natgillin/translations-raw huggingface dataset:
I alt deltog 902 patienter, som blev stratificeret efter forekomsten af levermetastaser, tidligere taxanbehandling og status for PD-L1-ekspression i tumorinfiltrerede immunceller (IC) (PD-L1 farvede tumorinfiltrerede immunceller [IC] <1% af tumorarealet vs. ≥ 1% af the tumorarealet) vurderet ved 
A total of 902 patients were enrolled and stratified by presence of liver metastases, prior taxane treatment, and by PD-L1 expression status in tumour-infiltrating immune cells (IC) (PD-L1 stained tumour-infiltrating immune cells [IC] <1% of tumour area vs. ≥ 1% of the tumour area) assessed by the VENTANA PD-L1 (SP142) Assay.
Tabel 11: Intravenøse behandlingsregimer (IMpower133) Behandlingsregime 
Table 11: Intravenous treatment regimens (IMpower133) Treatment regimen
Hos patienter med EGFR mutation eller ALK-positiv ikke-småcellet lungekræft, er behandling med Tecentriq i kombination med bevacizumab, paclitaxel og carboplatin kun indiceret efter behandlingssvigt med relevante targeterede lægemidler (se pkt. 
In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section
ADMINISTRATIONSMETODE Til intravenøst brug efter fortynding 
METHOD OF ADMINISTRATION For intravenous use after dilution.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1220/001 
EU/1/17/1220/001
I studie IMpower150 blev en alder på ≥ 65 år forbundet med øget risiko for udvikling af bivirkninger hos patienter, der fik atezolizumab i kombination med bevacizumab, carboplatin og paclitaxel. 
In study IMpower150, age ≥ 65 was associated with an increased risk of developing adverse events in patients receiving atezolizumab in combination with bevacizumab, carboplatin and paclitaxel.
Anbefalet dosis af Tecentriq er 1200 mg administreret intravenøst hver tredje uge. 
The recommended dose of Tecentriq is 1,200 mg administered intravenously every three weeks.
95% konfidensinterval 
95% CI
For at behandle småcellet lungekræft i udvidet sygdomsstadie vil du få Tecentriq sammen med carboplatin og etoposid. 
To treat extensive-stage SCLC, Tecentriq will be given to you in combination with carboplatin and etoposide.
Ved symptomatisk hypothyroidisme bør behandling med atezolizumab afbrydes og thyroideahormonsubstitutionsbehandling initieres efter behov. 
For symptomatic hypothyroidism, atezolizumab should be withheld and thyroid hormone replacement should be initiated as needed.
Patienterne blev behandlet indtil investigator vurderede, at der ikke længere var klinisk gavn af behandlingen eller uacceptabel toksicitet. 
Patients were treated until loss of clinical benefit as assessed by the investigator or unacceptable toxicity.
Immunrelateret pancreatitis 
Immune-related pancreatitis
Ved ≥grad 3 hyperglykæmi (fastende glucose >250 mg/dl eller 13,9 mmol/l) afbrydes behandling med atezolizumab. 
For ≥ Grade 3 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L), atezolizumab should be withheld.
Behandlingen kan genoptages, når symptomerne er under kontrol med thyroidsubstitutionsbehandling og TSH-niveauerne falder. 
Treatment may be resumed when symptoms are controlled by thyroid replacement therapy and TSH levels are decreasing
Guillain-Barré-syndrom indebar seponering af atezolizumab hos 1 patient (<0,1%). 
Guillain-Barré syndrome led to discontinuation of atezolizumab in 1 patient (< 0.1%).
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). 
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.
Hypofysitisk 
Hypophysitis
Induktion (fire eller seks 21-dages cyklus) 
Induction (Four or Six 21-day cycles)
Hud og subkutane væv Meget almindelig Udslætw, pruritus 
Skin and subcutaneous tissue disorders Very Common rashw, pruritus rashw, pruritus
Ved type 1 diabetes mellitus initieres behandling med insulin. 
Treatment with insulin should be initiated for type 1 diabetes mellitus.
Om Tecentriq 
Withhold Tecentriq
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%). 
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%).
z Inkluderer indberetninger om proteinuri, protein i urinen, hæmoglobinuri, nefrotisk syndrom. 
z Includes reports of proteinuria, protein urine present, haemoglobinurea, nephrotic syndrome.
Antal dødsfald (%) 
No. of deaths (%)
Ikke almindelig Hyperthyroidismeh, diabetes mellitusi, binyrebarkinsufficiensj 
Uncommon hyperthyroidismh, diabetes mellitusi, adrenal insufficiencyj
Infusionen anvendes straks efter fortynding (se pkt. 
Once the infusion is prepared it should be administered immediately (see section 6.3).
Kun få patienter havde svær nedsat nyrefunktion (estimeret glomerulær filtrationshastighed (eGFR) 15-29 ml/min/1,73 m2; n=8) (se pkt. 
Only a few patients had severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2; n=8) (see section 4.2).
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. 
ORR was 15.3% vs. 14.7% and median DOR was 18.6 months vs. 7.2 months for atezolizumab vs. docetaxel, respectively.
Risici ved brug af kombinationsbehandlingen med de 4 lægemidler atezolizumab, bevacizumab, paclitaxel og carboplatin, bør nøje overvejes af lægen før behandlingen påbegyndes (se pkt. 
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).
Medianalderen var 64 år (interval: 26 til 90 år), og 10% af patienterne var ≥75 år. 
The median age was 64 years (range: 26 to 90 years) with 10% of patients ≥75 years of age.
Mediantid til hændelse var 7,7 måneder (interval: 5,0 til 8,8 måneder). 
The median time to onset was 7.7 months (range: 5.0 to 8.8 months).
Atezolizumab bør seponeres permanent hos patienter med infusionsrelaterede reaktioner af grad 3 eller 4. 
Atezolizumab should be permanently discontinued in patients with Grade 3 or 4 infusion-related reactions.
Inkluderer indberetninger om fald i antal hvide blodceller, leukopeni f 
e Includes reports of white blood cell count decreased and leukopenia.
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%). 
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%).
· Gem indlægssedlen. 
• Keep this leaflet.
· Opbevar hætteglasset i æsken for at beskytte mod lys. 
• Keep the vial in the outer carton in order to protect from light.
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). 
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).
Tabel 6: Opsummering af opdateret effekt i ITT-populationen (IMpower150) Effekt endepunkt 
Table 6: Summary of updated efficacy in the ITT population (IMpower150) Efficacy endpoint
· Uddannelsesmateriale for sundhedspersonalet · Patientkort 
• Guide for healthcare professionals
Type I-hætteglas med butylgummiprop og aluminiumsforsegling med en grå flip-off plastikhætte, indeholdende 14 ml koncentrat til infusionsvæske,opløsning. 
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.
Randomiseringen blev stratificeret efter PD-L1-ekspressionsstatus i IC, efter antal tidligere kemoterapi-regimer samt histologi. 
Randomisation was stratified by PD-L1 expression status on IC, by the number of prior chemotherapy regimens and by histology.
Medianvarighed var 16,8 måneder (interval: 0 dage til 16,8 måneder). 
The median duration was 16.8 months (range: 0 day to 16.8 months).
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). 
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).
Hypothyroidisme: 
Hypothyroidism:
Ved baseline havde 14,7% af patienterne levermetastaser, og de fleste patienter var aktive eller tidligere rygere (90%). 
Fourteen point seven percent of patients had liver metastases at baseline, and most patients were current or previous smokers (90%).
Behandling med atezolizumab skal afbrydes ved grad 2 eller 3 diarré (≥4 gange så mange afføringer/dag i forhold til baseline) eller colitis (symptomatisk). 
Treatment with atezolizumab should be withheld for Grade 2 or 3 diarrhoea (increase of ≥ 4 stools/day over baseline) or colitis (symptomatic).
Antal med komplet respons (%) 
No. of complete response (%)
To patienter havde behov for kortikosteroidbehandling. 
Two patients required the use of corticosteroids.
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). 
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).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1200 mg/20 ml 
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,200 mg/20 mL
Immunrelateret myositis 
Immune-related myositis
Begge patienter havde behov for kortikosteroidbehandling. 
Both patients required the use of corticosteroids.
Inkluderer indberetninger om hypofysitis, forstyrrelser i temperaturreguleringen. 
Incudes reports of hypophysitis and temperature regulation disorder.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 840 mg/14 ml 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 840 mg/14 mL
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). 
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 ≤
Figur 5: Kaplan-Meier-kurve for samlet overlevelse hos patienter med PD-L1-ekspression ≥ 1% (IMpassion130) 
Figure 5: Kaplan-Meier Curve for Overall Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Induktionsfasen efterfølges af en vedligeholdelsesfase uden kemoterapi, hvor 1.200 mg Tecentriq administreres som intravenøs infusion hver 3. uge. 
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.
Sundhedspersonalet vil bortskaffe eventuelle medicinrester. 
Your healthcare professional will throw away any medicines that are no longer being used.
Behandling med atezolizumab bør afbrydes permanent ved grad 4 pancreatitis eller enhver grad af recidiverende pancreatitis. 
Treatment with atezolizumab should be permanently discontinued for Grade 4, or any grade of recurrent pancreatitis.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1200 mg/20 ml 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,200 mg/20 mL
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 
• Information that atezolizumab can cause serious side effects during or after treatment, that need to be treated right away
Inkluderer indberetninger om cytokinfrigivelsessyndrom, hypersensitivitet, anafylaksi g 
Includes reports of cytokine release syndrome, hypersensitivity, anaphylaxis.
u Inkluderer indberetninger om autoimmun pankreatitis, pankreatitis, akut pankreatitis, forøget lipase, amylase. 
u Includes reports of autoimmune pancreatitis, pancreatitis, pancreatitis acute, lipase increased, amylase increased.
Patienterne bør monitoreres omhyggeligt for symptomer tydende på akut pancreatitis. 
Patients should be closely monitored for signs and symptoms that are suggestive of acute pancreatitis.
Ved symptomatisk hyperthyroidisme bør behandling med atezolizumab afbrydes og antityroide midler initieres efter behov. 
For symptomatic hyperthyroidism, atezolizumab should be withheld and an anti-thyroid medicinal product should be initiated as needed.
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). 
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.
PD-L1 test for patienter med urotelialt carcinom 
PD-L1 testing for patients with UC
Opbevar hætteglasset i æsken for at beskytte mod lys. 
Keep the vial in the outer carton in order to protect from light.
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. 
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).
Det vides ikke om atezolizumab udskilles i modermælk. 
It is unknown whether atezolizumab is excreted in human milk.
Patienter bør monitoreres for tegn og symptomer på myositis. 
Patients should be monitored for signs and symptoms of myositis.
Type I-hætteglas med butylgummiprop og aluminiumsforsegling med en blå flip-off plastikhætte indeholdende 20 ml koncentrat til infusionsvæske, opløsning. 
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.
Tabel 5: Opsummering af effekt i den primære analysepopulation (alle grupper)* (OAK) 
Table 5: Summary of efficacy in the primary analysis population (all comers)* (OAK)
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. 
The PFS, ORR and DOR results from the primary analysis as well as the exploratory OS final analysis results are summarized in Table 12.
Det primære effekt-endepunkt for kohorte 1 var bekræftet objektiv responsrate vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECIST v1.1. 
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.
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 
Rare: may affect up to 1 in 1,000 people • inflammation of the heart muscle
Mediantid til hændelse var 3,4 måneder (interval: 3 dage til 24,8 måneder). 
The median time to onset was 3.4 months (range 3 days to 24.8 months).
4.2 og 4.8). 
24.8 months).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 840 mg/14 ml 
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 840 mg/14 mL
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 
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
Tecentriq er i kombination med carboplatin og etoposid indiceret til førstelinjebehandling af voksne patienter med småcellet lungekræft i udvidet sygdomsstadie (se pkt. 
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).
Mediantid til hændelse var 4,9 måneder (interval: 0 dage til 31,3 måneder). 
The median time to onset was 4.9 months (range: 0 day to 31.3 months).
Se også produktresuméet for kombinationsprodukterne (se pkt. 
Please also refer to the full prescribing information for the combination products (see also section 5.1).
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. 
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.
Efter fortynding, vil 1 ml opløsning indeholde ca. 4,4 mg Tecentriq (1200 mg/270 ml). 
After dilution, one mL of solution should contain approximately 4.4 mg of Tecentriq (1,200 mg/270 mL).
Medianalder var 67 år (interval: 31 til 88), og 77,1% af patienterne var mænd. 
The median age was 67 years (range: 31 to 88), and 77.1% of patients were male.
Patienter med infusionsrelaterede reaktioner af grad 1 eller 2 kan fortsætte behandling med atezolizumab under tæt overvågning. 
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.
Igangsættelse af systemisk kortikosteroid (i doser på 1 til 2 mg/kg/dag prednison eller ækvivalent produkt) bør overvejes. 
Initiation of systemic corticosteroids (at a dose of 1 to 2 mg/kg/day of prednisone or equivalent) should be considered.
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. 
The rate of complete response per IRF-RECIST v1.1 in the all comer population was 6.1% (95% CI: 3.7, 9.4).
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. 
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.
Mediantid til hændelse var 13,1 måneder (interval: 9,0 til 17,5 måneder). 
The median time to onset was 13.1 months (range: 9.0 to 17.5 months).
Infektioner og parasitære sygdomme Meget almindelig Urinvejsinfektiona 
Infections and infestations Very common urinary tract infectiona lung infectionb
Ved den endelige analyse af progressionsfri overlevelse havde patienterne en median opfølgningstid på 15,3 måneder. 
At the time of the final analysis for PFS, patients had a median follow up time of 15.3 months.
Der kan opstå immunrelaterede bivirkninger med atezolizumab efter sidste dosis er givet. 
Immune-related adverse reactions with atezolizumab may occur after the last dose of atezolizumab.
d Inkluderer indberetninger om neuropati, fald i neutrofiler, febril neutropeni, neutropenisk sepsis, granulocytopeni. 
d Includes reports of neutropenia, neutrophil count decreased, febrile neutropenia, neutropenic sepsis, granulocytopenia.
Patienterne bør monitoreres for kliniske symptomer på meningitis og encefalitis. 
Patients should be monitored for clinical signs and symptoms of meningitis or encephalitis.
Mediantid til hændelse var 3,6 måneder (interval: 3 dage til 9,9 måneder). 
The median time to onset was 3.6 months (range 3 days to 9.9 months).
For triplenegativ brystkræft anbefales det, at patienterne behandles med Tecentriq indtil sygdomsprogression eller indtil der opstår toksicitet, der ikke kan behandles (se pkt. 
For TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity (see section 5.1).
Tabel 10: Opsummering af effekt i den primære analysepopulation (alle grupper)* (OAK) 
Table 10: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Figur 4: Kaplan-Meier-kurve for progressionsfri overvelse hos patienter med PD-L1-ekspression ≥ 1% (IMpassion130) 
Figure 4: Kaplan-Meier Curve for Progression Free Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
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 
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
Figur 1: Kaplan-Meier-kurve for samlet overlevelse (IMvigor211) 
Figure 1: Kaplan-Meier curve for overall survival (IMvigor211)
y Inkluderer indberetninger om myositis, rabdomyolyse, polymyalgia rheumatica, dermatomyositis, muskelbyld, myoglobin i urinen. 
y Includes reports of myositis, rhabdomyolysis, polymyalgia rheumatica, dermatomyositis, muscle abscess, myoglobin urine present.
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. 
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,