FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 8: Summary of PFS per IRF and OS by number of risk factors in the phase 3 HL post-ASCT Study
Slovenian: Preglednica 8: Povzetek PFS po IRF in OS glede na število dejavnikov tveganja v študiji 3. faze HL po avtologni PKMC
English: If neutropenia develops, refer to Table 1: Dosing recommendations for neutropenia (see section 4.2).
Slovenian: Če se razvije nevtropenija, glejte preglednico 1: Priporočeno odmerjanje pri nevtropeniji (glejte poglavje 4.2).
English: Adcetris will be given to you together with doxorubicin, vinblastine and dacarbazine which are other chemotherapy medicines used to treat Hodgkin lymphoma.
Slovenian: Zdravilo Adcetris boste prejeli skupaj z doksorubicinom, vinblastinom in dakarbazinom, ki so druga kemoterapevtska zdravila, ki se uporabljajo za zdravljenje Hodgkinovega limfoma.
English: The most common prior systemic therapies in the ITT population were chemotherapy (71%), immunotherapy (43%) and bexarotene (38%).
Slovenian: Najpogostejša predhodna sistemska zdravljenja pri bolnikih iz populacije ITT so bili kemoterapija (71%), imunoterapija (43%) in beksaroten (38%).
English: In the event of new or worsening pulmonary symptoms (e.g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients should be treated appropriately.
Slovenian: V primeru pojava novih ali poslabšanja že obstoječih pljučnih simptomov (npr. kašelj, dispneja) je nemudoma treba izvesti ustrezne diagnostične postopke in bolnika ustrezno zdraviti.
English: When you first receive this medicine and during the course of treatment, tell your doctor if you: have confusion, trouble thinking, memory loss, blurred or loss of vision, decreased strength, decreased control or sensation in one arm or leg, a change in the way of walking, or loss of balance, as these may be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Slovenian: Ko boste to zdravilo prvič prejeli in med zdravljenjem, povejte zdravniku, če: - ste zmedeni, imate težave z razmišljanjem, izgubljate spomin, imate zamegljen vid ali izgubljate vid, imate zmanjšano moč, zmanjšan nadzor ali občutenje v eni roki ali nogi, spremenjen način hoje, izgubljate ravnotežje, saj so lahko to simptomi resne in potencialno smrtne bolezni možganov, imenovana progresivna multifokalna levkoencefalopatija (PML).
English: If neutropenia develops during treatment it should be managed by dose delays.
Slovenian: Če se med zdravljenjem razvije nevtropenija, jo je treba uravnati z odložitvijo odmerka.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Haematological toxicities
Slovenian: Hematološka toksičnost
English: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10
Slovenian: Pri zdravljenju z zdravilom ADCETRIS so poročali o febrilni nevtropeniji (zvišana telesna temperatura neznanega izvora brez klinično ali mikrobiološko dokumentirane okužbe z absolutnim številom nevtrofilcev < 1,0 x 10
English: Treatment response was assessed by spiral CT of chest, neck, abdomen and pelvis; PET scans and clinical data.
Slovenian: Odziv na zdravljenje so ocenili s spiralnim CT prsnega koša, vratu, trebuha in medenice, slikanji PET in kliničnimi podatki.
English: Among patients who experienced peripheral neuropathy in the pivotal phase 2 studies (SG035-0003 and SG035-0004) and randomised phase 3 monotherapy studies (SGN35-005 and C25001), the median follow up time from end of treatment until last evaluation ranged from 48.9 to 98 weeks.
Slovenian: Pri bolnikih, ki so imeli periferno nevropatijo v ključnih študijah 2. faze (SG035-0003 in SG035-0004) ter randomiziranih študijah samostojnega zdravljenja 3. faze (SGN35-005 in C25001), je mediani čas spremljanja od konca zdravljenja do zadnje ocenitve znašal od 48,9 do 98 tednov.
English: Nevertheless, ADCETRIS should be used with caution in other CD30+ CTCL patients after careful consideration of the potential benefit-risk on an individual basis (see section 5.1).
Slovenian: Kljub temu je treba zdravilo ADCETRIS pri drugih bolnikih s CD30-pozitivnim CTCL uporabljati previdno ter po skrbnem premisleku možnih koristi in tveganj v posameznih primerih (glejte poglavje 5.1).
English: Anaphylactic reactions have been reported (see section 4.4).
Slovenian: Poročali so o anafilaktičnih reakcijah (glejte poglavje 4.4).
English: Reconstituted vial concentration (5 mg/ml)
Slovenian: Koncentracija rekonstituirane viale (5 mg/ml)
English: Not estimable.
Slovenian: Ni mogoče oceniti.
English: Table 1: Dosing recommendations for neutropenia
Slovenian: Preglednica 1: Priporočeno odmerjanje pri nevtropeniji
English: Each pack of Adcetris consists of one vial.
Slovenian: Eno pakiranje zdravila Adcetris vsebuje eno vialo.
English: Discontinue treatment
Slovenian: Prekinite zdravljenje
English: In clinical trials, patients were periodically tested for antibodies to brentuximab vedotin using a sensitive electrochemiluminescent immunoassay.
Slovenian: Pri bolnikih v kliničnih preskušanjih so periodično testirali protitelesa proti brentuksimabu vedotinu z uporabo občutljivega elektrokemiluminescenčnega imunskega testa.
English: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom ADCETRIS in še 6 mesecev po zdravljenju uporabljati dve obliki učinkovite kontracepcije.
English: Patients with a concurrent diagnosis of systemic ALCL, Sezary syndrome and other nonHodgkin lymphoma (except for lymphomatoid papulosis [LyP]) were excluded from this study.
Slovenian: Bolniki s sočasno diagnozo sistemskega ALCL, Sézaryjevega sindroma in drugega ne-Hodgkinovega limfoma (razen limfomatoidne papuloze [LyP]) so bili izključeni iz te študije.
English: Grade 2 (interfering with function but not with activities of daily living) or
Slovenian: 2. stopnja (motnje funkcije, a brez motenj vsakodnevnih aktivnosti)
English: Patients should be closely monitored for new or worsening abdominal pain, which may be suggestive of acute pancreatitis.
Slovenian: Bolnike je treba skrbno nadzirati glede pojava nove ali poslabšanja že obstoječe bolečine v trebuhu, ki bi lahko kazala na pojav akutnega pankreatitisa.
English: Severity of peripheral sensory or motor neuropathy (signs and symptoms [abbreviated description of CTCAE
Slovenian: Resnost periferne senzorične ali motorične nevropatije (znaki in simptomi [okrajšan opis CTCAE
English: The primary endpoint in Study C25003 was modified PFS (mPFS) per independent review facility (IRF), defined as time from randomisation to disease progression, death, or evidence of non-complete response (non-CR) after completion of first-line therapy per IRF followed by subsequent anticancer therapy.
Slovenian: V študiji C25003 je bil primarni opazovani dogodek po oceni neodvisnega odbora za pregled (IRF, “Independent Review Facility”) modificirano preživetje brez napredovanja bolezni (mPFS, “modified progression free survival”), opredeljeno kot čas od randomizacije do napredovanja bolezni, smrti ali nepopolnega odziva (ne-CR) po končanem zdravljenju prve izbire po IRF, ki mu sledi nadaljnje zdravljenje raka.
English: In vitro data indicate that the MMAE metabolism that occurs is primarily via oxidation by CYP3A4/5.
Slovenian: Podatki in vitro kažejo, da poteka presnova MMAE, ki se pojavi, primarno kot oksidacija s CYP3A4/5.
English: Median age, years (range)
Slovenian: Mediana starost, leta (razpon)
English: The ADC is eliminated by catabolism with a typical estimated CL and half life of 1.5 l/day and 4-6 days respectively.
Slovenian: ADC se izloča s katabolizmom z običajnim ocenjenim očistkom in razpolovnim časom 1,5 l/dan v 4-6 dneh.
English: Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest and results in apoptotic death of the CD30-expressing tumour cell.
Slovenian: Vezava MMAE na tubulin prekine mikrotubulno omrežje znotraj celice, povzroči ustavitev celičnega cikla in apoptozo tumorskih celic z izraženim CD30.
English: ADCETRIS treatment should start following recovery from ASCT based on clinical judgment.
Slovenian: Zdravljenje z zdravilom ADCETRIS naj se začne po okrevanju od avtologne PKMC na osnovi klinične presoje.
English: There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with hepatic impairment, where total bilirubin is > 1.5 times the upper limit of normal (ULN) (unless due to Gilbert syndrome), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are > 3 times the ULN, or > 5 times the ULN if their elevation may be reasonably ascribed to the presence of HL in the liver.
Slovenian: Na voljo ni nobenih podatkov o izkušnjah iz kliničnih preskušanj z uporabo zdravila ADCETRIS v kombinaciji s kemoterapijo pri bolnikih z okvaro jeter, pri katerih skupni bilirubin znaša > 1,5-kratnik zgornje meje normalnih vrednosti (ULN) (razen če gre za Gilbertov sindrom) ali pri katerih aspartat-aminotransferaza (AST) ali alanin-aminotransferaza (ALT) znaša > 3-kratnik ULN oz. > 5-kratnik ULN, če je zadevne povišane vrednosti mogoče utemeljeno pripisati prisotnosti HL v jetrih.
English: These patients should receive up to 16 cycles (see section 5.1).
Slovenian: Ti bolniki naj prejmejo do 16 ciklov (glejte poglavje 5.1).
English: Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk.
Slovenian: Predhodno obstoječa jetrna bolezen, soobolenja in sočasno jemanje drugih zdravil lahko povečajo tveganje.
English: Across the study, a total of 16 patients with r/r HL and 17 patients with r/r sALCL, of whom 10 were in first relapse, were treated with 1.8 mg/kg of ADCETRIS.
Slovenian: V celotni študiji je bilo skupaj 16 bolnikov z r/r HL in 17 bolnikov z r/r sALCL, od katerih je bilo 10 v prvi ponovitvi, zdravljenih z 1,8 mg/kg zdravila ADCETRIS.
English: Intent to Treat (ITT) Population
Slovenian: Populacija “z namenom zdravljenja” (ITT)
English: The safety data in patients retreated with ADCETRIS (SGN35-006, see section 5.1) were consistent with those observed in the combined pivotal phase 2 studies, with the exception of peripheral motor neuropathy, which had a higher incidence (28% vs. 9% in the pivotal phase 2 studies) and was primarily Grade 2.
Slovenian: Podatki o varnosti pri bolnikih, pri katerih je bilo ponovno uvedeno zdravljenje z zdravilom ADCETRIS (SGN35-006, glejte poglavje 5.1), so se ujemali s podatki, zabeleženimi v kombiniranih ključnih študijah 2. faze, razen glede periferne motorične nevropatije, ki je imela višjo incidenco (28% v primerjavi z 9% v ključnih študijah 2. faze) in je bila predvsem 2. stopnje.
English: Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures.
Slovenian: Preiskava bolnika lahko vključuje klinični pregled, laboratorijske preiskave glede vrednosti amilaze in lipaze v serumu, slikovne preiskave trebuha, kot je ultrazvok, in druge ustrezne diagnostične ukrepe.
English: MMAE has been shown to have aneugenic properties (see section 5.3).
Slovenian: Pokazalo se je, da ima MMAE anevgenične lastnosti (glejte poglavje 5.3).
English: Safety was evaluated in a phase 1/2 study in paediatric patients aged 7-17 years of age (n = 36) with relapsed or refractory (r/r) HL and sALCL (see section 5.1).
Slovenian: Varnost je bila ocenjena v študiji faze I/II pri pediatričnih bolnikih, starih od 7 do 17 let (n = 36), s ponovljenim ali z refraktarnim (r/r) HL in sALCL (glejte poglavje 5.1).
English: 52 years (14-76)
Slovenian: 52 let (14-76)
English: Phase 1 included 3 r/r HL patients treated at 1.4 mg/kg and 9 patients (7 r/r HL and 2 sALCL) treated at 1.8 mg/kg.
Slovenian: V fazi I so bili vključeni 3 bolniki z r/r HL, zdravljeni z 1,4 mg/kg, in 9 bolnikov (7 r/r HL in 2 sALCL), zdravljenih z 1,8 mg/kg.
English: In patients with relapsed or refractory HL or sALCL who were retreated with ADCETRIS (SGN35-006), the majority of patients (80%) also had improvement or resolution of their peripheral neuropathy symptoms at the time of last evaluation.
Slovenian: Pri bolnikih s ponovljenim ali refraktarnim HL ali sALCL, pri katerih je bilo ponovno uvedeno zdravljenje z zdravilom ADCETRIS (SGN35-006), so se ob zadnji ocenitvi pri večini bolnikov (80%) simptomi periferne nevropatije izboljšali ali so izzveneli.
English: The recommended dose in combination with chemotherapy (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg administered as an intravenous infusion over 30 minutes on days 1 and 15 of each 28-day cycle for 6 cycles (see section 5.1).
Slovenian: Priporočeni odmerek v kombinaciji s kemoterapijo (doksorubicin [A], vinblastin [V] in dakarbazin [D] [AVD]) je 1,2 mg/kg v obliki 30-minutne intravenske infuzije na 1. in 15. dan vsakega 28-dnevnega cikla, 6 ciklov (glejte poglavje 5.1).
English: 1.44 vials
Slovenian: 1,44 viale
English: 15.8 months (95% CI [8.5, -])
Slovenian: 15,8 mesecev (95% IZ [8,5, -])
English: Febrile neutropenia
Slovenian: Febrilna nevtropenija
English: Timing of the modified event was the date of the first PET scan post completion of first-line therapy demonstrating the absence of complete response (CR), defined as Deauville score of ≥3.
Slovenian: Časovno je bil modificirani dogodek določen z datumom prvega slikanja PET po končanem zdravljenju prve izbire, ki pokaže odsotnost popolnega odziva (CR, “complete remission”), kar je opredeljeno z ≥ 3 točkami po lestvici Deauville.
English: • HL that was refractory to frontline treatment
Slovenian: • HL, ki je refraktaren na začetno zdravljenje.
English: An excretion study was undertaken in patients who received a dose of 1.8 mg/kg of brentuximab vedotin.
Slovenian: Opravili so študijo izločanja pri bolnikih, ki so prejeli odmerek 1,8 mg/kg brentuksimaba vedotina.
English: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 13,2 mg natrija na vialo, kar je enako 0,7% največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin.
Slovenian: Po rekonstituciji (glejte poglavje 6.6) en ml vsebuje 5 mg brentuksimaba vedotina.
English: Data were also collected from patients (n = 15) in phase 1 dose escalation and clinical pharmacology studies, and from patients (n = 26) in a NPP, with relapsed or refractory HL who had not received an ASCT, and who were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Slovenian: Podatke so pridobili tudi od bolnikov (n = 15) iz študij 1. faze z višanjem odmerkov in kliničnih farmakoloških študij ter od bolnikov (n = 26) iz NPP, ki so imeli ponovljen ali refraktarni HL brez presaditve avtolognih matičnih celic in so se zdravili z odmerkom 1,8 mg/kg zdravila ADCETRIS vsake tri tedne.
English: Eight HL patients and 9 sALCL patients went on to receive SCT following treatment with ADCETRIS.
Slovenian: Osmim bolnikom s HL in 9 bolnikom s sALCL so po zdravljenju z zdravilom ADCETRIS izvedli PKMC.
English: Pharmacokinetics in special populations
Slovenian: Farmakokinetika pri posebnih skupinah bolnikov
English: CD30+ CTCL
Slovenian: CD30-pozitivni CTCL
English: Approximately 24% of the total MMAE administered as part of the ADC during a brentuximab vedotin infusion was recovered in both urine and faeces over a 1-week period.
Slovenian: Približno 24% skupnega MMAE danega kot del ADC med infundiranjem brentuksimaba vedotina se je izločilo z urinom in blatom v obdobju 1 tedna.
English: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence.
Slovenian: Obseg učinka zdravljenja pri drugih CD30-pozitivnih podtipih CTCL, razen pri fungoidnem granulomu (MF, “mycosis fungoides”) in primarnem kožnem anaplastičnem velikoceličnem limfomu (pcALCL, “primary cutaneous anaplastic large cell lymphoma”), ni jasen zaradi pomanjkanja trdnih dokazov.
English: Because of the CD30-targeted mechanism of action brentuximab vedotin is able to overcome chemo-resistance as CD30 is consistently expressed in patients who are refractory to multi-agent chemotherapy, irrespective of prior transplant status.
Slovenian: Zaradi mehanizma delovanja brentuksimaba vedotina, ki je usmerjen proti CD30, lahko zdravilo premaga odpornost na kemoterapevtike, saj se CD30 stalno izraža pri bolnikih, ki so odporni na večtirno kemoterapijo, ne glede na morebitno predhodno presaditev celic.
English: Stage IV
Slovenian: Stadij IV
English: Hodgkin lymphoma and systemic anaplastic large cell lymphoma are both types of cancer of the white blood cells.
Slovenian: Hodgkinov limfom in sistemski anaplastični velikocelični limfom sta obliki raka belih krvnih celic (levkocitov).
English: While the presence of antibodies to brentuximab vedotin does not necessarily predict the development of an IRR, there was a higher incidence of IRRs observed in patients with persistently positive anti-drug antibodies (ADA) relative to patients with transiently positive ADA and never positive ADA.
Slovenian: Čeprav prisotnost protiteles proti brentuksimabu vedotinu ne napoveduje vedno razvoja IRR, so pri bolnikih, ki so trajno pozitivni na ADA (“anti-drug antibodies”, protitelesa proti zdravilu) v primerjavi z bolniki, ki so prehodno pozitivni na ADA ali niso bili nikoli pozitivni na ADA, opazili večjo incidenco IRR.
English: Tell your doctor if you have kidney or liver problems as your doctor may lower your starting dose to 0.9 mg/kg or may not recommend Adcetris.
Slovenian: Če imate težave z ledvicami ali jetri, to povejte zdravniku, saj vam lahko zmanjša začetni odmerek na 0,9 mg/kg ali pa vam odsvetuje uporabo zdravila Adcetris.
English: It is not known how frequently infusion-related reactions to this medicine are serious or fatal.
Slovenian: Pogostnost hudih ali smrtnih infuzijskih reakcij po infundiranju tega zdravila ni znana.
English: ADCETRIS may cause peripheral neuropathy, both sensory and motor.
Slovenian: Zdravilo ADCETRIS lahko povzroči periferno nevropatijo, tako senzorično kot motorično.
English: Nonclinical data suggest that the biological activity of brentuximab vedotin results from a multi-step process.
Slovenian: Predklinični podatki kažejo, da povzroči biološka aktivnost brentuksimaba vedotina večstopenjski postopek.
English: The CD30-targeted mechanism of action of brentuximab vedotin, the consistent expression of CD30 throughout the classical HL, sALCL and CD30+ CTCL disease and therapeutic spectrums and clinical evidence in CD30-positive malignancies following multiple lines of treatment provide a biologic rationale for its use in patients with relapsed and refractory classical HL, sALCL with or without prior ASCT and CD30+ CTCL after at least 1 prior systemic therapy.
Slovenian: Mehanizem delovanja brentuksimaba vedotina, ki je usmerjen proti CD30, stalno izražanje CD30 v celotnem poteku bolezni klasičnega HL, sALCL in CD30-pozitivnega CTCL in pri vseh načinih zdravljenja ter klinični dokazi iz študij CD30-pozitivnih malignomov po številnih načinih zdravljenja predstavljajo biološko osnovo za njegovo uporabo pri bolnikih s ponovljenim ali z refraktarnim klasičnim HL, sALCL, z ali brez predhodne presaditve avtolognih matičnih celic, in CD30-pozitivnim CTCL po vsaj enem predhodnem sistematičnem zdravljenju.
English: 1.92 vials
Slovenian: 1,92 viale
English: The analyses showed a consistent trend towards benefit for patients who received ADCETRIS compared with patients who received placebo with the exception of patients ≥65 years of age (n = 8).
Slovenian: Analize so pokazale dosleden trend koristi za bolnike, ki so prejemali zdravilo ADCETRIS v primerjavi z bolniki, ki so prejemali placebo, z izjemo bolnikov, starih ≥ 65 let (n = 8).
English: In the study, patients were to receive their first dose after recovery from ASCT (between days 30-45 following ASCT).
Slovenian: V študiji so bolniki prejeli prvi odmerek po okrevanju po avtologni PKMC (med 30. do 45. dnevom po avtologni PKMC).
English: Study SGN35-006 (Retreatment study)
Slovenian: Študija SGN35-006 (študija ponovne uvedbe zdravljenja)
English: Pharmacotherapeutic group: Antineoplastic agents; other antineoplastic agents; monoclonal antibodies, ATC code: L01XC12
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki); druga zdravila z delovanjem na novotvorbe (citostatiki); monoklonska protitelesa, oznaka ATC: L01XC12
English: Patients with CTCL should receive up to 16 cycles (see section 5.1).
Slovenian: Bolniki s CTCL naj prejmejo do 16 ciklov (glejte poglavje 5.1).
English: Fatigue, pyrexia, infusion-related reactions
Slovenian: utrujenost, pireksija, reakcije, povezane z infundiranjem utrujenost, pireksija
English: What Adcetris looks like and contents of the pack
Slovenian: Izgled zdravila Adcetris in vsebina pakiranja
English: ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Slovenian: Zdravilo ADCETRIS je indicirano za zdravljenje odraslih bolnikov s ponovljenim ali z refraktarnim sistemskim anaplastičnim velikoceličnim limfomom (sALCL, “systemic anaplastic large cell lymphoma”).
English: The presence of antibodies to brentuximab vedotin did not correlate with a clinically meaningful reduction in serum brentuximab vedotin levels and did not result in a decrease in the efficacy of brentuximab vedotin.
Slovenian: Prisotnost protiteles proti brentuksimabu vedotinu ni sovpadala s klinično pomembnim zmanjšanjem ravni brentuksimaba vedotina v serumu in ni povzročila zmanjšanja učinkovitosti brentuksimaba vedotina.
English: The influence of age on pharmacokinetics was investigated in each analysis and it was not a significant covariate.
Slovenian: Pri posamezeni analizi so proučili vpliv starosti na farmakokinetiko in ugotovili, da ne gre za pomembno spremenljivko.
English: Refer to the summary of product characteristics (SmPC) of chemotherapy agents given in combination with ADCETRIS for patients with previously untreated HL.
Slovenian: Glejte povzetek glavnih značilnosti zdravila (SmPC) kemoterapevtikov, ki se dajejo v kombinaciji z zdravilom ADCETRIS za bolnike s predhodno nezdravljenim HL.
English: In patients with Stage IV disease for whom no extranodal disease was reported, no benefit has been shown at time of analysis ([n = 85] [HR = 1.49, 95% CI (0.51, 4.31)]).
Slovenian: Za bolnike z boleznijo stadija IV, pri katerih niso poročali o ekstranodalni bolezni, koristi v času analize niso zaznali ([n = 85] [HR = 1,49; 95-% IZ (0,51; 4,31)]).
English: The most common prior skin directed therapies in the ITT population were radiotherapy (64%), phototherapy (48%) and topical steroids (17%).
Slovenian: Pri bolnikih iz populacije ITT so bila najpogostejša predhodna zdravljenja, usmerjena na kožo, radioterapija (64%), fototerapija (48%) in lokalni steroidi (17%).
English: Patients experiencing new or worsening peripheral neuropathy may require a delay and a dose reduction of ADCETRIS or discontinuation of treatment (see section 4.2).
Slovenian: Pri bolnikih, pri katerih se pojavi nova ali poslabša obstoječa periferna nevropatija, bo morda treba odmerek zdravila ADCETRIS odložiti ali zmanjšati ali zdravljenje prekiniti (glejte poglavje 4.2).