FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical Pregnane X Receptor (PXR) interaction study, co-administration of TAGRISSO with fexofenadine (P-gp substrate) increased the AUC and Cmax of fexofenadine by 56% (90% CI 35, 79) and 76% (90% CI 49, 108) after a single dose and 27% (90% CI 11, 46) and 25% (90% CI 6, 48) at steady state, respectively.
Danish: I et klinisk pregnane-X-receptor (PXR)-interaktionsstudie viste co-administration af TAGRISSO med fexofenadin (P-gp substrat) en øgning i fexofenadins AUC og Cmax med henholdsvis 56 % (90 % CI 35, 79) og 76 % (90 % CI 49, 108) efter en enkelt dosis og 27 % (90 % CI 11, 46) og 25 % (90 % CI 6, 48) ved steady state.
English: Irrespective of CNS lesion status at study entry, patients in the TAGRISSO arm demonstrated an efficacy benefit over those in the EGFR TKI comparator arm and there were fewer patients with new CNS lesions in the TAGRISSO arm compared to the EGFR TKI comparator arm (TAGRISSO, 11/279 [3.9%] compared to EGFR TKI comparator, 34/277 [12.3%]).
Danish: Uanset CNS-læsionsstatus ved studieinklusion viste patienter i TAGRISSO-armen en effektivitetsgevinst overfor de i EGFR TKI-komparatorarmen, og der var færre patienter med nye CNS-læsioner i TAGRISSO-armen sammenlignet med EGFR TKI-komparatorarmen (TAGRISSO 11/279 [3,9 %] sammenlignet med EGFR TKI-komparator, 34/277 [12,3 %]).
English: Number of patients who had second subsequent treatment or died (%)
Danish: Antal patienter, der fik anden efterfølgende behandling eller afgik ved døden (%)
English: CNS disease control rate
Danish: CNS-sygdomskontrolrate
English: Based on a population pharmacokinetic analysis of 593 patients with mild renal impairment (CLcr 60 to less than 90 mL/min), 254 patients with moderate renal impairment (CLcr 30 to <than 60 mL/min), 5 patients with severe renal impairment (CLcr 15 to <than 30 mL/min) and 502 patients with normal renal function (greater than or equal to 90 mL/min), osimertinib exposures were similar.
Danish: Baseret på en farmakokinetisk populationsanalyse med 593 patienter med let nedsat nyrefunktion (CLcr 60 til < 90 ml/min), 254 patienter med moderat nedsat nyrefunktion (CLcr 30 til < 60 ml/min), 5 patienter med svært nedsat nyrefunktion (CLcr 15 til < 30 ml/min) og 502 patienter med normal nyrefunktion (CLcr ≥ 90 ml/min) var osimertinibeksponeringerne sammenlignelige.
English: CNS metastases efficacy data in Phase 2 studies (AURAex and AURA2) A BICR assessment of CNS efficacy by RECIST v 1.1 was performed in a subgroup of 50 (out of 411) patients identified to have measurable CNS metastases on a baseline brain scan.
Danish: Effektdata for CNS-metastaser i Fase 2-studier (AURAex and AURA2) Der blev udført en BICR-vurdering af CNS-effekt ved RECIST v 1.1 i en undergruppe med 50 (ud af 411) patienter, der var identificeret som havende målbare CNS-metastaser ved en baseline-hjernescanning.
English: Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies.
Danish: Patienter med klinisk betydende anormaliteter i rytme og overledning, målt ved hvile-elektrokardiogram (EKG) (f.eks. QTc-interval længere end 470 ms), blev udelukket fra disse studier.
English: In a clinical pharmacokinetic study in patients, co-administration with 200 mg itraconazole twice daily (a strong CYP3A4 inhibitor) had no clinically significant effect on the exposure of osimertinib (area under the curve (AUC) increased by 24% and Cmax decreased by 20%).
Danish: I et klinisk farmakokinetisk studie med patienter havde samtidig administration af 200 mg itraconazol to gange dagligt (en potent CYP3A4-hæmmer) ingen klinisk signifikant indvirkning på eksponeringen af osimertinib (areal under kurven (AUC) steg med 24 %, og Cmax faldt med 20 %).
English: Includes cases reported within the clustered terms: Interstitial lung disease, pneumonitis.
Danish: Inkluderer tilfælde rapporteret inden for termgruppen: Interstitiel lungesygdom, pneumonitis.
English: Breast-feeding should be discontinued during treatment with TAGRISSO.
Danish: Amning bør afbrydes under behandling med TAGRISSO.
English: Pre-treated T790M positive NSCLC patients-AURA3
Danish: Tidligere behandlede T790M-positive NSCLC-patienter - AURA3
English: Includes cases reported within the clustered terms: Dry skin, skin fissures, xerosis, eczema, xeroderma.
Danish: Inkluderer tilfælde rapporteret inden for termgruppen: Tør hud, hudfissurer, xerose, eksem, xeroderma.
English: Key lung cancer symptoms analysis
Danish: Analyse af væsentlige symptomer på lungecancer
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist (see section 4.2 Table 1).
Danish: Patienter med symptomer, der kunne tyde på keratitis, såsom akut opståen eller forværring af okulær inflammation, tåreflåd, lysfølsomhed, sløret syn, øjensmerter og/eller røde øjne, skal straks henvises til en øjenlæge (se pkt.
English: ECGs: Electrocardiograms; QTc: QT interval corrected for heart rate
Danish: QTc: QT-interval korrigeret for hjertefrekvens
English: Pulmonary ILD/Pneumonitis
Danish: Interstitiel lungesygdom (ILD)/ pneumonitis
English: CNS Progression-free survival Number of Events (%) Median, Months (95% CI)
Danish: CNS progressionsfri overlevelse Antal hændelser (%) Median, måneder (95 % CI)
English: CNS progression free and alive at 6 months (%) (95% CI) CNS progression free and alive at 12
Danish: CNS-progressionsfri og i live efter 6 måneder (%) (95 % CI) CNS-progressionsfri og i live efter 12 måneder (%) (95 % CI)
English: Patients with a medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD were excluded from clinical studies.
Danish: Patienter med ILD i anamnesen, lægemiddelinduceret ILD, strålepneumonitis, der krævede steroidbehandling, eller med påvist klinisk aktiv ILD blev udelukket fra de kliniske studier.
English: Talk to your doctor, pharmacist or nurse before taking TAGRISSO if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager TAGRISSO, hvis:
English: TAGRISSO is supplied in blisters containing 30 x 1 film-coated tablets, packed in cartons containing 3 blisters of 10 tablets each.
Danish: TAGRISSO leveres i blisterkort indeholdende 30 x 1 filmovertrukne tabletter, pakket i æsker indeholdende 3 blisterkort med hver 10 tabletter.
English: Patients taking concomitant medications with disposition dependent upon P-gp and with narrow therapeutic index (e.g. digoxin, dabigatran, aliskiren) should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving TAGRISSO (see section 5.2).
Danish: Patienter, der samtidig tager medicin med disposition afhængig af P-gp og med smalt terapeutisk indeks (f.eks. digoxin, dabigatran, aliskiren) bør overvåges nøje for tegn på ændret tolerabilitet som følge af øget eksponering af samtidig behandling med TAGRISSO (se pkt.
English: TAGRISSO is supplied in blisters containing 28 x 1 film-coated tablets, packed in cartons containing 4 blisters of 7 tablets each.
Danish: TAGRISSO leveres i blisterkort indeholdende 28 x 1 filmovertrukne tabletter, pakket i æsker indeholdende 4 blisterkort med hver 7 tabletter.
English: Number of Events (62% maturity)
Danish: Antal hændelser (62 % modenhed)
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Unchanged osimertinib accounted for approximately 2% of the elimination with 0.8% in urine and 1.2% in faeces.
Danish: Ca. 2% blev elimineret som omdannet osimertinib med 0,8 % i urin og 1,2 % i fæces.
English: Forty-seven percent (47%) of patients had metastatic bone disease.
Danish: 47 % af patienterne havde metastatisk knoglesygdom.
English: The primary efficacy outcome was progression-free survival (PFS) as assessed by investigator.
Danish: Det primære effektmål var progressionsfri overlevelse (PFS) vurderet af investigator.
English: Based on population PK analysis, serum albumin was identified as a significant covariate with a <30% change in osimertinib AUCss expected across the albumin range of 29 to 46 g/L respectively (95% to 5% quantiles) when compared to the AUCss for the median baseline albumin of 39 g/L.
Danish: På baggrund af en farmakokinetisk populationsanalyse blev serumalbumin identificeret som en signifikant kovariat med en forventet ændring på <30 % i osimertinibs AUCss over albuminintervallet på henholdsvis 29 til 46 g/l (95 % til 5 % kvantiler) ved sammenligning med AUCss for den mediane baseline-albumin på 39 g/l.
English: Cartons of 28 x 1 tablets (4 blisters).
Danish: Æske med 28 x 1 tabletter (4 blisterkort).
English: Cartons of 30 x 1 tablets (3 blisters).
Danish: Æske med 30 x 1 tabletter (3 blisterkort).
English: In vitro, osimertinib does not inhibit OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 and MATE2K at clinically relevant concentrations.
Danish: In vitro hæmmer osimertinib ikke OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 og MATE2K i klinisk relevante koncentrationer.
English: Efficacy results from AURA3 by investigator assessment are summarised in Table 5, and the Kaplan-Meier curve for PFS is shown in Figure 3.
Danish: Effektresultater fra AURA3 efter investigators vurdering er sammenfattet i tabel 5, og Kaplan-Meier-kurverne for PFS er vist i figur 3.
English: The T790M mutation status was also assessed retrospectively using ctDNA extracted from a plasma sample taken during screening.
Danish: T790M-mutationsstatus blev også vurderet retrospektivt under anvendelse af ctDNA, ekstraheret fra en plasmaprøve taget under screening.
English: Forty-two percent (42%) of patients had metastatic bone disease.
Danish: 42 % af patienterne havde metastatisk knoglesygdom.
English: • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
Danish: • behandling af voksne patienter med lokalt fremskreden eller metastatisk EGFR T790Mmutationspositiv NSCLC.
English: Pregnancy - information for men
Danish: Graviditet - information til mænd
English: Patients taking concomitant medications with disposition dependent upon BCRP and with narrow therapeutic index should be closely monitored for signs of changed tolerability of the concomitant medication as a result of increased exposure whilst receiving TAGRISSO (see section 5.2).
Danish: Patienter, der samtidig tager medicin, hvis eksponering er afhængig af BCRP, og som har et snævert terapeutisk indeks, bør monitoreres nøje for tegn på ændret tolerance for det samtidige medikament på grund af øget eksponering under behandling med TAGRISSO (se pkt.
English: Caution should be exercised when treating patients with severe and end-stage renal impairment (see section 5.2).
Danish: Der skal udvises forsigtighed ved behandling af patienter med svært nedsat nyrefunktion og nyresygdom i slutstadiet (se pkt.
English: Al/Al perforated unit dose blisters.
Danish: Al/Al-perforerede enkeltdosisblisterkort.
English: St. John's Wort should not be used together with TAGRISSO (see section 4.5).
Danish: Perikon må ikke anvendes sammen med TAGRISSO (se pkt.
English: Grade 3 or higher adverse reaction Withhold TAGRISSO for up to 3 weeks If Grade 3 or higher adverse reaction improves to Grade 0-2 after withholding of TAGRISSO for up to
Danish: Hvis en bivirkning af grad 3 eller højere forbedres til grad 0-2 efter afbrydelse af TAGRISSO i op til 3 uger
English: TAGRISSO improved patient-reported lung cancer symptoms compared to chemotherapy by demonstrating a statistically significant difference in mean change from baseline versus chemotherapy during the overall time period from randomisation until 6 months for 5 pre-specified primary PRO symptoms (appetite loss, cough, chest pain, dyspnoea, and fatigue) as shown in Table 7.
Danish: TAGRISSO forbedrede patientrapporterede symptomer på lungecancer sammenlignet med kemoterapi ved at udvise statistisk signifikant forskel i den gennemsnitlige ændring fra baseline for 5 præspecificerede primære PRO-symptomer (appetitløshed, hoste, brystsmerter, dyspnø og træthed) versus kemoterapi i den samlede tidsperiode fra randomisering og indtil 6 måneder, se tabel 7.
English: Similarly, based on population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) >ULN or total bilirubin >1.0 to 1.5x ULN and any AST) or moderate hepatic impairment (total bilirubin between 1.5 to 3 times ULN and any AST).
Danish: Baseret på farmakokinetisk populationsanalyse, er dosisjustering ligeledes ikke nødvendig hos patienter med let nedsat leverfunktion (total-bilirubin ≤ øvre normalgrænse (ULN) og aspartataminotransferase (ASAT) > ULN eller total-bilirubin > 1,0-1,5 x ULN og en hvilken som helst ASAT) eller moderat nedsat leverfunktion (total-bilirubin fra 1,5-3,0 x ULN og en hvilken som helst ASAT).
English: Clinical studies have not been conducted in patients with de novo EGFR T790M mutation-positive NSCLC.
Danish: Der er ikke udført kliniske studier med patienter med de novo-EGFR T790M-mutationspositiv NSCLC.
English: Includes cases reported within the clustered terms: pruritus, pruritus generalised, eyelid pruritus.
Danish: Inkluderer tilfælde rapporteret inden for termgruppen: Pruritus, generaliseret pruritus, øjenlågspruritus.
English: Clinically meaningful improvements in PFS with HRs less than 0.50 in favour of patients receiving TAGRISSO compared to those receiving chemotherapy were consistently observed in all predefined subgroups analysed, including ethnicity, age, gender, smoking history and EGFR mutation (Exon 19 deletion and L858R).
Danish: Der blev konsekvent observeret klinisk betydende forbedringer i PFS med HR under 0,50 i de patienters favør, som fik TAGRISSO, sammenlignet med dem, der fik kemoterapi, i alle analyserede prædefinerede undergrupper, herunder etnicitet, alder, køn, rygehistorie og EGFR-mutation (Exon 19-deletion og L858R).
English: CNS Objective Response Rate
Danish: CNS objektiv responsrate
English: A pre-specified PFS subgroup based on CNS metastases status (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) at study entry was performed in FLAURA and is shown in Figure 2.
Danish: En prædefineret PFS-undergruppe baseret på CNS-metastasestatus (identificeret ved CNS-læsionssted ved baseline, anamnese og/eller tidligere kirurgi og/eller tidligere strålebehandling for CNSmetastaser) ved studieinklusion blev udført i FLAURA og er vist i figur 2.
English: Number of deaths, (25% maturity)
Danish: Antal dødsfald, (25 % modenhed)
English: If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
Danish: Spørg lægen, hvis du har spørgsmål til, hvordan dette lægemiddel virker, eller hvorfor du skal have denne medicin.
English: The T790M mutation status was also assessed using ctDNA extracted from a plasma sample taken during screening.
Danish: T790M-mutationsstatus blev også vurderet under anvendelse af ctDNA, ekstraheret fra en plasmaprøve taget under screening.
English: In a clinical PK study, co-administration of TAGRISSO with rosuvastatin (sensitive BCRP substrate) increased the AUC and Cmax of rosuvastatin by 35% and 72%, respectively.
Danish: I et klinisk farmakokinetisk studie øgede samtidig administration af TAGRISSO og rosuvastatin (sensitivt BCRP-substrat) AUC og Cmax af rosuvastatin med henholdsvis 35 % og 72 %.
English: Withhold TAGRISSO until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then restart at a reduced dose (40 mg)
Danish: Afbryd TAGRISSO-behandlingen, indtil QTc-intervallet er under 481 msek eller vendt tilbage til baseline-niveau, hvis baseline-QTc er over eller lig med 481 msek.
English: What you need to know before you take TAGRISSO
Danish: Det skal du vide, før du begynder at tage TAGRISSO
English: The baseline demographic and disease characteristics of the overall study population were: median age 64 years (range 26-93 years), ≥75 years old (14%), female (63%), White (36%), Asian (62%), never smokers (64%), World Health Organization (WHO) performance status of 0 or 1 (100%), metastatic bone disease (36%), extra-thoracic visceral metastases (35%), CNS metastases (21%, identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases).
Danish: Den samlede undersøgelsespopulations demografiske og sygdomskarakteristika ved baseline var: medianalder 64 år (interval 26-93 år), ≥75 år (14 %), kvinder (63 %), kaukasere (36 %), asiater (62 %), aldrig røget (64 %), Verdenssundhedsorganisationens (WHO) performance status på 0 eller 1 (100 %), metastatisk knoglesygdom (36 %), ekstra thorakal viscerale metastaser (35 %), CNS-metastaser (21 %, identificeret ved CNS-læsionssted ved baseline, anamnese og/eller tidligere kirurgi og/eller tidligere strålebehandling for CNS-metastaser).
English: Efficacy results from FLAURA by investigator assessment are summarised in Table 3, and the Kaplan-Meier curve for PFS is shown in Figure 1.
Danish: Effektresultaterne fra FLAURA, ud fra investigators vurdering, er opsummeret i tabel 3, og Kaplan-Meier-kurven for PFS er vist i figur 1.
English: - If you get any side effects, talk to yourdoctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.
Danish: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Based on in vitro studies, osimertinib is not an inhibitor of UGT1A1 and UGT2B7 at clinically relevant concentrations hepatically.
Danish: Baseret på in vitro-studier hæmmer osimertinib ikke UGT1A1 og UGT2B7 hepatisk ved klinisk relevante koncentrationer.
English: CNS response rate % (n/N) (95% CI)
Danish: CNS-responsrate % (n/N) (95 % CI)
English: There are no data available on patients with severe hepatic impairment (see section 4.2).
Danish: Der er ingen data tilgængelige for patienter med svært nedsat leverfunktion (se pkt.
English: A pharmacokinetic/pharmacodynamic analysis predicted a drug-related QTc interval prolongation at 80 mg of 14 msec with an upper bound of 16 msec (90% CI).
Danish: Ved en dosis på 80 mg forudsagde en farmakokinetisk/farmakodynamisk analyse en lægemiddelrelateret forlængelse af QTc-intervallet på 14 msek med en øvre grænse på 16 msek (90 % KI).
English: CNS metastases efficacy data in AURA3 study
Danish: Effektdata for CNS-metastaser i AURA3-studiet
English: Based on in vitro data, osimertinib is an inhibitor of BCRP and P-gp (see section 4.5).
Danish: Baseret på in vitro-data hæmmer osimertinib BCRP og P-gp (se pkt.
English: Of the 1142 patients in FLAURA and AURA studies treated with TAGRISSO 80 mg, 0.9% of patients (n=10) were found to have a QTc greater than 500 msec, and 3.6% of patients (n=41) had an increase from baseline QTc greater than 60 msec. A pharmacokinetic/pharmacodynamic analysis with TAGRISSO predicted a concentration-dependent increase in QTc interval prolongation.
Danish: Af de 1.142 patienter i FLAURA- og AURA-studierne behandlet med TAGRISSO 80 mg havde 0,9 % (n=10) QTc længere end 500 msek, og 3,6 % (n=41) havde en stigning i forhold til baseline-QTc på mere end 60 msek.
English: In healthy volunteers administered an 80 mg tablet where gastric pH was elevated by dosing of omeprazole for 5 days, osimertinib exposure was not affected (AUC and Cmax increase by 7% and 2%, respectively) with the 90% CI for exposure ratio contained within the 80-125% limit.
Danish: Hos raske forsøgspersoner, der fik en 80 mg tablet, og hvor ventriklens pH blev hævet ved administration af omeprazol i 5 dage, blev osimertinibeksponeringen ikke påvirket (AUC og Cmax stiger med henholdsvis 7 % og 2 %) med 90 % KI for eksponeringsforholdet inden for 80-125 % grænserne.
English: Neutrophils decreased
Danish: Nedsat antal neutrofilocytter
English: Effect of gastric acid reducing active substances on osimertinib In a clinical pharmacokinetic study, co-administration of omeprazole did not result in clinically relevant changes in osimertinib exposures.
Danish: Virkning af syrenedsættende substanser på osimertinib I et klinisk farmakokinetisk studie resulterede samtidig administration af omeprazol ikke i klinisk relevante ændringer i osimertinibeksponeringen.
English: • TAGRISSO may interfere with how well oral hormonal contraceptives work.
Danish: • TAGRISSO kan påvirke, hvor godt svangerskabsforebyggende tabletter (f.eks. p-piller) virker.
English: Previously untreated EGFR mutation positive locally advanced or metastatic NSCLC - FLAURA The efficacy and safety of TAGRISSO for the treatment of patients with EGFR mutation positive locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC, who had not received previous systemic treatment for advanced disease, was demonstrated in a randomised, double-blind, active-controlled study (FLAURA).
Danish: Virkning og sikkerhed med TAGRISSO til behandling af patienter med EGFR-mutationspositiv lokalt fremskreden NSCLC, der ikke er egnet til kurativ kirurgi eller strålebehandling, eller metastatisk NSCLC, som ikke tidligere havde fået systemisk behandling for fremskreden sygdom, blev påvist i et randomiseret, dobbeltblindet, aktiv-kontrolleret studie (FLAURA).
English: Includes cases reported within the clustered terms: Nail bed disorder, nail bed inflammation, nail bed infection, nail discolouration, nail pigmentation, nail disorder, nail toxicity, nail dystrophy, nail infection, nail ridging, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia.
Danish: Inkluderer tilfælde rapporteret inden for termgruppen: Neglelejesygdom, neglelejeinflammation, neglelejeinfektion, neglemisfarvning, neglepigmentering, neglesygdom, negletoksicitet, negledystrofi, negleinfektion, negleriller, neglesmerter, onykoklase, onykolyse, onykomadose, onykomalacia, paronychion.
English: Very common (68%) 1.5%
Danish: Meget almindelig (68 %) 1,5 %
English: Leucocytes decreased
Danish: Nedsat antal leukocytter
English: All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory prior to treatment.
Danish: Alle patienter skulle have EGFR T790M-mutationspositiv NSCLC identificeret med cobas EGFR-mutationstest udført i et centralt laboratorium inden behandling.
English: CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in AURA3
Danish: BICR hos patienter med CNS-metastaser ved en baseline-hjernescanning i AURA3
English: Very common (20%) 0.2%
Danish: Meget almindelig (20 %) 0,2 %
English: Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in FLAURA
Danish: Samlet PFS efter investigators vurdering efter status for CNS-metastaser ved studiets start, Kaplan-Meier-plot (fuldt analysesæt) i FLAURA
English: Very common (49%) 1.2%
Danish: Meget almindelig (49 %) 1,2 %
English: The safety and efficacy of this medicinal product has not been established in patients with severe hepatic impairment.
Danish: TAGRISSOs sikkerhed og virkning er ikke klarlagt hos patienter med svært nedsat leverfunktion.
English: The primary efficacy end-point was progression-free survival (PFS) as assessed by investigator.
Danish: Det primære virknings-endepunkt var progressionsfri overlevelse (PFS) vurderet af investigator.