsesmateriale for sundhedspersonalet · Patientkort
English: Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic, grey flip-off cap containing 14 mL of concentrate for solution for infusion.
Danish: Type I-hætteglas med butylgummiprop og aluminiumsforsegling med en grå flip-off plastikhætte, indeholdende 14 ml koncentrat til infusionsvæske,opløsning.
English: Randomisation was stratified by PD-L1 expression status on IC, by the number of prior chemotherapy regimens and by histology.
Danish: Randomiseringen blev stratificeret efter PD-L1-ekspressionsstatus i IC, efter antal tidligere kemoterapi-regimer samt histologi.
English: The median duration was 16.8 months (range: 0 day to 16.8 months).
Danish: Medianvarighed var 16,8 måneder (interval: 0 dage til 16,8 måneder).
English: Per the pre-specified hierarchical testing order, the IC2/3 population was tested first, with an OS HR of 0.87 (95% CI: 0.63, 1.21; median OS of 11.1 vs. 10.6 months for atezolizumab and chemotherapy respectively).
Danish: I den præspecificerede hierarkiske test-rækkefølge, blev IC2/3-populationen testet først med en samlet overlevelse hazardratio på 0,87 (95% konfidensinterval: 0,63; 1,21; median samlet overlevelse på 11,1 versus 10,6 måneder for henholdsvis atezolizumab og kemoterapi).
English: Hypothyroidism:
Danish: Hypothyroidisme:
English: Fourteen point seven percent of patients had liver metastases at baseline, and most patients were current or previous smokers (90%).
Danish: Ved baseline havde 14,7% af patienterne levermetastaser, og de fleste patienter var aktive eller tidligere rygere (90%).
English: Treatment with atezolizumab should be withheld for Grade 2 or 3 diarrhoea (increase of ≥ 4 stools/day over baseline) or colitis (symptomatic).
Danish: Behandling med atezolizumab skal afbrydes ved grad 2 eller 3 diarré (≥4 gange så mange afføringer/dag i forhold til baseline) eller colitis (symptomatisk).
English: No. of complete response (%)
Danish: Antal med komplet respons (%)
English: Two patients required the use of corticosteroids.
Danish: To patienter havde behov for kortikosteroidbehandling.
English: A phase II, multi-centre, international, two-cohort, single-arm clinical trial, IMvigor210, was conducted in patients with locally advanced or metastatic UC (also known as urothelial bladder cancer).
Danish: Der er gennemført et fase II, internationalt, enkeltarmet multicenterstudie med 2 kohorter (IMvigor210) med patienter med lokalt fremskredent eller metastatisk urotelialt carcinom (også kaldet blærekræft).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,200 mg/20 mL
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1200 mg/20 ml
English: Immune-related myositis
Danish: Immunrelateret myositis
English: Both patients required the use of corticosteroids.
Danish: Begge patienter havde behov for kortikosteroidbehandling.
English: Incudes reports of hypophysitis and temperature regulation disorder.
Danish: Inkluderer indberetninger om hypofysitis, forstyrrelser i temperaturreguleringen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 840 mg/14 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 840 mg/14 ml
English: In the population pharmacokinetic analysis, there were no clinically important differences in the clearance of atezolizumab between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 × to 1.5 × ULN and any AST, n= 71) and normal hepatic function (bilirubin and AST ≤
Danish: I den farmakokinetiske populationsanalyse fandtes ingen klinisk betydelige forskelle i clearance af atezolizumab hos patienter med let nedsat leverfunktion (bilirubin £øvre referencegrænse og ASAT >øvre referencegrænse eller bilirubin >1,0 til 1,5 gange øvre referencegrænse og enhver ASAT, n= 71) i forhold patienter med normal leverfunktion (bilirubin og ASAT £øvre referencegrænse, n= 401).
English: Figure 5: Kaplan-Meier Curve for Overall Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Danish: Figur 5: Kaplan-Meier-kurve for samlet overlevelse hos patienter med PD-L1-ekspression ≥ 1% (IMpassion130)
English: The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks.
Danish: Induktionsfasen efterfølges af en vedligeholdelsesfase uden kemoterapi, hvor 1.200 mg Tecentriq administreres som intravenøs infusion hver 3. uge.
English: Your healthcare professional will throw away any medicines that are no longer being used.
Danish: Sundhedspersonalet vil bortskaffe eventuelle medicinrester.
English: Treatment with atezolizumab should be permanently discontinued for Grade 4, or any grade of recurrent pancreatitis.
Danish: Behandling med atezolizumab bør afbrydes permanent ved grad 4 pancreatitis eller enhver grad af recidiverende pancreatitis.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,200 mg/20 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1200 mg/20 ml
English: • Information that atezolizumab can cause serious side effects during or after treatment, that need to be treated right away
Danish: Kort introduktion af atezolizumab (indikation og formålet med kortet) Information om, at atezolizumab kan forårsage alvorlige bivirkninger under og efter behandling, som skal behandles omgående
English: Includes reports of cytokine release syndrome, hypersensitivity, anaphylaxis.
Danish: Inkluderer indberetninger om cytokinfrigivelsessyndrom, hypersensitivitet, anafylaksi g
English: u Includes reports of autoimmune pancreatitis, pancreatitis, pancreatitis acute, lipase increased, amylase increased.
Danish: u Inkluderer indberetninger om autoimmun pankreatitis, pankreatitis, akut pankreatitis, forøget lipase, amylase.
English: Patients should be closely monitored for signs and symptoms that are suggestive of acute pancreatitis.
Danish: Patienterne bør monitoreres omhyggeligt for symptomer tydende på akut pancreatitis.
English: For symptomatic hyperthyroidism, atezolizumab should be withheld and an anti-thyroid medicinal product should be initiated as needed.
Danish: Ved symptomatisk hyperthyroidisme bør behandling med atezolizumab afbrydes og antityroide midler initieres efter behov.
English: In the population pharmacokinetic analysis, no clinically important differences in the clearance of atezolizumab were found in patients with mild (estimated glomerular filtration rate [eGFR] 60 to 89 mL/min/1.73 m2; n=208) or, moderate (eGFR 30 to 59 mL/min/1.73 m2; n=116) renal impairment compared to patients with normal (eGFR greater than or equal to 90 mL/min/1.73 m2; n=140) renal function.
Danish: I den farmakokinetiske populationsanalyse fandtes ingen klinisk betydelige forskelle i clearance af atezolizumab hos patienter med let (eGFR 60-89 ml/min/1,73 m2; n=208) eller moderat svær (eGFR 30-59 ml/min/1,73 m2; n=116) nedsat nyrefunktion i forhold til patienter med normal nyrefunktion (eGFR ≥ 90 ml/min/1,73 m2; n=140).
English: PD-L1 testing for patients with UC
Danish: PD-L1 test for patienter med urotelialt carcinom
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset i æsken for at beskytte mod lys.
English: Patients with previously untreated UC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).
Danish: Tidligere ubehandlede patienter med urotelialt carcinom, skal udvælges til behandling baseret på tumor ekspression af PD-L1, som skal bekræftes ved en valideret test (se pkt.
English: It is unknown whether atezolizumab is excreted in human milk.
Danish: Det vides ikke om atezolizumab udskilles i modermælk.
English: Patients should be monitored for signs and symptoms of myositis.
Danish: Patienter bør monitoreres for tegn og symptomer på myositis.
English: Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic aqua flip-off cap containing 20 mL of concentrate solution for infusion.
Danish: Type I-hætteglas med butylgummiprop og aluminiumsforsegling med en blå flip-off plastikhætte indeholdende 20 ml koncentrat til infusionsvæske, opløsning.
English: Table 5: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Danish: Tabel 5: Opsummering af effekt i den primære analysepopulation (alle grupper)* (OAK)
English: The PFS, ORR and DOR results from the primary analysis as well as the exploratory OS final analysis results are summarized in Table 12.
Danish: Resultaterne for progressionsfri overlevelse, objektiv responsrate og varighed af respons fra den primære analyse, samt resultaterne fra den endelige eksploratoriske analyse af samlet overlevelse er opsummeret i tabel 12.
English: The primary efficacy endpoint for Cohort 1 was confirmed objective response rate (ORR) as assessed by an independent review facility (IRF) using RECIST v1.1.
Danish: Det primære effekt-endepunkt for kohorte 1 var bekræftet objektiv responsrate vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1.
English: Rare: may affect up to 1 in 1,000 people • inflammation of the heart muscle
Danish: Sjælden: Kan påvirke op til 1 ud af 1000 patienter · hjertemuskelbetændelse · myasthenia gravis, en sygdom, der kan give muskelsvaghed · inflammation af hypofysen, som sidder i hjernen · nyrebetændelse
English: The median time to onset was 3.4 months (range 3 days to 24.8 months).
Danish: Mediantid til hændelse var 3,4 måneder (interval: 3 dage til 24,8 måneder).
English: 24.8 months).
Danish: 4.2 og 4.8).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 840 mg/14 mL
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 840 mg/14 ml
English: IMvigor130 (WO30070): Phase III multi-center, randomized, placebo-controlled study of atezolizumab as monotherapy and in combination with platinum-based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma
Danish: IMvigor 130 (WO30070): Randomiseret, placebo-kontrolleret, fase III multicenter-studie med atezolizumab som monoterapi og i kombination med platinholdig kemoterapi hos patienter med ubehandlet lokalt fremskredent eller metastatisk urotelialt carcinom
English: Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).
Danish: Tecentriq er i kombination med carboplatin og etoposid indiceret til førstelinjebehandling af voksne patienter med småcellet lungekræft i udvidet sygdomsstadie (se pkt.
English: The median time to onset was 4.9 months (range: 0 day to 31.3 months).
Danish: Mediantid til hændelse var 4,9 måneder (interval: 0 dage til 31,3 måneder).
English: Please also refer to the full prescribing information for the combination products (see also section 5.1).
Danish: Se også produktresuméet for kombinationsprodukterne (se pkt.
English: PFS, ORR and DOR results of IMpassion130 for patients with PD-L1 expression ≥ 1% at the time of the final analysis for PFS with a median survival follow up of 13 months are summarized in Table 6 with Kaplan-Meier curves for PFS in Figure 4.
Danish: Resultater fra IMpassion130, målt ved den endelige analyse for progresisonsfri overlevelse, objektiv responsrate og varighed af respons hos patienter med PD-L1-ekspression ≥ 1% med en median overlevelsesopfølgning på 13 måneder er vist i tabel 6 og Kaplan-Meier-kurven for progressionsfri overlevelse er vist i figur 4.
English: After dilution, one mL of solution should contain approximately 4.4 mg of Tecentriq (1,200 mg/270 mL).
Danish: Efter fortynding, vil 1 ml opløsning indeholde ca. 4,4 mg Tecentriq (1200 mg/270 ml).
English: The median age was 67 years (range: 31 to 88), and 77.1% of patients were male.
Danish: Medianalder var 67 år (interval: 31 til 88), og 77,1% af patienterne var mænd.
English: Patients with Grade 1 or 2 infusion-related reactions may continue to receive atezolizumab with close monitoring; premedication with antipyretic and antihistamines may be considered.
Danish: Patienter med infusionsrelaterede reaktioner af grad 1 eller 2 kan fortsætte behandling med atezolizumab under tæt overvågning.
English: Initiation of systemic corticosteroids (at a dose of 1 to 2 mg/kg/day of prednisone or equivalent) should be considered.
Danish: Igangsættelse af systemisk kortikosteroid (i doser på 1 til 2 mg/kg/dag prednison eller ækvivalent produkt) bør overvejes.
English: The rate of complete response per IRF-RECIST v1.1 in the all comer population was 6.1% (95% CI: 3.7, 9.4).
Danish: Forekomst af fuldstændigt respons, vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1, var 6,1% (95% konfidensinterval: 3,7; 9,4) i ITT-populationen.
English: The effect of moderate or severe hepatic impairment (bilirubin > 1.5 × to 3 × ULN and any AST or bilirubin > 3 × ULN and any AST) on the pharmacokinetics of atezolizumab is unknown.
Danish: Det vides ikke om moderat eller svært nedsat leverfunktion (bilirubin >1,5 til 3 gange øvre referencegrænse, enhver ændring i ASAT eller bilirubin >3 gange øvre referencegrænse samt enhver ændring i ASAT) påvirker atezolizumabs farmakokinetik.
English: The median time to onset was 13.1 months (range: 9.0 to 17.5 months).
Danish: Mediantid til hændelse var 13,1 måneder (interval: 9,0 til 17,5 måneder).
English: Infections and infestations Very common urinary tract infectiona lung infectionb
Danish: Infektioner og parasitære sygdomme Meget almindelig Urinvejsinfektiona
English: At the time of the final analysis for PFS, patients had a median follow up time of 15.3 months.
Danish: Ved den endelige analyse af progressionsfri overlevelse havde patienterne en median opfølgningstid på 15,3 måneder.
English: Immune-related adverse reactions with atezolizumab may occur after the last dose of atezolizumab.
Danish: Der kan opstå immunrelaterede bivirkninger med atezolizumab efter sidste dosis er givet.
English: d Includes reports of neutropenia, neutrophil count decreased, febrile neutropenia, neutropenic sepsis, granulocytopenia.
Danish: d Inkluderer indberetninger om neuropati, fald i neutrofiler, febril neutropeni, neutropenisk sepsis, granulocytopeni.
English: Patients should be monitored for clinical signs and symptoms of meningitis or encephalitis.
Danish: Patienterne bør monitoreres for kliniske symptomer på meningitis og encefalitis.
English: The median time to onset was 3.6 months (range 3 days to 9.9 months).
Danish: Mediantid til hændelse var 3,6 måneder (interval: 3 dage til 9,9 måneder).
English: For TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity (see section 5.1).
Danish: For triplenegativ brystkræft anbefales det, at patienterne behandles med Tecentriq indtil sygdomsprogression eller indtil der opstår toksicitet, der ikke kan behandles (se pkt.
English: Table 10: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Danish: Tabel 10: Opsummering af effekt i den primære analysepopulation (alle grupper)* (OAK)
English: Figure 4: Kaplan-Meier Curve for Progression Free Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Danish: Figur 4: Kaplan-Meier-kurve for progressionsfri overvelse hos patienter med PD-L1-ekspression ≥ 1% (IMpassion130)
English: IMvigor210 (GO29293): Single-arm trial in previously untreated urothelial carcinoma patients who are ineligible for cisplatin therapy and in urothelial carcinoma patients previously treated with chemotherapy
Danish: IMvigor210 (GO29293): Enkeltarmet studie med patienter med tidligere ubehandlet urotelialt carcinom, hvor behandling med cisplatin ikke er egnet samt med urotelialt carcinom-patienter tidligere behandlet med kemoterapi
English: Figure 1: Kaplan-Meier curve for overall survival (IMvigor211)
Danish: Figur 1: Kaplan-Meier-kurve for samlet overlevelse (IMvigor211)
English: y Includes reports of myositis, rhabdomyolysis, polymyalgia rheumatica, dermatomyositis, muscle abscess, myoglobin urine present.
Danish: y Inkluderer indberetninger om myositis, rabdomyolyse, polymyalgia rheumatica, dermatomyositis, muskelbyld, myoglobin i urinen.
English: Prior to launch of Tecentriq in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media,
Danish: Indehaveren af markedsføringstilladelse skal aftale med de nationale myndigheder om indholdet og formatet af uddannelsesmaterialet, herunder kommunikationsmedier, distributionsmetoder og alle andre aspekter for materialet, før lancering af Tecentriq i hvert medlemsland.
English: (25.5%), nausea (23.5%), cough (20.8%), dyspnoea (20.5%), pyrexia (20.1%), diarrhoea (19.7%), rash (19.5%), back pain (15.3%), vomiting (15.0%), asthenia (14.5%), arthralgia (13.9%), musculoskeletal pain (13.0%), pruritus (12.6%) and urinary tract infection (11.6%).
Danish: De mest almindelige bivirkninger (>10%) var træthed (35,9%), nedsat appetit (25,5%), kvalme (23,5%), hoste (20,8%), dyspnø (20,5%), pyreksi (20,1%), diarré (19,7%), udslæt (19,5%), rygsmerter (15,3%), opkastning (15,0%), asteni (14,5%), arthralgi (13,9%), smerter i bevægeapparatet (13,0%), pruritus (12,6%) og urinvejsinfektion (11,6%).
English: However, patients with EGFR mutations did not show improved OS with atezolizumab compared to docetaxel (HR of 1.24, 95% CI: 0.71, 2.18; median OS of 10.5 vs. 16.2 months for atezolizumab and docetaxel, respectively).
Danish: Patienter med EGFR-mutationer havde dog ikke forbedret samlet overlevelse med atezolizumab sammenlignet med docetaxel (hazardratio 1,24; 95% konfidensinterval: 0,71; 2,18; median samlet overlevelse på 10,5 versus 16,2 måneder for henholdsvis atezolizumab og docetaxel).
English: Guillain-Barré syndrome and demyelinating polyneuropathy occurred in 0.2% (5/3,178) of patients who received atezolizumab monotherapy.
Danish: Guillain-Barré-syndrom og demyeliserende polyneuropati sås hos 0,2% (5/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
English: No formal pharmacokinetic drug interaction studies have been conducted with atezolizumab.
Danish: Der er ikke gennemført formelle interaktionsstudier med atezolizumab.
English: Chemotherapy (n = 464)
Danish: Kemoterapi (n=464)
English: There were 310 patients treated with atezolizumab 1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit.
Danish: 310 patienter blev behandlet med atezolizumab 1200 mg ved intravenøs infusion hver 3. uge og indtil der ikke længere var klinisk effekt.
English: Treatment with atezolizumab may be resumed when symptoms are controlled and thyroid function is improving.
Danish: Behandling med atezolizumab kan genoptages, når symptomerne er under kontrol og thyroideafunktionen i bedring.