FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia)
Danish: • hvis du har stærkt nedsat antal hvide blodceller eller blodplader (leucopeni, neutropeni eller trombocytopeni),
English: Hand and foot syndrome also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.
Danish: Hånd- og fodsyndrom, også kendt som hånd- og fodhudreaktion, palmoplantar erytrodysæstesi eller kemoterapiinduceret akralt erytem.
English: There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Capecitabine Accord.
Danish: Der er nogen evidens for, at dexpanthenol er virksomt som profylakse mod hånd- og fodsyndrom hos patienter, der behandles med Capecitabine Accord.
English: Treatment with capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decrease to ≤ 2.5 x ULN.
Danish: Behandlingen med capecitabin-monoterapi kan genoptages, når bilirubin er faldet til ≤ 3,0 x UNL eller levertransaminaserne er faldet til ≤ 2,5 x UNL.
English: Following grade 3 hand-foot syndrome, subsequent doses of capecitabine should be decreased.
Danish: Efter grad 3 hånd- og fodsyndrom skal dosis af capecitabin sættes ned.
English: • Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Danish: Stevens-Johnsons syndrom: hvis du oplever smertefuldt rødt eller lilla udslæt, der spreder sig og danner blistre og/eller andre læsioner, der opstår i slimhinderne (fx mund eller læber), især hvis du tidligere har været følsom over for lys, haft infektioner i luftvejene (fx bronkitis) og/eller feber.
English: Capecitabine Accord is not indicated in children and adolescent.
Danish: Capecitabine Accord er ikke beregnet til børn eller unge.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. For Aluminium-aluminium blisters
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og på blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Dihydropyrimidine dehydrogenase (DPD) deficiency Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity.
Danish: Dihydropyrimidindehydrogenase- (DPD-) mangel Sjælden, uventet, svær toksicitet (fx stomatitis, diarré, slimhindeinflammation, neutropeni og neurotoksicitet) i forbindelse med 5-FU er tilskrevet manglende DPD-aktivitet.
English: Patients with renal impairment: Based on a pharmacokinetic study in cancer patients with mild to severe renal impairment, there is no evidence for an effect of creatinine clearance on the pharmacokinetics of intact drug and 5-FU.
Danish: Patienter med nyreinsufficiens: Baseret på et farmakokinetisk studie hos kræftpatienter med let til svær nyreinsufficiens er der ingen tegn på effekt af creatininclearance på farmakokinetikken af det intakte lægemiddel og 5-FU.
English: Capecitabine Accord should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products.
Danish: Capecitabine Accord må kun ordineres af en kvalificeret læge med erfaring i brug af antineoplastiske lægemidler.
English: The overall safety profile of capecitabine is based on data from over 3,000 patients treated with capecitabine as monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications.
Danish: Den overordnede sikkerhedsprofil for capecitabin er baseret på data fra flere end 3.000 patienter, der fik capecitabin-monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer.
English: If the other medicinal product(s) have to be discontinued permanently, capecitabine treatment can be resumed when the requirements for restarting capecitabine are met.
Danish: Hvis behandling med det andet lægemiddel/de andre lægemidler skal afbrydes permanent , kan behandlingen med capecitabin genoptages, når betingelserne for genoptagelse af behandlingen med capecitabin er opfyldt.
English: Patients with renal impairment (see section 4.2, 4.4, and 5.2):
Danish: 4.2, 4.4 og 5.2):
English: 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 30 x 1 film-coated tablets 60 x 1 film-coated tablets 120 x 1 film-coated tablets
Danish: 30 filmovertrukne tabletter 60 filmovertrukne tabletter 120 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 60 x 1 filmovertrukne tabletter 120 x 1 filmovertrukne tabletter
English: Capecitabine Accord dose calculations
Danish: Capecitabine Accord-dosisberegninger
English: If you have an unrecognised DPD deficiency and take Capecitabine Accord, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects.
Danish: Hvis du har DPD-mangel uden at vide det og tager Capecitabine Accord, har du en øget risiko for akut tidlig indtræden af bivirkningerne, anført i punkt 4 Bivirkninger, i svær form.
English: XELOX was demonstrated to be non-inferior to FOLFOX-4 in terms of progression-free survival in the perprotocol population and intent-to-treat population (see Table 10).
Danish: Det blev vist, at XELOX var noninferior i forhold til FOLFOX-4 med hensyn til progressionsfri overlevelse i per-protokolpopulationen og intent-to-treat-populationen (se tabel 10).
English: - The active substance is capecitabine.
Danish: - Aktivt stof: capecitabin.
English: ADRs considered by the investigator to be possibly, probably, or remotely related to the administration of capecitabine are listed in Table 5 for capecitabine given as monotherapy and in Table 6 for capecitabine given in combination with different chemotherapy regimens in multiple indications.
Danish: De bivirkninger, der af den behandlende investigator blev vurderet som muligvis, sandsynligvis eller tvivlsomt relateret til administrationen af capecitabin er angivet i tabel 5 for capecitabin-monoterapi og i tabel 6 for capecitabin givet i kombination med forskellige kemoterapiregimer indenfor flere indikationer.
English: Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus(e.g. DPYD*2A, c.1679T>G, c.2846A>T and c.1236G>A/HapB3 variants), which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of lifethreatening or fatal toxicity and should not be treated with Capecitabine Accord (see section 4.3).
Danish: Selvom DPD-mangel ikke kan fastsættes præcist, er det kendt, at patienter med visse homozygote eller visse sammensatte heterozygote mutationer i DPYD-genlocuset (fx DPYD*2A, c.1679T>G, c.2846A>T og c.1236G>A/HapB3 varianter), som kan forårsage fuldstændigt eller næsten fuldstændigt fravær af DPD-enzymaktivitet (bestemt ved laboratorieprøver), har den højeste risiko for livstruende eller dødelig toksicitet, og disse patienter bør ikke behandles med Capecitabine Accord (se pkt.
English: There is no relevant use of capecitabine in the paediatric population in the indications colon, colorectal, gastric and breast cancer.
Danish: Anvendelse af capecitabin er ikke relevant inden for den pædiatriske population i indikationerne kolonkræft, kolorektal kræft, gastrisk kræft og brystkræft.
English: Capecitabine Accord should only be prescribed by a doctor experienced in the use of anticancer medicines.
Danish: Capecitabine Accord må kun ordineres af en læge, der har erfaring med anvendelse af kræftmedicin.
English: An analysis of safety data in patients ≥ 60 years of age treated with capecitabine monotherapy and an analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse reactions compared to patients < 60 years of age.
Danish: En analyse af sikkerhedsdata fra patienter ≥ 60 år, som behandledes med capecitabin-monoterapi og en analyse af patienter, som behandledes med capecitabin plus docetaxel, viste en stigning i incidensen af behandlingsrelaterede bivirkninger af grad 3 og 4 og af behandlingsrelaterede alvorlige bivirkninger, sammenlignet med patienter < 60 år.
English: The MTD of capecitabine was 2000 mg/m2 per day when combined with interferon alpha-2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when capecitabine was used alone.
Danish: Capecitabins MTD var 2.000 mg/m2/dag, når det kombineredes med interferon alfa-2a (3 MIE/m2/dag) sammenlignet med 3.000 mg/m2/dag, når capecitabin blev givet alene.
English: Aluminium/aluminium or PVC/PVdC/Aluminium blister containing 30, 60 or 120 film-coated tablets.
Danish: Aluminium/aluminium- eller PVC/PVdC/aluminiumblister indeholdende 30, 60 eller 120 filmovertrukne tabletter.
English: Patients with hepatic impairment due to liver metastases: According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Danish: Patienter med leverinsufficiens pga. levermetastaser: I henhold til et farmakokinetisk studie på kræftpatienter med let til moderat leverinsufficiens pga. levermetastaser kan capecitabins biotilgængelighed og eksponeringen for 5-FU øges sammenlignet med patienter uden leverinsufficiens.
English: Bone marrow depression, +Febrile Neutropenia
Danish: Knoglemarvsdepression, +febril neutropeni
English: -for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
Danish: - som adjuverende behandling af patienter, som er opereret for stadium III (Dukes stadium C) kolonkræft (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing capecitabine in all subsets of the paediatric population in adenocarcinoma of the colon and rectum, gastric adenocarcinoma and breast carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har fraveget betingelsen til at fremlægge resultater af studier med referencepræparatet indeholdende capecitabin i alle undergrupper af den pædiatriske population i colon- og rektumadenocarcinom og gastrisk karcinom (se pkt.
English: In patients with moderate renal impairment at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m2 is recommended.
Danish: Til patienter med moderat nyreinsufficiens ved baseline anbefales det at reducere dosis til 75 % af en initialdosis på 1.250 mg/m2.
English: Careful monitoring and prompt treatment interruption is recommended if the patient develops a grade 2, 3 or 4 adverse event during treatment and subsequent dose adjustment as outlined in Table 3 above.
Danish: Hvis patienterne under behandlingen får uønskede hændelser af grad 2, 3 eller 4 tilrådes omhyggelig overvågning og øjeblikkelig afbrydelse af behandlingen med efterfølgende dosisjustering som beskrevet i tabel 3 ovenover.
English: Table 3 Capecitabine dose reduction schedule (3-weekly cycle or continuous treatment).
Danish: Tabel 3 Dosisreduktion af capecitabin (3-ugers serier eller kontinuerlig behandling)
English: • DPD Deficiency: if you have a known DPD deficiency, you are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by Capecitabine Accord (e.g. stomatitis, mucosal inflammation, diarrhoea, neutropenia, and neurotoxicity).
Danish: DPD-mangel: Hvis du ved, at du har DPD-mangel, har du en øget risiko for akut tidlig indtræden af bivirkninger og svære, livstruende eller dødelige bivirkninger forårsaget af Capecitabine Accord (f.eks. mundbetændelse, betændelseslignende reaktion (inflammation) i slimhinder, diarré, neutropeni og neurotoksicitet).
English: Median overall survival
Danish: Median samlet overlevelse ITT
English: Also contains lactose, see the package leaflet for further information.
Danish: Se indlægssedlen for yderligere information.
English: XELOX+ Bevacizumab
Danish: XELOX eller XELOX+ Bevacizumab
English: Patients ≥ 60 years of age treated with capecitabine plus docetaxel also had more early withdrawals from treatment due to adverse reactions compared to patients < 60 years of age.
Danish: Der var flere patienter ≥ 60 år, som behandledes med capecitabin plus docetaxel, som måtte stoppe behandlingen tidligt på grund af bivirkninger, sammenlignet med patienter < 60 år.
English: Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Table 6 Summary of related ADRs reported in patients treated with capecitabine in combination treatment in addition to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to capecitabine monotherapy
Danish: Tabel 6 Sammenfatning af relaterede bivirkninger, som blev rapporteret hos patienter, der blev behandlet med capecitabin i kombinationsbehandling set ud over bivirkninger efter behandling med capecitabin-monoterapi eller set i en højere frekvensgruppe sammenlignet med capecitabinmonoterapi
English: Capecitabine Accord is available in blister packs containing 30, 60 or 120 film-coated tablets or in perforated unit dose blister packs containing 30 x 1, 60 x 1 or 120 x 1 film-coated tablets.
Danish: Capecitabine Accord fås i blisterpakninger indeholdende 30, 60 eller 120 filmovertrukne tabletter eller i perforerede enhedsdosisblisterpakninger indeholdende 30 x 1, 60 x 1 eller 120 x 1 filmovertrukne tabletter.
English: Neurotoxicity, Tremor, Neuralgia, Hypersensitivity reaction, Hypoaesthesia
Danish: Neurotoksicitet, tremor, neuralgi, overfølsomhedsreaktioner, hypoæstesi
English: You might get the following side effects if you take a lot more capecitabine than you should, feeling or being sick, diarrhoea, inflammation or ulceration of the gut or mouth, pain or bleeding from the intestine or stomach, or bone marrow depression (reduction in certain kinds of blood cells).
Danish: Du kan få følgende bivirkninger, hvis du tager mere capecitabin, end du skal: utilpashed, diarré, betændelse eller sår i tarme eller munden, smerter eller blødning fra tarme eller mave, nedsat antal af visse blodceller (såkaldt knoglemarvsdepression).
English: 5 mg/kg intravenous 30-90 mins
Danish: 5 mg/kg intravenøst 30-90 min.
English: Median progression free survival
Danish: konfidensinterval Median progressionsfri overlevelse ITT
English: If you are a male patient and your female partner could become pregnant, you should use effective contraception during treatment with Capecitabine Accord and for 3 months after the last dose.
Danish: Hvis du er en mandlig patient og din kvindelige partner kan blive gravid, så skal du anvende sikker prævention under behandling med Capecitabine Accord og i 3 måneder efter sidste dosis.
English: At the dose of 1250 mg/m2 on day 14 with administration after food intake, the peak plasma concentrations (Cmax in µg/ml) for capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 4.67, 3.05, 12.1, 0.95 and 5.46 respectively.
Danish: Efter en dosis på 1250 mg/m2 efter indtagelse af føde var peak-plasmakoncentrationerne på dag 14 (Cmax, µg/ml) for capecitabin, 5'-DFCR, 5'-DFUR, 5-FU og FBAL 4,67; 3,05; 12,1; 0,95 og 5,46.
English: as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Danish: - som monoterapi til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af taxoider og et kemoterapiregime indeholdende et anthracyklin eller hos hvem anthracyklinbehandling ikke er indiceret.
English: Capecitabine Accord 300 mg film-coated tablets Table 4 Capecitabine dose reduction shedule(3-weeklycycle or continuous treatment).
Danish: Capecitabine Accord 300 mg filmovertrukne tabletter Tabel 4 Dosisreduktion af capecitabin (3-ugers serier eller kontinuerlig behandling)
English: Other medicines and Capecitabine Accord
Danish: Brug af anden medicin sammen med Capecitabine Accord
English: Diarrhoea, Vomiting, Nausea, Stomatitis, Abdominal pain
Danish: Diarré, Opkastning, Kvalme, Stomatitis, Abdominalsm erter
English: Each pack contains 30 x 1, 60 x 1 or 120 x 1 film-coated tablets.
Danish: Hver pakke indeholder 30 x 1, 60 x 1 eller 120 x 1 filmovertrukne tabletter.
English: Premedication to maintain adequate hydration and anti-emesis according to the cisplatin summary of product characteristics should be started prior to cisplatin administration for patients receiving the capecitabine plus cisplatin combination.
Danish: Præmedicinering til opretholdelse af adækvat hydrering og antiemetisk behandling påbegyndes, i henhold til produktresumeet for cisplatin, før administration af cisplatin, hos de patienter, som får kombinationsbehandling med capecitabin og cisplatin.
English: If you are a woman who could become pregnant you should use effective contraception during treatment with Capecitabine Accord and for 6 months after the last dose.
Danish: Hvis du er en kvinde, der kan blive gravid, skal du anvende sikker prævention under behandling med Capecitabine Accord og i 6 måneder efter sidste dosis.
English: Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E5) Magnesium stearate
Danish: Mikrokrystallinsk cellulose (E460) Croscarmellosenatrium Hypromellose (E5) Magnesiumstearat
English: Herpes zoster, Urinary tract infection, Oral candidiasis, Upper respiratory tract infection , Rhinitis, Influenza, +Infection, Oral herpes
Danish: Herpes zoster, urinvejsinfektion, oral candidiasis, øvre luftvejsinfektion, rhinitis, influenza, +infektion, oral herpes
English: Median overall survival time was 703 days (95% CI: 671; 745) in patients treated with capecitabine -containing regimens and 683 days (95% CI:
Danish: Den mediane samlede overlevelse var 703 dage (95 % konfidensinterval: 671, 745) hos patienter, som blev behandlet med regimer, der indeholdt capecitabin og 683 dage (95 % konfidensinterval: 646, 715) hos patienter, som blev behandlet med regimer, der indeholdt 5-FU.
English: • Medicines used to treat folic acid deficiency.
Danish: • lægemidler til behandling af folsyremangel.
English: Dihydropyrimidinase cleaves the pyrimidine ring to yield 5fluoro-ureidopropionic acid (FUPA).
Danish: Dihydropyrimidinase spalter pyrimidinringen til 5-fluoroureidopropionsyre (FUPA).
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 8).
Danish: Resultaterne indikerer, at XELOX er ækvivalent med FOLFOX-4 med hensyn til den samlede overlevelse (se tabel 8).
English: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m2 leucovorin intravenous followed by 425 mg/m2 intravenous bolus 5-FU, on days 1 to 5, every 28 days).
Danish: 604 patienter randomiseredes til behandling med 5-FU og leucovirin (Mayo regime: 20 mg/m2 leucovirin intravenøst efterfulgt af en 5-FU bolus på 425 mg/m2 intravenøst på dag 1 til 5, hver 28. dag).
English: What you need to know before you take Capecitabine Accord Do not take Capecitabine Accord
Danish: Det skal du vide, før du begynder at tage Capecitabine Accord Tag ikke Capecitabine Accord:
English: • if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er overfølsom (allergisk) overfor capecitabin eller et af de øvrige indholdsstoffer i Capecitabine Accord (angivet i pkt.
English: The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/min at baseline) is increased compared to the overall population.
Danish: Incidensen af bivirkninger af sværhedsgrad 3 eller 4 er højere hos patienter med moderat nyreinsufficiens (creatininclearance 30 - 50 ml/min ved baseline), sammenlignet med den samlede population.
English: If you forget to take Capecitabine Accord
Danish: Hvis du har glemt at tage Capecitabine Accord
English: Oxaliplatin 85 mg/m2 intravenous 2 hr
Danish: Oxaliplatin 85 mg/m2 intravenøst 2 timer
English: In case you are using coumarin anticoagulants (containing e.g. phenprocoumon), stopping capecitabine might require that your doctor adjusts your anticoagulant dose.
Danish: Hvis du bruger blodfortyndende medicin (antikoagulantia) af coumarintypen (f.eks. phenprocoumon) kan det blive nødvendigt, at din læge ændrer dosis af denne medicin, hvis behandlingen med capecitabin stopper.
English: 7.5 mg/kg intravenous 30-90 mins
Danish: 7,5 mg/kg intravenøst 30-90 min.
English: The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 10).
Danish: Resultaterne indikerer, at XELOX er ækvivalent med FOLFOX-4 med hensyn til samlet overlevelse (se tabel 10).
English: Posology adjustments during treatment General
Danish: Dosisjusteringer under behandlingen:
English: FOLFOX-4 + Bevacizumab
Danish: FOLFOX-4 eller FOLFOX-4 + Bevacizumab
English: For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every 3weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination therapy.
Danish: For en capecitabindosis på 1.000 mg/m2 to gange daglig på dagene 1 til 14 hver 3. uge blev der observeret hånd- og fodsyndrom i alle grader med en hyppighed på 22 % til 30 % i capecitabin-kombinationsbehandling.
English: PVC/PVdC/Aluminium blisters Do not store above 30°C.
Danish: PVC/PVdC/aluminium-blistere Må ikke opbevares ved temperaturer over 30 °C.
English: Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of Capecitabine of 1000 mg/m2
Danish: Tabel 2 Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en initial dosis af capecitabin på 1.000 mg/m2
English: Standard and reduced dose calculations according to body surface area for starting doses of Capecitabine Accord of 1250 mg/m2 and 1000 mg/m2 are provided in Tables 1 and 2, respectively.
Danish: Standard og reducerede initialdosisberegninger af Capecitabine Accord på 1.250 mg/kg og 1.000 mg/kg ud fra legemsoverfladeareal er anført i henholdsvis tabel 1 og 2.
English: If you stop taking Capecitabine Accord
Danish: Hvis du holder op med at tage Capecitabine Accord
English: In combination treatment, the recommended starting dose of capecitabine should be reduced to 800-1000 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m2 twice daily when administered continuously (see section 5.1).
Danish: Ved kombinationsbehandling skal den anbefalede initialdosis af capecitabin reduceres til 800-1.000 mg/m2, når det administreres to gange daglig i 14 dage efterfulgt af en pause på 7 dage eller til 625 mg/m2 to gange daglig, når det gives kontinuerligt (se pkt.
English: • gout medicines (allopurinol),
Danish: • medicin mod urinsyregigt (allopurinol)
English: Leucovorin 200 mg/m2 intravenous 2 hr
Danish: Leucovorin 200 mg/m2 intravenøst 2 timer
English: In first-line treatment the median progression-free survival in the intent-to-treat population was 5.8 months (95%CI 5.1 - 6.2 months) for capecitabine monotherapy and 7.8 months (95%CI 7.0 - 8.3 months; p=0.0002) for XELIRI.
Danish: I 1. linjebehandlingen var den mediane progressionsfri overlevelse i intent-to-treat-populationen 5,8 måneder (95 % konfidensinterval 5,1-6,2 måneder) for capecitabin monoterapi og 7,8 måneder (95 % konfidensinterval 7,0 -8,3 måneder; p = 0,0002) for XELIRI.