FrancophonIA/ELRC3.0 huggingface dataset:
English: Do NOT use Adcetris if you:
Slovenian: NE uporabljajte zdravila Adcetris:
English: The maximal recommended dose is 180 mg.
Slovenian: Največji priporočeni odmerek je 180 mg.
English: Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Austria
Slovenian: Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Avstrija
English: Tell your doctor if you are taking any other medicines, if you have taken any recently, or if you start taking new ones.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.
Slovenian: Tega zdravila ne uporabljajte, če ste noseči, razen če zdravnik presodi, da so koristi za vas večje od možnega tveganja za nerojenega otroka.
English: Premedication may include paracetamol, an antihistamine and a corticosteroid.
Slovenian: Premedikacija lahko vključuje paracetamol, antihistaminik in kortikosteroid.
English: For intravenous use after reconstitution and dilution
Slovenian: za intravensko uporabo po rekonstituciji in razredčenju
English: Within each System Organ Class, adverse reactions are listed under frequency categories of: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: Znotraj vsakega organskega sistema so neželeni učinki navedeni po kategorijah pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The upper 90% confidence interval (CI) around the mean effect on QTc was < 10 msec at each of the Cycle 1 and Cycle 3 post-baseline time points.
Slovenian: Zgornji 90% interval zaupanja (IZ) okoli srednjega učinka na QTc je bil < 10 msek na vsaki časovni točki po izhodišču v 1. ciklu in 3. ciklu.
English: Partial Response
Slovenian: Delni odziv
English: Less than half of the patients in the pivotal phase 2 population with Grade 3 or Grade 4 neutropenia had temporally associated infections, and the majority of temporally associated infections were Grade 1 or Grade 2.
Slovenian: Manj kot polovica bolnikov ključne populacije 2. faze z nevtropenijo 3. stopnje ali 4. stopnje je imela začasne povezane okužbe, pri čemer je bila večina začasnih povezanih okužb 1. ali 2. stopnje.
English: Data in HL Patients Who Are Not Stem Cell Transplant (SCT) Candidates
Slovenian: Podatki pri bolnikih s HL, ki niso kandidati za presaditev krvotvornih matičnih celic (PKMC)
English: Previously Untreated HL
Slovenian: Predhodno nezdravljeni HL
English: B symptoms
Slovenian: Simptomi B
English: More serious adverse events and dose modifications (including dose delays, reductions, and discontinuations) were reported in the older patients compared with the overall study population.
Slovenian: O resnejših neželenih dogodkih in spremembah odmerkov (vključno z odložitvami in zmanjšanjem odmerkov ter prekinitvami zdravljenja) so poročali pri starejših bolnih v primerjavi s celotno populacijo bolnikov, ki so sodelovali v študiji.
English: Fifty nine percent (59%) of patients had advanced stage disease (Stage III or IV) at initial diagnosis.
Slovenian: Devetinpetdeset odstotkov (59%) bolnikov je imelo ob ugotovitvi diagnoze bolezen v napredovalem stadiju (stadij III ali IV).
English: 27.9 months
Slovenian: 27,9 mesecev
English: Classical Hodgkin lymphoma expresses specific proteins on the cell surface that are different from non-classical Hodgkin lymphoma.
Slovenian: Klasični Hodgkinov limfom izraža specifične beljakovine na površini celice, ki so drugačne od neklasičnega Hodgkinovega limfoma.
English: Adcetris is used to treat CTCL where a specific type of protein is present on the cells' surface.
Slovenian: Zdravilo Adcetris se uporablja za zdravljenje CTCL v primerih, ko je na površini celic prisotna specifična vrsta proteina.
English: These patients should be monitored closely and managed according to best medical practice.
Slovenian: Te bolnike je treba skrbno nadzirati in zdraviti po najboljši medicinski praksi.
English: Proper aseptic technique throughout the handling of this medicinal product should be followed.
Slovenian: Ves čas ravnanja s tem zdravilom morate uporabljati ustrezne aseptične tehnike.
English: In vitro, MMAE was a substrate of P-gp and was not an inhibitor of P-gp at clinical concentrations.
Slovenian: In vitro je bil MMAE substrat P-gp in ne zaviralec P-gp v kliničnih koncentracijah.
English: Each vial contains approximately 13.2 mg of sodium.
Slovenian: Ena viala vsebuje približno 13,2 mg natrija.
English: Patients with known cerebral/meningeal disease, including history of PML were excluded from the study.
Slovenian: Bolniki z znano cerebralno/meningealno boleznijo, vključno z anamnezo PML, so bili izključeni iz študije.
English: This is equivalent to 0.7% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 0,7% največjega priporočeneg dnevnega vnosa natrija s hrano za odrasle osebe.
English: The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
Slovenian: Rekonstituirana raztopina v viali je bistra do rahlo opalescentna, brezbarvna raztopina s končno pH vrednostjo 6,6.
English: Exposures were approximately dose proportional with a trend observed for lower ADC exposures at lower ages/ body weights in the study population.
Slovenian: Izpostavljenosti so bile približno sorazmerne z odmerkom, s trendom z nižjo izpostavljenostjo ADC, ki je bil v študijski populaciji opažen pri nižjih starostih/telesnih masah.
English: Classical HL, sALCL and subtypes of CTCL (including MF and pcALCL) express CD30 as an antigen on the surface of their malignant cells.
Slovenian: Klasični HL, sALCL in podtipi CTCL (vključno z MF in pcALCL) izražajo CD30 kot antigen na površini svojih malignih celic.
English: Patients who develop Grade 3 or Grade 4 lymphopenia may continue treatment without interruption.
Slovenian: Bolniki, pri katerih se razvije limfopenija 3. stopnje ali 4. stopnje, lahko z zdravljenjem nadaljujejo brez prekinitve.
English: The best overall response rate (ORR) per independent review facility (IRF) was analysed across both study phases at the RP2D.
Slovenian: Delež najboljšega celokupnega odziva (ORR, “overall response rate”), po oceni odbora za neodvisni pregled (IRF, “independent review facility”), je bil v obeh študijskih fazah analiziran pri odmerku RP2D.
English: Based on population PK estimation the typical apparent central volume of distribution of MMAE was 35.5 l
Slovenian: Na podlagi populacijske farmakokinetične ocene je bil običajen navidezen osrednji volumen porazdelitve za MMAE 35,5 l.
English: This medicine contains 13.2 mg sodium (main component of cooking/table salt) in each vial.
Slovenian: To zdravilo vsebuje 13,2 mg natrija (glavne sestavine kuhinjske soli) na vialo.
English: Provision of the results of the ongoing Non-Interventional Post-Authorization Safety Study (PASS) conducted in HL and sALCL patient populations (Study MA25101).
Slovenian: Zagotavljanje rezultatov potekajoče neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet (PASS), ki se izvaja s populacijami bolnikov s HL in sALCL (študija MA25101).
English: Calculation to determine the total number of ADCETRIS vials needed:
Slovenian: Izračun za določitev skupnega števila potrebnih vial zdravila ADCETRIS:
English: This expression is independent of disease stage, line of therapy or transplant status.
Slovenian: To izražanje je neodvisno od stadija bolezni, vrste zdravljenja ali morebitne presaditve celic.
English: At the time of analysis, the median modified PFS follow-up time for both arms was 24.6 months Data from an interim OS analysis
Slovenian: V času analize je v obeh krakih mediani čas spremljanja modificiranega PFS znašal 24,6 mesecev Podatki iz vmesne analize OS
English: Best clinical response (n = 102 )
Slovenian: Najboljši klinični odziv (n = 102 )
English: ECOG status
Slovenian: Stanje zmogljivosti po ECOG
English: Relapsed or refractory sALCL
Slovenian: Ponovljen ali refraktarni sALCL
English: Best clinical response (n = 58 )
Slovenian: Najboljši klinični odziv (n = 58 )
English: Grade 3 (interfering with activities of daily living)
Slovenian: 3. stopnja (motnje vsakodnevnih aktivnosti)
English: This medicine is given to you into a vein (intravenously) as an infusion.
Slovenian: To zdravilo se daje v veno (intravensko) v obliki infuzije.
English: The infusion may be restarted at a slower rate after symptom resolution.
Slovenian: Infundiranje se lahko ponovno začne z nižjo hitrostjo, ko simptomi izzvenijo.
English: In vitro studies using human liver microsomes indicate that MMAE inhibits only CYP3A4/5 at concentrations much higher than was achieved during clinical application.
Slovenian: Študije in vitro s človeškimi jetrnimi mikrosomi kažejo, da MMAE zavira samo CYP3A4/5 v koncentracijah, ki so veliko višje, kot so bile dosežene med klinično uporabo.
English: No patients required dose reduction or discontinued treatment for neutropenia.
Slovenian: Pri nobenem od bolnikov ni bilo potrebno zmanjšanje odmerka ali prekinitev zdravljenja zaradi nevtropenije.
English: Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Slovenian: Tega zdravila ne uporabljajte, če pred uporabo opazite kakršne koli trde delce ali obarvanost.
English: ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases.
Slovenian: Periferna nevropatija, ki jo povzroči zdravilo ADCETRIS, je običajno učinek kumulativne izpostavljenosti temu zdravilu in je v večini primerov reverzibilna.
English: Patients who discontinued due to peripheral neuropathy received a median of 8 doses of ADCETRIS+AVD (A+AVD) before discontinuation of one or more agents.
Slovenian: Bolniki, pri katerih je bilo zdravljenje prekinjeno zaradi periferne nevropatije, so mediano prejeli 8 odmerkov zdravila ADCETRIS + AVD (A + AVD), preden so prenehali uporabljati eno ali več učinkovin.
English: Severity grade of neutropenia (signs and symptoms [abbreviated description of CTCAE a])
Slovenian: Stopnja resnosti nevtropenije (znaki in simptomi [okrajšan opis CTCAE a])
English: Response assessments were performed at cycles 2, 4, 7, 10, 13 and 16 with PET at cycles 4 and 7.
Slovenian: Oceno odziva so opravili v 2., 4., 7., 10., 13. in 16. ciklu in s slikanjem PET v 4. in 7. ciklu.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Progressive multifocal leukoencephalopathy
Slovenian: Progresivna multifokalna levkoencefalopatija
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Grade 4 (sensory neuropathy which is disabling or motor neuropathy that is life threatening or leads to paralysis)
Slovenian: 4. stopnja (senzorična nevropatija, ki onemogoča vsakdanje dejavnosti ali motorična nevropatija, ki ogroža življenje ali vodi v paralizo)
English: Doxorubicin, vinblastine and dacarbazine (AVD)
Slovenian: Doksorubicin, vinblastin in dakarbazin (AVD)
English: Table 5 provides the efficacy results for modified PFS and overall survival (OS) in the ITT population and patients with Stage IV disease.
Slovenian: V preglednici 5 so navedeni rezultati učinkovitosti za modificirano PFS in celokupno preživetje (OS, “overall survival”) pri populaciji ITT in bolnikih z boleznijo stadija IV.
English: Reduce dose to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks
Slovenian: Zmanjšajte odmerek na 0,9 mg/kg do največ 90 mg vsaka 2 tedna.
English: No meaningful differences in quality of life (assessed by the EuroQol five dimensions questionnaire [EQ-5D] and Functional Assessment of Cancer Therapy-General [FACT-G]) were observed between the treatment arms.
Slovenian: Med obema skupinama zdravljenja niso zaznali pomembnih razlik glede kakovosti življenja (ki so jo ocenjevali z vprašalnikom EuroQol s petimi dimenzijami [EQ-5D] in splošnim vprašalnikom za funkcionalno oceno zdravljenja raka [FACT-G, “Functional Assessment of Cancer Therapy-General”]).
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Slovenian: V posamezni skupini glede na pogostnost so neželeni učinki navedeni po padajoči resnosti.
English: The analysis indicated that MMAE clearance was 2-fold lower in patients with low serum albumin concentrations <3.0 g/dl compared with patients with serum albumin concentrations within the normal range.
Slovenian: Analiza je pokazala, da je bil očistek MMAE 2-krat nižji pri bolnikih z nizkimi koncentracijami albumina v serumu < 3,0 g/dl v primerjavi z bolniki s koncentracijami albumina v serumu znotraj normalnega razpona.
English: No benefit in terms of PFS or OS has been observed in patients with one risk factor for relapse or progression.
Slovenian: Prednosti glede PFS ali OS pri bolnikih z enim dejavnikom tveganja ponovitve ali napredovanja bolezni niso bile opažene.
English: Excipient with known effect
Slovenian: Pomožne snovi z znanim učinkom
English: ADCETRIS dose (mg/kg) x patient's body weight (kg)
Slovenian: Odmerek zdravila ADCETRIS (mg/kg) x telesna masa bolnika (kg)
English: A monoclonal antibody is a protein which recognises certain cancer cells.
Slovenian: Monoklonsko protitelo je beljakovina, ki prepoznava nekatere rakave celice.
English: Of the 329 patients, 165 patients were randomised to the treatment arm and 164 patients were randomised to the placebo arm.
Slovenian: Od 329 bolnikov je bilo 165 bolnikov razporejenih v skupino z zdravilom ADCETRIS in 164 bolnikov v skupino s placebom.
English: Older patients who received G-CSF primary prophylaxis had lower incidence of neutropenia and febrile neutropenia than those who did not receive G-CSF primary prophylaxis.
Slovenian: Starejši bolniki, ki so prejeli primarno profilakso z G-CSF, so imeli manjšo incidenco nevtropenije in febrilne nevtropenije kot bolniki, ki niso prejeli primarne profilakse z G-CSF.
English: PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens.
Slovenian: O PML so poročali pri bolnikih, ki so prejeli zdravilo po predhodnem zdravljenju z več režimi kemoterapije.
English: Unknown
Slovenian: Neznano
English: Medical resource utilization (MRU) analysis showed that hospitalizations and outpatient visits, as well as working days/other activities missed by patients and caregivers were lower with ADCETRIS compared with placebo in patients with HL at increased risk of relapse.
Slovenian: Analiza uporabe medicinskih virov (MRU, »medical resource utilization«) je pokazala, da je bilo hospitalizacij in ambulantnih obiskov, kot tudi delovnih dni/drugih dejavnosti, ki jih bolniki in skrbniki niso opravili, pri zdravljenju z zdravilom ADCETRIS manj v primerjavi z bolniki, ki so prejemali placebo, pri bolnikih s HL s povečanim tveganjem ponovitve bolezni.
English: You may experience the following side effects:
Slovenian: Pojavijo se lahko naslednji neželeni učinki:
English: The pharmacokinetics of ADCETRIS in combination with AVD were evaluated in a single phase 3 study in 661 patients.
Slovenian: Farmakokinetiko zdravila ADCETRIS v kombinaciji z AVD so ocenili v eni študiji 3. faze s podatki za 661 bolnikov.
English: Total volume per vial (10 mL/vial)
Slovenian: Skupni volumen na vialo (10 ml/vialo)
English: • Relapsed or progressive HL that occurred <12 months from the end of frontline treatment
Slovenian: • Ponovitev ali napredovanje HL, ki se je pojavilo < 12 mesecev po zaključku začetnega zdravljenja.
English: Insomnia a.
Slovenian: nespečnost a.
English: Special patient populations
Slovenian: Posebne populacije bolnikov
English: have abnormal liver test results as this may be related to a serious and potentially fatal liver injury (hepatotoxicity).
Slovenian: - imate nenormalne izvide jetrnih testov, saj so ti lahko povezani z resnimi in potencialno smrtnimi poškodbami jeter (hepatotoksičnost).
English: The Cmax of ADC was typically observed at the end of infusion or the sampling closest to the end of infusion.
Slovenian: Cmax za ADC je bil običajno opažen ob koncu infuzije ali pri vzorčenju, ki je bilo najbližje koncu infuzije.
English: Liver disease and other medical conditions that may have been present before you start taking Adcetris and some medications that you are currently taking might increase the risk of liver injury.
Slovenian: Jetrna bolezen in druga zdravstvena stanja, ki so prisotna pred jemanjem zdravila Adcetris in druga zdravila, ki jih trenutno jemljete, lahko povečajo tveganje za poškodbe jeter.
English: - are currently using bleomycin, an anti-cancer agent
Slovenian: - če trenutno uporabljate bleomicin, zdravilo proti raku.
English: Serious cases of hepatotoxicity, including fatal outcomes, have also occurred.
Slovenian: Pojavili so se tudi hujši primeri hepatotoksičnosti z nekaj smrtnimi izidi.
English: Name and address of the manufacturers of the biological active substance
Slovenian: Ime in naslov izdelovalcev biološke zdravilne učinkovine
English: Adcetris is also used to lower the likelihood of classical Hodgkin Lymphoma coming back after an autologous stem cell transplant in patients with certain risk factors.
Slovenian: Zdravilo Adcetris se prav tako uporablja za zmanjšanje verjetnosti ponovitve klasičnega Hodgkinovega limfoma po avtologni presaditvi matičnih celic pri bolnikih z določenimi dejavniki tveganja.
English: At least one metabolite of MMAE has been shown to be active in vitro.
Slovenian: Pokazalo se je, da je vsaj en presnovek MMAE in vitro aktiven.
English: The most commonly reported opportunistic infections were herpes viral infections.
Slovenian: Oportunistične okužbe, o katerih so najpogosteje poročali, so bile herpesvirusne okužbe.
English: Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder.
Slovenian: Steklena viala iz stekla tipa I z zamaškom iz butilne gume in aluminijasto/plastično dvižno zaporko, ki vsebuje 50 mg praška.
English: The median time from onset to resolution or improvement of peripheral neuropathy events was 10 weeks (ranged from 0 weeks to 139 weeks).
Slovenian: Mediani čas od začetka do prenehanja ali izboljšanja dogodkov periferne nevropatije je znašal 10 tednov (razpon od 0 tednov do 139 tednov).
English: Number of events (%)
Slovenian: Število dogodkov (%)
English: HL Status after the end of frontline standard chemotherapy
Slovenian: Stanje HL po zaključku začetne standardne kemoterapije
English: ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness), see section 4.8.
Slovenian: Zdravilo ADCETRIS ima zmeren vpliv na sposobnost vožnje in upravljanja strojev (npr. omotica), glejte poglavje 4.8.
English: ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus.
Slovenian: Zdravila ADCETRIS ne smete uporabljati med nosečnostjo, razen če so koristi za mater večje od možnega tveganja za plod.
English: If your infusion is restarted, your doctor may increase the time over which your infusion is given so that you may be able to tolerate it better.
Slovenian: Pri ponovnem začetku infundiranja lahko vaš zdravnik podaljša čas infundiranja, da bi zdravilo bolje prenašali.
English: No differences were observed in quality of life between the treatment and placebo arms.
Slovenian: V kakovosti življenja med skupino zdravljeno z zdravilom ADCETRIS in skupino s placebom ni bilo opaziti nobene razlike.
English: Binding of the ADC to CD30 on the cell surface initiates internalisation of the ADC-CD30 complex, which then traffics to the lysosomal compartment.
Slovenian: Vezava ADC na CD30 na površini celic začne internalizacijo kompleksa ADC-CD30, ki se nato prenese v lizosomalni kompartment.
English: Combined use of bleomycin and ADCETRIS causes pulmonary toxicity (see section 4.5).
Slovenian: Kombinirana uporaba bleomicina in zdravila ADCETRIS povzroča pljučno toksičnost (glejte poglavje 4.5).
English: Number of deaths (%)
Slovenian: Število smrti (%)
English: In the pivotal phase 2 population (SG035-0003 and SG035-0004), the median duration of Grade 3 or Grade 4 neutropenia was limited (1 week); 2% of patients had Grade 4 neutropenia that lasted ≥ 7 days.
Slovenian: V ključni populaciji 2. faze (SG035-0003 in SG035-0004) je bilo mediano trajanje nevtropenije 3. stopnje ali 4. stopnje omejeno (1 teden); 2% bolnikov sta imela nevtropenijo 4. stopnje, ki je trajala ≥ 7 dni.
English: For refractory disease, or upon progression or relapse after frontline therapy.
Slovenian: Za refraktarno bolezen ali ob napredovanju oz. ponovitvi po začetnem zdravljenju.
English: Objective Response Rate lasting at least 4 months (ORR4) per IRF n (%)
Slovenian: Objektivni odziv na zdravljenje, ki traja vsaj 4 mesece (ORR4) po IRF n (%)
English: ADC accumulation (as assessed by AUC14D between Cycle 1 and Cycle 3) was 1.27-fold.
Slovenian: Kopičenje ADC (ocenjeno z AUC14D med 1. in 3. ciklom) je bilo 1,27-kratno.
English: The estimated overall survival at 5 years was 60% (95% CI [47%,73%]).
Slovenian: Ocenjeno celokupno preživetje pri 5 letih je znašalo 60% (95% IZ [47%, 73%]).
English: Alternatively, treatment may be started at the last tolerated dose (see section 5.1).
Slovenian: Alternativno se zdravljenje lahko uvede tudi v zadnjem odmerku, ki ga je bolnik prenašal (glejte poglavje 5.1).
English: Your treatment may influence your ability to drive or operate machines.
Slovenian: Zdravljenje lahko vpliva na sposobnost upravljanja vozil in strojev.
English: In the physician's choice arm, the median duration of treatment (number of cycles) for patients receiving bexarotene was approximately 16 weeks (5.5 cycles) and 11 weeks (3 cycles) for patients receiving methotrexate.
Slovenian: V skupini z zdravilom po izbiri zdravnika je mediano trajanje zdravljenja (število ciklov) pri bolnikih, ki so prejemali beksaroten, znašalo približno 16 tednov (5,5 cikla), pri bolnikih, ki so prejemali metotreksat, pa 11 tednov (3 cikle).
English: Patients with rapidly proliferating tumour and high tumour burden are at risk of tumour lysis syndrome.
Slovenian: Pri bolnikih s hitro proliferacijskimi tumorji in veliko tumorsko obremenitvijo obstaja tveganje za sindrom tumorske lize.
English: This medicine has been given ‘conditional approval'.
Slovenian: Zdravilo je pridobilo tako imenovano “pogojno dovoljenje za promet”.
English: The other chemotherapy medicines are doxorubicin, vinblastine and dacarbazine.
Slovenian: Druga kemoterapevtska zdravila so doksorubicin, vinblastin in dakarbazin.
English: In older patients (≥ 60 years of age; n = 83 [13%]), the incidence of adverse events was similar across treatment arms.
Slovenian: Pri starejših bolnikih (≥ 60 let; n = 83 [13%]) je bila incidenca neželenih dogodkov podobna v vseh skupinah zdravljenih bolnikov.
English: The pharmacokinetics of brentuximab vedotin were evaluated in phase 1 studies and in a population pharmacokinetic analysis of data from 314 patients.
Slovenian: Farmakokinetiko brentuksimaba vedotina so ocenili v študijah 1. faze in v farmakokinetični analizi populacije s podatki za 314 bolnikov.
English: Progression Free Survival (PFS) per IRF Median (months)
Slovenian: Preživetje brez napredovanja bolezni (PFS) po IRF Mediana (meseci)