natgillin/translations-raw huggingface dataset:
Nøgleresultaterne er vist i tabel 9, og Kaplan-Meier-kurver for samlet overlevelse og progressionsfri overlevelse er vist i henholdsvis figur 6 og 8. 
The key results are summarised in Table 9 and Kaplan-Meier curves for OS and PFS are presented in Figures 6 and 8, respectively.
Patienterne havde en median overlevelsesopfølgningstid på 18,6 måneder, og der sås forbedret samlet overlevelse og progressionsfri overlevelse med atezolizumab, nab-paclitaxel og carboplatin sammenlignet med kontrolarmen. 
Patients had a median survival follow up time of 18.6 months and showed improved OS and PFS with atezolizumab, nab-paclitaxel and carboplatin as compared to the control.
Inkluderer indberetninger om diarré, defækationstrang, hyppig afføring, gastrointestinal hypermotilitet. 
Includes reports of diarrhoea, defaecation urgency, frequent bowel movements, gastrointestinal hypermotility.
Bivirkninger er angivet efter MedDRAs systemorganklasse (SOC) og hyppighed i tabel 2 for atezolizumab som enkeltstofbehandling eller kombinationsbehandling. 
The Adverse Drug Reactions (ADRs) are listed by MedDRA system organ class (SOC) and categories of frequency in Table 2 for atezolizumab given as monotherapy or as combination therapy.
Patienter blev randomiseret til at få atezolizumab 840 mg eller placebo administreret ved intravenøs infusion på dag 1 og 15 for hver serie af 28 dage, samt nab-paclitaxel (100 mg/m2) administreret ved intravenøs infusion på dag 1, 8 og 15 for hver serie af 28 dage. 
Patients were randomised to receive atezolizumab 840 mg or placebo by intravenous infusions on days 1 and 15 of every 28-day cycle, plus nab-paclitaxel (100 mg/m2) administered via intravenous infusion on days 1, 8 and 15 of every 28-day cycle.
Beskrivelse af symptomer af immunrelaterede bivirkninger. 
Description of the signs and symptoms of immune-related adverse reactions.
ǂStratificeret efter kemoterapi (vinflunin vs. taxan), IC-status (<5% vs. ≥5%), antal prognostiske risikofaktorer (0 vs. 1-3) og levermetastaser (ja vs. nej). 
ǂ Stratified by chemotherapy (vinflunine vs. taxane), status on IC (< 5% vs. ≥ 5%), number of prognostic risk factors (0 vs. 1-3), and liver metastases (yes vs. no).
* Endelig eksploratorisk analyse af samlet overlevelse ved klinisk cut-off den 24. januar 2019 ** Analyse af progressionsfri overlevelse, objektiv responsrate og varighed af respons ved klinisk cut-off den 24. april 2018 *** Kun til beskrivende formål ^ Konfirmeret objektiv responsrate og varighed af respons er eksploratoriske endepunkter 
* Exploratory OS final analysis at clinical cut-off 24 January 2019 ** PFS, ORR and DOR analyses at clinical cut-off 24 April 2018 *** For descriptive purposes only ^ Confirmed ORR and DoR are exploratory endpoints
Infusionsrelateret reaktionf Det endokrine system Meget almindelig 
Immune system disorders Common infusion-related reactionf Endocrine disorders Very common hypothyroidismg
Til orientering; i ITT-populationen, blev sammenligninger mellem arm B and arm C og ligeledes mellem arm A og arm C endnu ikke formelt testet i overensstemmelse med det præ-specificerede analysehierarki Overordnet bedste respons for fuldstændigt respons and delvist respons ‡ Stratificeret efter køn, tilstedeværelsen af levermetastaser, og PD-L1-ekspression på TC og IC 
Based on the stratified log-rank test For informational purposes; in the ITT population, comparisons between Arm B and Arm C as well as between Arm A and Arm C were not formally tested yet as per the pre-specified analysis hierarchy Overall best response for complete response and partial response ‡ Stratified by sex, presence of liver metastases and PD-L1 tumour expression on TC and IC
Myasthenisyndrom/myasthenia gravis, Guillain-Barré syndrome og meningoencefalitis 
Myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome and Meningoencephalitis
Patienterne, der fik behandlingsregime B, fik mulighed for at skifte over til atezolizumab enkeltstofbehandling efter sygdomsprogression. 
Patients receiving treatment regimen B were able to crossover and receive atezolizumab monotherapy following disease progression.
Der er gennemført en opdateret analyse med en median varighed af overlevelsesopfølgning på 17,2 måneder for kohorte 1. 
An updated analysis was performed with a median duration of survival follow-up of 17.2 months for Cohort 1 and is summarised in Table 4.
Tecentriq er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion (se pkt. 
Tecentriq has not been studied in patients with moderate or severe hepatic impairment (see section 5.2).
Kohorte 1 omfattede 45 patienter (38%) med en ECOG-performancestatus på 0, 50 patienter (42%) med en ECOG-performancestatus på 1 og 24 patienter (20%) med en ECOG-performancestatus på 2, 35 patienter (29%) uden Bajorin-risikofaktorer (ECOG-performancestatus ≥2 og viskerale metastaser), 66 patienter (56%) med 1 Bajorin-risikofaktor og 18 patienter (15%) med 2 Bajorin-risikofaktorer, 84 patienter (71%) med nedsat nyrefunktion (glomerulær filtrationshastighed [GFR] <60 ml/min) og 25 patienter (21%) med levermetastaser. 
Cohort 1 included 45 patients (38%) with ECOG performance status of 0, 50 patients (42%) with ECOG performance status of 1 and 24 patients (20%) with ECOG performance status of 2, 35 patients (29%) with no Bajorin risk factors (ECOG performance status ≥ 2 and visceral metastasis), 66 patients (56%) with one Bajorin risk factor and 18 patients (15 %) with two Bajorin risk factors, 84 patients (71%) with impaired renal function (glomerular filtration rate [GFR] < 60 mL/min), and 25 patients (21%) with liver metastasis.
Tecentriq må ikke administreres sammen med andre lægemidler i samme infusionsslange. 
Do not co-administer other medicinal products through the same infusion line.
Der er ikke set uforligelighed mellem Tecentriq og infusionsposer med kontaktoverflader af polyvinylchlorid (PVC), polyolefin (PO), polyethylen (PE) eller polypropylen (PP). 
No incompatibilities have been observed between Tecentriq and intravenous bags with product-contacting surfaces of polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP).
(National Cancer Institute Common Terminology Criteria for Adverse Event Version 4.0) 
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Event Version 4.0 (NCI-CTCAE v.4.
Kvalme, diarré, stomatitis, træthed, pyreksi, slimhindebetændelse, nedsat appetit, vægttab, hypertension og proteinuri blev rapporteret hyppigere (³5% forskel) hos patienter der fik atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin. 
Nausea, diarrhoea, stomatitis, fatigue, pyrexia, mucosal inflammation, decreased appetite, weight decreased, hypertension and proteinuria were reported higher (≥5% difference) in patients receiving atezolizumab in combination with bevacizumab,
Detaljeret information om de signifikante bivirkninger for atezolizumab i kombinationsbehandling er angivet hvis kliniske relevante forskelle er noteret sammenlignet med atezolizumab enkeltstofbehandling. 
Details for the significant adverse reactions for atezolizumab when given in combination are presented if clinically relevant differences were noted in comparison to atezolizumab monotherapy.
I en eksploratorisk analyse med længere opfølgningstid (median: 24,1 måned), var median samlet overlevelse for begge behandlingsarme uændret i forhold til den primære analyse med hazardratio: 0,82 (95% konfidensinterval: 0,67; 1,01). 
In an exploratory analysis with longer follow up (median: 24.1 months), the median OS for both arms was unchanged relative to the primary analysis, with HR = 0.82 (95% CI: 0.67, 1.01).
For at blande opløsningen, vendes posen forsigtigt for at undgå skumdannelse. 
The bag should be gently inverted to mix the solution in order to avoid foaming.
Influenzalignende sygdom, kulderystelser a 
Common influenza like illness, chills a
Brug af atezolizumab til urotelialt carcinom hos tidligere ubehandlede patienter, hvor behandling med cisplatin ikke vurderes at være velegnet 
Use of atezolizumab in urothelial carcinoma for previously untreated patients who are considered cisplatin ineligible
Tabel 3: Opsummering af effekt hos alle grupper (IMvigor211) 
Table 3: Summary of efficacy in all comers (IMvigor211)
En populationsanalyse af 472 patienter beskriver atezolizumabs farmakokinetik for dosisintervallet: 1 til 20 mg/kg med en lineær 2-kompartment dispositionsmodel med førsteordenselimination. 
472 patients described atezolizumab pharmacokinetics for the dose range: 1 to 20 mg/kg with a linear two-compartment disposition model with first-order elimination.
Det sekundære effekt-endepunkt inkluderede objektiv responsrate og varighed af respons per RECIST v1.1. 
Secondary efficacy endpoints included objective response rate (ORR) and duration of response (DOR) per RECIST v1.1.
Størstedelen af patienterne var mænd (59%) og hvide (90%). 
The majority of the patients were male (59%) and white (90%).
Table 12: Opsummering af effekt (IMpower133) Vigtigste Effekt-endepunkter 
Table 12: Summary of efficacy (IMpower133) Key efficacy endpoints
Atezolizumab kombinationsbehandling 
Atezolizumab in combination therapy
Programmeret celledød-ligand 1 (PD-L1) kan være udtrykt på tumorceller (TC) og/eller tumorinfiltrerende immunceller (IC) og kan bidrage til hæmningen af antitumor-immunresponset i tumormikromiljøet. 
Programmed death-ligand 1 (PD-L1) may be expressed on tumour cells and/or tumour-infiltrating immune cells, and can contribute to the inhibition of the antitumour immune response in the tumour microenvironment.
Patienter med følgende tilstande kunne ikke inkluderes i kliniske studier: autoimmun sygdom i anamnesen, tidligere tilfælde af pneumonitis, aktive hjernemetastaser, HIV, hepatitis B eller C, signifikant hjertekar sygdom og patienter med utiltrækkelig hæmatologisk funktion og utilstrækkelig funktion af endeorgan. 
Patients with the following conditions were excluded from clinical trials: a history of autoimmune disease, history of pneumonitis, active brain metastasis, HIV, hepatitis B or hepatitis C infection, significant cardiovascular disease and patients with inadequate hematologic and end-organ function.
Nedenstående data afspejler information om signifikante bivirkninger for atezolizumab enkelstofbehandling i kliniske studier (se pkt. 
The data below reflect information for significant adverse reactions for atezolizumab as monotherapy in clinical studies (see section 5.1).
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med atezolizumab i alle subgrupper af den pædiatriske population til behandling af maligne neoplasier (bortset fra tumorer i centralnervesystemet samt neoplasier i hæmatopoietisk og lymfoidt væv) (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with atezolizumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use).
Der er ikke gennemført mutagenicitetsstudier med henblik på at vurdere atezolizumabs mutagene potentiale. 
Mutagenicity studies have not been performed to establish the mutagenic potential of atezolizumab.
Hos 2 ud af de 62 patienter var bivirkningen dødelig. 
Of the 62 patients, two experienced a fatal event.
Der er ikke gennemført fertilitetsstudier med atezolizumab; dog har studiet vedrørende kronisk toksicitet omfattet en vurdering af han- og huncynomolgusabers reproduktive organer. 
No fertility studies have been conducted with atezolizumab; however assessment of the cynomolgus monkey male and female reproductive organs was included in the chronic toxicity study.
Brug af atezolizumab i kombination med nab-paclitaxel ved metastatisk triple-negativ brystkræft 
Use of atezolizumab in combination with nab-paclitaxel in metastatic triple negative breast cancer
Patienterne bør monitoreres for symptomer på motoriske og sensoriske neuropatier. 
Patients should be monitored for symptoms of motor and sensory neuropathy.
Patienterne randomiseredes (1:1) til atezolizumab eller docetaxel. 
Patients were randomised (1:1) to receive either atezolizumab or docetaxel.
Det er endnu ikke muligt at beregne den samlede overlevelse med en hændelsesfrekvens på ca. 40%. 
OS was not mature with an event patient ratio of approximately 40%.
Asymptomatiske patienter med unormale thyroideaværdier kan behandles med atezolizumab. 
Asymptomatic patients with abnormal thyroid function tests can receive atezolizumab.
Grad 3 eller 4 stigninger i serumamylase- eller lipaseniveauer (>2 gange øvre referencegrænse) eller grad 2 eller 3 pancreatitis 
Grade 3 or 4 serum amylase or lipase levels increased (> 2 x ULN) or Grade 2 or 3 pancreatitis
^ Arm C er sammenligningsgruppen for alle hazardratios * Opdateret analyse af progressionsfri overlevelse og interim analyse af samlet overlevelse ved klinisk cut-off 22. januar 2018 RECIST = Response Evaluation Criteria in Solid Tumours v1.1. 
^ The Arm C is the comparison group for all hazard ratios * Updated PFS analysis and interim OS analysis at clinical cut-off 22 January 2018 PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Medianvarighed af respons blev ikke nået i nogen af PDL1- ekspressions-subgrupperne eller i hele gruppen. 
The median DOR was not reached in any PD-L1 expression subgroup or in all comers.
Medianalderen var 55 år (interval: 20 til 86 år). 
The median age was 55 years (range: 20-86).
Hver ml indeholder 60 mg atezolizumab. 
Each mL contains 60 mg of atezolizumab.
o Inkluderer indberetninger om myasthenia gravis p 
o Incudes reports of myasthenia gravis.
Efter sygdomsprogression fik 59% af patienterne i nab-paclitaxel og carboplatinarmen behandling med en form for immunterapi mod kræft, inklusiv atezolizumab som overkrydsningsbehandling (41% af alle patienterne) sammenlignet med 7,3% af patienterne i atezolizumab, nab-paclitaxel og carboplatinarmen. 
Fifty-nine percent of patients in the nab-paclitaxel and carboplatin arm received any cancer immunotherapy after disease progression, which includes atezolizumab as crossover treatment (41% of all patients), compared to 7.3% of patients in the atezolizumab, nab paclitaxel and carboplatin arm.
I tilfælde af overdosis skal patienten monitoreres tæt for symptomer på bivirkninger og relevant symptombehandling påbegyndes. 
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Inkluderer indberetninger om perifer neuropati, autoimmun neuropati, perifer sensorisk neuropati, polyneuropati, herpes zoster, perifer motorisk neuropati, neuralgisk amyotrofi, perifer sensormotorisk neuropati, toksisk neuropati, aksonal neuropati, lumbosakral plexopati, neuropatisk artropati, perifer nervebetændelse. 
l Includes reports of neuropathy peripheral, autoimmune neuropathy, peripheral sensory neuropathy, polyneuropathy, herpes zoster, peripheral motor neuropathy, neuralgic amyotrophy, peripheral sensorimotor neuropathy, toxic neuropathy, axonal neuropathy, lumbosacral plexopathy, neuropathic arthropathy, peripheral nerve infection.
Tabel 6: Opsummering af effect hos patienter med PD-L1-ekspression ≥1% (IMpassion130) Nøgleeffekt-endpunkter 
Table 6 - Summary of efficacy in patients with PD-L1 expression ≥1% (IMpassion130) Key efficacy endpoints
Der blev i alt inkluderet 1202 patienter, som var randomiseret (1:1:1) til at få et af behandlingsregimerne beskrevet i tabel 5. 
A total of 1,202 patients were enrolled and were randomised (1:1:1) to receive one of the treatment regimens described in Table 5.
Kohorte 2 inkluderede patienter, der havde modtaget mindst én platinbaseret kemoterapi for lokalt fremskredent eller metastatisk urotelialt carcinom eller havde oplevet sygdomsprogression inden for 12 måneder efter behandling med platinholdig neoadjuverende eller adjuverende kemoterapi. 
Cohort 2 included patients who received at least one platinum-based chemotherapy regimen for locally advanced or metastatic UC or had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
Hvis du har sprunget en dosis Tecentriq over 
If you miss a dose of Tecentriq
En farmakokinetisk populationsanalyse har vist, at steady-state opnås efter gentagen dosering efter 6-9 uger (2-3 serier). 
A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks (2 to 3 cycles) of repeated dosing.
Ved interimanalysen af den samlede overlevelse havde patienterne en median opfølgningstid på 19,7 måneder. 
At the time of the interim OS analysis, patients had a median follow-up of 19.7 months.
Dyrestudier har vist, at hæmning af PD-L1/PD-1-vejen kan medføre immunrelateret afstødning af fostret og føtal død. 
Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to immune-related rejection of the developing foetus resulting in foetal death.
I alt 287 patienter blev randomiseret i forholdet 1:1 til atezolizumab (1200 mg ved intravenøs infusion hver 3. uge indtil der ikke længere var klinisk gavn) eller docetaxel (75 mg/m2 ved intravenøs infusion på dag 1 i hver 3-ugers cyklus indtil sygdomsprogression). 
A total of 287 patients were randomised 1:1 to receive either atezolizumab (1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit) or docetaxel (75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression).
Hvert hætteglas indeholder 1200 mg atezolizumab (i 20 ml). 
Each vial contains 1,200 mg of atezolizumab (in 20 mL).
I studie IMpower150 blev en alder på ≥ 65 år forbundet med formindsket effekt hos patienter, der fik atezolizumab i kombination med carboplatin og paclitaxel. 
In study IMpower150, age ≥ 65 was associated with a diminished effect of atezolizumab in patients receiving atezolizumab in combination with carboplatin and paclitaxel.
Følgende bivirkninger er indberettet i kliniske studier hvor Tecentriq er givet sammen med kemoterapi: 
The following side effects have been reported in clinical trials when Tecentriq is given in combination with anticancer medicines:
Behandling med atezolizumab kan genoptages, hvis der opnås metabolisk kontrol med insulinsubstitutionsbehandling. 
Treatment with atezolizumab may be resumed if metabolic control is achieved on insulin replacement therapy.
Der foreligger ingen data fra studie IMpower150 om effekten af atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin hos EGFR+ patienter, som har progredieret under tidligere behandling med erlotinib+bevacizumab. 
In study IMpower150, there are no data on the efficacy of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in EGFR+ patients who have progressed previously on erlotinib+bevacizumab.
Der er ingen tilgængelige kliniske data om hvorvidt atezolizumab påvirker fertiliteten. 
No clinical data are available on the possible effects of atezolizumab on fertility.
Der blev også gennemført en analyse af kohorte 2 med en medianvarighed af overlevelsesopfølgning på 21,1 måneder. 
An analysis was also performed with a median duration of survival follow-up of 21.1 months for
Ca. 10% af patienterne havde kendt EGFR-mutation, 4% havde kendt ALK-rearrangement, 14% havde levermetastaser ved baseline, og de fleste patienter var aktive eller tidligere rygere (80%). 
Approximately 10% of patients had known EGFR mutation, 4% had known ALK rearrangements, 14% had liver metastasis at baseline, and most patients were current or previous smokers (80%).
Dyreforsøg har vist, at PD-L1/PD-1-hæmning i muse-graviditetsmodeller kan medføre immunrelateret afstødelse af fostret under udvikling og føtal død (se pkt. 
Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway in murine pregnancy models can lead to immune-related rejection of the developing foetus resulting in foetal death (see section 5.3).
Der er ikke observeret generelle forskelle i sikkerheden mellem patienter ≥ 65 år og yngre patienter der fik atezolizumab enkeltstofbehandling. 
No overall differences in safety were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Schweiz 
SWITZERLAND
Hos én ud af de 87 patienter var bivirkningen dødelig. 
Of the 87 patients, one experienced a fatal event.
Baseret på en farmakokinetisk populationsanalyse er dosisjustering ikke nødvendig hos patienter med let nedsat leverfunktion. 
Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1220/002 
EU/1/17/1220/002
Tabel 5: Intravenøse behandlingsregimer (IMpower150) Behandlingsregime 
Table 5: Intravenous treatment regimens (IMpower150) Treatment regimen
Vedligeholdelse (21-dages cyklus) 
Maintenance (21-day cycles)
Tecentriq er i kombination med nab-paclitaxel indiceret til behandling af voksne patienter med inoperabel lokalt fremskreden eller metastatisk triplenegativ brystkræft (TNBC), hvor patientens tumorer har en PD-L1-ekspression ≥ 1%, og som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom. 
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Der er set hypofysitis hos 0,4% (2/473) af patienter behandlet med atezolizumab i kombination med nab-paclitaxel og carboplatin. 
Hypophysitis occurred in 0.4% (2/473) of patients who received atezolizumab in combination with nab-paclitaxel and carboplatin.
Behandling med atezolizumab bør seponeres permanent ved enhver grad af meningitis eller encefalitis. 
Treatment with atezolizumab must be permanently discontinued for any grade of meningitis or encephalitis.
Antal patienter med hændelser (%) Median (måneder) (95% konfidensinterval) 
Patients with event (%) Median (months) (95% CI)
Grad 3 eller 4: (kreatininniveau >3,0 gange baseline eller >3,0 gange øvre referencegrænse) 
Grade 3 or 4: (creatinine level > 3.0 x baseline or > 3.0 x ULN)
4.4 og 4.8) Tabel 1: Anbefalinger vedrørende Tecentriq dosisændringer Immunrelateret bivirkning 
Dose delay or discontinuation (see also sections 4.4 and 4.8) Table 1: Dose modification advice for Tecentriq Immune related adverse reaction
Kohorte 1 inkluderede tidligere ubehandlede patienter med lokalt fremskreden eller metastatisk urotelialt carcinom, der ikke var egnede til cisplatinbaseret kemoterapiregime eller havde sygdomsprogression mindst 12 måneders efter neoadjuverende behandling med platinholdigt lægemiddel eller adjuverende kemoterapiregime. 
Cohort 1 included previously untreated patients with locally advanced or metastatic UC who were ineligible or unfit for cisplatin-based chemotherapy or had disease progression at least 12 months after treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
Det anvendes til denne kræftform: når kræften har spredt sig til andre dele af kroppen når kræften er vendt tilbage efter tidligere behandling hvis du ikke kan behandles med cisplatin (en bestemt type af kemoterapi) og din læge har undersøgt din kræft og fundet høje niveauer af et bestemt protein, som kaldes programmeret døds-ligand 1 (PD-L1), i din krop. 
It is used when this cancer has: spread to other parts of the body come back after previous treatment or, if you cannot receive anticancer medicine (a chemotherapy called cisplatin), and your doctor has tested your cancer and found high levels of a specific protein in your body called programmed death-ligand 1 (PD-L1).