FrancophonIA/ELRC3.0 huggingface dataset:
English: The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab treated patients in the FOLFOX treatment subgroup, HR=0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Danish: Den mediane, samlede overlevelse var 20,3 måneder for placebogruppen vs. 21,2 måneder for bevacizumab-behandlede patienter i FOLFOX undergruppen, HR = 0,94, 97,5 % konfidensinterval = [0,75-1,16]; p-værdi = 0,4937.
English: Aneurysms and artery dissections, Renal thrombotic microangiopathy b,c
Danish: Aneurismer og arterielle dissektioner, renal trombotisk mikroangiopati
English: Palmar-plantar erythrodysaesth esia syndrome
Danish: Palmoplantar erytrodysæstesisy ndrom
English: 400 mg/m2 intravenous bolus,
Danish: 400 mg/m2 intravenøs bolus, 600 mg/m2 intravenøs
English: The incidence of venous thromboembolic reactions in clinical trials was similar in patients receiving bevacizumab in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Danish: Venøs tromboemboli: Hyppigheden af venøse tromboemboliske bivirkninger i kliniske studier var den samme for patienter, som fik bevacizumab i kombination med kemoterapi, sammenlignet med dem, som fik kemoterapi alene.
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and intravenous oxaliplatin (XELOX), administered on a 3- weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Danish: Dette var et fase III, randomiseret, dobbeltblindet (med hensyn til bevacizumab), klinisk studie, hvori bevacizumab 7,5 mg/kg i kombination med oral capecitabin og intravenøs oxaliplatin (XELOX) administreret hver 3. uge blev undersøgt i forhold til bevacizumab 5 mg/kg i kombination med leucovorin med 5-fluoruracil bolus efterfulgt af 5-fluoruracil infusion og intravenøs oxaliplatin (FOLFOX-4), administreret hver 2. uge.
English: Zirabev will be administered together with a chemotherapy regimen containing platinum.
Danish: Zirabev blive givet sammen med kemoterapibehandling, der indeholder platin.
English: Gallbladder perforation b,c
Danish: Galdeblæreperf oration b,c
English: Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and topotecan 0.75 mg/m2
Danish: Paclitaxel 175 mg/m2 intravenøst over 3 timer på dag 1 og topotecan 0,75 mg/m intravenøst over 30 minutter på dag 1-3, hver 3. uge
English: Other reactions with a higher frequency seen in patients over 65 were Grade 3-4 leucopenia and thrombocytopenia (NCI-CTCAE v.3); and all Grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with bevacizumab (see sections 4.4 and 4.8 under Thromboembolism).
Danish: Andre bivirkninger ved behandling med bevacizumab, der blev set med en højere frekvens hos patienter over 65 år versus patienter ≤ 65 år, var grad 3-4 leukopeni og trombocytopeni (NCI-CTCAE v. 3) samt neutropeni (alle grader), diarré, kvalme, hovedpine og træthed (se pkt.
English: In study BO25041 of bevacizumab added to postoperative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
Danish: I studie BO25041 blev bevacizumab føjet til post-operativ strålebehandling med samtidig adjuverende temozolomidbehandling hos pædiatriske patienter med nyligt diagnosticeret supratentorielt, infratentorielt, cerebellært eller pedunkulært høj-grads-gliom.
English: Schedule
Danish: KARTON
English: Posterior reversible encephalopathy syndrome a,b,d
Danish: Posteriort reversibelt encefalopatis yndrom a,b,d
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Danish: 4.4 og Overfølsomhedsreaktioner/infusionsreaktioner ovenfor)
English: Table 10 Trial E2100 efficacy results Progression-free survival
Danish: Tabel 10 Virkningsresultater i studie E2100
English: Number of patients Overall survival Median time (months) 95% CI
Danish: Antal patienter Samlet overlevelse Median tid (måneder) 95 % konfidensinterval
English: Overall survival Median (months)
Danish: Samlet overlevelse Median (måneder)
English: • diarrhoea, nausea, vomiting and abdominal pain.
Danish: • diarré, kvalme, opkastning, mavesmerter,
English: Intestinal perforation, Ileus, Intestinal obstruction,
Danish: Intestinal perforation, Ileus, Intestinal obstruktion, Rektovaginale fistler d,e
English: Fistula a,b
Danish: Fistler a,b,
English: nose bleeds.
Danish: • næseblod.
English: Secondary endpoints
Danish: (p-værdi Sekundære endepunkter
English: Myalgia, Arthralgia, Muscular weaknes s, Back pain
Danish: Myalgi, Artralgi, Muskelsvaghed , Rygsmerter
English: Other special populations Elderly patients
Danish: Ældre patienter
English: Paclitaxel 135 mg/m intravenous over 24 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 2, every 3 weeks (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 (q3w); or
Danish: • Paclitaxel 135 mg/m 2 intravenøst over 24 timer på dag 1 og cisplatin 50 mg/m 2 intravenøst på dag 2, hver 3. uge; eller Paclitaxel 175 mg/m 2 intravenøst over 3 timer på dag 1 og cisplatin 50 mg/m 2 intravenøst på dag 2, hver 3. uge; eller Paclitaxel 175 mg/m 2 intravenøst over 3 timer på dag 1 og cisplatin 50 mg/m 2 intravenøst på dag 1, hver 3. uge
English: 4.5 Interaction with other medicinal products and other forms of interaction Effect of antineoplastic agents on bevacizumab pharmacokinetics
Danish: Effekt af antineoplastiske lægemidler på bevacizumabs farmakokinetik
English: Disodium edetate
Danish: efter fortynding
English: In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in bevacizumab-treated patients and 0.9% in control patients, all of whom had a history of prior pelvic radiation.
Danish: I et studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer var forekomsten af gastrointestinale-vaginale fistler 8,3 % hos bevacizumabbehandlede patienter og 0,9 % i kontrolgruppen.
English: Gall bladder perforation (not known)
Danish: Lever og galdeveje Galdeblæreperforation (ikke kendt)
English: Hypertensive encephalopathy c
Danish: Hypertensiv encephalopati
English: Gastrointestinal (GI) perforations and fistulae (see section 4.4)
Danish: Gastrointestinale perforationer og fistler (se pkt.
English: As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see section 5.3), women must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of bevacizumab.
Danish: 5.3), skal kvinden stoppe med at amme under behandlingen og i mindst 6 måneder efter sidste bevacizumabdosis.
English: • Gastrointestinal perforations (see section 4.4).
Danish: Gastrointestinale perforationer (se pkt.
English: c Based on a substudy from NSABP C-08 with 295 patients d
Danish: Baseret på et substudie fra NSABP C-08 med 295 patienter For yderligere information henvises til nedenstående afsnit "Yderligere information om visse alvorlige bivirkninger".
English: Overall survival - Follow-up analysis Median (months)
Danish: Samlet overlevelse - followup-analyse
English: Name and address of the manufacturer responsible for batch release Pfizer Ireland Pharmaceuticals
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Uncommon (≥ 0.1% to < 1%) reports of fistulae that involve areas of the body other than the gastrointestinal tract (e.g. bronchopleural and biliary fistulae) were observed across various indications.
Danish: Ved forskellige indikationer er der set fistler, der involverer andre dele af kroppen end mavetarmkanalen (fx bronkopleurale og biliære fistler).
English: Each vial contains 400 mg bevacizumab.
Danish: Hvert hætteglas indeholder 400 mg bevacizumab.
English: In a randomized phase II study (BO25041) a total of 121 patients aged ≥ 3 years to <18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG)
Danish: I et randomiseret fase II-studie (BO25041) blev 121 patienter ≥ 3 år til < 18 år med nyligt diagnosticeret supratentorielt eller infratentorielt cerebellært eller pedunkulært høj-grads-gliom behandlet med post-operativ strålebehandling (RT) og adjuverende temozolomid (T) med og uden bevacizumab: 10 mg/kg intravenøst hver 2. uge.
English: The recommended dose of Zirabev is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af Zirabev er 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
English: Gallbladder perforation a,b
Danish: Blæreperforation a,b
English: Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with bevacizumab and all patients with GI perforation had a history of prior radiation.
Danish: Hos patienter, behandlet med bevacizumab for persisterende, recidiverende eller metastatisk cervixcancer, er tidligere strålebehandling en risikofaktor for gastrointestinal perforation og alle patienter, som fik gastrointestinal perforation, havde tidligere fået strålebehandling.
English: Gastrointestinal ulcer c, Rectal haemorrhage
Danish: Gastrointestinal t ulcus c,
English: ● a blood clot in the blood vessels of your lungs,
Danish: ● en blodprop i lungerne,
English: The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af Zirabev er 10 mg/kg legemsvægt en gang hver 2. uge eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
English: The recommended dose of Zirabev is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af Zirabev er 15 mg/kg kropsvægt en gang hver 3. uge som intravenøs infusion.
English: Gastrointestinal ulcer a
Danish: Gastrointestinalt ulcus
English: Chemotherapy + bevacizumab (n=227)
Danish: Kemoterapi + bevacizumab (n=227)
English: NAME OF THE MEDICINAL PRODUCT Zirabev 25 mg/ml concentrate for solution for infusion.
Danish: Zirabev 25 mg/ml koncentrat til infusionsvæske, opløsning.
English: The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Danish: Den anbefalede dosis af Zirabev er 10 mg/kg legemsvægt en gang hver 2. uge administreret som intravenøs infusion.
English: For intravenous use after dilution Read the package leaflet before use
Danish: Læs indlægssedlen inden brug
English: 4.6 Fertility, pregnancy and lactation Women of childbearing potential
Danish: 4.6 Fertilitet, graviditet og amning og i pkt.
English: Overall survival Median (months) Hazard ratio 95% CI
Danish: Samlet overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval)
English: If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Danish: Tal med din læge, hvis du har tilstande, som forårsager betændelse i maveregionen (fx diverticulitis, mavesår, tyktarmsbetændelse forbundet med kemoterapi).
English: What Zirabev is and what it is used for What you need to know before you use Zirabev How to use Zirabev
Danish: Det skal du vide, før du begynder at bruge Zirabev Sådan skal du bruge Zirabev Bivirkninger
English: Zirabev is also used for treatment of adult patients with advanced kidney cancer.
Danish: Zirabev bruges også hos voksne til behandling af fremskreden nyrekræft.
English: assessment)**
Danish: Median PFS**
English: Foetal abnormalities a,c
Danish: Føtale anormaliteter a,c
English: Arthralgia, Myalgia
Danish: Artralgi Myalgi
English: • Superiority of the bevacizumab-containing arms versus the chemotherapy alone arms in the overall comparison was demonstrated in terms of progression-free survival in the ITT population (Table 7).
Danish: Bevacizumab-armene var bedre med hensyn til progressionsfri overlevelse i ITT (intentto-treat) populationen (tabel 7) i forhold til behandlingsarmene, der kun indeholdt kemoterapi.
English: Method and route of administration
Danish: Anvendelsesmåde og indgivelsesmåde
English: The primary efficacy variable of the trial was overall survival.
Danish: Den primære effektparameter var varighed af samlet overlevelse.
English: An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Danish: Disse bivirkninger inkluderer cerebrovaskulære tilfælde, myokardieinfarkt, transitorisk cerebral iskæmi og andre arterielle tromboemboliske bivirkninger.
English: Febrile neutropenia, Leucopenia, Neutropenia a,
Danish: Blod og lymfesystem Febril neutropeni, Leukopeni,
English: The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Zirabev fails to stop your tumour growing.
Danish: Du skal fortsætte med Zirabev, indtil Zirabev ikke længere hindrer tumoren i at vokse.
English: 1 vial of 16 ml 400 mg/16 ml
Danish: 1 hætteglas á 4 ml 100 mg/4 ml
English: Eye disorder, Lacrimation increased
Danish: Øjengener, Tåreflåd
English: Trial BO17704 was a randomised, double-blind phase III trial of bevacizumab in addition to cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with locally advanced (stage IIIb with supraclavicular lymph node metastases or with malignant pleural or pericardial effusion), metastatic or recurrent non-squamous NSCLC, who had not received prior chemotherapy.
Danish: Studie BO17704 var et randomiseret dobbeltblindet fase III-studie med bevacizumab i kombination med cisplatin og gemcitabin, der blev sammenlignet med placebo, cisplatin og gemcitabin.
English: Thrombo-embolism (venous)
Danish: Tromboemboli (venøs)
English: Hepatic impairment
Danish: Hypertensiv encefalopati
English: ● If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: ● Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Osteonecrosis of the jaw a,b
Danish: Osteonekrose af kæben a,b
English: Foetal abnormalities a,b
Danish: Ovariesvigt a,b
English: Pulmonary embolism, Hypoxia, Dysphonia a
Danish: Lungeemboli, Epistaxis, Dyspnø, Hypoksi hypertension c,
English: The addition of bevacizumab to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Danish: Den progressionsfrie overlevelse og den objektive tumorresponsrate forøgedes signifikant ved tillæg af bevacizumab til IFN alfa-2a behandlingen.
English: Each vial contains 100 mg bevacizumab.
Danish: Hvert hætteglas indeholder 100 mg bevacizumab.
English: Zirabev is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
Danish: Zirabev bruges også i behandlingen af voksne patienter med vedvarende livmoderhalskræft, med livmoderhalskræft, som er kommet igen, eller med livmoderhalskræft, der har spredt sig (dannet metastaser).
English: At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
Danish: Hazard ratio var 0,93 (95 % konfidensinterval: 0,61-1,41; p-værdi = 0,72).
English: Number of patients Progression-free survival Median (months) Hazard ratio
Danish: Antal patienter Progressionsfri overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval)
English: Proteinuria b,d
Danish: Blødning b,d
English: Grade 3-5 reactions have been observed in up to 2.3% of patients treated with bevacizumab plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Danish: Dette skal ses i sammenligning med < 1 % af de patienter, der kun fik kemoterapi (NCICTCAE v. 3).
English: Contents of the pack and other information What Zirabev contains
Danish: Zirabev indeholder
English: Overall survival - Primary analysis6 Median (months)
Danish: Samlet overlevelse - primær analyse
English: were reported in up to 2.7% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
Danish: Cerebrovaskulære tilfælde (inklusiv transitorisk iskæmisk attak) blev rapporteret hos op til 2,7 % af patienterne, som fik bevacizumab i kombination med kemoterapi i forhold til op til 0,5 % af patienterne, som fik kemoterapi alene.
English: Pain, Lethargy, Mucosal inflammation
Danish: Smerter, Letargi, Slimhindeinfla mmation
English: A high proportion of patients (approximately 63% IFN/placebo;
Danish: En stor del af patienterne (ca.
English: Wound healing complications b,d
Danish: Hud og subkutane væv Sårhelingskomplik ationer b,d
English: pancreas and prostate.
Danish: Nyrer og urinveje
English: Succinic acid
Danish: Bækkensmerter
English: Nas al s eptum perforation a
Danish: Nasal septumperforati on
English: 6.3 Shelf life Vial (unopened)
Danish: Hætteglas (uåbnet)
English: The observed changes were only partially reversible.
Danish: De observerede ændringer var kun delvist reversible.
English: No improvement within 7 days or 2nd occurrence
Danish: Ingen bedring i løbet af 7 dage eller 2. forekomst
English: Stivarga should be taken at the same time each day.
Danish: Stivarga bør tages på samme tidspunkt hver dag.
English: • Median age: 63 years
Danish: • Gennemsnitlig alder: 63 år
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 22 May 2018
Danish: Dato for første markedsføringstilladelse: 26. august 2013 Dato for seneste fornyelse: 22. maj 2018
English: This may be due to acceleration of an age-related physiological process.
Danish: Dette kan skyldes acceleration af en aldersrelateret fysiologisk proces.
English: Stivarga should be permanently discontinued if there is no resolution.
Danish: Stivarga bør seponeres permanent, hvis der ikke er nogen resolution.
English: This 4-week period is considered a treatment cycle.
Danish: Denne 4-ugers periode anses for at være en behandlingscyklus.
English: Environmental risk assessment (ERA)
Danish: Miljørisikovurdering (Environmental Risk Assessment, ERA)
English: This medicine may also affect the results of some blood tests.
Danish: Denne medicin kan også påvirke resultaterne af nogle blodprøver.
English: Your doctor will usually ask you to take Stivarga for 3 weeks and then to stop for 1 week.
Danish: Din læge vil normalt bede dig tage Stivarga i 3 uger og dernæst stoppe i 1 uge.
English: • Male: 88%
Danish: • Mand: 88 %
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke estimeres ud fra de forhåndenværende data)
English: An increase in AUC of irinotecan of approximately 28% was also observed.
Danish: Der blev også observeret en stigning i AUC for irinotecan på ca. 28 %.
English: Avoid drinking grapefruit juice while taking Stivarga.
Danish: Undgå at drikke grapefrugtjuice, mens du tager Stivarga.
English: Thereafter, the medicinal product is to be discarded.
Danish: Derefter skal lægemidlet bortskaffes.
English: They are classified according to System Organ Class and the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Danish: De er klassificeret i henhold til organsystem og den mest hensigtsmæssige MedDRA-term anvendes til at beskrive en bestemt reaktion og dets synonymer og relaterede tilstande.
English: A pre-planned interim analysis for efficacy was performed when 432 deaths had occurred.
Danish: En forud planlagt interimanalyse for virkning blev foretaget efter 432 dødsfald.
English: • Caucasian: 36%, Asian: 41%
Danish: • Kaukasisk: 36 %, asiatisk: 41 %
English: Your doctor may change your dose.
Danish: Din læge kan ændre din dosis.
English: Tell your doctor immediately if you have any of the following symptoms:
Danish: Fortæl det straks til lægen, hvis du har nogle af følgende symptomer:
English: The overall median time since most recent progression or relapse to randomisation was 6 weeks.
Danish: Den samlede mediantid fra seneste progression eller recidiv til randomisering var 6 uger.
English: Grade b All Grades % Grade 3/4 % All Grades % Grade 3/4 % All Grades % Grade 3/4 %
Danish: Grad b Alle grader % Grad 3/4 % Alle grader % Grad 3/4 % Alle grader % Grad 3/4 %
English: Dose interruptions and/or dose reductions may be required based on individual safety and tolerability.
Danish: Dosisafbrydelser og/eller dosisreduktioner kan være påkrævet på baggrund af individuel sikkerhed og tolerans.
English: You will usually take Stivarga as long as you are benefiting and not suffering unacceptable side effects.
Danish: Normalt skal du tage Stivarga, så længe du drager fordel deraf og ikke har uacceptable bivirkninger.
English: Take Stivarga at the same time each day after a light (low-fat) meal.
Danish: Tag Stivarga på samme tidspunkt hver dag efter et let (fedtfattigt) måltid.
English: This is equivalent to 3% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 3 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: Thereafter, periodic monitoring should be continued at least monthly and as clinically indicated.
Danish: Derefter bør regelmæssig kontrol fortsættes mindst månedligt og efter klinisk behov.
English: Stivarga may reduce fertility in both men and women.
Danish: Stivarga kan reducere fertiliteten hos både mænd og kvinder.
English: Your doctor may temporarily stop your treatment.
Danish: Din læge kan midlertidigt stoppe din behandling.
English: • ECOG Performance Status (PS) of 0: 66% or ECOG PS of 1: 34%
Danish: • ECOG Performance Status (PS) på 0: 66 % eller ECOG PS på 1: 34 %
English: • Median duration of sorafenib treatment: 7.8 months
Danish: • Gennemsnitlig behandlingstid med sorafenib: 7,8 måneder
English: However, physiology-based pharmacokinetic modelling does not predict any relevant change in exposure in these patients.
Danish: Fysiologi-baseret farmakokinetisk modellering forudsiger imidlertid ingen relevant ændring i eksponering hos disse patienter.
English: Taking Stivarga with food and drink
Danish: Brug af Stivarga sammen med mad og drikke
English: Take the dose of Stivarga that your doctor prescribes for you.
Danish: Tag den dosis Stivarga, som din læge har ordineret til dig.
English: Method of administration Stivarga is for oral use.
Danish: Administration Stivarga er til oral anvendelse.
English: This is 1 cycle of treatment.
Danish: Det er 1 behandlingscyklus.
English: Pharmacokinetic interactions of other antibiotics have not been studied.
Danish: Farmakokinetiske interaktioner med andre antibiotika er ikke undersøgt.
English: - if you get chest pain or have any heart problems.
Danish: - Hvis du får brystsmerter eller har hjerteproblemer.
English: Randomisation was performed within 10 weeks after the last treatment with sorafenib.
Danish: Randomiseringen blev foretaget inden for 10 uger efter den sidste behandling med sorafenib.
English: These events are also known to be common disease-related complications in patients with intra-abdominal malignancies.
Danish: Disse hændelser vides også at være almindelige sygdomsrelaterede komplikationer hos patienter med intraabdominale maligniteter.
English: • Radiotherapy prior to regorafenib treatment: 15%
Danish: • Radioterapi inden regorafenib-behandling: 15 %