FrancophonIA/ELRC3.0 huggingface dataset:
English: - reduction in the number of white blood cells (leucopenia) - decreased activity of the thyroid gland (hypothyroidism) - low levels of potassium, phosphate, calcium, sodium or magnesium in your blood
Danish: - reduktion i antallet af hvide blodlegemer (leukopeni) - nedsat aktivitet af skjoldbruskkirtlen (hypotyreoidisme) - lave niveauer af kalium, fosfat, calcium, natrium eller magnesium i blodet (hypokaliæmi,
English: Secondary endpoints were Progression-Free Survival (PFS), Time To Progression (TTP), Objective Tumour Response Rate (ORR) and Disease Control Rate (DCR).
Danish: Sekundære endepunkter var progressionsfri overlevelse (PFS), tid til progression (TTP), objektiv tumorresponsrate (ORR) og sygdomskontrolrate (DCR).
English: This medicine contains 1.68 mg of lecithin (derived from soya) per daily dose (4 tablets).
Danish: Denne medicin indeholder 1,68 mg lecithin (deriveret fra soja) pr. daglig dosis (4 tabletter).
English: Posterior reversible encephalopathy syndrome (PRES) PRES has been reported in association with Stivarga treatment (see section 4.8).
Danish: Posteriort reversibelt leukoencefalopatisk syndrom (PRES) PRES er blevet rapporteret i forbindelse med behandling med Stivarga (se pkt.
English: The most serious side effects, for which a fatal outcome has been observed, are: - Severe liver problems, bleeding, gastrointestinal perforation and infection.
Danish: De alvorligste bivirkninger, for hvilke der er observeret et dødeligt udfald er: - svære leverproblemer, blødning, mave-tarm-perforation og infektion.
English: * International normalized ratio BSC = Best Supportive Care
Danish: BSC = Bedste understøttende behandling
English: What you need to know before you take Stivarga Do not take Stivarga
Danish: Det skal du vide, før du begynder at tage Stivarga Tag ikke Stivarga:
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejersken eller apotekspersonalet.
English: Management of HFSR may include the use of keratolytic creams (e.g. urea-, salicylic acid-, or alpha hydroxyl acid-based creams applied sparingly only on affected areas) and moisturizing creams (applied liberally) for symptomatic relief.
Danish: Behandling af HFSR kan inkludere brug af keratolytiske cremer (f.eks. cremer baseret på urea, salicylsyre eller alpha hydroxysyre påført sparsomt og kun på de berørte områder), fugtighedsgivende cremer (påført i rigelige mængder) for symptomatisk lindring.
English: Secondary endpoints were Progression-Free Survival (PFS), Objective Tumour Response Rate (ORR) and Disease Control Rate (DCR).
Danish: Sekundære endepunkter var progressionsfri overlevelse (PFS), objektiv tumorresponsrate (ORR) og sygdomskontrolrate (DCR).
English: Get medical help immediately if you get the following symptoms, as they may be signs of a heart attack or decreased blood flow to the heart: chest discomfort or pain which may spread beyond your chest to your shoulders, arms, back, neck, teeth, jaw or stomach and may come and go; shortness of breath; sudden outbreak into a sweat with cold, clammy skin, feeling dizzy or fainting.
Danish: Få straks medicinsk hjælp, hvis du får de følgende symptomer, da de kan være tegn på et hjerteanfald eller nedsat blodomløb til hjertet: Utilpashed i brystet eller smerter, der kan spredes fra brystet til skuldrene, armene, ryggen, halsen, tænderne, kæben eller maven, og de kan komme og gå, stakåndethed, pludselig svedtendens med kold, klam hud, svimmelhed eller besvimelse.
English: The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy.
Danish: Den anbefalede dosis regorafenib er 160 mg (4 tabletter med 40 mg), der tages én gang dagligt i 3 uger, efterfulgt af 1 uge uden behandling.
English: The HR for OS was 0.772 (95% CI, 0.423, 1.408; p = 0.199; median OS not reached in either arm); 85% of patients initially randomised to the placebo arm received post-progression treatment with regorafenib (see Table 6, Figure 3).
Danish: Hazard ratio for OS var 0,772 (95 % CI 0,423; 1,408; p = 0,199; median-OS blev ikke nået i nogen af armene); 85 % af de patienter, der til at begynde med blev randomiseret til placeboarmen, fik behandling med regorafenib efter progression (se tabel 6, figur 3).
English: Table 4: Treatment-emergent laboratory test abnormalities reported in placebo-controlled phase III trials in patients with metastatic CRC (CORRECT), GIST (GRID) and HCC (RESORCE)
Danish: Tabel 4: Laboratorieprøveanomalier opstået under behandlingen og rapporteret i placebokontrolleret fase III-studie hos patienter med metastaserende KRC (CORRECT), GIST (GRID) og HCC (RESORCE) mKRC (CORRECT)
English: Asthenia/ fatigue
Danish: Asteni/ træthed
English: Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: The most frequently observed adverse drug reactions at this dose were dermatological events, dysphonia, diarrhoea, mucosal inflammation, dry mouth, decreased appetite, hypertension, and fatigue.
Danish: De hyppigst observerede lægemiddelbivirkninger ved denne dosis var dermatologiske hændelser, dysfoni, diaré, slimhindeinflammation, tør mund, nedsat appetit, hypertension og træthed.
English: Strong inducers of CYP3A4 should be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered.
Danish: Alternativt bør det overvejes at vælge et andet samtidigt lægemiddel uden potentiale eller med minimalt potentiale for at inducere CYP3A4.
English: In clinical studies, no relevant differences in exposure, safety or efficacy were observed between male and female patients.
Danish: I kliniske studier blev der ikke observeret relevante forskelle i eksponering, sikkerhed eller effekt mellem mænd og kvinder.
English: Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm marked with ‘BAYER' on one side and ‘40' on the other side.
Danish: Lyserøde, ovale, filmovertrukne tabletter, der er 16 mm lange og 7 mm brede og mærket med ”BAYER” på den ene side og ”40” på den anden side.
English: The incidence of Grade 3 hypertension was 8.7% (CRC), 28.0% (GIST) and 15.2% (HCC).
Danish: Forekomsten af hypertension af grad 3 var 8,7 % (KRC), 28,0 % (GIST) og 15,2 % (HCC).
English: Major human metabolites (M-2 and M-5) exhibited similar efficacies, compared to regorafenib in in vitro and in vivo models.
Danish: Vigtige metabolitter (M-2 og M-5) udviste lignende virkning sammenlignet med regorafenib i in vitro- og in vivo-modeller.
English: The hazard ratio (95% CI) of PFS was 0.475 (0.362 to 0.623) for patients with KRAS wild-type tumours and 0.525 (0.425 to 0.649) for patients with KRAS mutant tumours.
Danish: Hazard ratio (95 % CI) for PFS var 0,475 (0,362-0,623) for patienter med KRAS-wildtype tumorer og 0,525 (0,425-0,649) for patienter med KRAS-muterede tumorer.
English: Treatment with Stivarga may lead to a higher risk of infections, especially of the urinary tract, nose, throat and lung.
Danish: Behandling med Stivarga kan medføre en større risiko for infektioner, særligt i urinvejene, næsen, halsen og lungerne.
English: Regorafenib, M-2 and M-5 are likely to undergo enterohepatic circulation (see section 5.2).
Danish: Regorafenib, M-2 og M-5 undergår sandsynligvis enterohepatisk cirkulation (se pkt.
English: Get medical help immediately if you get the following symptoms: - high fever - severe cough with or without an increase in mucus (sputum) production - severe sore throat
Danish: Få omgående akuthjælp, hvis du får følgende symptomer: - høj feber - alvorlig hoste med eller uden stigning i slim(spyt)produktion - meget øm hals
English: Severe liver function test abnormalities (Grade 3 to 4) and hepatic dysfunction with clinical manifestations (including fatal outcomes) have been reported in a small proportion of patients (see section 4.8).
Danish: Alvorlige påvirkninger af leverfunktionsprøver (grad 3 og 4) og klinisk leversvigt (inklusive dødelige udfald) er blevet rapporteret hos en lille andel af patienter (se pkt.
English: Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dose recommendation can be provided.
Danish: Da der kun foreligger begrænsede data for patienter med moderat nedsat leverfunktion (Child-Pugh B), kan der ikke gives nogen dosisanbefalinger til sådanne patienter.
English: Dose reduction and/or temporary interruption of Stivarga, or in severe or persistent cases, permanent discontinuation of Stivarga should be considered (see section 4.2).
Danish: Dosisreduktion og/eller en midlertidig afbrydelse af Stivarga, eller i svære eller vedvarende tilfælde en permanent seponering af Stivarga, bør overvejes (se pkt.
English: An effect of regorafenib on intrauterine development was shown in rabbits at exposures below the anticipated human exposure (based on AUC comparison).
Danish: Det blev påvist, at regorafenib havde en virkning på intrauterin udvikling hos kaniner ved en lavere eksponeringer end den forventede humane eksponering (baseret på AUC-sammenligning).
English: Treatment with Stivarga may also lead to a higher risk of fungal infections of the mucous membrane, skin or the body.
Danish: Behandling med Stivarga kan også medføre en større risiko for svampeinfektioner i slimhinderne, på huden eller kroppen.
English: The concentrations of regorafenib and its major pharmacologically active metabolites (M-2 and M-5) were highest when given after a low-fat (light) breakfast, compared to either a high-fat breakfast or fasting condition.
Danish: Koncentrationerne af regorafenib og dets vigtigste farmakologisk aktive metabolitter (M-2 og M-5) var højest, når det blev givet efter fedtfattig (let) morgenmad sammenlignet med enten morgenmad med højt fedtindhold eller ved fastende tilstand.
English: Important information about some of the ingredients This medicinal product contains 55.8 mg sodium per daily dose of 160 mg, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya).
Danish: Vigtig information om nogle af indholdsstofferne Dette lægemiddel indeholder 55,8 mg natrium pr. daglig dosis på 160 mg svarende til 3 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: No dose adjustment is necessary based on ethnicity (see section 5.2).
Danish: Dosisjustering baseret på etnicitet er ikke nødvendig (se pkt.
English: >5 times ULN ≤20 times ULN (Grade 3)
Danish: > 5 gange ULN til ≤ 20 gange ULN (grad 3)
English: Stivarga 40 mg film-coated tablets.
Danish: Stivarga 40 mg filmovertrukne tabletter.
English: The most frequently observed adverse drug reactions (≥30%) in patients receiving Stivarga are pain, hand foot skin reaction, asthenia/fatigue, diarrhoea, decreased appetite and food intake, hypertension and infection.
Danish: De hyppigst observerede lægemiddelbivirkninger (≥ 30 %) hos patienter, der får Stivarga, er smerte, hånd-fod-hudreaktion, asteni/træthed, diaré, nedsat appetit og fødeindtagelse, hypertension og infektion.
English: M-5 may be reduced to M-4 in the gastrointestinal tract by microbial flora, allowing reabsorption of M-4 (enterohepatic circulation).
Danish: M-5 kan reduceres af mikrobiel flora til M-4 i mave-tarm-kanalen, og gøre reabsorption af M-4 mulig (enterohepatisk cirkulation).
English: 0.9 months
Danish: 0,9 måneder
English: vomiting, and fever (pancreatitis) - nail disorder (changes to the nail such as ridges and/or splitting) - multiple skin eruptions (erythema multiforme).
Danish: opkastning og feber (pankreatitis) - neglesygdom (ændringer i neglene, f.eks. riller og/eller flækker let) - multiple huderuptioner (erythema multiforme).
English: Figure 5: Kaplan-Meier curve of PFS (mRECIST)
Danish: Figur 5: Kaplan-Maier kurver for PFS (mRECIST)
English: Haemorrhage* Hypertension
Danish: Blødning* Hypertension
English: Co-administration of a strong UGT1A9 inhibitor (e.g. mefenamic acid, diflunisal, and niflumic acid) during regorafenib treatment should be avoided, as their influence on the steady-state exposure of regorafenib and its metabolites has not been studied.
Danish: Samtidig administration af kraftige UGT1A9-hæmmere (f.eks. mefenaminsyre, diflunisal og nifluminsyre) i løbet af behandlingen med regorafenib bør undgås, da deres indflydelse på steady state-eksponeringen over for regorafenib og metabolitter herfra ikke er blevet undersøgt.
English: Taking too much Stivarga may make some side effects more likely or more severe, especially: - skin reactions (rash, blisters, redness, pain, swelling, itching or peeling of your skin) - voice changes or hoarseness (dysphonia) - frequent or loose bowel movements (diarrhoea) - mouth sores (mucosal inflammation)
Danish: Hvis du tager for meget Stivarga, kan det gøre nogle bivirkninger mere sandsynlige eller mere alvorlige, især: - hudreaktioner (udslæt, blærer, rødme, smerte, hævelse, kløe eller afskallende hud) - stemmeændringer eller hæshed (dysfoni) - hyppig eller løs afføring (diaré)
English: Treatment with Stivarga may lead to a higher risk of bleeding.
Danish: Behandling med Stivarga kan medføre en større risiko for blødning.
English: It is recommended to monitor blood pressure and to treat hypertension in accordance with standard medical practice.
Danish: Det anbefales at kontrollere blodtrykket og at behandle hypertension iht.
English: A KRAS mutation was reported in 57% of patients at study entry.
Danish: 57 % af patienterne havde KRAS-muteret tumor ved studiestart.
English: Treatment should continue as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4).
Danish: Behandling fortsættes så længe, der findes klinisk indikation herfor, eller indtil der opstår uacceptabel toksicitet (se pkt.
English: The exposure of regorafenib and its metabolites M-2 and M-5 is comparable in patients with mild hepatic impairment (Child-Pugh A) and patients with normal hepatic function.
Danish: Eksponeringen for regorafenib og dets metabolitter M-2 og M-5 er sammenlignelig hos patienter med let nedsat leverfunktion (Child-Pugh A) og patienter med normal leverfunktion.
English: If you have any questions about how Stivarga works or why this medicine has been prescribed for you, please ask your doctor.
Danish: Spørg lægen, hvis du har spørgsmål om, hvordan Stivarga virker, eller hvorfor du har fået ordineret dette lægemiddel.
English: Each bottle contains 28 film-coated tablets.
Danish: Hver tabletbeholder indeholder 28 filmovertrukne tabletter.
English: Discontinuation of Stivarga is recommended in patients developing gastrointestinal perforation or fistula.
Danish: Det anbefales at seponere Stivarga hos patienter, der udvikler mave-tarm-perforation eller fistel.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Most infections in patients treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 23.0%), and included urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) as well as pneumonia (2.6%).
Danish: De fleste infektioner hos patienter behandlet med Stivarga var milde til moderate i sværhedsgrad (grad 1 og 2: 23,0 %) og inkluderede urinvejsinfektioner (5,7 %), nasofaryngitis (4,0 %), slimhinde- og systemiske svampeinfektioner (3,3 %) samt lungebetændelse (2,6 %).
English: Fatal outcome in patients treated with Stivarga was uncommon (0.7%), and included cerebral, respiratory, gastrointestinal and genitourinary events.
Danish: Dødeligt udfald hos patienter i behandling med Stivarga var ikke almindelige (0,7 %) og inkluderede cerebrale hændelser og hændelser i luftvejene, mave-tarm-kanalen og urogenitalvejene.
English: Severe stomach and bowel problems (gastrointestinal perforation or fistula) Get medical help immediately, if you get the following symptoms: - severe stomach (abdominal) pain or stomach pain that does not go away - vomiting blood - red or black stools.
Danish: Alvorlige mave- og tarmproblemer (mave-tarm-perforation eller fistel) Få omgående akuthjælp, hvis du får følgende symptomer: - alvorlig mave (abdominal)-smerte eller mavesmerte, der ikke forsvinder - opkastning af blod - rød eller sort afføring.
English: Dose interruption or reduction, or permanent discontinuation of Stivarga should be considered in case of persistent or recurrent significant abnormalities (see section 4.2).
Danish: Dosisafbrydelse eller dosisreduktion eller permanent seponering af Stivarga bør overvejes i tilfælde med vedvarende eller recidiverende signifikante anomalier (se pkt.
English: Exception: patients with Gilbert's syndrome who develop elevated transaminases should be managed as per the above outlined recommendations for the respective observed elevation of ALT and/or AST.
Danish: Undtagelse: patienter med Gilberts syndrom, der udvikler forhøjede transaminaser, skal behandles iht.
English: - if you get an infection with signs such as high fever, severe cough with or without an increase in mucus (sputum) production, severe sore throat, shortness of breath, burning/pain when urinating, unusual vaginal discharge or irritation, redness, swelling and/or pain in any part of the body.
Danish: - Hvis du får en infektion med tegn såsom høj feber, alvorlig hoste med eller uden stigning i slim(spyt)produktion, meget øm hals, stakåndethed, brændende fornemmelse/smerte ved vandladning, usædvanligt udflåd fra skeden eller irritation, rødme, hævelse og/eller smerter vilkårlige steder på kroppen.
English: Stivarga is used to treat: - colon or rectal cancer that has spread to other parts of the body in adult patients who have received other treatments or cannot be treated with other medicines (fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy)
Danish: Stivarga bruges til at behandle: - kræft i tyktarmen eller endetarmen, der har spredt sig til andre dele af kroppen hos voksne patienter, som har fået andre behandlinger, eller som ikke kan behandles med andre lægemidler (fluorpyrimidin-baseret kemoterapi, et VEGF-hæmmende middel og en anti-EGFR-behandling)
English: Breast cancer resistance protein (BCRP) and P-glycoprotein substrates Administration of regorafenib (160 mg for 14 days) prior to administration of a single dose of rosuvastatin (5 mg), a BCRP substrate, resulted in a 3.8-fold increase in mean exposure (AUC) of rosuvastatin and a 4.6-fold increase in Cmax.
Danish: Substrater for brystcancer-resistent protein (BCRP) og P-glykoprotein Administration af regorafenib (160 mg i 14 dage) før administration af en enkeltdosis rosuvastatin (5 mg), et BCRP-substrat, gav en stigning i den gennemsnitlige eksponering (AUC) for rosuvastatin på 3,8 gange og en stigning i Cmax på 4,6 gange.
English: Disease-specific precautions - Hepatocellular carcinoma (HCC) In the pivotal placebo-controlled phase III study, patients received prior therapy with sorafenib.
Danish: Sygdomsspecifikke forsigtighedsregler - Hepatocellulært karcinom (HCC) I det pivotale placebokontrollerede fase III-studie fik patienterne sorafenib inden behandlingen.
English: Monitor liver function weekly until resolution or return to baseline.
Danish: Kontrollér leverfunktionen ugentligt, indtil leverfunktionen normaliseres eller vender tilbage til baseline.
English: A second phase III, international, multi-centre, randomised, double blind, placebo-controlled study (CONCUR) evaluated the efficacy and safety of Stivarga in 204 pre-treated Asian patients (> 90% East Asian) with metastatic colorectal cancer who have progressed after failure of fluoropyrimidinebased chemotherapy.
Danish: Et andet internationalt, randomiseret, dobbeltblindet, placebokontrolleret fase III-multicenterstudie (CONCUR) evaluerede Stivargas virkning og sikkerhed hos 204 tidligere behandlede asiatiske patienter (> 90 % fra Østasien) med metastaserende kolorektal cancer, der havde progredieret efter svigt af fluorpyrimidin-baseret kemoterapi.
English: No dose adjustment is required in patients with mild, moderate or severe renal impairment (see also section 5.2).
Danish: Dosisjustering hos patienter med let, moderat eller svært nedsat nyrefunktion er ikke nødvendig (se også pkt.
English: A dose re-escalation is permitted at the discretion of the physician.
Danish: Dosen kan eventuelt sættes op igen efter lægens skøn.
English: * fatal cases have been reported ** palmar-plantar erythrodysesthesia syndrome in MedDRA terminology # according to drug-induced liver injury (DILI) criteria of the international DILI expert working group
Danish: Stigning i amylase Stigning i lipase Unormal international normaliseret ratio * Dødelige tilfælde er blevet rapporteret ** palmoplantar erytrodysæstesi-syndrom i MedDRA-terminologi # i henhold til kriterierne for lægemiddelinduceret hepatotoksicitet (DILI) fra den internationale DILI-ekspertarbejdsgruppe.
English: Stivarga 40 mg film-coated tablets regorafenib
Danish: Stivarga 40 mg filmovertrukne tabletter regorafenib
English: Stivarga can cause severe bleeding in the digestive system such as stomach, throat, rectum or intestine, or in the lungs, kidneys, mouth, vagina and/or brain.
Danish: Stivarga kan medføre alvorlig blødning i fordøjelsessystemet, f.eks. mave, hals, endetarm eller tarm, eller i lungerne, nyrerne, munden, skeden og/eller hjernen.
English: White opaque HDPE bottle closed with a PP/PP (polypropylene) screw cap with sealing insert and a molecular sieve desiccant.
Danish: Hvid, uigennemsigtig HDPE-tabletbeholder, lukket med et PP/PP (polypropylen) skruelåg med indsat forsegling og molekylær si-tørremiddel.
English: Table 3: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with Stivarga
Danish: Tabel 3: Lægemiddelbivirkninger (ADR'er) rapporteret hos patienter behandlet med Stivarga i kliniske studier
English: The concentration-time profile indicates that regorafenib and its metabolites may undergo enterohepatic circulation (see section 5.2).
Danish: Koncentrations-/tidskurven indikerer, at regorafenib og dets metabolitter kan undergå enterohepatisk cirkulation (se pkt.
English: Table 4a: Treatment emergent liver enzyme test abnormalities reported in placebo-controlled phase III trial in Asian patients with metastatic CRC (CONCUR)
Danish: Tabel 4a: Anomalier i leverfunktionsprøver opstået under behandlingen og rapporteret i det placebokontrolleret fase III-studie hos asiatiske patienter med metastaserende KRC (CONCUR)
English: Stivarga has been associated with an increased incidence of arterial hypertension (see section 4.8).
Danish: Stivarga er blevet associeret med en øget forekomst af arteriel hypertension (se pkt.
English: Pack of 84 (3 bottles of 28) film-coated tablets.
Danish: Pakke med 84 (3 tabletbeholdere à 28) filmovertrukne tabletter.
English: In patients with severe renal impairment compared to patients with normal renal function, regorafenib exposure was similar while exposure to M-2 and M-5 was decreased by about 30% under steady-state conditions, which is not considered clinically relevant.
Danish: Eksponeringen for regorafenib var den samme hos patienter med svært nedsat nyrefunktion som hos patienter med normal nyrefunktion, mens eksponeringen for M-2 og M-5 ved steady state var ca. 30 % lavere, hvilket ikke anses for at være klinisk relevant.
English: Hand-foot skin reaction** Rash
Danish: Hånd-fodhudreaktion** Udslæt
English: No dosage adjustment is necessary if you have a mildly impaired liver function.
Danish: Det er ikke nødvendigt at justere dosis, hvis du har let nedsat leverfunktion.
English: 4.8 months
Danish: 4,8 måneder
English: At steady state, regorafenib reaches mean peak plasma levels of about 3.9 mg/L (8.1 micromolar) after oral administration of 160 mg regorafenib and the peak-to-trough ratio of mean plasma concentrations is less than 2.
Danish: Ved steady state når regorafenib gennemsnitlige top-plasmaniveauer på ca. 3,9 mg/l (8,1 mikromolær) efter oral administration af 160 mg regorafenib og peak-to-trough ratio for gennemsnitlige plasmakoncentrationer er under 2.