FrancophonIA/ELRC3.0 huggingface dataset:
English: Thelin 100 mg film-coated tablets Sitaxentan sodium
Danish: Thelin 100 mg filmovertrukne tabletter Sitaxentannatrium
English: • The tablet core contains cellulose, microcrystalline (E460), lactose monohydrate, hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate (E339), ascorbyl palmitate (E304), disodium edetate and monobasic sodium phosphate (E339).
Danish: • Øvrige indholdsstoffer: o Tabletkernen indeholder mikrokrystallinsk cellulose (E460),lactosemonohydrat, hypromellose (E464), natriumstivelsesglycolat, magnesiumstearat (E470b) vandfri dinatriumphosphat (E339), ascorbylpalmitat (E304), dinatriumedetat, natriumdihydrogenphosphatdihydrat (E339).
English: Endothelin-1 (ET-1) is a potent vascular paracrine and autocrine peptide in the lung, and can also promote fibrosis, cell proliferation, cardiac hypertrophy, and remodelling and is pro-inflammatory.
Danish: Endothelin-1 (ET-1) er et potent vaskulært parakrint og autokrint peptid i lungen.
English: The information collected should include: o Anonymised patient details - age, sex and aetiology of PAH o Concomitant medications o Reason for discontinuation o ADRs o All serious ADRs o Increase in hepatic enzymes to > 3 × ULN o Elevated direct bilirubin > 2 ×ULN o Anaemia o Haemorrhage o Pregnancy and outcome o Pulmonary oedema (associated with veno-occlusive disease) o Suspected interactions o Unexpected ADRs according to the SPC.
Danish: ○ Alle alvorlige bivirkninger ○ Stigning i leverenzymer til > 3 x ULN ○ Forhøjet direkte bilirubin > 2 x ULN ○ Anæmi ○ Hæmoragi ○ Graviditet og udfald ○ Lungeødem (forbundet med veneokklusiv sygdom) ○Formodede interaktioner ○Uventede bivirkninger i henhold til produktresumé.
English: 14 film-coated tablets in blisters 28 film-coated tablets in blisters 56 film-coated tablets in blisters 84 film-coated tablets in blisters
Danish: 84 filmovertrukne tabletter i blisterkort.
English: Ketoconazole (substrate and inhibitor of CYP3A4/5): Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or ketoconazole.
Danish: Ketoconazol (CYP3A4/5-substrat og -hæmmer): Samtidig administration af Thelin og ketoconazol forårsagede ikke en klinisk siginifikant ændring af hverken sitaxentannatriums eller ketoconazols clearance.
English: • If any side effect becomes serious, or if you notice any side effects not listed in this leaflet,
Danish: • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: If the aminotransferase levels return to pre-treatment values, consider resuming the initial treatment schedule according to the conditions described below.
Danish: Hvis aminotransferaseniveauerne vender tilbage til niveauerne inden indledning af behandlingen, bør genoptagelse af den initiale dosering ud fra betingelserne beskrevet nedenfor overvejes.
English: If any of these apply to you, tell your doctor before you start taking Thelin.
Danish: Tal med lægen, inden De begynder at tage Thelin, hvis nogen af ovenstående punkter gælder for Dem.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Henvend Dem til Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: Women of child-bearing potential
Danish: Kvinder i den fertile alder:
English: • If you are taking or begin to take anticoagulants (e.g. warfarin, acenocoumarol, fenprocoumon or fluindione) to prevent blood clots.
Danish: acenocoumarol, phenprocoumon eller fluindion) for at forebygge blodpropper.
English: If the aminotransferase levels return to pre-treatment values, consider reintroducing Thelin according to the conditions described below.
Danish: Hvis aminotransferasenivauerne returnerer til værdierne inden behandling, kan genoptagelse af Thelinbehandling overvejes i henhold til omstændighederne beskrevet nedenfor.
English: Functional Class
Danish: Funktionsklasse
English: If AST and/or ALT are > 3 x ULN prior to initiation of therapy, or direct bilirubin is > 2 x ULN, use of sitaxentan is contraindicated (see section 4.3)
Danish: Brug af Thelin er kontraindiceret, hvis ASAT og/eller ALAT er > 3 x ULN, inden behandling påbegyndes eller hvis direkte bilirubin er > 2 x ULN (se pkt.
English: • flushed
Danish: • Rødmen
English: • cramp in muscles
Danish: • Muskelkramper
English: (See Annex I: Summary of Product Characteristics, section 4.2)
Danish: bilag I: Produktresumé; pkt.
English: Nelfinavir (substrate of CYP3A4/5, CYP2C19): Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or nelfinavir.
Danish: Nelfinavir (CYP2C19- og CYP3A4/5-substrat): Samtidig administration af Thelin og nelfinavir forårsagede ikke en klinisk signifikant ændring i clearance af sitaxentannatrium eller af nelfinavir.
English: Dosage in hepatic impairment:
Danish: Dosering ved nedsat leverfunktion:
English: At high doses, dose-related increases in prothrombin time (PT) and activated partial thromboplastin time (APTT) were also seen, most prominently in rats, and coagulopathy (bleedings) in rats and dogs, but not mice.
Danish: Ved høje doser sås endvidere dosisrelaterede stigninger i protrombintid (PT) og aktiveret delvis tromboplastintid (APTT).
English: If you are intolerant to some sugars, contact your doctor before taking Thelin tablets.
Danish: Kontakt lægen før De tager Thelin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Cellulose, microcrystalline (E460) Lactose monohydrate Hypromellose (E464) Sodium starch glycolate Magnesium stearate (E470b) Disodium phosphate, anhydrous (E339) Ascorbyl palmitate (E304) Disodium edetate
Danish: Natriumstivelsesglycolat Magnesiumstearat (E470b) Dinatriumphosphat, vandfri (E339) Ascorbylpalmitat (E304) Dinatriumedetat
English: > 5 and ≤ 8 x ULN: Confirm by another liver test; if confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks until levels have normalised.
Danish: Ved bekræftelse skal behandlingen afbrydes, og aminotransferaseniveauer monitoreres mindst hver fjortende dag, indtil niveauerne normaliseres.
English: Increased Liver Aminotransferases (see section 4.4) Elevations of AST and/or ALT are associated with sitaxentan sodium.
Danish: Forhøjet ASAT og/eller ALAT er forbundet med sitaxentannatrium.
English: Liver aminotransferase elevations may reverse spontaneously while continuing treatment with sitaxentan sodium.
Danish: Ved fortsat sitaxentannatrium-behandling er forhøjelse af leveraminotransferaser spontant reversible.
English: Bleeding
Danish: Amning;
English: > 3 and ≤ 5 x ULN: Confirm by another liver test;if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
Danish: > 3 og ≤ 5 × ULN: Bekræft med en ny levertest.
English: If the aminotransferase levels return to pre-treatment values consider resuming the initial treatment schedule.
Danish: Hvis aminotransferaseniveauerne vender tilbage til niveauerne, inden indledning af behandlingen, bør genoptagelse af initial-dosering overvejes.
English: BEFORE YOU TAKE THELIN
Danish: Hvis De har taget for meget Thelin
English: Following oral administration to healthy volunteers, sitaxentan sodium is highly metabolised.
Danish: Sitaxentannatrium er yderst omsætteligt efter oral indgivelse til raske frivillige.
English: Discontinuation of treatment
Danish: Seponering af behandling:
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret Thelin til Dem personligt.
English: >3 and ≤ 5 x ULN: Confirm by another liver test; if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
Danish: Ved bekræftelse bør det på individuel basis afgøres, om Thelin-behandlingen skal fortsættes eller standses.
English: Decreased Haemoglobin (see section 4.4)
Danish: Hypromellose (E464)
English: If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: (twice daily)
Danish: (to gange dagligt)
English: Risk Management Plan (RMP)
Danish: · Risikostyringsplan (RMP)
English: Palmar-plantar erythrodysaesthesia syndrome**
Danish: Palmar-plantar erytrodysæstesi syndrom**
English: It is important that you take all your medicine as prescribed by your doctor.
Danish: · Det er vigtigt at du tager al din medicin som foreskrevet af din læge.
English: • Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
Danish: · Kvalme: hvis du mister appetitten, og hvis du spiser meget mindre hver dag, end du plejer.
English: Xeloda may be used either alone or in combination with other medicines.
Danish: Xeloda kan anvendes enten alene eller i kombination med andre lægemidler.
English: • Infection: if you experience signs of infection caused by bacteria or virus, or other organisms.
Danish: · Infektion: hvis du oplever tegn på infektion forårsaget af bakterier eller virus eller andre organismer.
English: • Vomiting: if you vomit more than once in a 24-hour time period.
Danish: · Opkastning: hvis du kaster op mere end én gang i løbet af 24 timer.
English: • Fever: if you have a temperature of 38°C or greater.
Danish: · Feber: hvis din temperatur stiger til 38 °C eller derover.
English: About 3% of the administered dose is excreted in urine unchanged
Danish: Ca. 3 % af den indgivne dosis udskilles uændret i urinen.
English: Severe and/or Lifethreatening (grade 3-4) or considered medically relevant
Danish: Alvorlige og/eller livstruende (grad 3-4) eller vurderet som klinisk relevant
English: There is no data on Xeloda and impact on fertility.
Danish: Der er ingen data om Xeloda og dets virkning på fertiliteten.
English: It is therefore possible that Xeloda could affect your ability to drive a car or operate machines.
Danish: Det er derfor muligt, at Xeloda kan påvirke din evne til at køre bil og betjene maskiner.
English: See also section “Do not take Xeloda”.
Danish: Se også afsnittet 'Tag ikke Xeloda'.
English: Xeloda tablets should not be crushed or cut.
Danish: Xeloda tabletter må ikke deles eller knuses.
English: Take the tablets morning and evening as prescribed by your doctor.
Danish: · Tag tabletterne morgen og aften på den måde, som din læge har ordineret til dig.
English: The dose of Xeloda is based on your body surface area.
Danish: Xeloda-dosis er baseret på arealet af din legemsoverflade.
English: Xeloda tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Danish: Xeloda-tabletter tages normalt i 14 dage efterfulgt af 7 dages pause (hvor der ikke tages tabletter).
English: Do not give Xeloda to children and adolescents.
Danish: Giv ikke Xeloda til børn eller unge.
English: Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water.
Danish: · Tag tabletterne senest 30 min efter et måltid (morgenmad og aftensmad) og slug dem hele med vand.
English: *EPP=eligible patient population; **ITT=intent-to-treat population
Danish: *EPP=egnet patientpopulation; **ITT=intent-to-treat population
English: If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.
Danish: · Hvis der forekommer kontraindikationer til et af lægemidlerne i kombinationsregimet, bør det pågældende lægemiddel ikke anvendes.
English: 820 Patients were randomised to receive either sequential treatment (n=410) or combination treatment (n=410).
Danish: 820 patienter blev randomiseret til at få enten sekventiel behandling (n = 410) eller kombinationsbehandling (n = 410).
English: Table 6 Treatment regimens in study NO16966 (mCRC) Treatment
Danish: Tabe1 6 Behandlingsregimer i studie NO16966 (mCRC) Behandling
English: *PPP=per-protocol population; **ITT=intent-to-treat population
Danish: *PPP=per protokol population; **ITT=intent-to-treat population
English: Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Xeloda.
Danish: Lægen vil måske bede dig om at sætte dosis ned og/eller midlertidigt afbryde behandlingen med Xeloda.
English: Pharmacotherapeutic group: cytostatic (antimetabolite), ATC code: L01BC06
Danish: Farmakoterapeutisk klassifikation: Cytostatikum (antimetabolit), ATC kode: L01BC06
English: Xeloda belongs to the group of medicines called "cytostatic medicines", which stop the growth of cancer cells.
Danish: Xeloda tilhører en gruppe lægemidler som kaldes “cytostatika”, som standser væksten af kræftceller.
English: The enhanced toxicity may be relevant when switching from 5- FU/LV to a capecitabine regimen.
Danish: Den forstærkede toksicitet kan være relevant, når 5-FU/LV skiftes til et capecitabin-regime.
English: Careful monitoring of patients ≥60 years of age is advisable.
Danish: Omhyggelig monitorering af patienter ³ 60 år tilrådes.
English: If you take more Xeloda than you should, contact your doctor as soon as possible before taking the next dose.
Danish: Hvis du har taget for mange Xeloda-tabletter, skal du kontakte lægen så hurtigt som muligt, før du tager næste dosis.
English: 5-fluorouracil intravenous bolus/infusion, each on Days 1 and 2, every 2 weeks
Danish: 5-fluoruracil intravenøs bolus/infusion, hver på dag 1 og 2, hver 2. uge
English: Name and address of the manufacturer responsible for batch release Roche Pharma AG
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Roche Pharma AG
English: Doses of capecitabine omitted for toxicity are not replaced.
Danish: Capectabin-doser, som ikke tages på grund af toksicitet, erstattes ikke.
English: Posology adjustments for special populations:
Danish: Dosisjusteringer for særlige populationer:
English: • Grade 1
Danish: · Grad 1
English: Furthermore, Xeloda is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Danish: Desuden bruges Xeloda til forebyggelse af ny optræden af tyktarmskræft efter fuldstændig fjernelse af svulsten ved operation.
English: Date of latest renewal: 02 February 2006
Danish: Dato for første markedsføringstilladelse: 2. februar 2001 Dato for seneste fornyelse: 2. februar 2006
English: • Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.
Danish: · Brystsmerter: hvis du får smerter i midten af brystet, specielt hvis det sker under anstrengelse.
English: The inclusion of bevacizumab in a combination regimen has no effect on the starting dose of capecitabine.
Danish: Inklusionen af bevacizumab i et kombinationsregime har ingen indflydelse på initialdosis af capecitabin.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Roche Registration GmbH
English: Xeloda should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Danish: Xeloda skal seponeres permanent hos patienter, der oplever en alvorlig hudreaktion under behandlingen.
English: Children and adolescents Xeloda is not indicated in children and adolescents.
Danish: Børn og unge Xeloda er ikke beregnet til børn eller unge.
English: Xeloda tablets should be swallowed whole with water within 30 minutes after a meal.
Danish: Xeloda tabletter skal synkes hele med vand senest 30 minutter efter et måltid.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid , tror du er gravid, påtænker at blive gravid eller hvis du ammer, bør du snakke med din læge eller apoteketpersonalet inden du tager dette lægemiddel.
English: Finally, β-ureido-propionase cleaves FUPA to α-fluoro-βalanine (FBAL) which is cleared in the urine.
Danish: Endeligt spalter b-ureido-propionase FUPA til a-fluoro-b-alanin (FBAL), som udskilles i urinen.
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a
Danish: 256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/m2
English: Xeloda with food and drink You should take Xeloda no later than 30 minutes after meals.
Danish: Brug af Xeloda sammen med mad og drikke Du skal tage Xeloda senest 30 minutter efter et måltid.
English: Table 3 Capecitabine dose reduction schedule (3 weekly cycle or continuous treatment) Toxicity grades*
Danish: Tabel 3 Dosisreduktion af capecitabin (3 -ugers serier eller kontinuerlig behandling) Toksicitet graduering*
English: However, grade 3 or 4 treatment-related adverse reactions were more frequent in patients ≥60 years of age compared to younger patients.
Danish: Behandlingsrelaterede bivirkninger af sværhedsgrad 3 eller 4 var dog hyppigere hos patienter ³ 60 år sammenlignet med yngre patienter.
English: 1 hour intravenous infusion every 3 weeks).
Danish: som 1 times intravøs infusion hver 3. uge).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: · på anmodning fra Det Europæiske Lægemiddelagentur · når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Oxaliplatin 85 mg/m intravenous
Danish: Oxaliplatin 85 mg/m intravenøs
English: The Xeloda pivotal studies included females of childbearing potential and males only if they agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a reasonable period thereafter.
Danish: De pivotale Xeloda-studier inkluderede kun kvinder i den fertile alder og mænd, hvis de indgik aftale om at anvende en egnet præventionsmetode for at undgå graviditet under studiet og i en passende periode efter studiet.
English: Patients were randomised to receive either FOLFIRI plus bevacizumab (Arm-A, n=167) or XELIRI plus bevacizumab (Arm-B, n-166).
Danish: Patienterne blev randomiseret til enten at få FOLFIRI plus bevacizumab (arm-A, n=167) eller XELIRI plus bevacizumab (arm-B, n=166).
English: Xeloda should only be prescribed by a qualified physician experienced in the utilisation of antineoplastic medicinal products.
Danish: Xeloda må kun ordineres af en kvalificeret læge med erfaring i brug af antineoplastiske lægemidler.
English: These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use (see also section “Elderly” below).
Danish: Rekommendationer for dosisjustering ved nedsat nyrefunktion gælder både for monoterapi og for kombinationsbehandling (se også afsnittet om ældre nedenfor).
English: Xeloda dose calculations
Danish: Xeloda-dosisberegninger
English: Toxicity due to capecitabine administration may be managed by symptomatic treatment and/or modification of the dose (treatment interruption or dose reduction).
Danish: Toksicitet som skyldes administration af capecitabin, kan behandles symptomatisk og/eller med modifikation af Xeloda-dosis (afbrydelse af behandlingen eller reduktion af dosis).
English: - first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1).
Danish: -1. linjebehandling af fremskreden ventrikelkræft i kombination med et platinbaseret regime (se pkt.
English: Xeloda contains capecitabine, which itself is not a cytostatic medicine.
Danish: Xeloda indeholder capecitabin, som i sig selv ikke virker cytostatisk.
English: 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Danish: intravenøs bolus injektion umiddelbart efter leucovorin
English: Capecitabine 1000 mg/m oral twice daily
Danish: Capecitabin 1.000 mg/m2 oral 2 gange daglig
English: In vitro human plasma studies have determined that capecitabine, 5'-DFCR, 5'-DFUR and 5-FU are 54%, 10%, 62% and 10% protein bound, mainly to albumin.
Danish: Humane plasmaundersøgelser in vitro har vist at capecitabin, 5¢-DFCR, 5¢-DFUR og 5-FU er hhv. 54 %, 10 %, 62 % og 10 % bundet til protein, hovedsageligt til albumin.
English: There are no side effects caused by stopping treatment with capecitabine.
Danish: Der er ingen bivirkninger forbundet med at stoppe behandlingen med capecitabin.
English: Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: The following headings are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Danish: (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000
English: In the study published by Skof et al, patients were randomised to receive either FOLFIRI or XELIRI .
Danish: I studiet publiceret af Skof et al blev patienterne randomiseret til enten at få FOLFIRI eller XELIRI.
English: The median overall survival was 10.0 months in cisplatin-based regimens and 10.4 months in oxaliplatin-based regimens.
Danish: Den mediane samlede overlevelse var 10,0 måneder for de cisplatinbaserede regimer og 10,4 måneder for de oxaliplatinbaserede regimer.
English: Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30 °C
English: Other side-effects seen in this setting are the following:
Danish: Andre bivirkninger, der kan ses i den sammenhæng, er:
English: Capecitabine dose reduction decreases systemic exposure to 5-FU more than doseproportionally, due to non-linear pharmacokinetics for the active metabolite.
Danish: Dosisreduktion af capecitabin nedsætter den systemiske eksponering for 5-FU mere end svarende til dosisproportionaliteten på grund af den aktive metabolits non-lineære farmakokinetik.
English: For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of Xeloda are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjusment according to toxicity.
Danish: For patienter med delvis DPD-mangel (fx med heterozygote mutationer i DPYD-genet), og hvor fordelene af Xeloda anses for at opveje risikoen (under hensyntagen til egnetheden af et alternativt ikke-fluorpyrimidin kemoterapeutisk regime), gælder, at de skal behandles med yderste forsigtighed og hyppig monitorering med dosisjustering i henhold til toksicitet.
English: Oxaliplatin on Day 1, every 2 weeks Leucovorin on Days 1 and 2, every 2 weeks
Danish: Oxaliplatin på dag 1, hver 2. uge Leucovorin på dag 1 og 2, hver 2. uge
English: Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU).
Danish: Capecitabin er et non-cytotoksisk fluorpyrimidincarbamat, som virker som en oral administreret prækursor for det cytotoksiske 5- fluoruracil (5-FU).
English: PRIMARY ANALYSI S XELOX/XELOX+P/ XELOX+BV (EPP*: N=967; ITT**: N=1017)
Danish: PRIMÆRE ANALYSE XELOX/XELOX+P/ XELOX+BV (EPP*: N = 967; ITT**: N = 1017)