natgillin/translations-raw huggingface dataset:
Eksplorative analyser af PFS og OS i intent to treat (ITT-) populationen har også vist konsistente resultater til fordel for CABOMETYX sammenlignet med everolimus i forskellige undergrupper i henhold til alder (<65 vs. ≥65, køn, MSKCC-risikogruppe (gunstig, middel, høj), ECOG-status (0 vs. 1), varighed fra diagnose til randomisering (<1 år vs. ≥1 år), tumor MET-status (høj vs. lav vs. ukendt), knoglemetastaser (fravær vs. tilstedeværelse), viscerale metastaser (fravær vs. tilstedeværelse), viscerale og knoglemetastaser (fravær vs. tilstedeværelse), antal tidligere VEGFR-TKIs (1 vs. ≥2), varighed af første VEGFR-TKI (≤6 måneder vs.>6 måneder).
Exploratory analyses of PFS and OS in the ITT population have also shown consistent results in favour of CABOMETYX compared to everolimus across different subgroups according to age (<65 vs. ≥65, sex, MSKCC risk group (favourable, intermediate, poor), ECOG status (0 vs. 1), time from diagnosis to randomisation (<1 year vs. ≥1 year), tumour MET status (high vs. low vs. unknown), bone metastases (absence vs. presence), visceral metastases (absence vs. presence), visceral and bone metastases (absence vs. presence), number of prior VEGFR-TKIs (1 vs. ≥2), duration of first VEGFRTKI (≤6 months vs. >6 months).
Mandlige og kvindelige patienter og deres partnere bør anvende effektive kontraceptionsmetoder under behandlingen og i mindst 4 måneder efter afsluttet behandling.
Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy.
Både patienter med positiv og negativ MET-status opnåede en gunstig effekt af CABOMETYX sammenlignet med sunitinib, med større aktivitet hos patienter med positiv MET-status sammenlignet med patienter med negativ MET-status (HR = 0,32 (0,16; 0,63) vs 0,67 (0,37; 1.23)).
Patients with both positive and negative MET status showed a favourable effect with CABOMETYX compared to sunitinib, with greater activity in patients with a positive MET status compared to patients with a negative MET status (HR=0.32 (0.16, 0.63) vs 0.67 (0.37, 1.23)) respectively.
Objektive responsrate-værdier (ORR) er opsummeret i tabel 5.
Objective response rate (ORR) findings are summarized in Table 5.
Derudover hæmmer cabozantinib andre tyrosinkinaser inklusive GAS6receptoren (AXL), RET, ROS1, TYR03, MER, stamcellefaktor-receptoren (KIT), TRKB, Fms-lignende tyrosinkinase-3 (FLT3) og TIE-2.
In addition, cabozantinib inhibits other tyrosine kinases including the GAS6 receptor (AXL), RET, ROS1, TYRO3, MER, the stem cell factor receptor (KIT), TRKB, Fms-like tyrosine kinase-3 (FLT3), and TIE-2.
• Nedsat mængde af calcium, natrium og fosfat i blodet
• Decrease in levels of; calcium, sodium and phosphate in the blood
Cabozantinib anbefales ikke til patienter med svært nedsat nyrefunktion, da sikkerheden og virkningen ikke er blevet fastslået hos denne population.
Cabozantinib is not recommended for use in patients with severe renal impairment as safety and efficacy have not been established in this population.
Tættere overvågning anbefales hos patienter med let eller moderat nedsat leverfunktion.
Closer monitoring is advised in patients with mild or moderate hepatic impairment.
Patienter, der har alvorlig blødning i anamnesen, skal evalueres omhyggeligt, inden behandling med cabozantinib initieres.
Patients who have a history of severe bleeding prior to treatment initiation should be carefully evaluated before initiating cabozantinib therapy.
• Lavt indhold af albumin i blodet
• Low level of albumin in blood
RPLS er en sjælden bivirkning (påvirker færre end 1 ud af 1000 mennesker)
RPLS is rare (it affects less than 1 in 1000 people).
To ikke-konjugerede metabolitter (XL184-N-oxid og XL184-amid spaltningsprodukt), der har <1 % af cabozantinibs on-target kinasehæmningspotentiale, repræsenterer hver især <10 % af de samlede lægemiddelrelaterede plasmaeksponering.
Two non-conjugated metabolites (XL184N-oxide and XL184 amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Cabozantinib er blevet evalueret for dets hæmmende aktivitet på en række kinaser og blev identificeret som en hæmmer af MET- (hepatocyt vækstfaktor-receptorprotein) og VEGF- (vaskulær endotelial vækstfaktor) receptorer.
Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors.
Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANKRIG
Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCE
• Byld (ophobning af pus med hævelse og betændelse)
• Abscess (collection of pus, with swelling and inflammation)
I et studie med nedsat nyrefunktion udført med en enkelt 60 mg dosis cabozantinb var ratioerne af middelværdierne for plasma-cabozantinib, Cmax og AUC0-inf var 19 % og 30 % højere hos forsøgspersoner med let nedsat nyrefunktion (90 % CI for Cmax 91,60-155,51 %; for AUC0-inf 98,79-171,26 %) og 2 % og 6-7 % højere (90 % CI for Cmax 78,64-133,52 %; for AUC0-inf 79,61-140,11 %) hos forsøgspersoner med moderat nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
In a renal impairment study conducted with a single 60 mg dose of cabozantinib, the ratios of geometric LS mean for plasma cabozantinib, Cmax and AUC0-inf were 19% and 30% higher, for subjects with mild renal impairment (90% CI for Cmax 91.60% to 155.51%; AUC0-inf 98.79% to 171.26%) and 2% and 6-7% higher (90% CI for Cmax 78.64% to 133.52%; AUC0-inf 79.61% to 140.11%), for subjects with moderate renal impairment compared to subjects with normal renal function.
CABOMETYX anbefales ikke til patienter med svært nedsat leverfunktion (ChildPugh C), da cabozantinib ikke er undersøgt i denne population, og eksponering kan være øget hos disse patienter.
Cabometyx is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) as cabozantinib has not been studied in this population and exposure might be increased in these patients.
Virkningen af cabozantinib på farmakokinetikken for kontraceptive steroider er ikke blevet undersøgt.
Effect of cabozantinib on other medicinal products The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
• Hårtab og udtynding af håret (alopeci), ændret hårfarve
• Alopecia (hair loss and thinning), hair colour change
Dette skyldes, at CABOMETYX kan påvirke virkningen af visse andre lægemidler, ligesom visse andre lægemidler kan påvirke virkningen af CABOMETYX.
This is because CABOMETYX can affect the way some other medicines work.
I henhold til kriterierne fra Memorial Sloan Kettering Cancer Center (MSKCC) for prognostisk risiko-kategori var 46 % i risikogruppen lav (0 risikofaktorer), 42 % var i risikogruppen middel (1 risikofaktor), og 13 % var i risikogruppen høj (2 eller 3 risikofaktorer).
According to the Memorial Sloan Kettering Cancer Center criteria for prognostic risk category, 46% were favorable (0 risk factors), 42% were intermediate (1 risk factor), and 13% were poor (2 or 3 risk factors).
Størstedelen af patienterne var mænd (78 %) med en medianalder på 62 år.
The majority of the patients were male (78%) with a median age of 62 years.
Mediantiden var 55 dage til første dosisreduktion og 38 dage til førstebehandlingsafbrydelse.
The median time to first dose reduction was 55 days, and to first dose interruption was 38 days.
Galdesaltbindende midler såsom colestyramin og colesevelam kan interferere med cabozantinib og påvirke absorptionen (eller reabsorptionen), hvilket kan resultere i nedsat eksponering (se pkt.
Bile salt-sequestering agents such as cholestyramine and cholestagel may interact with cabozantinib and may impact absorption (or reabsorption) resulting in potentially decreased exposure (see section 5.2).
Objektiv responsrate n (%) per IRC Fuldstændig respons
Objective Response Rate n (%) by IRC Complete responses
CABOMETYX blokerer virkningen af proteiner, der kaldes receptor-tyrosinkinaser (RTK'er), og som er involveret i cellevækst og udvikling af nye blodkar til at forsyne celler.
CABOMETYX blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
I det 2-årige karcinogenicitetsstudie med rotter bestod de cabozantinib-relaterede neoplastiske fund af en øget forekomst af benignt fæokromocytom, alene eller i kombination med malignt fæokromocytom/komplekst malignt fæokromocytom i binyremarven hos begge køn ved eksponering langt under den tilsigtede eksponering hos mennesker.
In the 2-year rat carcinogenicity study, cabozantinibrelated neoplastic findings consisted of an increased incidence of benign pheochromocytoma, alone or in combination with malignant pheochromocytoma/complex malignant pheochromocytoma of the adrenal medulla in both sexes at exposures well below the intended exposure in humans.
Efter en enkelt dosis 14C-cabozantinib hos raske frivillige blev cirka 81 % af den samlede administrerede radioaktivitet genfundet inden for en indsamlingsperiode på 48 dage, med 54 % i fæces og 27 % i urin.
Within a 48-day collection period after a single dose of 14C-cabozantinib in healthy volunteers, approximately 81% of the total administered radioactivity was recovered with 54% in faeces and 27% in urine.
Sikkerheden og virkningen af CABOMETYX blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie (CELESTIAL).
The safety and efficacy of CABOMETYX were evaluated in a randomized, double-blind, placebocontrolled Phase 3 study (CELESTIAL).
Brug ikke lægemidlet efter den udløbsdato, der står på blister, tabletbeholderens etiket og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the blister, bottle label and carton after EXP.
Størstedelen af patienterne var mænd (75 %) med en medianalder på 62 år.
The majority of the patients were male (75%), with a median age of 62 years.
Cabozantinib er et lille molekyle, der hæmmer multiple receptor-tyrosinkinaser (RTK'er) impliceret i tumorvækst og angiogenese, patologisk knogleremodellering, lægemiddelresistens og metastatisk progression af cancer.
Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, drug resistance, and metastatic progression of cancer.
Baseret på en integreret populationsfarmakokinetisk analyse af cabozantinib hos raske forsøgspersoner og cancerpatienter (herunder HCC), blev der ikke observeret nogen klinisk signifikant forskel i den gennemsnitlige cabozantinib-plasmaeksponering blandt forsøgspersoner med normal leverfunktion (n=1425) og let nedsat leverfunktion (n=558).
Based on an integrated population pharmacokinetic analysis of cabozantinib in healthy subjects and cancer patients (including HCC), no clinically significant difference in the mean cabozantinib plasma exposure was observed amongst subjects with normal liver function (n=1425) and mild hepatic impairment (n=558).
Cabozantinib skal seponeres hos patienter, som udvikler akut myokardieinfarkt eller nogen anden klinisk signifikant tromboembolisk komplikation.
Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant thromboembolic complication.
Hver æske indeholder 4 blistere med 28 filmovertrukne tabletter.
Each carton contains 4 blisters with 28 film-coated tablets.
Figur 4: Kaplan-Meier-kurve for samlet overlevelse (CELESTIAL)
Figure 4: Kaplan-Meier curve of overall survival (CELESTIAL)
Reversibelt posteriort leukoencefalopatisk syndrom (RPLS)
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Gentagen dosering af cabozantinib på 140 mg daglig i 19 dage resulterede i gennemsnitlig akkumulering af cabozantinib på ca. 4 til 5gange (baseret på AUC) sammenlignet med administration af en enkelt dosis; steady state opnås på ca. 15 dage.
Repeat daily dosing of cabozantinib at 140 mg for 19 days resulted in an approximately a 4- to 5-fold mean cabozantinib accumulation (based on AUC) compared to a single dose administration; steady state is achieved by approximately Day 15.
Traumer, forgiftninger og behandlingskomplikationer
Injury, poisoning and procedural complications wound complications
En populationsfarmakokinetisk analyse identificerede ingen klinisk relevante forskelle i cabozantinibs farmakokinetik baseret på race.
A population PK analysis did not identify clinically relevant differences in PK of cabozantinib based on race.
• Appetitløshed, vægttab, ændret smagssans
• Decreased appetite, weight loss, altered sense of taste
Figur 5: Kaplan Meier-kurve for progressionsfri overlevelse (CELESTIAL)
Figure 5: Kaplan Meier curve for progression-free survival (CELESTIAL)
• Følelse af døsighed, forvirring eller tab af bevidsthed.
• Feeling drowsy, confused or loss of consciousness.
Der er blevet observeret reversibelt posteriort leukoencefalopatisyndrom (RPLS), også kendt som posteriort reversibelt encefalopatisyndrom (PRES) med cabozantinib.
Reversible posterior leukoencephalopathy syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES), has been observed with cabozantinib.
Data for nedenstående bivirkninger er baseret på patienter, der fik Cabometyx 60 mg oralt dagligt i de pivotale studier i RCC efter tidligere VEGF-målrettet behandling og i behandlingsnaivt RCC og i HCC efter forudgående systemisk behandling (pkt.
Data for the following reactions are based on patients who received Cabometyx 60 mg qd po in the pivotal studies in RCC following prior VEGF-targeted therapy and in treatment-naïve RCC and in HCC following prior systemic therapy (section 5.1).
Det skal du vide, før du begynder at tage CABOMETYX 3.
What you need to know before you take CABOMETYX 3.
HDPE-tabletbeholder med en børnesikret polypropylenlukning og tre små dåser med silicagel som tørremiddel.
HDPE bottle with a polypropylene child-resistant closure and three silica gel dessicant canisters.
Hver filmovertrukne tablet indeholder 15,54 mg lactose.
Each film-coated tablet contains 15.54 mg lactose.
En statistisk signifikant forbedring i PFS, som efterfølgende blev vurderet af en blindet, uafhængig radiologisk komité (IRC), blev påvist for CABOMETYX sammenlignet med sunitinib (figur 3 og tabel 5).
A statistically significant improvement in PFS as retrospectively assessed by a blinded Independent Radiology Committee (IRC) was demonstrated for CABOMETYX compared to sunitinib (Figure 3 and Table 5).
CABOMETYX tabletter fås i pakninger med 4 blisterkort med 7 tabletter pr. stk. (28 tabletter i alt) eller en plastiktabletbeholder med 30 tabletter.
CABOMETYX tablets are available in packs containing either 4 blisters with 7 tablets each (28 total), or one plastic bottle with 30 tablets.
Hver filmovertrukne tablet indeholder 31,07 mg lactose.
Each film-coated tablet contains 31.07 mg lactose.
Cabozantinib kan derfor have potentialet til at øge plasmakoncentrationen af samtidigt administrerede P-gp-substrater.
Therefore, cabozantinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
En statistisk signifikant forbedring i OS blev påvist for CABOMETYX sammenlignet med placebo (tabel 6 og figur 4).
A statistically significant improvement in OS was demonstrated for CABOMETYX compared to placebo (Table 6 and Figure 4).
Kvinder i den fertile alder/antikonception hos mænd og kvinder Kvinder i den fertile alder skal opfordres til at undgå at blive gravide, mens de får cabozantinib.
Women of childbearing potential/Contraception in males and females Women of childbearing potential must be advised to avoid pregnancy while on cabozantinib.
Patienter (n=707) med HCC, der ikke kan behandles med kurativ behandling og som tidligere havde fået sorafenib til fremskreden sygdom, blev randomiseret (2:1) til at få CABOMETYX (n=470) eller placebo (n=237).
Patients (N=707) with HCC not amenable to curative treatment and who had previously received sorafenib for advanced disease were randomized (2:1) to receive CABOMETYX (N=470) or placebo (N=237).
I tilfælde af vedvarende hypertension på trods af behandling med antihypertensiva skal cabozantinibdosis reduceres.
In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib dose should be reduced.
Hos kaniner fremkaldte cabozantinib ændringer i føtale bløddele (reduceret miltstørrelse, lille eller manglende intermediær lunge-lap), og det totale antal misdannelser hos fostrene var øget.
In rabbits, cabozantinib produced foetal soft tissue changes (reduced spleen size, small or missing intermediate lung lobe) and increased foetal incidence of total malformations.
• Lavt antal blodplader og hvide blodlegemer
• Low level of platelets and white blood cells
• Følelse af døsighed, forvirring eller tab af bevidsthed på grund af leverproblemer
• Feeling drowsy, confused or loss of consciousness due to liver problems
Kliniske data ved behandlingsnaivt nyrecellekarcinom
Clinical data in treatment-naïve renal cell carcinoma
Patienter (N=658) med fremskreden RCC med en clearcelle-komponent, der tidligere havde fået mindst 1 VEGF-receptor-tyrosinkinasehæmmer (VEGFR TKI), blev randomiseret (1:1) til at få CABOMETYX (N=330) eller everolimus (N=328).
Patients (N=658) with advanced RCC with a clear cell component who had previously received at least 1 prior VEGF receptor tyrosine kinase inhibitor (VEGFR TKI) were randomized (1:1) to receive CABOMETYX (N=330) or everolimus (N=328).
Du må ikke spise noget mindst 2 timer, før du tager CABOMETYX, og 1 time efter, du har taget medicinen.
You should not eat anything for at least 2 hours before taking CABOMETYX and for 1 hour after taking the medicine.
Cabozantinib elimineres hovedsageligt via leveren.
Cabozantinib is eliminated mainly via the hepatic route.
• Kramper, hovedpine, forvirring eller problemer med at koncentrere sig.
• Fits, headaches, confusion, or finding it difficult to concentrate.
Sekundære effekt-endepunkter var objektiv responsrate (ORR) og samlet overlevelse (OS).
Secondary efficacy endpoints were objective response rate (ORR) and overall survival (OS).
4 metabolitter var til stede i plasma med eksponeringer (AUC), der var >10 % af cabozantinibs: XL184-N-oxid, XL184-amid spaltningsprodukt, XL184monohydroxysulfat og XL184-6-desmethylamid spaltningsprodukt sulfat.
Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate.
Hypertension blev observeret oftere i gruppen af behandlings-naive RCC-patienter (67 %) sammenlignet med RCC-patienter efter tidligere VEGF-målrettet behandling (37 %).
Hypertension was observed more frequently in the treatment naïve RCC population (67%) compared to RCC patients following prior VEGF-targeted therapy
Antallet af blodplader bør monitoreres under behandling med cabozantinib og dosis justeres i overensstemmelse med sværhedsgraden af trombocytopeni (se tabel 1).
Platelet levels should be monitored during cabozantinib treatment and the dose modified according to the severity of the thrombocytopenia (see Table 1).
Tabel 2: Bivirkninger indberettet i kliniske forsøg hos patienter i behandling med cabozantinib
Table 2: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with cabozantinib
Tabel 1: Anbefalede dosisændringer af CABOMETYX ved bivirkninger Bivirkning og sværhedsgrad
Table 1: Recommended CABOMETYX dose modifications for adverse reactions Adverse reaction and severity
En planlagt interimanalyse af OS, udført på tidspunktet for PFS-analysen, nåede ikke interimgrænsen for statistisk signifikans (202 hændelser, HR=0,68 [0,51-0,90], p=0,006).
A planned interim analysis of OS was conducted at the time of the PFS analysis and did not reach the interim boundary for statistical significance (202 events, HR=0.68 [0.51, 0.90], p=0.006).
Et måltid med højt fedtindhold øgede Cmax og AUC moderat (henholdsvis 41 % og 57 %) i forhold til fastende tilstand hos raske frivillige, der fik en enkelt oral dosis på 140 mg cabozantinib.
A high-fat meal moderately increased Cmax and AUC values (41% and 57%, respectively) relative to fasted conditions in healthy volunteers administered a single 140 mg oral cabozantinib dose.
I en populationsfarmakokinetisk analyse af cabozantinib med anvendelse af data fra oral administration af cabozantinibdoser fra 20 til 140 mg til 1883 patienter og 140 raske frivillige var cabozantinibs terminale halveringstid i plasma ca. 110 timer.
In a population PK analysis of cabozantinib using data collected from 1883 patients and 140 healthy volunteers following oral administration of a range of doses from 20 to 140 mg, the plasma terminal half-life of cabozantinib is approximately 110 hours.
• Følelsesløshed, prikkende, brændende fornemmelse eller smerter i lemmerne
• Numbness, tingling, burning sensation or pain in the limbs
Figur 3: Kaplan-Meier-kurve for progressionsfri overlevelse ved IRC hos behandlings-naive RCCpatienter
Figure 3: Kaplan Meier curve for progression-free survival by IRC in treatment-naïve RCC subjects
Sikkerhed og effekt af CABOMETYX til behandling af behandlingsnaivt nyrecellekarcinom blev evalueret i et randomiseret, open-label, multicenter studie (CABOSUN).
The safety and efficacy of CABOMETYX for the treatment of treatment-naïve renal cell carcinoma were evaluated in a randomized, open-label, multicenter study (CABOSUN).
En eksploratorisk OS-analyse censureret til anvendelsen af NPACT understøttede den primære analyse: HR, justeret for stratifikationsfaktorer (pr. IxRS), var 0,66 (95 % CI: 0,52; 0,84; stratificeret logrank p-værdi = 0,0005).
An exploratory OS analysis censoring for the use of NPACT supported the primary analysis: the HR, adjusted for stratification factors (per IxRS), was 0.66 (95% CI: 0.52, 0.84; stratified logrank p-value = 0.0005).
Tabel 5: Resultat af effekt på behandlingsnaive RCC-patienter (ITT-population, CABOSUN) CABOMETYX (N=79)
Table 5: Efficacy results in treatment-naïve RCC subjects (ITT population, CABOSUN) CABOMETYX (N=79)
CYP3A4-hæmmere og -induktorer
CYP3A4 inhibitors and inducers
Hver beholder indeholder 30 filmovertrukne tabletter.
Each bottle contains 30 film-coated tablets.
Patienter, som har inflammatorisk tarmsygdom (f.eks. Crohns sygdom, ulcerativ colitis, peritonitis eller diverticulitis eller appendicitis), tumorinfiltration i gastrointestinalkanalen eller komplikationer fra tidligere gastrointestinalkirurgi (især forbundet med forsinket eller ufuldstændig heling), skal evalueres omhyggeligt inden indledning af behandling med cabozantinib og monitoreres tæt for symptomer på perforation og fisteldannelse, herunder absces og sepsis.
Patients who have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, peritonitis, diverticulitis, or appendicitis), have tumour infiltration in the GI tract, or have complications from prior GI surgery (particularly when associated with delayed or incomplete healing) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas including abscesses and sepsis.
Delvis respons ORR (Kun delvis respons) Stabil sygdom Progressiv sygdom a i overensstemmelse med EU-censurering b Stratificeringsfaktorer pr. IxRS omfatter IMDC-risikokategorier (middel risiko, høj risiko og knoglemetastaser (ja,nej) c Estimeret ved hjælp af Cox proportionel risikomodel justeret for stratificeringsfaktorer pr. IxRS.
Progressive Disease a in accord with EU censoring b Stratification factors per IxRS comprise IMDC risk categories (intermediate risk, poor risk and bone metastasis (yes, no) c Estimated using the Cox proportional hazard model adjusted for stratification factors per IxRS.