FrancophonIA/ELRC3.0 huggingface dataset:
English: g Includes reports of autoimmune hypothyroidism, autoimmune thyroiditis, blood thyroid stimulating hormone abnormal, blood thyroid stimulating hormone decreased, blood thyroid stimulating hormone increased, euthyroid sick syndrome, goitre, hypothyroidism, myxoedema, thyroid disorder, thyroid function test abnormal, thyroiditis, thyroiditis acute, thyroxine decreased, thyroxine free decreased, thyroxine free increased, thyroxine increased, tri-iodothyronine decreased, tri-iodothyronine free abnormal, tri-iodothyronine free decreased, tri-iodothyronine free increased.
Danish: Inkluderer indberetninger om cytokinfrigivelsessyndrom, hypersensitivitet, anafylaksi g Inkluderer indberetninger om autoimmun hypothyroidisme, autoimmun thyroiditis, unormalt niveau af thyroideastimulerende hormon i blodet, fald i thyroideastimulerende hormon i blodet, stigninger i thyroideastimulerende hormon i blodet, euthyroid sick syndrome, struma, hypothyroidisme, myxødem, thyroidea-sygdom, unormal thyroideafunktionstest, thyroiditis, akut thyroiditis, fald i thyroxin, fald i frit thyroxin, stigning i frit thyroxin, stigning i thyroxin, fald i triiodthyronin, unormalt niveau af frit triiodthyronin, fald i frit triiodthyronin, stigning i frit triiodthyronin.
English: IMvigor211 (GO29294): Randomised trial in locally advanced or metastatic UC patients previously treated with chemotherapy
Danish: IMvigor211 (GO29294): Randomiseret studie med patienter med lokalt fremskredent eller metastatisk urotelialt carcinom, tidligere behandlet med kemoterapi
English: Vinflunine was administered 320 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Danish: Vinflunin blev administreret i en dosis på 320 mg/m2 ved intravenøs infusion på dag 1 af hver 3-ugers cyklus indtil sygdomsprogression eller uacceptabel toksicitet.
English: Docetaxel was administered 75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression.
Danish: Docetaxel blev administreret i en dosis på 75 mg/m2 ved intravenøs infusion på dag 1 i hver 3 ugers-cyklus indtil sygdomsprogression.
English: Secondary and exploratory endpoints Investigator-assessed ORR (RECIST 1.1)
Danish: Sekundære og eksplorative endepunkter Investigatorvurderet objektiv responsrate (RECIST 1.1)
English: Figure 3: Forest plot of overall survival by PD-L1 expression in the ITT population, Arm B vs. C (IMpower150)
Danish: Figur 3: Forest-plot over samlet overlevelse fordelt på PD-L1-ekspressionen i ITT-populationen, arm B versus arm C (IMpower150)
English: Tumour assessments were conducted every 6 weeks for the first 36 weeks, and every 9 weeks thereafter.
Danish: Der blev gennemført tumorvurderinger hver 6. uge i de første 36 uger og herefter hver 9. uge.
English: The median time to onset was 4.7 months (range 15 days to 17.2 months).
Danish: Mediantid til hændelse var 4,7 måneder (interval: 15 dage til 17,2 måneder).
English: Rash
Danish: Roche
English: Respiratory, thoracic, and mediastinal disorders Very common cough, dyspnoea dyspnoea, cough
Danish: Luftveje, thorax og mediastinum Meget almindelig Hoste, dyspnø
English: Carboplatin and etoposide were administered until completion of 4 cycles, or progressive disease or unacceptable toxicity, whichever occurs first c
Danish: bCarboplatin og etoposid blev administreret indtil afslutning af 4 serier, eller progressiv sygdom, eller uacceptabel toxicitet, hvad der end forekom først.
English: Immune-related neuropathies
Danish: Immunrelaterede neuropatier
English: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis and type 1 diabetes mellitus, including diabetic ketoacidosis have been observed in clinical trials with atezolizumab (see section
Danish: Der er i kliniske forsøg med atezolizumab observeret hypothyroidisme, hyperthyroidisme, binyrebarkinsufficiens, hypofysitis og type 1 diabetes mellitus, inklusiv diabetisk ketoacidose (se pkt.
English: 6-month OS (%) 12-month OS (%)
Danish: 6 måneder progressionsfri overlevelse (%) 12 måneders progressionsfri overlevelse (%) Andre endepunkter
English: Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
Danish: Tecentriq er i kombination med bevacizumab, paclitaxel og carboplatin indiceret til førstelinjebehandling af voksne patienter med metastatisk ikke-planocellulært, ikke-småcellet lungekræft.
English: IMpassion130 (WO29522): Randomised phase III trial in locally advanced or metastatic TNBC patients previously untreated for metastatic disease
Danish: IMpassion130 (WO29522): Randomiseret fase III-studie med patienter med lokalt fremskredent eller metastatisk triplenegativ brystkræft, som ikke tidligere er behandlet for metastatisk sygdom
English: Tecentriq used alone The following side effects have been reported in clinical trials with Tecentriq used alone:
Danish: Følgende bivirkninger er indberettet i kliniske studier, hvor Tecentriq er givet alene:
English: Patients with PD-L1 expression <1% did not show improved PFS when atezolizumab was added to nab-paclitaxel (HR of 0.94, 95% CI 0.78, 1.13).
Danish: Patienter med PD-L1-ekspression <1% viste ikke forbedret progressionsfri overlevelse ved tilføjelse af atezolizumab til nab-paclitaxel (Hazardratio: 0,94 (95% konfidensinterval: 0,78; 1,13)).
English: Tecentriq 840 mg concentrate for solution for infusion atezolizumab
Danish: Tecentriq 840 mg koncentrat til infusionsvæske, opløsning atezolizumab
English: No overall differences in efficacy were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Danish: Effekt hos ældre Der er ikke observeret generelle forskelle i effekt mellem patienter ≥ 65 år og yngre patienter, der fik atezolizumab enkeltstofbehandling.
English: Tumour specimens were evaluated prospectively for PD-L1 expression on tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below.
Danish: Tumorprøver blev evalueret prospektivt for PD-L1-ekspression i tumorinfiltrerende immunceller (IC), og resultaterne blev brugt til at definere de PD-L1-ekspressionssubgrupper, der er anvendt i nedenfor beskrevne analyser.
English: Elderly patients
Danish: Alle patienter
English: Tumour specimens were evaluated for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below.
Danish: Tumorprøver blev evalueret for PD-L1ekspression på tumorceller (TC) og tumorinfiltrerede immunceller (IC), og resultaterne blev brugt til af definere subgrupperne af PD-L1-ekspression i analyserne beskrevet nedenfor.
English: The median time to onset was 1.5 months (range 6 days to 18.8
Danish: Mediantid til hændelse var 1,5 måneder (interval: 6 dage til 18,8 måneder).
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 en konklusion vedrørende denne population.
English: Pancreatitis led to the discontinuation of atezolizumab in 3 (< 0.1%) patients.
Danish: Pancreatitis førte til seponering af atezolizumab hos 3 (< 0,1%) patienter.
English: Includes reports of urinary tract infection, cystitis, pyelonephritis, escherichia urinary tract infection, urinary tract infection bacterial, kidney infection, pyelonephritis acute, urinary tract infection fungal, urinary tract infection pseudomonal.
Danish: Inkluderer indberetninger om urinvejsinfektioner, cystitis, pyelonefritis, escherichia urinvejsinfektion, bakteriel urinvejsinfektion, nyreinfektion, akut pyelonefritis, fungal urinvejsinfektion, pseudomonas urinvejsinfekton.
English: q Includes reports of pneumonitis, lung infiltration, bronchiolitis, interstitial lung disease, radiation pneumonitis.
Danish: Inkluderer indberetninger om pneumonitis, lungeinfiltration, bronchiolitis, interstitiel lungesygdom, strålingspneumonitis r
English: A decision must be made whether to discontinue breast-feeding or to discontinue Tecentriq therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Barnets gavn af amning og kvindens gavn af behandling skal afvejes, og på den baggrund bør det besluttes om eventuel amning bør ophøre eller om behandling med Tecentriq skal seponeres.
English: 22.9 months), the median OS for both arms was unchanged relative to the primary OS interim analysis.
Danish: I en eksploratorisk endelig analyse af samlet overlevelse med længere opfølgningstid (median: 22,9 måneder) var median samlet overlevelse for begge arme uændret i forhold til den primære interimanalyse af samlet overlevelse.
English: The recommended dose of Tecentriq is:
Danish: Tecentriq indeholder:
English: The demographic and baseline disease characteristics of the primary analysis population were well balanced between the treatment arms.
Danish: Demografi og baseline karakteristika for sygdommen i den primære analysepopulation var velbalanceret behandlingsarmene imellem.
English: 8.1 months).
Danish: 4.8 og 5.1).
English: IMpower133 (GO30081): Randomised phase I/III trial in patients with chemotherapy-naïve extensivestage SCLC, in combination with carboplatin and etoposide
Danish: IMpower133 (GO30081): Randomiseret fase I/III-studie med patienter med småcellet lungekræft i udvidet stadie, der ikke tidligere er behandlet med kemoterapi, i kombination med carboplatin og etoposid
English: The median time to onset 7.2 months (range: 24 days to 13.7 months).
Danish: Medianttid til hændelse var 7,2 måneder (interval: 24 dage til 13,7 måneder).
English: Co-primary endpoints OS analysis*
Danish: Co-primære endepunkter Samlet overlevelse*
English: Figure 10: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
Danish: Figur 10: Kaplan-Meier-kurve over samlet overlevelse i den primære analysepopulation (alle patienter) (OAK)a
English: • a cancer that affects the lungs, called non-small cell lung cancer.
Danish: · en kræftform, ikke-småcellet lungekræft, der rammer lungerne.
English: Treatment may be resumed if the event improves to ≤ Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and the patient is stable on replacement therapy (if required).
Danish: Behandlingen kan genoptages hvis bivirkningen er forbedret til ≤grad 1 inden for 12 uger, og kortikosteroiddosis er reduceret til ≤10 mg/dag prednison eller ækvivalent produkt, og patienten er stabil i substitutionsbehandling (hvis dette er nødvendigt).
English: Figure 2: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
Danish: Figur 2: Kaplan-Meier-kurve over samlet overlevelse i den primære analysepopulation (alle patienter) (OAK)a
English: The median duration was 2.8 months (range 15 days to 9.5+ months; + denotes a censored value).
Danish: Medianvarighed var 2,8 dage (interval: 15 dage til 9,5+ måneder; + angiver en censureret værdi).
English: • The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Tecentriq.
Danish: Påmindelse om at have patientkortet på sig altid og at vise det til alle sundhedspersoner, som behandler dem. - Kortet skal også anmode om, at kontaktinformation til lægen er indført og det bør indeholde en advarsel om at patienten er i behandling med Tencentriq, til alle sundhedspersoner, som kan behandle patienten, herunder også i nødstilfælde.
English: A phase III, open-label, multi-center, international, randomised study, (IMvigor211), was conducted to evaluate the efficacy and safety of atezolizumab compared with chemotherapy (investigator's choice of vinflunine, docetaxel, or paclitaxel) in patients with locally advanced or metastatic UC who progressed during or following a platinum-containing regimen.
Danish: Der er gennemført et åbent, internationalt, randomiseret, fase III-multicenter-studie (IMvigor211) med henblik på at evaluere effekt og sikkerhed af atezolizumab sammenlignet med kemoterapi (investigators valg mellem vinflunin, docetaxel eller paclitaxel) hos patienter med lokalt fremskredent eller metastatisk urotelialt carcinom, der havde oplevet progression under eller efter platinbaseret regime.
English: Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 pneumonitis.
Danish: Behandling med atezolizumab skal seponeres permanent ved grad 3 eller 4 pneumonitis.
English: Tecentriq used in combination with anticancer medicines
Danish: Tecentriq givet sammen med kemoterapi
English: Patients with previously untreated UC and TNBC 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 eller triplenegativ brystkræft, skal udvælges til behandling baseret på tumor ekspression af PD-L1, som skal bekræftes ved en valideret test (se pkt.
English: In Cohort 1, 119 patients were treated with atezolizumab 1,200 mg by intravenous infusion every
Danish: I kohorte 1 blev 119 patienter behandlet med atezolizumab 1200 mg ved intravenøs infusion hver 3. uge indtil sygdomsprogression.
English: Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment; systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal products within 2 weeks prior to study entry were excluded from clinical trials.
Danish: Patienter, der havde modtaget levende, svækket vaccine inden for 28 dage inden rekruttering, systemiske immunstimulerende midler inden for 4 uger inden rekruttering eller systemisk immunsuppressiv behandling inden for 2 uger inden rekruttering til studiet kunne ikke inkluderes i kliniske studier.
English: General disorders and administration site conditions Very Common pyrexia, fatigue, asthenia pyrexia, fatigue, asthenia
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig Pyreksi, træthed, asteni
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Danish: Data fra patienter med svær nedsat nyrefunktion er for begrænsede til, at der kan drages konklusioner vedrørende denne population.
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin
Danish: Brug af atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin
English: Arm A (Atezolizumab + carboplatin + etoposide)
Danish: Arm A (Atezolizumab + carboplatin + etoposid)
English: Investigator-assessed PFS (RECIST v1.1) - Primary analysis
Danish: Investigatorvurderet progressionsfri overlevelse (RECIST v1.1) - primær analyse
English: One patient required the use of corticosteroids and treatment with atezolizumab was discontinued.
Danish: En patient havde behov for kortikosteroidbehandling og fik seponeret behandlingen med atezolizumab.
English: The Kaplan-Meier curve for OS in the all comer population is presented in Figure 1.
Danish: Kaplan-Meier-kurven for samlet overlevelse i hele populationen præsenteres i figur 1.
English: Common hypokalaemia, hyponatraemia, hyperglycaemia hypokalaemia, hyponatraemia, hypomagnesaemia
Danish: Hypokaliæmi, hyponatriæmi, hypomagnesæmi
English: After dilution (see section 6.6), one mL of solution contains approximately 4.4 mg of atezolizumab.
Danish: 6.6), indeholder én ml opløsning ca. 4,4 mg atezolizumab.
English: Second-line treatment of non-small cell lung cancer
Danish: Andenlinjebehandling af ikke-småcellet lungekræft
English: The primary analysis was conducted in all patients, excluding those with EGFR mutations or ALK
Danish: Den primære analyse blev udført på alle patienter, undtagen dem med EGFR mutationer eller ALK-rearrangementer, defineret som ITT-WT-populationen (n=679).
English: Table 7: Summary of updated efficacy for Arm A vs.
Danish: Tabel 7: Opsummering af opdateret effekt for arm A versus arm B i ITT-populationen (IMpower150)
English: Post-authorisation efficacy study (PAES): In order to evaluate the efficacy of atezolizumab monotherapy versus atezolizumab plus carboplatin/gemcitabine versus placebo plus cisplatin/gemcitabine in patients with locally advanced or metastatic urothelial cancer who are platinum -ineligible and -eligible patients, the MAH should submit the final CSR of study IMvigor130.
Danish: Effektstudie efter godkendelse (PAES): Indehaveren af markedsføringstilladelse skal indsende den endelige kliniske studierapport for studiet IMvigor 130, for at vurdere effekten af atezolizumab monoterapi versus atezolizumab plus carboplatin/gemcitabin versus placebo plus cisplatin/gemcitabin hos patienter med lokalt fremskredent eller metastatisk urotelialt carcinom, som ikke er egnet til platinholdig behandling, samt dem som er egnet til platinholdig behandling.
English: It is recommended that patients are treated with Tecentriq until loss of clinical benefit (see section 5.1) or unmanageable toxicity.
Danish: Det anbefales, at patienterne behandles med Tecentriq indtil der ikke længere er klinisk gavn af behandlingen (se pkt.
English: Cases of myositis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8).
Danish: Der er observeret tilfælde af myositis, inklusive dødelige tilfælde, i kliniske studier med atezolizumab (se pkt.
English: The primary analysis of study IMvigor211 did not meet its primary endpoint of OS. Atezolizumab did not demonstrate a statistically significant survival benefit compared to chemotherapy in patients with previously treated, locally advanced or metastatic urothelial carcinoma.
Danish: Der blev ikke vist statistisk signifikant overlevelse med atezolizumab sammenlignet med kemoterapi hos patienter med tidligere behandlet, lokalt fremskredent eller metastatisk urotelialt carcinom.
English: 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and the patient is stable on replacement therapy (if required).
Danish: ≤10 mg/dag prednison, eller ækvivalent produkt, og patienten er stabil på substitutionsbehandling (hvis dette er nødvendigt).
English: Withhold Tecentriq Treatment may be resumed when metabolic control is achieved on insulin replacement therapy
Danish: Behandlingen kan genoptages, når der er etableret metabolisk kontrol med insulinsubstitutionsbehandling.
English: Colitis occurred in 1.1% (34/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er konstateret colitis hos 1,1% (34/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
English: Tel: +371 - 6 7039831
Danish: Roche Latvija SIA Tel: +371 - 6 7039831
English: • a cancer that arises from the breast, called triple negative breast cancer.
Danish: · en kræftform, triplenegativ brystkræft, der påvirker brystet.
English: 14.1 (9.2, NE) 15.9 (10.4, NE)
Danish: Median (måneder) (95% konfidenseinterval) 12,3 (6,0 ; NE) 14,1 (9,2 ; NE) 15,9 (10,4 ; NE)
English: Baseline ECOG performance status was 0 (45.6%) or 1 (54.4%).
Danish: ECOG-performancestatus ved baseline var 0 (45,6%) eller 1 (54.4%).
English: Treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Danish: Behandling igangsættes med intravenøse kortikosteroider (1 til 2 mg/kg/dag methylprednisolon eller ækvivalent produkt).
English: The demographic and baseline disease characteristics of the study population were well balanced between the treatment arms.
Danish: Demografiske og baseline sygdomskarakteristika i studiepopulationen var velafbalanceret behandlingsarmene imellem.
English: Roche Pharma AG Emil-Barell-Strasse 1
Danish: Roche Pharma AG Emil-Barell-Strasse 1 D-79639
English: The median time to onset was 2.1 months (range 21 days to 15.7 months).
Danish: Mediantid til hændelse var 2,1 måneder (interval: 21 dage til 15,7 måneder).
English: Patient demographics and baseline tumour disease in patients with PD-L1 expression ≥1% were generally representative of the broader study population.
Danish: ekspression ≥1% var generelt repræsentativt for den brede studiepopulation.
English: Hypersensitivity to atezolizumab or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for atezolizumab eller over for et eller flere af hjælpestofferne anført i pkt.
English: For Grade 3 diarrhoea or colitis, treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Danish: Ved grad 3 diarré eller colitis igangsættes behandling med intravenøst kortikosteroid (1 til 2 mg/kg/dag methylprednisolon eller ækvivalent produkt).
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in metastatic non-squamous non-small cell lung cancer
Danish: Brug af atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin ved metastatisk ikke-planocellulært ikke-småcellet lungekræft
English: Stratified hazard ratio‡ (95% CI) p-value
Danish: Stratificeret hazardratio‡ (95% konfidensinterval) p-værdi
English: Each 14 mL vial of concentrate contains 840 mg atezolizumab After dilution, 1 mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 14 ml koncentrat indeholder 840 mg atezolizumab Efter fortynding indeholder 1 ml opløsning ca. 3,2 mg atezolizumab for en dosis på 840 mg og 6,0 mg atezolizumab for en dosis på 1680 mg.
English: Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy of atezolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer, the MAH should submit the final OS results of study IMvigor210.
Danish: Effektstudie efter godkendelse (PAES): Indehaveren af markedsføringstilladelsen skal indsende de endelige resultater for den samlede overlevelse i studiet IMvigor 210, for at yderligere vurdere effekten af atezolizumab til behandling af patienter med lokalt fremskredent eller metastatisk urotelialt carcinom.
English: Each 14 mL vial contains 840 mg of atezolizumab.
Danish: Hvert 14 ml hætteglas indeholder 840 mg atezolizumab.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 mL vial of concentrate contains 840 mg of atezolizumab*.
Danish: Et 14 ml hætteglas med koncentrat indeholder 840 mg atezolizumab*
English: The median duration was 26 days (range 6 days to 14.5+ months; + denotes a censored value).
Danish: Medianvarigheden var 26 dage (interval: 6 dage til 14,5+ måneder; + angiver en censureret værdi).
English: Grade 2: (ALT or AST > 3 to 5 x upper limit of normal [ULN]
Danish: Grad 2: (ALAT eller ASAT >3 til 5 gange øvre referencegrænse eller blod-bilirubin >1,5 til 3 gange øvre referencegrænse)
English: Patients were excluded if they had active or untreated CNS metastases; history of autoimmune disease; administration of live, attenuated vaccine within 4 weeks prior to randomisation; administration of systemic immunosuppressive medications within 1 week prior to randomisation.
Danish: Patienter blev ekskluderet fra studiet, hvis de havde: Aktive eller ubehandlede CNS-metastaser, autoimmun sygdom i anamnesen, fået administreret levende, svækket vaccine inden for 4 uger inden randomisering eller fået administreret systemiske immunsupprimerende midler inden for 1 uge inden randomisering.
English: Pneumonitis occurred in 2.7% (87/3,178) of patients who received atezolizumab monotherapy.
Danish: Der er konstateret pneumonitis hos 2,7% (87/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.