FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of hepatic impairment on the single-dose pharmacokinetics of ceritinib (750 mg under fasted conditions) was evaluated in subjects with mild (Child-Pugh class A; N=8), moderate (ChildPugh class B; N=7), or severe (Child-Pugh class C; N=7) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Danish: Effekten af nedsat leverfunktion på enkeltdosis-farmakokinetikken for ceritinib (750 mg fastende) blev vurderet for forsøgspersoner med let (Child-Pugh klasse A, N=8), moderat (Child-Pugh klasse B, N=7) eller svært (Child-Pugh klasse C, N=7) nedsat leverfunktion og hos 8 raske forsøgspersoner med normal leverfunktion.
English: Patients should be monitored for QT prolongation and managed as recommended in sections 4.2 and
Danish: Patienter skal monitoreres for QT-forlængelse og behandles som anbefalet i pkt.
English: If you stop taking Zykadia
Danish: Hvis du holder op med at tage Zykadia
English: Adverse drug reactions (ADRs) described below reflect exposure to Zykadia 750 mg once daily fasted in 925 patients with ALK-positive advanced NSCLC across a pool of seven clinical studies including two randomised, active-controlled, phase 3 studies (studies A2301 and A2303).
Danish: Nedenstående bivirkninger afspejler eksponering af Zykadia 750 mg dagligt fastende hos 925 patienter med ALK-positiv fremskreden NSCLC i syv kliniske studier inklusive to randomiserede, kontrollerede fase 3-studier (studierne A2301 og A2303).
English: Titanium dioxide (E171) Macrogol
Danish: Hypromellose Titandioxid (E171) Macrogol Talcum
English: Printing ink: Shellac (bleached, de-waxed) glaze 45%, iron oxide black (E172), propylene glycol and ammonium hydroxide 28%.
Danish: Trykfarve: Shellac-glasur (bleget, afvokset) 45 %, sort jernoxid (E172), propylenglycol og ammoniumhydroxid 28 %.
English: After single oral administration of ceritinib in patients, plasma exposure to ceritinib, as represented by Cmax and AUClast, increased dose-proportionally over the 50 to 750 mg dose range under fasted conditions.
Danish: Efter en enkelt oral administration af ceritinib til patienter steg plasmaeksponeringen for ceritinib, repræsenteret ved Cmax og AUClast, dosisproportionalt over dosisområdet 50 til 750 mg fastende.
English: Zykadia may increase the side effects associated with the following medicines: medicines used to treat irregular heartbeat or other heart problems (e.g. amiodarone, disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide and digoxin).
Danish: Zykadia kan øge de bivirkninger, der er forbundet med følgende medicin: medicin, der bruges til behandling af uregelmæssig hjerterytme eller andre hjerteproblemer (fx amiodaron, disopyramid, procainamid, quinidin, sotalol, dofetilid, ibutilid og digoxin).
English: The frequency of these selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) is based on patients treated with the recommended dose of ceritinib 450 mg with food (N=89) in the study A2112 (ASCEND-8) (see subsection ‘Gastrointestinal adverse reactions' below)
Danish: Frekvensen af disse udvalgte bivirkninger (diarré, kvalme og opkastning) er baseret på patienter, som er behandlet med den anbefalede dosis ceritinib på 450 mg taget med mad (N=89) i studiet A2112 (ASCEND-8) (se afsnittet ”Gastrointestinale bivirkninger” nedenfor)
English: How long to take Zykadia
Danish: Hvor længe skal du tage Zykadia
English: Following single oral doses of ceritinib under fasted conditions, the geometric mean apparent plasma terminal half-life (T½) of ceritinib ranged from 31 to 41 hours in patients over the 400 to 750 mg dose range.
Danish: Efter orale enkeltdoser af ceritinib fastende lå ceritinibs geometriske, gennemsnitlige tilsyneladende plasmahalveringstid (T½) på mellem 31 og 41 timer hos patienter i dosisområdet 400 til 750 mg.
English: 50 hard capsules.
Danish: 50 hårde kapsler.
English: Vision disorder (vision impairment, vision blurred, photopsia, vitreous floaters, visual acuity reduced, accommodation disorder, presbyopia)
Danish: Synsforstyrrelser (nedsat syn, sløret syn, fotopsi, mouches volantes, nedsat synsskarphed, akkomodationslidelse, presbyopi)
English: Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Danish: Andre potentielle årsager til ILD/pneumonitis bør udelukkes (se pkt.
English: Packs containing 40, 90 or 150 (3 packs of 50) hard capsules.
Danish: Pakninger bestående af 40, 90 eller 150 (3 pakninger med 50) hårde kapsler.
English: Treatment with ceritinib is not recommended in patients who have congenital long QT syndrome or who are taking medicinal products known to prolong the QTc interval (see sections 4.4 and 4.5).
Danish: Behandling med ceritinib anbefales ikke til patienter med medfødt lang QT-syndrom eller patienter, der tager lægemidler, der vides at forlænge QT-intervallet (se pkt.
English: These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin).
Danish: medicin, der bruges til behandling af infektioner, herunder medicin til behandling af svampeinfektioner (midler mod svamp, som fx ketoconazol, itraconazol, voriconazol, posaconazol) og medicin til behandling af visse typer bakterieinfektioner (antibiotika, som fx telithromycin).
English: Skin and subcutaneous tissue disorders Rash j
Danish: Hud og subkutane væv Udslæt j
English: Based on in vitro data, ceritinib competitively inhibits the metabolism of a CYP3A substrate, midazolam, and a CYP2C9 substrate, diclofenac.
Danish: Baseret på in vitro-data er ceritinib kompetitiv hæmmer af metabolismen af CYP3A-substratet midazolam og CYP2C9-substratet diclofenac.
English: Hyperglycaemia (all grades) was reported in 9.4% of patients treated with ceritinib across the seven clinical studies; grade 3 or 4 events were reported in 5.4% of patients.
Danish: Hyperglykæmi (alle grader) blev rapporteret hos 9,4 % af patienterne, der blev behandlet med ceritinib på tværs af de syv kliniske studier; grad 3 eller 4 blev rapporteret hos 5,4 % af patienterne.
English: Any grade treatment-related interstitial lung disease (ILD)/pneumonitis
Danish: Alle grader af behandlingsrelateret interstitiel lungesygdom (ILD)/pneumonitis
English: Increases to grade 3 or 4 ALT elevations were observed in 25% of patients receiving ceritinib.
Danish: ALAT-stigninger til grad 3 eller 4 blev observeret hos 25 % af patienterne, der fik ceritinib.
English: However, based on available data, ceritinib elimination via the kidney is negligible.
Danish: Ifølge de tilgængelige data er elimination af ceritinib via nyrerne dog ubetydelig.
English: QTc prolongation has been observed in patients treated with ceritinib.
Danish: QTc-forlængelse blev observeret hos patienter, der blev behandlet med ceritinib.
English: Avoid concomitant use of strong CYP3A inhibitors during treatment with Zykadia.
Danish: Samtidig brug af potente CYP3A-hæmmere skal undgås under behandling med Zykadia.
English: medicines used to treat depression (e.g. nefazodone).
Danish: medicin, der bruges til behandling af depression (fx nefazodon).
English: Based on in vitro data, ceritinib is predicted to inhibit intestinal P-gp and BCRP at clinically relevant concentrations.
Danish: Baseret på in vitro-data forventes ceritinib at hæmme intestinal P-gp og BCRP i klinisk relevante koncentrationer.
English: Light blue, round, biconvex film-coated tablet with bevelled edges, without score, debossed with “NVR” on one side and “ZY1” on the other side.
Danish: Lyseblå, rund, bikonvex filmovertrukket tablet med skrå kanter, uden delekærv, præget med ”NVR” på den ene side og ”ZY1” på den anden side.
English: Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis have been observed in patients treated with ceritinib.
Danish: Svær, livstruende eller dødelig interstitiel lungesygdom (ILD)/pneumonitis blev observeret hos patienter, der blev behandlet med ceritinib.
English: There are no safety data in patients older than 85 years of age.
Danish: Der findes ingen sikkerhedsdata for patienter over 85 år.
English: There are no available data on patients over 85 years of age.
Danish: Der findes ingen tilgængelige data for patienter over 85 år.
English: Caution should be exercised when driving or using machines during treatment as patients may experience fatigue or vision disorders.
Danish: Patienter skal udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, da de kan opleve træthed eller synsforstyrrelser.
English: If these side effects become severe, please tell your doctor or pharmacist.
Danish: Hvis disse bivirkninger bliver alvorlige, skal du fortælle det til lægen eller apotekspersonalet.
English: Tell your doctor or pharmacist immediately if you get any of the following signs or symptoms during treatment with Zykadia: tiredness, itchy skin, yellowing of your skin or the whites of your eyes, nausea (feeling sick) or vomiting, decreased appetite, pain on the right side of your abdomen (belly), dark or brown urine, bleeding or bruising more easily than normal.
Danish: Fortæl det straks til lægen eller apotekspersonalet, hvis du får et eller flere af følgende symptomer under behandlingen med Zykadia: træthed, hudkløe, gulfarvning af huden eller det hvide i øjnene, kvalme eller opkastning, nedsat appetit, smerter i højre side af maven, mørk eller brun urin, blødning eller tendens til blå mærker i højere grad end normalt.
English: Patients should not alternate between fasted and fed dosing.
Danish: Patienter bør ikke veksle mellem fastende dosering og dosering sammen med mad.
English: Ceritinib 750 mg 115 87 68 40 31 18 12 9 Chemotherapy
Danish: Ceritinib 750 mg 115 87 68 40 31 18 12 9 Kemoterapi
English: Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment.
Danish: Dosisjustering er derfor ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: One hundred and eighty-nine (189) patients were randomised to ceritinib and one hundred eightyseven (187) were randomised to chemotherapy.
Danish: Ethundredeogniogfirs (189) patienter blev randomiseret til ceritinib og ethundredeogsyvogfirs (187) blev randomiseret til kemoterapi.
English: Abnormal results of blood tests to check liver function (high levels of enzymes called alanine aminotransferase and/or aspartate aminotransferase and/or gamma glutamyltransferase and/or blood alkaline phosphatase, high levels of bilirubin) Abdominal pain
Danish: Unormale blodprøveresultater ved måling af din leverfunktion (høje værdier af et enzym kaldet alaninaminotransferase og/eller aspartataminotransferase og/eller gamma-glutamyltransferase og/eller alkalisk fosfatase i blodet, høje bilirubin-værdier) Mavesmerter
English: Capsule with white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body, containing white to almost white powder.
Danish: Kapsel med hvid, uigennemsigtig underdel og blå, uigennemsigtig overdel, der er præget med ”LDK 150MG” på overdelen og ”NVR” på underdelen indeholdende et hvidt til næsten hvidt pulver.
English: The use of Zykadia in the treatment of ALK-positive NSCLC patients previously treated with an ALK inhibitor was investigated in two global, multicentre, open-label, single-arm phase 1/2 studies (Study X2101 and Study A2201).
Danish: Anvendelse af Zykadia i behandlingen af ALK-positive NSCLC-patienter, der tidligere har været behandlet med en ALK-hæmmer blev undersøgt i to globale, multicenter-, open-label, enkeltarmede, fase-1/2-studier (Studie X2101 og Studie A2201).
English: Liver laboratory tests including ALT, AST and total bilirubin should be performed prior to the start of treatment, every 2 weeks during the first three months of treatment and monthly thereafter, with more frequent testing for grade 2, 3 or 4 elevations.
Danish: ALAT, ASAT og totalbilirubin før initiering af behandling med ceritinib, hver anden uge i de første tre måneders behandling samt månedligt derefter med mere hyppig kontrol ved grad 2, 3 og 4-stigninger.
English: A dedicated pharmacokinetic study in patients with renal impairment has not been conducted.
Danish: Der er ikke udført et specifikt farmakokinetisk studie hos patienter med nedsat nyrefunktion.
English: Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Danish: Zykadia som monoterapi er indiceret til behandling af voksne patienter med anaplastisk lymfomkinase (ALK)-positiv fremskreden ikke-småcellet lungecancer (NSCLC), der tidligere har været behandlet med crizotinib.
English: Reproductive toxicology studies (i.e. embryo-foetal development studies) in pregnant rats and rabbits indicated no foetotoxicity or teratogenicity after dosing with ceritinib during organogenesis; however, maternal plasma exposure was less than that observed at the recommended human dose.
Danish: Reproduktionstoksikologiske studier (dvs. studier af embryo-føtal udvikling) hos gravide rotter og kaniner viste ingen føtotoksicitet eller teratogenicitet efter dosering med ceritinib under organogenesen.
English: Across the seven clinical studies, any grade ILD/pneumonitis has been reported in 2.1% of patients treated with ceritinib, and grade 3 or 4 events have been reported in 1.2% of patients.
Danish: På tværs af de syv kliniske studier er der rapporteret ILD/pneumonitis (alle grader) hos 2,1 % af patienterne, der blev behandlet med ceritinib og grad 3 og 4 hos 1,2 % af patienterne.
English: In clinical studies, QT prolongation was observed with ceritinib.
Danish: I kliniske studier blev der observeret QT-forlængelse med ceritinib.
English: In Study A2301, 44 patients with measurable brain metastasis at baseline and at least one post-baseline brain radiological assessment (22 patients in the ceritinib arm and 22 patients in the chemotherapy arm) were assessed for intracranial response by BIRC neuro-radiologist per modified RECIST 1.1 (i.e.
Danish: I studie A2301 blev 44 patienter med målbare hjernemetastaser ved baseline og mindst en postbaseline radiologisk undersøgelse af hjernen (22 patienter i ceritinib-armen og 22 patienter i kemoterapi-armen) vurderet for intrakranielt respons af en BIRC neuroradiolog ifølge modificeret RECIST 1.1 (dvs. op til 5 læsioner i hjernen).
English: After discontinuation of a strong CYP3A inhibitor, resume at the dose that was taken prior to initiating the strong CYP3A inhibitor.
Danish: Efter ophør af behandling med en potent CYP3A-hæmmer, fortsættes med den dosis, der blev taget før behandling med den potente CYP3A-hæmmer startede.
English: Therefore, ceritinib should be used with caution in patients who have or may develop prolongation of the QT interval, including those patients taking anti-arrhythmic medicinal products such as class I (e.g. quinidine, procainamide, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) anti-arrhythmics or other medicinal products that may lead to QT prolongation such as domperidone, droperidol, chloroquine, halofantrine, clarithromycin, haloperidol, methadone, cisapride and moxifloxacin.
Danish: Ceritinib bør derfor anvendes med forsigtighed hos patienter, der har eller kan udvikle forlængelse af QT-intervallet, herunder patienter, der tager antiarytmiske lægemidler, såsom klasse I (fx quinidin, procainamid, disopyramid) eller klasse III (fx amiodaron, sotalol, dofetilid, ibutilid) antiarytmika eller andre lægemidler, der kan forårsage QT-forlængelse, såsom domperidon, droperidol, chloroquin, halofantrin, clarithromycin, haloperidol, methadon, cisaprid og moxifloxacin.
English: The frequency of selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) are based on patients treated with a dose of 450 mg once-daily with food (N=89).
Danish: Frekvensen af udvalgte gastrointestinale bivirkninger (diarré, kvalme og opkastning) er baseret på patienter, som er behandlet med en dosis på 450 mg en gang daglig sammen med mad.
English: If you forget to take Zykadia
Danish: Hvis du har glemt at tage Zykadia
English: Agents whose plasma concentration may be altered by ceritinib
Danish: Lægemidler, hvis plasmakoncentration kan ændres af ceritinib
English: Grade 3-4 ADRs with an incidence of ≥5% in patients treated with Zykadia 750 mg fasted were liver laboratory test abnormalities, fatigue, vomiting, hyperglycaemia, nausea and diarrhoea.
Danish: Bivirkninger af grad 3-4 med en forekomst på ≥5 % hos patienter behandlet med Zykadia 750 mg fastende var unormale leverfunktionstests, træthed, opkastning, hyperglykæmi, kvalme og diarré.
English: In cases of symptomatic bradycardia that is not life-threatening, Zykadia should be withheld until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, the use of concomitant medicinal products should be evaluated and the Zykadia dose adjusted if necessary.
Danish: I tilfælde af symptomatisk bradykardi, som ikke er livstruende, skal Zykadia pauseres indtil bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover, brug af samtidige lægemidler skal evalueres og Zykadia-dosen justeres om nødvendigt.
English: Duration of follow-up Median (months) (min - max) Progression-free survival (based on BIRC) Number of events, n (%) Median, months (95% CI) HR (95% CI)
Danish: Opfølgningsvarighed Median (måneder) (min - max) Progressionsfri overlevelse (baseret på BIRC) Antal hændelser, n (%) Median, måneder (95 % CI) HR (95 % CI)
English: Severe, life-threatening or fatal ILD/pneumonitis have been observed in patients treated with ceritinib in clinical studies.
Danish: Svær, livstruende eller fatal ILD/pneumonitis blev observeret hos patienter, der blev behandlet med ceritinib i kliniske studier.
English: CYP3A and CYP2C9 substrates
Danish: CYP3A- og CYP2C9-substrater
English: chest pain or discomfort, changes in your heartbeat (fast or slow), light-headedness, fainting, dizziness, blue discoloration of your lips, shortness of breath, swelling of your lower limbs or skin.
Danish: brystsmerter eller -ubehag, ændringer i hjerterytmen (hurtig eller langsom), ørhed, besvimelse, svimmelhed, blå misfarvning af læberne, kortåndethed, hævelse af benene eller huden.
English: sulfasalazine, a medicine used to treat inflammatory bowel disease or rheumatoid arthritis.
Danish: sulfasalazin, der bruges til at behandle inflammatorisk tarmsygdom eller kronisk leddegigt.
English: Chemotherapy (N=187)
Danish: Kemoterapi (N=187)
English: QT corrected for heart rate (QTc) >500 msec on at least 2 separate electrocardiograms (ECGs)
Danish: QT korrigeret for hjertefrekvens (QTc) >500 msek.
English: 1% of patients required permanent discontinuation of treatment in clinical studies with ceritinib (see sections 4.2 and 4.4).
Danish: 1 % af patienterne krævede permanent seponering af behandling i kliniske studier med ceritinib (se pkt.
English: Shellac (bleached, de-waxed) glaze 45% Iron oxide black (E172) Propylene glycol
Danish: Shellac-glasur (bleget, afvokset) 45 % Jernoxid, sort (E172) Propylenglycol
English: If it is not possible to avoid concomitant use with strong CYP3A inhibitors (including, but not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone), reduce the ceritinib dose by approximately one third, rounded to the nearest multiple of the 150 mg dosage strength.
Danish: Hvis samtidig brug af potente CYP3A-hæmmere ikke kan undgås (herunder, men ikke begrænset til, ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol og nefazodon), skal dosis reduceres med ca. en tredjedel, afrundet til den nærmeste dosis 150 mg-styrken går op i. Efter ophør af behandling med en potent CYP3A-hæmmer, fortsættes med ceritinib i den dosis, der blev taget før behandling med den potente CYP3A-hæmmer startede.
English: A categorical outlier analysis of ECG data demonstrated new QTc >500 msec in 12 patients (1.3%).
Danish: En kategorisk afvigelsesanalyse af EKG-data viste et nyt QTc >500 msek.
English: ADRs with an incidence of ≥10% in patients treated with Zykadia 750 mg fasted were diarrhoea, nausea, vomiting, fatigue, liver laboratory test abnormalities, abdominal pain, decreased appetite, weight decreased, constipation, blood creatinine increased, rash, anaemia and oesophageal disorder.
Danish: Bivirkninger med en forekomst ≥10 % hos patienter behandlet med Zykadia 750 mg fastende var diarré, kvalme, opkastning, træthed, unormale leverfunktionstests, mavesmerter, nedsat appetit, vægttab, obstipation, forhøjet blodkreatinin, udslæt, anæmi og øsofagussygdom.
English: Patients who develop symptomatic bradycardia should be managed as recommended in sections 4.2 and 4.4.
Danish: Patienter, der udvikler symptomatisk bradykardi skal behandles som anbefalet i pkt.
English: Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products.
Danish: Samtidig brug af lægemidler, som vides at forårsage bradykardi, samt antihypertensiva bør evalueres.
English: A dedicated pharmacokinetic study under steady-state in patients with hepatic impairment has not been conducted.
Danish: Der er ikke udført et specifikt steady-state farmakokinetisk studie hos patienter med nedsat leverfunktion.
English: Oesophageal disorder (dyspepsia, gastro-oesophageal reflux disease, dysphagia)
Danish: Øsofagussygdom (dyspepsi, gastroøsofageal reflukssygdom, dysphagi)
English: Monitoring of fasting serum glucose is required prior to the start of ceritinib treatment and periodically thereafter as clinically indicated.
Danish: Fasteplasmaglucose skal monitoreres før initiering af behandling med ceritinib og periodisk derefter som klinisk indiceret.
English: Ceritinib 750 mg fasted (N=40)
Danish: Ceritinib 750 mg fastende (N=40)
English: CI: Confidence Interval
Danish: CI: Konfidensinterval
English: The recommended dose of Zykadia is 450 mg taken orally once daily with food at the same time each day.
Danish: Den anbefalede dosis af Zykadia er 450 mg oralt én gang daglig taget sammen med mad og på samme tid hver dag.
English: Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Danish: Zykadia som monoterapi er indiceret til førstelinjebehandling af voksne patienter med anaplastisk lymfomkinase (ALK)-positiv fremskreden ikke-småcellet lungecancer (NSCLC).
English: The PFS benefit of Zykadia was consistent across various subgroups including age, gender, race, smoking class, ECOG performance status, and presence of brain metastases or prior response to crizotinib.
Danish: alder, køn, race, rygerklasse, ECOG performance status og tilstedeværelse af hjernemetastaser eller tidligere respons af crizotinib.
English: The maximum recommended dose with food is 450 mg taken orally once daily.
Danish: Den maksimale anbefalede daglige dosis sammen med mad er 450 mg oralt én gang daglig.
English: Liver laboratory test abnormalities (alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, blood bilirubin increased, transaminases increased, hepatic enzyme increased, liver function test abnormal, liver function test increased, blood alkaline phosphatase increased)
Danish: Unormale resultater af leverlaboratorietests (forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet gamma-glutamyltransferase, forhøjet blodbilirubin, forhøjede transaminaser, forhøjede leverenzymer, unormal leverfunktionstest, stigning i leverfunktionstest, forhøjet alkalisk fosfatase i blodet)
English: The geometric mean AUCinf (unbound AUCinf) of ceritinib was increased by 18% (35%) and 2% (22%) in subjects with mild and moderate hepatic impairment, respectively, compared to subjects with normal hepatic function.
Danish: Det geometriske gennemsnit af AUCinf (ubundet AUC inf) af ceritinib blev øget med henholdvis 18 % (35 %) og 2 % (22 %) hos forsøgspersoner med let og moderat nedsat leverfunktion sammenlignet med forsøgspersoner med normal leverfunktion.