natgillin/translations-raw huggingface dataset:
Et andet fase III, internationalt, multicenter, randomiseret, dobbeltblindt, placebo-kontrolleret studie (studie 4, 11849) evaluerede den kliniske fordel af sorafenib hos 226 patienter med fremskredent hepatocellulært karcinom.
A second Phase III, international, multi-centre, randomised, double blind, placebo-controlled study (Study 4, 11849) evaluated the clinical benefit of sorafenib in 226 patients with advanced hepatocellular carcinoma.
Den cirkulerende hovedmetabolit af sorafenib i plasma, pyridin N-oxid, viser in vitro den samme effekt som den for sorafenib.
The main circulating metabolite of sorafenib in plasma, the pyridine N-oxide, shows in vitro potency similar to that of sorafenib.
Før behandling indledes, anbefales det, at lægen omhyggeligt evaluerer den enkelte patients prognose ved at vurdere den maksimale læsionsstørrelse (se pkt.
Before initiating treatment, physicians are recommended to carefully evaluate the prognosis in the individual patient considering maximum lesion size (see section 5.1), symptoms related to the disease (see section 5.1) and progression rate.
Sorafenib er vist at hæmme transportproteinet p-glykoprotein (P-pg) in vitro.
In vitro, sorafenib has been shown to inhibit the transport protein p-glycoprotein (P-gp).
Nexavar indeholder natrium
Nexavar contains sodium
Hos patienter med hepatocellulært karcinom (HCC) og Child-Pugh A eller B (let til moderat) nedsat leverfunktion var eksponeringsværdierne sammenlignelige og inden for det interval, der blev observeret hos patienter uden nedsat leverfunktion.
In hepatocellular carcinoma (HCC) patients with Child-Pugh A or B (mild to moderate) hepatic impairment, exposure values were comparable and within the range observed in patients without hepatic impairment.
Sorafenibs kliniske virkning og sikkerhed er undersøgt hos patienter med hepatocellulært karcinom (HCC), hos patienter med fremskredent renalcellekarcinom (RCC) og hos patienter med differentieret thyreoideacancer (DTC).
The clinical safety and efficacy of sorafenib have been studied in patients with hepatocellular carcinoma (HCC), in patients with advanced renal cell carcinoma (RCC) and in patients with differentiated thyroid carcinoma (DTC).
At tage en for stor mængde Nexavar øger risikoen for bivirkninger eller svære bivirkninger, især diarré og hududslæt.
Taking too much Nexavar makes side effects more likely or more severe, especially diarrhoea and skin reactions.
I et klinisk farmakologistudie (enkeltdosis på 400 mg sorafenib) blev der ikke observeret nogen sammenhæng mellem sorafenibeksponering og nyrefunktion hos forsøgspersoner med normal nyrefunktion, let, moderat eller svært nedsat nyrefunktion.
In a clinical pharmacology study (single dose of 400 mg sorafenib), no relationship was observed between sorafenib exposure and renal function in subjects with normal renal function, mild, moderate or severe renal impairment.
Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejersken eller apotekpersonalet.
If you get any side effects, talk to your doctor or pharmacist.
Metabolisme og ernæring anoreksi hypofosfatæmi hypokalcæmi hypokaliæmi hyponatriæmi hypoglykæmi dehydrering
Metabolism and nutrition disorders anorexia hypophosphataemia hypocalcaemia hypokalaemia hyponatraemia hypoglycaemia dehydration
Yderligere oplysninger om udvalgte bivirkninger
Further information on selected adverse drug reactions
Almindelig Ikke almindelig Sjælden Ikke kendt
Uncommon Rare
Nervesystemet perifer sensorisk neuropati dysgeusi reversibel posterior leukoencefalopati encephalopati
Nervous system disorders peripheral sensory neuropathy dysgeusia reversible posterior leukoencephalopathy*
Psykiske forstyrrelser depression
Psychiatric disorders depression
Afvigelser i laboratorieanalyser hos patienter med DTC (studie 5)
Laboratory test abnormalities in DTC patients (study 5)
De vigtigste alvorlige bivirkninger var myokardieinfarkt/myokardieiskæmi, gastrointestinal perforation, lægemiddelinduceret hepatitis, blødning og hypertension/hypertensiv krise.
The most important serious adverse reactions were myocardial infarction/ischaemia, gastrointestinal perforation, drug induced hepatitis, haemorrhage, and hypertension/hypertensive crisis.
Hypokalcæmi af grad 3 og 4 opstod hos 6,8 % og 3,4 % af sorafenibbehandlede DTC-patienter (se pkt.
Hypocalcaemia grade 3 and 4 occurred in 6.8% and 3.4% of sorafenib-treated patients with DTC (see section 4.8).
Højrisikopatienter - i henhold til MSKCC- (Memorial Sloan Kettering Cancer Center) prognosegruppe - var ikke inkluderet i det kliniske fase III-studie for renalcellekarcinom (se studie 1 i pkt.
High Risk Patients, according to MSKCC (Memorial Sloan Kettering Cancer Center) prognostic group, were not included in the phase III clinical study in renal cell carcinoma (see study 1 in section 5.1), and benefit-risk in these patients has not been evaluated.
Samtidig administration af sorafenib og midazolam, dextrometorphan eller omeprazol, som er substrater for henholdsvis CYP3A4, CYP2D6 og CYP2C919, forandrede ikke eksponeringen af disse substanser.
Concomitant administration of sorafenib and midazolam, dextromethorphan or omeprazole, which are substrates for cytochromes CYP3A4, CYP2D6 and CYP2C19 respectively, did not alter the exposure of these agents.
Samtidig indgift af neomycin har vist sig at påvirke denne proces og nedsætte sorafenibs gennemsnitlige biotilgængelighed med 54 %.
Coadministration of neomycin has been shown to interfere with this process, decreasing the mean bioavailability of sorafenib by 54%.
Deres læge vil overvåge indholdet af calcium og skjoldbruskkirtel-hormon i blodet.
Your doctor will monitor blood calcium and thyroid hormone levels.
Den mediane behandlingsvarighed i den dobbeltblindede periode var 46 uger (interval 0,3-135) for patienter, der fik sorafenib, og 28 uger (interval 1,7-132) for patienter, der fik placebo.
The median duration of therapy in the double-blind period was 46 weeks (range 0.3-135) for patients receiving sorafenib and 28 weeks (range 1.7-132) for patients receiving placebo.
Nexavar er indiceret til behandling af patienter med progressiv, lokalt fremskreden eller metastaserende differentieret (papillær/follikulær/Hürthle-celle) thyreoideacancer, refraktær over for radioaktivt iod.
Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Den kliniske signifikans for disse data er ikke kendt (se pkt.
The clinical significance of these findings is unknown (see section 4.4).
Det skal De vide, før De begynder at tage Nexavar Tag ikke Nexavar
What do you need to know before you take Nexavar Do not take Nexavar
anafylaktisk reaktion angioødem
anaphylactic reaction angioedema
** Hånd-fod-hud-reaktion (HFSR) svarende til palmoplantar erytrodysæstesi-syndrom i MedDRA
** Hand foot skin reaction corresponds to palmar plantar erythrodysaesthesia syndrome in
Nexavar er ikke blevet undersøgt på børn og unge.
Children and adolescents have not yet been tested with Nexavar.
Nexavar er indiceret til behandling af patienter med fremskredent renalcellekarcinom, hvor tidligere interferon-alfa- og interleukin-2-baseret behandling ikke har hjulpet, eller hvor en sådan behandling ikke er blevet vurderet passende.
Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
De må ikke amme Deres barn under behandlingen med Nexavar, da dette lægemiddel kan påvirke
You must not breast-feed your baby during Nexavar treatment, as this medicine may interfere with the growth and development of your baby.
Patienter med stabil sygdom i behandling med sorafenib var randomiseret til placebo eller fortsat behandling med sorafenib.
Patients with stable disease on therapy with sorafenib were randomised to placebo or continued sorafenib therapy.
Progressionsfri overlevelse hos patienter med RCC var signifikant længere i Nexavargruppen (163 dage) end i placebogruppen (41 dage) (p = 0,0001, HR = 0,29).
Progression-free survival in patients with RCC was significantly longer in the sorafenib group (163 days) than in the placebo group (41 days) (p = 0.0001, HR = 0.29).
Sorafenib er en multikinasehæmmer, som nedsætter proliferationen af tumorceller in vitro.
Sorafenib is a multikinase inhibitor that decreases tumour cell proliferation in vitro.
Der bør udvises forsigtighed, når sorafenib administreres sammen med lægemidler, der hovedsageligt metaboliseres/elimineres gennem UGT1A1 (f.eks. irinotecan) eller UGT1A9-systemet (se pkt.
Caution is recommended when administering sorafenib with compounds that are metabolised/eliminated predominantly by the UGT1A1 (e.g. irinotecan) or UGT1A9 pathways (see section 4.5).
HR for progressionsfri overlevelse var 0,39 (95% CI: 0,21-0,72) for patienter med symptomer ved baseline og 0,60 (95% CI: 0,45-1,81) for patienter uden symptomer ved baseline.
The HR of progression free survival was 0.39 (95% CI: 0.21 - 0.72) for patients with symptoms at baseline and 0.60 (95% CI: 0.45 - 0.81) for patients without symptoms at baseline.
CTCAE Grad 3 eller 4 laboratorieafvigelser forekommer hos ≥ 5 % af sorafenib-behandlede patienter og inkluderer lymfopeni og neutropeni.
CTCAE Grade 3 or 4 laboratory abnormalities occurring in ≥ 5 % of sorafenib treated patients included lymphopenia and neutropenia.
Studie 1 (studie 11213) var et fase III, multicenter, randomiseret, dobbeltblind, placebo-kontrolleret studie med 903 patienter.
Study 1 (study 11213) was a Phase III, multi-centre, randomised, double blind, placebo-controlled study in 903 patients.
Dyrestudier har påvist reproduktionstoksicitet inklusive fosterskader (se pkt.
Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Luftveje, thorax og mediastinum rinoré dysfoni bivirkninger, der ligner interstitiel lungesygdom* (pneumonitis, strålepneumonitis, akut dyspnø etc.)
Respiratory, thoracic and mediastinal disorders rhinorrhoea dysphonia interstitial lung disease-like events* (pneumonitis, radiation pneumonitis, acute respiratory distress, etc. )
Bivirkningerne er præsenteret i faldende alvorlighed inden for hver frekvensgruppering.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
- Hul på mave-tarm-kanalen (gastrointestinal perforation) kan forekomme under behandlingen (se også Bivirkninger, punkt 4).
- Holes in the gut wall (gastrointestinal perforation) may occur during treatment (see section 4:
De fleste indberetninger om hypokalcæmi var hypokalcæmi af lav grad (CTCAE grad 1 og 2).
Most reports of hypocalcaemia were low grade (CTCAE Grade 1 and 2).
Der er set en højere dødelighed hos patienter med pladecellekarcinom i lungerne, som blev behandlet med sorafenib i kombination med platinbaseret kemoterapi.
Higher mortality has been reported in patients with squamous cell carcinoma of the lung treated with sorafenib in combination with platinum-based chemotherapies.
Behandling af formodede bivirkninger kan kræve midlertidig afbrydelse eller dosisreduktion af sorafenib.
Management of suspected adverse drug reactions may require temporary interruption or dose reduction of sorafenib therapy.
De hyppigste bivirkninger var diarré, træthed, alopeci, infektion, hånd-fod-hud-reaktion (HFSR) (svarende til palmoplantar erytrodysæstesisyndrom i MedDRA) samt udslæt.
The most common adverse reactions were diarrhoea, fatigue, alopecia, infection, hand foot skin reaction (corresponds to palmar plantar erythrodysaesthesia syndrome in MedDRA) and rash.
Tabel 2: Afvigelser i laboratorieanalyser rapporteret hos DTC-patienter i den dobbeltblinde periode (studie 5)
Table 2: Treatment-emergent laboratory test abnormalities reported in DTC patient (study 5) double blind period
Resultater fra dyrestudier indikerer yderligere, at sorafenib kan nedsætte fertiliteten hos hanner og hunner (se pkt.
Results from animal studies further indicate that sorafenib can impair male and female fertility (see section 5.3).
Sorafenib hæmmer aktiviteten af målfaktorer, som findes i tumorceller (CRAF, BRAF, V600E BRAF, c-KIT og FLT-3) og i tumorens kar (CRAF, VEGFR-2, VEGFR-3 og PDGFR-β).
Sorafenib inhibits the activity of targets present in the tumour cell (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and in the tumour vasculature (CRAF, VEGFR-2, VEGFR-3, and PDGFR-ß).
En post-hoc-undergruppeanalyse i forhold til maksimal tumorstørrelse viste en bedre behandlingseffekt (PFS) for sorafenib i forhold til placebo for patienter med maksimal tumorstørrelse på 1,5 cm eller derover (HR 0,54 (95% CI: 0,41-0,71)), hvorimod en numerisk mindre virkning blev rapporteret hos patienter med en maksimal tumorstørrelse på under 1,5 cm (HR 0,87 (CI: 0,40-1,89)).
A post-hoc subgroup analysis by maximum tumour size showed a treatment effect for PFS in favour of sorafenib over placebo for patients with maximum tumour size of 1.5 cm or larger (HR 0.54 (95% CI: 0.41 - 0.71)) whereas a numerically lower effect was reported in patients with a maximum tumour size of less than 1.5 cm (HR 0.87 (95% CI: 0.40 - 1.89).
5.1) fik 37 % af personerne afbrudt dosis, og 35 % fik dosis reduceret allerede i den første cyklus af sorafenib-behandlingen.
In study 5 (see section 5.1), 37% of subjects had dose interruption and 35% had dose reduction already in cycle 1 of sorafenib treatment.
Disse data tyder på, at kliniske farmakokinetiske interaktioner mellem sorafenib og CYP3A4-hæmmere ikke foreligger.
These data suggest that clinical pharmacokinetic interactions of sorafenib with CYP3A4 inhibitors are unlikely.
Der findes ingen tilgængelige data for patienter, som kræver dialyse (se pkt.
No data is available in patients requiring dialysis (see section 5.2).
I kliniske studier, der var sponsoreret af firmaet, blev der set hjerteinsufficiens som bivirkning hos 1,9 % af de patienter, der blev behandlet med sorafenib (N=2.276).
In company sponsored clinical trials congestive heart failure was reported as an adverse event in 1.9% of patients treated with sorafenib (N= 2276).
In vivo studier af CYP-enzyminduktion
In vitro studies of CYP enzyme induction
Adverse Events (CTCAE)), version 3.0 ** Ætiologien af hypofosfatæmi forbundet med sorafenib er ukendt.
Lipase increased * Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 ** The aetiology of hypophosphatemia associated with sorafenib is not known.
Den anbefalede dosis til voksne er 400 mg sorafenib (to tabletter a 200 mg) to gange dagligt (ækvivalent med en total daglig dosis på 800 mg).
The recommended dose of Nexavar in adults is 400 mg sorafenib (two tablets of 200 mg) twice daily (equivalent to a total daily dose of 800 mg).
I kliniske studier opstod hypokalcæmi hyppigere og med større sværhedsgrad hos patienter med DTC, især hvis de tidligere havde haft hypoparatyreoidisme, sammenlignet med patienter med renalcellekarcinom eller hepatocellulært karcinom.
In clinical trials, hypocalcaemia was more frequent and more severe in patients with DTC, especially with a history of hypoparathyroidism, compared to patients with renal cell or hepatocellular carcinoma.
- Hvis De har kræft i skjoldbruskkirtlen.
- If you have thyroid cancer.
Klinisk pankreatitis blev rapporteret hos 2 ud af 451 patienter behandlet med sorafenib (CTCAE Grad 4) i studie 1, 1 ud af 297 patienter behandlet med sorafenib i studie 3 (CTCAE grad 2) og 1 ud af 451 patienter (CTCAE Grad 2) i placebogruppen i studie 1.
Clinical pancreatitis was reported in 2 of 451 sorafenib treated patients (CTCAE Grade 4) in study 1, 1 of 297 sorafenib treated patients in study 3 (CTCAE Grade 2), and 1 of 451 patients (CTCAE Grade 2) in the placebo group in study 1.
Der er intet, der tyder på, at sorafenib påvirker evnen til at føre bil og betjene maskiner.
There is no evidence that sorafenib affects the ability to drive or to operate machinery.
I kliniske farmakokinetiske studier medførte samtidig administration af sorafenib 400 mg to gange dagligt og cyclophosphamid, et CYP2B6-substrat, eller paclitaxel, et CYP2C8-substrat, dog ikke en klinisk relevant hæmning.
However, in clinical pharmacokinetic studies, concomitant administration of sorafenib 400 mg twice daily with cyclophosphamide, a CYP2B6 substrate, or paclitaxel, a CYP2C8 substrate, did not result in a clinically meaningful inhibition.
TSH-suppression ved DTC
TSH suppression in DTC
Brug af anden medicin sammen med Nexavar
Other medicines and Nexavar
I fire fase-I kliniske studier var steady state eksponering af sorafenib ens hos patienter med let til moderat nedsat nyrefunktion sammenlignet med eksponeringen af patienter med normal nyrefunktion.
In four Phase I clinical trials, steady state exposure to sorafenib was similar in patients with mild or moderate renal impairment compared to the exposures in patients with normal renal function.
Filmovertræk: Hypromellose; macrogol; titandioxid (E 171); jernoxid (E 172).
Tablet coating: hypromellose, macrogol, titanium dioxide (E 171), ferric oxide red (E 172).
Der var ingen rapporterede tilfælde af CTCAE Grad 4 hypofosfatæmi (< 1 mg/dl) hos hverken sorafenib- eller placebopatienter i studie 1, og 1 tilfælde i placebogruppen i studie 3.
There were no cases of CTCAE Grade 4 hypophosphataemia (< 1 mg/dl) reported in either sorafenib or placebo patients in study 1, and 1 case in the placebo group in study 3.
Når dosisreduktion er nødvendig under behandling af hepatocellulært karcinom (HCC) og fremskredent renalcellekarcinom (RCC), bør dosis af Nexavar reduceres til to tabletter a 200 mg sorafenib én gang dagligt (se pkt.
When dose reduction is necessary during the treatment of hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), the Nexavar dose should be reduced to two tablets of 200 mg sorafenib once daily (see section 4.4).
CYP3A4-, CYP2D6- og CYP2C19-substrater
CYP3A4, CYP2D6 and CYP2C19 substrates
Hypokalcæmi blev rapporteret hos 35,7 % af de sorafenibbehandlede patienter sammenlignet med hos 11,0 % af placebopatienterne.
Hypocalcaemia was reported in 35.7% of sorafenib treated patients compared to 11.0% of placebo patients.
Samtidig indgift af neomycin eller andre antibiotika, der forårsager større forstyrrelser i mikrofloraen i mave og tarm, kan medføre en nedsat biotilgængelighed af sorafenib (se pkt.
Co-administration of neomycin or other antibiotics that cause major ecological disturbances of the gastrointestinal microflora may lead to a decrease in sorafenib bioavailability (see section 4.5).
Fald i blodglukoseniveau er blevet rapporteret under behandling med sorafenib, og det har i nogle tilfælde været klinisk symptomatisk og krævet hospitalsindlæggelse på grund af bevidstløshed.
Decreases in blood glucose, in some cases clinically symptomatic and requiring hospitalization due to loss of consciousness, have been reported during sorafenib treatment.
CYP2B6-, CYP2C8- og CYP2C9-substrater
CYP2B6, CYP2C8 and CYP2C9 substrates
Dosisreduktion er ikke nødvendig hos patienter med Child Pugh A eller B (let til moderat) nedsat leverfunktion.
No dose adjustment is required in patients with Child Pugh A or B (mild to moderate) hepatic impairment.
De fleste rapporter af hypokaliæmi var af lav grad (CTCAE grad 1).
Most reports of hypokalaemia were low grade (CTCAE Grade 1).
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med sorafenib i alle undergrupper af den pædiatriske population med nyre- og nyre-bækken-karcinom (undtagen nefroblastom, nefroblastomatose, clear cell-sarkom, mesoblastisk nefrom, renal medullært karcinom og rabdoid tumor i nyrerne) og lever- og intrahepatisk galdegangskarcinom (undtagen hepatoblastom) og differentieret thyreoideacancer (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies, in all subsets of the paediatric population, in kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) and liver and intrahepatic bile duct carcinoma (excluding hepatoblastoma) and differentiated thyroid carcinoma (see section 4.2 for information on paediatric use).
Den anbefalede dosis af Nexavar til voksne er 2 x 200 mg tabletter to gange dagligt.
How to take Nexavar The recommended dose of Nexavar in adults is 2 x 200 mg tablets, twice daily.
Hvis yderligere dosisreduktion er nødvendig, kan Nexavar reduceres til 400 mg sorafenib dagligt i delte doser (en tablet a 200 mg 2 gange dagligt med 12 timers mellemrum), og om nødvendigt reduceres ydereligere til én tablet a 200 mg én gang dagligt.
If additional dose reduction is necessary, Nexavar may be reduced to 400 mg sorafenib daily in divided doses (two tablets of 200 mg twelve hours apart), and if necessary further reduced to one tablet of 200 mg once daily.
Hånd-fod-hud-reaktion (HFSR) (palmoplantar erytrodysæstesi) og hududslæt er de hyppigste bivirkninger med sorafenib.
Hand foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse drug reactions with sorafenib.
Hvis De er en kvinde i den fødedygtige alder, skal De bruge effektiv prævention, mens De er under behandling.
If you could become pregnant use adequate contraception during treatment.
Den mediane PFS-tid var 10,8 måneder i sorafenib-gruppen sammenlignet med 5,8 måneder i placebogruppen (HR =0,587, 95 % konfidensinterval (CI): 0,454-0,758, ensidet p < 0,0001).
Median PFS time was 10.8 months in the sorafenib group compared to 5.8 months in the placebo group (HR=0.587; 95% Confidence Interval (CI): 0.454, 0.758; one-sided p <0.0001).
Studie 5 (studie 14295) var et fase III, internationalt, randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie med 417 patienter med lokalt fremskreden eller metastatisk DTC refraktær over for radioaktivt iod.
Study 5 (study 14295) was a Phase III, international, multi-centre, randomised, double blind, placebocontrolled trial in 417 patients with locally advanced or metastatic DTC refractory to radioactive iodine.
Ingen af patienterne viste et QTcB eller QTcF på >500 msek.
No subject showed a QTcB or QTcF >500 msec during the post-treatment ECG monitoring (see section 4.4).
Sygdomsspecifikke advarsler
Disease specific warnings
Hypofosfatæmi var et meget almindeligt laboratoriefund, som blev observeret hos 45 % og 35 % af patienterne, der blev behandlet med sorafenib sammenlignet med 12 % og 11 % hos placebopatienter i henholdsvis studie 1 og studie 3.
Hypophosphataemia was a very common laboratory finding, observed in 45 % and 35 % of sorafenib treated patients compared to 12 % and 11 % of placebo patients in study 1 and study 3, respectively.
Patienter, der samtidigt tager warfarin eller phenprocoumon, bør følges regelmæssigt med hensyn til ændringer i protrombin tid, INR eller kliniske blødningstilfælde (se pkt.
Patients taking concomitant warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes (see sections 4.5 and 4.8).
Hjerteinsufficiens* Myokardieiskæmi og myokardieinfarkt*
Cardiac disorders congestive heart failure* myocardial ischaemia and infarction*
Den gennemsnitlige overlevelse var 19,3 måneder for patienter randomiseret til sorafenib sammenlignet med 15,9 måneder for placebopatienterne (HR = 0,77; 95 % CI: 0,63 - 0,95; p = 0,015).
The median survival was 19.3 months for patients randomised to sorafenib compared to 15.9 months for placebo patients (HR = 0.77; 95 % CI: 0.63 - 0.95; p = 0.015).
Midlertidig eller permanent seponering af sorafenib bør overvejes hos patienter, som udvikler hjerteiskæmi og/eller infarkt (se pkt.
Temporary or permanent discontinuation of sorafenib should be considered in patients who develop cardiac ischaemia and/or infarction (see section 4.8).
Hypokalcæmi blev indberettet hos 12% og 26,5% af de patienter, der blev behandlet med sorafenib, sammenlignet med hos 7,5% og 14,8% af placebo-patienterne i henholdsvis studie 1 og 3.
Hypocalcaemia was reported in 12% and 26.5% of sorafenib treated patients compared to 7.5% and 14.8% of placebo patients in study 1 and study 3, respectively.