natgillin/translations-raw huggingface dataset:
Resultater af subgruppe-analyser i forhold til historisk KRAS-mutationsstatus viste en behandlingseffekt på overlevelsen, der var bedre for regorafenib end for placebo, hos patienter med KRAS-vildtype tumorer, mens der blev rapporteret en numerisk lavere effekt hos patienter med KRAS-mutante tumorer. 
Subgroup analysis results by historical KRAS mutational status showed a treatment effect for OS in favour of regorafenib over placebo for patients with KRAS wild-type tumours whereas a numerically lower effect was reported in patients with KRAS mutant tumours; the treatment effect for PFS favouring regorafenib was observed regardless of KRAS mutational status.
Keratoakantom/ Planocellulært karcinom i huden 
Keratoacanthoma/ Squamous cell carcinoma of the skin
Afbryd behandlingen indtil toksiciteten er forsvundet eller forbedret til grad 0-1. 
Interrupt therapy until toxicity resolves to Grade 0-1.
Perifer neuropati 
Headache Tremor Peripheral neuropathy
Din læge vil muligvis anbefale at bruge cremer og/eller skoindlæg og handsker for at kontrollere dine symptomer. 
To manage your symptoms, your doctor may recommend the use of creams and/or the use of shoe cushions and gloves.
§ Bedste understøttende behandling * Hazard ratio < 1: Stivarga er bedre end placebo ** baseret på investigatorens bedømmelse af tumorrespons 
§ BSC Supportive Care * Hazard ratio < 1 favours Stivarga ** based on investigator's assessment of tumour response
Gastrointestinal perforation (herunder nogle med dødelig udgang) og fistler er blevet rapporteret hos patienter behandlet med Stivarga (se pkt. 
Gastrointestinal perforation (including fatal outcome) and fistulae have been reported in patients treated with Stivarga (see section 4.8).
Anvendelse af Stivarga i den pædiatriske population for indikationen hepatocellulært karcinom er ikke relevant. 
There is no relevant use of Stivarga in the paediatric population in the indication of hepatocellular carcinoma.
Se tabel 2 for anbefalede foranstaltninger og dosismodifikationer i tilfælde af forværring af leverfunktionsprøver, der anses for at have forbindelse med behandlingen med Stivarga (se også pkt. 
For recommended measures and dose modifications in case of worsening of liver function tests considered related to treatment with Stivarga see Table 2 (see also section 4.4).
1,7 måneder 
1.7 months
PFS var også signifikant længere hos patienter, der fik Stivarga plus BSC (hazard ratio: 0,311, p<0,000001), median PFS var 3,2 måneder med Stivarga vs. 1,7 måneder med placebo. 
PFS was also significantly longer in patients receiving Stivarga plus BSC (hazard ratio: 0.311, p<0.000001), median PFS 3.2 months with Stivarga vs. 1.7 months with placebo.
hypofosfatæmi, hypokalcæmi, hyponatriæmi og hypomagnesæmi) - højt niveau af urinsyre i blodet (hyperurikæmi) - tab af kropsvæske (dehydrering) - hovedpine - rysten (tremor) - nervesygdomme, der kan forårsage ændringer i følesansen, såsom følelsesløshed, snurren, 
(hypokalaemia, hypophosphatemia, hypocalcaemia, hyponatraemia and hypomagnesaemia) - high level of uric acid in the blood (hyperuricaemia) - loss of body fluids (dehydration) - headache - shaking (tremor) - disorder of the nerves which can cause a change in sensation, such as numbness, tingling,
Der kræves ingen dosisjustering for patienter med let nedsat leverfunktion. 
No dose adjustment is required in patients with mild hepatic impairment.
I prækliniske studier har regorafenib vist potent anti-tumoraktivitet i et bredt spektrum af tumormodeller sandsynligvis ved at mediere anti-proliferativ og anti-angiogenetisk effekt, inkl. 
In preclinical studies regorafenib has demonstrated potent antitumour activity in a broad spectrum of tumour models including colorectal, gastrointestinal stromal and hepatocellular tumour models which is likely mediated by its anti-angiogenic and anti-proliferative effects.
Stivarga bør ikke anvendes til patienter med svært nedsat leverfunktion (Child-Pugh C), da Stivarga ikke er blevet undersøgt hos denne population. 
Stivarga is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) as Stivarga has not been studied in this population.
Hvis du har taget for meget Stivarga 
If you take more Stivarga than you should
Patienter med ustabil angina eller nyopstået angina (inden for 3 måneder efter påbegyndelse af Stivarga), nylig myokardieinfarkt (inden for 6 måneder efter påbegyndelse af behandling med 
Patients with unstable angina or new onset angina (within 3 months of starting Stivarga therapy), recent myocardial infarction (within 6 months of starting Stivarga therapy) and those with cardiac failure New York Heart Association (NYHA) Classification 2 or higher were excluded from the clinical studies.
M-2 metaboliseres yderligere ved oxidativ metabolisme medieret af CYP3A4, samt ved glucuronidation medieret af UGT1A9. 
M-2 is further metabolised by oxidative metabolism mediated by CYP3A4, as well as by glucuronidation mediated by UGT1A9.
PFS var signifikant længere hos patienter, der fik Stivarga plus BSC (hazard ratio: 0,494, p<0,000001, se tabel 5). 
PFS was significantly longer in patients receiving Stivarga plus BSC (hazard ratio: 0.494, p<0.000001, see Table 5).
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Stivarga i en eller flere undergrupper af den pædiatriske population ved behandling af solide maligne tumorer (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with Stivarga in one or more subsets of the paediatric population in the treatment of solid malignant tumours (see section 4.2 for information on paediatric use).
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE TABLETBEHOLDER-ETIKET 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
(trombocytopeni) - reduktion i antallet af røde blodlegemer (anæmi) - nedsat appetit og fødeindtagelse - højt blodtryk (hypertension) - stemmeændringer eller hæshed (dysfoni) - hyppig eller løs afføring (diaré) - smertefuld eller tør mund, smertefuld tunge, mundsår (stomatitis og/eller slimhindeinfektion) - kvalme - opkastning - højt indhold af bilirubin i blodet, et stof, der dannes i leveren (hyperbilirubinæmi) - ændringer i enzymer, der produceres af leveren, som kan indikere, at der er noget galt med leveren (stigning i transaminaser) - rødme, smerte, blærer og hævelse af håndfladerne eller fodsålerne (hånd-fod-hudreaktion) - udslæt - svaghed, manglende styrke og energi, overdreven træthed og unormal søvnighed 
(thrombocytopenia) - reduction in the number of red blood cells (anaemia) - decreased appetite and food intake - high blood pressure (hypertension) - voice changes or hoarseness (dysphonia) - frequent or loose bowel movements (diarrhoea) - painful or dry mouth, painful tongue, mouth sores (stomatitis and/or mucosal inflammation) - feeling sick (nausea) - vomiting - high blood levels of bilirubin, a substance produced by the liver (hyperbilirubinaemia) - changes in enzymes produced by the liver, which may indicate that something is wrong with the liver (increase in transaminases) - redness, pain, blisters and swelling of the palms of the hands or soles of the feet (hand-foot skin reaction) - rash - weakness, lack of strength and energy, excessive tiredness and unusual sleepiness
Forekomsten af grad 3 hånd-fod-hudreaktion var 17,1 % (KRC), 22,0 % (GIST) og 12,3 % (HCC). 
The incidence of Grade 3 hand-foot skin reaction was 17.1% (CRC), 22.0% (GIST) and 12.3% (HCC).
svaghed eller smerte (perifer neuropati) - smagsforstyrrelser - tør mund - halsbrand (gastroøsofageal refluks) - infektion eller irritation i maven og tarmene (gastroenteritis) - hårtab (alopeci) - tør hud - udslæt med afskalning af hud (eksfoliativt udslæt) - pludselige, ufrivillige muskelsammentrækninger (muskelspasmer) - protein i urinen (proteinuri) - høje niveauer af visse enzymer, der er involveret i fordøjelsen (stigning i amylase og lipase) - unormal blodkoagulationstilstand (unormal international normaliseret ratio) 
weakness or pain (peripheral neuropathy) - taste disorders - dry mouth - heartburn (gastro-oesophageal reflux) - infection or irritation of the stomach and intestines (gastroenteritis) - hair loss (alopecia) - dry skin - rash with flaking or peeling of skin (exfoliative rash) - a sudden, involuntary contraction of a muscle (muscle spasms) - protein in the urine (proteinuria) - high levels of certain enzymes involved in digestion (increase in amylase and lipase) - abnormal blood clotting condition (abnormal International Normalized Ratio).
Pakke med 28 filmovertrukne tabletter. 
Pack of 28 film-coated tablets.
Stomatitis Opkastning Kvalme 
Diarrhoea Stomatitis Vomiting Nausea
7,8 måneder 
7.8 months
Administration af rifampicin (600 mg i 9 dage), en kraftig CYP3A4-induktor, med en enkelt dosis regorafenib (160 mg på dag 7) resulterede i en reduktion i AUC over for regorafenib på ca. 50 %, en stigning på 3-4 gange i gennemsnitlig eksponering for den aktive metabolit M-5, og ingen ændring i eksponering for den aktive metabolit M-2. 
Administration of rifampicin (600 mg for 9 days), a strong CYP3A4 inducer, with a single dose of regorafenib (160 mg on day 7) resulted in a reduction in AUC of regorafenib of approximately 50%, a 3- to 4-fold increase in mean exposure of the active metabolite M-5, and no change in exposure of active metabolite M-2.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON/KARTON 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Oprethold dosisniveau og indled omgående symptomlindrende behandling 
Maintain dose level and immediately institute supportive measures for symptomatic relief.
I de placebokontrollerede fase III-studier blev infektioner observeret oftere hos patienter behandlet med Stivarga, sammenlignet med patienter, der fik placebo (alle grader: 31,6 % vs. (17,2 %). 
In the placebo-controlled phase III trials, infections were more often observed in patients treated with Stivarga, compared to patients receiving placebo (all grades: 31.6% vs. 17.2%).
Anvendelse af Stivarga i den pædiatriske population for indikationen metastaserende kolorektal cancer er ikke relevant. 
There is no relevant use of Stivarga in the paediatric population in the indication of metastatic colorectal cancer.
5,4 måneder 
5.4 months
Koncentrationen af fri trijodthyronin (FT3) under den nedre normalgrænse (< LLN) efter start på behandling blev rapporteret hos 29,2 % af patienterne i behandling med Stivarga, og hos 20,4 % af patienterne, der fik placebo. 
Concentration of free triiodothyronine (FT3) post baseline below lower limit of normal (<LLN) was reported in 29.2% of patients treated with Stivarga and in 20.4% of patients receiving placebo.
Koncentrationen af fri thyroxin (FT4) <LLN efter start på behandling blev rapporteret hos 8,1 % af patienterne i behandling med Stivarga, og hos 5,6 % af patienterne, der fik placebo. 
Concentration of free thyroxin (FT4) post baseline <LLN was reported in 8.1% of patients treated with Stivarga and 5.6% of patients receiving placebo.
Tilgængelige kliniske data og fysiologi-baseret farmakokinetisk modellering indikerer sammenlignelig steady state eksponering for regorafenib og metabolit M-2 og M-5 hos patienter med let eller moderat nedsat nyrefunktion og hos patienter med normal nyrefunktion. 
Available clinical data and physiology-based pharmacokinetic modelling indicate similar steady-state exposure of regorafenib and its metabolites M-2 and M-5 in patients with mild or moderate renal impairment, compared to patients with normal renal function.
Resultater fra dyrestudier indikerer, at regorafenib kan hæmme fertiliteten hos hanner og hunner (se pkt. 
Results from animal studies indicate that regorafenib can impair male and female fertility (see section 5.3).
Fortæl det til lægen, hvis nogle af disse tilstande gælder for dig, inden du tager Stivarga. 
Before you take Stivarga tell your doctor if any of these conditions apply to you.
- gastrointestinale stromale tumorer (GIST, en kræfttype i mave-tarm-systemet), der har spredt sig, eller som ikke kan opereres, hos voksne patienter, som tidligere er blevet behandlet med andre lægemidler mod kræft (imatinib og sunitinib) 
- gastrointestinal stromal tumours (GIST), a type of cancer of the stomach and bowel, that has spread to other parts of the body or is not amenable to surgery, in adult patients who have been previously treated with other anticancer medicines (imatinib and sunitinib)
Hånd-fod-hudreaktion (HFSR) eller palmoplantar erytrodysæstesi-syndrom og udslæt er de dermatologiske bivirkninger, der hyppigst observeres med Stivarga (se pkt. 
Hand-foot skin reaction (HFSR) or palmar-plantar erythrodysesthesia syndrome and rash represent the most frequently observed dermatological adverse reactions with Stivarga (see section 4.8).
Se tabel 1 for anbefalede dosismodifikationer og foranstaltninger i tilfælde af hånd-fod-hudreaktion (HFSR) (palmoplantar erytrodysæstesi-syndrom). 
For recommended dose modifications and measures in case of hand-foot skin reaction (HFSR)/palmar-plantar erythrodysesthesia syndrome see Table 1.
De fleste tilfælde af hypertension hos patienter behandlet med Stivarga opstod i løbet af den første behandlingscyklus, og de var lette til moderate i sværhedsgrad (grad 1 og 2: 20,9 % (KRC), 31,8 % (GIST) og 15,8 % (HCC)). 
Most cases of hypertension in patients treated with Stivarga appeared during the first cycle of treatment and were mild to moderate in severity (Grades 1 and 2: 20.9%, CRC, 31.8%, GIST and 15.8% HCC).
I de placebokontrollerede fase III-studier var den samlede forekomst af proteinuri, som opstod under behandlingen, 9,1 % hos patienter behandlet med Stivarga, sammenlignet med 1,9 % hos patienter, der fik placebo. 
In the placebo-controlled phase III trials, the overall incidence of treatment emergent proteinuria was 9.1% in patients treated with Stivarga, compared to 1.9% in patients receiving placebo.
Der blev observeret en højere forekomst af hånd-fodhudreaktion (HFSR)/palmoplantar erytrodysæstesi-syndrom, svære anomalier i leverfunktionsprøver og leverdysfunktion hos asiatiske patienter (især japanske) behandlet med Stivarga sammenlignet med kaukasiske patienter. 
A higher incidence of hand foot skin reaction (HFSR)/palmar-plantar erythrodysesthesia syndrome, severe liver function test abnormalities and hepatic dysfunction was observed in Asian (in particular Japanese) patients treated with Stivarga compared with Caucasians.
I de placebokontrollerede fase III-studier var den samlede forekomst af hånd-fod-hudreaktion højere hos patienter behandlet med Stivarga, sammenlignet med patienter, der fik placebo (alle grader: 51,4 % vs. 6,5 % KRC, 66,7 % vs. 15,2 % GIST og 51,6 % vs.7,3 % HCC). 
In the placebo-controlled phase III trials, the overall incidence of hand-foot skin reaction was higher in patients treated with Stivarga, compared to patients receiving placebo (all grades: 51.4% vs. 6.5% CRC, 66.7% vs. 15.2% GIST and 51.6% vs.7.3% HCC).
Få straks medicinsk hjælp, hvis du får de følgende symptomer: alvorlige mavesmerter eller mavesmerter, der ikke går væk, opkastning af blod, rød eller sort afføring. 
Get medical help immediately, if you get the following symptoms: severe stomach pain or stomach pain that does not go away, vomiting blood, red or black stools.
Hjælpestoffer, som behandleren skal være opmærksom på En daglig dosis på 160 mg indeholder 2,427 mmol (eller 55,8 mg) natrium (se pkt. 
Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium (see section 4.4).
Fortsæt behandlingen med Stivarga. 
Continue Stivarga treatment.
Behandling med Stivarga kan medføre en større risiko for alvorlige leverproblemer. 
Treatment with Stivarga may lead to a higher risk of severe liver problems.
Regorafenib metaboliseres primært i leveren af oxidativ metabolisme medieret af CYP3A4, samt af glucuronidering medieret af UGT1A9. 
Regorafenib is metabolized primarily in the liver by oxidative metabolism mediated by CYP3A4, as well as by glucuronidation mediated by UGT1A9.
I alt 760 patienter blev randomiseret 2:1 til at modtage 160 mg regorafenib (4 tabletter Stivarga, der hver indeholder 40 mg regorafenib) oralt én gang dagligt (N=505) plus bedste understøttende behandling (BSC) eller tilsvarende placebo (N=255) plus BSC i 3 uger efterfulgt af 1 uge uden behandling. 
In total, 760 patients were randomised 2:1 to receive 160 mg regorafenib (4 tablets Stivarga each containing 40 mg regorafenib) orally once daily (N=505) plus Best Supportive Care (BSC or matching placebo (N=255) plus BSC for 3 weeks on therapy followed by 1 week off therapy.
I de placebokontrollerede fase III-studier var den samlede forekomst af hypertension højere hos patienter behandlet med Stivarga, sammenlignet med patienter, der fik placebo (29,6 % vs. 7,5 % (KRC), 60,6 % vs. 25,8 % (GIST) og 31,0 % vs. 6,2 % (HCC)). 
In the placebo-controlled phase III trials, the overall incidence of hypertension was higher in patients treated with Stivarga, compared to patients receiving placebo (29.6% vs. 7.5% CRC, 60.6% vs. 25.8% GIST and 31.0% vs. 6.2% HCC).
Administration af ketoconazol (400 mg i 18 dage), en kraftig CYP3A4-inhibitor, med en enkelt dosis regorafenib (160 mg på dag 5) resulterede i en stigning i gennemsnitlig eksponering (AUC) over for regorafenib på ca. 33 % og et fald i gennemsnitlig eksponering for de aktive metabolitter, M-2 (N-oxid) og M-5 (N-oxid og N-desmethyl) på ca. 90 %. 
Administration of ketoconazole (400 mg for 18 days), a strong CYP3A4 inhibitor, with a single dose of regorafenib (160 mg on day 5) resulted in an increase in mean exposure (AUC) of regorafenib of approximately 33%, and a decrease in mean exposure of the active metabolites, M-2 (N-oxide) and
Påvirkning af laboratorieprøver 
Laboratory test abnormalities
Stivargas kliniske virkning og sikkerhed er blevet evalueret i et internationalt, randomiseret, dobbeltblindet, placebokontrolleret fase III-multicenterstudie (GRID) hos patienter med gastrointestinale stromale tumorer (GIST), der tidligere er blevet behandlet med 2-tyrosinkinasehæmmere (imatinib og sunitinib). 
The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (GRID) in patients with gastrointestinal stromal tumours (GIST) previously treated with 2 tyrosine kinase inhibitors (imatinib and sunitinib).
I de to placebokontrollerede fase III-studier var den samlede forekomst af blødning 18,2 % hos patienter behandlet med Stivarga og 9,5 % hos patienter, der fik placebo. 
In the placebo-controlled phase III trials, the overall incidence of haemorrhage was 18.2% in patients treated with Stivarga and 9.5% in patients receiving placebo.
De fleste tilfælde af hånd-fod-hudreaktion hos patienter i behandling med Stivarga opstod i løbet af den første behandlingscyklus, og de var lette til moderate i sværhedsgrad (grad 1 og 2: 34,3 % (KRC), 44,7 % (GIST) og 39,3 % (HCC)). 
Most cases of hand-foot skin reaction in patients treated with Stivarga appeared during the first cycle of treatment and were mild to moderate in severity (Grades 1 and 2: 34.3%%, CRC, 44.7%, GIST and 39.3%, HCC).
kinaser, der har betydning for tumorangiogenese ((VEGFR1, -2, -3, TIE2), onkogenese (KIT, RET, RAF-1, BRAF, BRAFV600E), metastaser (VEGFR3, PDGFR, FGFR) og tumorimmunitet (CSF1R). 
Mechanism of action and pharmacodynamic effects Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R).
Tilgængelige kliniske data tyder på, at eksponeringen for regorafenib og dets metabolitter M-2 og M-5 er den samme hos patienter med let, moderat eller svært nedsat nyrefunktion som hos patienter med normal nyrefunktion. 
Available clinical data indicate similar exposure of regorafenib and its metabolites M-2 and M-5 in patients with mild, moderate or severe renal impairment compared to patients with normal renal function.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Stivarga i alle undergrupper af den pædiatriske population til behandling af adenokarcinom af kolon og rektum (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with Stivarga in all subsets of the paediatric population in the treatment of adenocarcinoma of the colon and rectum (see section 4.2 for information on paediatric use).
Stivargas kliniske virkning og sikkerhed er blevet evalueret i et internationalt, randomiseret, dobbeltblindet, placebokontrolleret fase III-multicenterstudie (RESORCE) hos patienter med hepatocellulært karcinom, der tidligere er blevet behandlet med sorafenib. 
The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (RESORCE) in patients with hepatocellular carcinoma who have been previously treated with sorafenib.
I de placebokontrollerede fase III-studier måltes tyreoidea-stimulerende hormon (TSH) værdier forhøjet over normalværdien (>ULN) hos 34,6 % af patienterne i behandling med Stivarga og hos 17,2 % af patienterne, der fik placebo. 
In the placebo-controlled phase III trials, tests on thyroid stimulating hormone (TSH) showed post baseline >ULN in 34.6% of patients treated with Stivarga and in 17.2% of patients receiving placebo.
Forekomsten af grad 3 hånd-fod-hudreaktion hos asiater var 20,5 % (KRC), 23,5 % (GIST) og 13,5 % (HCC) (se pkt. 
The incidence of Grade 3 hand-foot skin reaction in Asians was 20.5% (CRC), 23.5% (GIST) and 13.5% (HCC) (see sections 4.2 and 4.4).
I alt blev 573 patienter med HCC randomiseret i forholdet 2:1 til enten 160 mg regorafenib oralt én gang dagligt (n=379) plus bedste understøttende behandling (BSC) eller matchende placebo (n=194) plus BSC i 3 uger, efterfulgt af 1 uge uden behandling. 
In total, 573 patients with HCC were randomised 2:1 to receive either 160 mg regorafenib orally once daily (n=379) plus Best Supportive Care (BSC) or matching placebo (n=194) plus BSC for 3 weeks on therapy followed by 1 week off therapy.
Behandling med Stivarga kan medføre en større risiko for leverproblemer. 
Treatment with Stivarga may lead to a higher risk of liver problems.
1,5 måneder 
1.5 months
Stivarga er associeret med en øget forekomst af myokardieiskæmi og myokardieinfarkt (se pkt. 
Stivarga has been associated with an increased incidence of myocardial ischaemia and infarction (see section 4.8).
4.2) for patienter med forværring/påvirkning af leverfunktionsprøver, der anses for at være relateret til behandlingen med Stivarga (dvs. hvor der ikke er nogen anden tydelig årsag, f.eks. post-hepatisk kolestase eller sygdomsprogression). 
For patients with observed worsening of liver function tests considered related to treatment with Stivarga (i.e. where no alternative cause is evident, such as post-hepatic cholestasis or disease progression), the dose modification and monitoring advice in Table 2 should be followed (see section 4.2).
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Stivarga i alle undergrupper af den pædiatriske population ved behandling af hepatocellulært karcinom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with Stivarga in all subsets of the paediatric population in the treatment of hepatocellular carcinoma (see section 4.2 for information on paediatric use).
De fleste blødningshændelser hos patienter i behandling med Stivarga var lette til moderate i sværhedsgrad (grad 1 og 2: 15,2 %), hovedsageligt næseblod (6,1 %). 
Most cases of bleeding events in patients treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 15.2%), most notably epistaxis (6.1%).
En daglig dosis på 160 mg indeholder1,68 mg lecithin (deriveret fra soja) (se pkt. 
Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya) (see section 4.4).