FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary objective was to evaluate the effect of brentuximab vedotin on cardiac ventricular re-polarization and the predefined primary analysis was the change in QTc from baseline to multiple time points in Cycle 1.
Croatian: Primarni cilj bio je procijeniti učinak brentuksimab vedotina na repolarizaciju srčanih klijetki, a unaprijed je definirano da će se analizirati promjena QTc od početne do više vremenskih točki u ciklusu 1.
English: In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology.
Croatian: U dva ispitivanja lijeka ADCETRIS faze II s jednom skupinom, aktivnost bolesti pokazana je u podtipovima Sézary sindroma (SS), limfomatoidne papuloze (LyP) i CTCL-a miješane histologije.
English: Pneumonia, oral candidiasis, sepsis/septic shock, herpes simplex
Croatian: Pneumonija, oralna kandidijaza, sepsa/septički šok, herpes simplex
English: In vivo data in animals and humans suggest that only a small fraction of MMAE released from brentuximab vedotin is metabolised.
Croatian: In vivo podaci u životinja i ljudi pokazuju da se metabolizira samo mali dio MMAE oslobođenog iz brentuksimab vedotina.
English: The efficacy and safety of ADCETRIS were evaluated in two additional open-label studies in 108 patients with relapsed CD30+ CTCL (including MF and pcALCL as well as SS, LyP and mixed CTCL histology), regardless of CD30 expression level.
Croatian: Djelotvornost i sigurnost lijeka ADCETRIS procijenjene su u dva dodatna otvorena ispitivanja u 108 bolesnika s relapsom CD30+ CTCL-a (uključujući MF i pcALCL kao i SS, LyP i CTCL miješane histologije), bez obzira na razinu ekspresije CD30.
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.
Croatian: U skupini bolesnika s relapsom ili refraktornim oblikom HL-a ili sALCL-a koji su ponovno primali ADCETRIS (SGN35-006), simptomi periferne neuropatije su se u vrijeme zadnje procjene također poboljšali ili povukli u većine bolesnika (80%).
English: If you are breast-feeding, you should discuss with your doctor whether you should receive this medicine.
Croatian: Ako dojite, razgovarajte sa svojim liječnikom trebate li uzimati ovaj lijek.
English: Per IRF, the ORR was 51% (95% CI [36%, 66%]) for the patients who had received > 1 prior cancer-related treatment and 45% (95% CI [17%, 77%]) for the patients who had received 1 prior cancer-related treatment.
Croatian: Po IRF-u, objektivna stopa odgovora bila je 51% (95% CI [36%; 66%]) za bolesnike koji su primili >1 prethodno liječenje zbog raka, a 45% (95% CI [17%; 77%]) za bolesnike koji su primili 1 prethodno liječenje zbog raka.
English: The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date.
Croatian: Sigurnosni profil lijeka ADCETRIS temelji se na do danas dostupnim podacima iz kliničkih ispitivanja, projekta Programa imenovanih bolesnika (engl.
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.
Croatian: Bolesnici s istovremenom dijagnozom sistemskog ALCL-a, Sézary sindroma i drugog ne-Hodgkinovog limfoma (osim limfomatoidne papuloze [LyP]) bili su isključeni iz ovog ispitivanja.
English: Percent Difference (95% CI) p-value
Croatian: Postotak razlike (95% CI) p-vrijednost
English: Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; see neuropathy: motor; neuropathy: sensory; and neuropathic pain.
Croatian: Stupnjevanje na temelju verzije 3.0 Zajedničkih terminoloških kriterija za nuspojave (CTCAE) Nacionalnog instituta za rak (NCI); vidjeti neuropatija: motorička; neuropatija: senzorna i neuropatska bol.
English: Pancreatitis acute
Croatian: Akutni pankreatitis
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).
Croatian: Preporučena doza u kombinaciji s kemoterapijom (doksorubicin [A], vinblastin [V] i dakarbazin [D] [AVD]) je 1,2 mg/kg primijenjena kao intravenska infuzija u trajanju od 30 minuta na 1. i 15. dan svakog 28-dnevnog ciklusa, tijekom 6 ciklusa (vidjeti dio 5.1).
English: Baseline patient characteristics showed failure from multiple prior chemotherapy regimens (median of 3 with a range of 1 to 7) before first administration with ADCETRIS.
Croatian: Početne osobine bolesnika pokazale su da je više prethodnih kemoterapijskih režima (medijan od 3 s rasponom od 1 do 7) bilo neuspješno prije prve primjene lijeka ADCETRIS.
English: MMAE is the major metabolite of brentuximab vedotin.
Croatian: MMAE je glavni metabolit brentuksimab vedotina.
English: After multiple-dose, IV infusion of 1.2 mg/kg brentuximab vedotin every two weeks, maximal serum concentrations of ADC were observed near the end of the infusion and elimination exhibited a multi-exponential decline with a t1/2z of approximately 4 to 5 days.
Croatian: Nakon višestruke primjene intravenske infuzije 1,2 mg/kg brentuksimab vedotina svaka dva tjedna, maksimalna serumska koncentracija ADC-a je bila opažena na kraju infuzije, a eliminacija je pokazivala multieksponencijalni pad sa t1/2z od približno 4 do 5 dana.
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).
Croatian: Analize su pokazale dosljedan trend prema koristi za bolesnike koji su primali ADCETRIS u usporedbi s bolesnicima koji su primali placebo, s izuzetkom bolesnika starosti ≥ 65 godina (n=8).
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.
Croatian: U slučaju pojave ili pogoršanja plućnih simptoma (npr. kašalj, dispneja), treba se provesti brza dijagnostička procjena i bolesnika treba liječiti na odgovarajući način.
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).
Croatian: U bolesnika s novonastalom perifernom neuropatijom ili pogoršanjem postojeće može biti potrebno odgoditi primjenu ili sniziti dozu lijeka ADCETRIS ili prekinuti liječenje (vidjeti dio 4.2).
English: Modification of dose and schedule
Croatian: Prilagodba doze i rasporeda Prilagodba doze i rasporeda
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.
Croatian: Mehanizam djelovanja brentuksimab vedotina usmjeren na CD30, dosljedno izražavanje CD30 tijekom cijelog trajanja klasičnog HL-a, sALCL-a i CD30+ CTCL bolesti te terapijski rasponi i klinički dokazi zloćudnih bolesti s pozitivnim CD30 nakon višestrukih linija liječenja čine biološku osnovu za primjenu brentuksimab vedotina u bolesnika s relapsom ili refraktornim oblikom klasičnog HL-a, sALCL-a sa ili bez prethodnog ASCT-a i s CD30+ CTCL-om nakon najmanje 1 prethodnog sistemskog liječenja.
English: If neutropenia develops during treatment it should be managed by dose delays.
Croatian: Ako se neutropenija razvije tijekom liječenja, treba odgoditi primjenu sljedeće doze.
English: Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose.
Croatian: Muškarcima koji se liječe ovim lijekom savjetuje se da ne začinju dijete tijekom liječenja i do 6 mjeseci nakon zadnje doze.
English: Adverse reactions for ADCETRIS are listed by MedDRA System Organ Class and Preferred Term (see Table 3).
Croatian: Nuspojave lijeka ADCETRIS navedene su prema MedDRA klasifikaciji organskih sustava i preporučenim izrazima (vidjeti tablicu 3).
English: Maximum concentrations of brentuximab vedotin ADC were typically observed at the end of infusion or the sampling timepoint closest to the end of infusion.
Croatian: Maksimalne koncentracije brentuksimab vedotin ADC obično su bile opažene na kraju infuzije ili u vremenskoj točki uzimanja uzorka koja je bila najbliža završetku infuzije.
English: Pneumocystis jiroveci pneumonia, staphylococcal bacteraemia, cytomegalovirus infection or reactivation, sepsis/septic shock
Croatian: Pneumonija uzrokovana s Pneumocystis jiroveci, stafilokokna bakterijemija, infekcija citomegalovirusom ili reaktivacija, sepsa/septički šok
English: Adcetris contains sodium
Croatian: Adcetris sadrži natrij
English: Tumour lysis syndrome (TLS) has been reported with ADCETRIS.
Croatian: Sindrom lize tumora (TLS) zabilježen je uz lijek ADCETRIS.
English: These patients should receive up to 16 cycles (see section 5.1).
Croatian: Ti bolesnici trebaju primiti do 16 ciklusa (vidjeti dio 5.1).
English: Procedures for proper handling and disposal of anticancer medicines should be considered.
Croatian: Potrebno je razmotriti postupke za ispravno rukovanje antitumorskim lijekovima i njihovo odlaganje.
English: Among patients who experienced peripheral neuropathy, the median follow up time from end of treatment until last evaluation was approximately 91 weeks.
Croatian: Među bolesnicima kod kojih se pojavila periferna neuropatija, medijan vremena od kraja liječenja do posljednje posjete iznosio je oko 91 tjedan.
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).
Croatian: Sigurnost je procijenjena u ispitivanju faze 1/2 u pedijatrijskih bolesnika u dobi od 7-17 godina (n = 36) s relapsom ili refraktornim (r/r) oblikom HL-a i sALCL-a (vidjeti dio 5.1).
English: The objective response rate (ORR) per IRF assessment was 75% (76 of 102 patients in the intent-to-treat [ITT] set) and tumour reduction was achieved in 94% of patients.
Croatian: Stopa objektivnog odgovora (ORR) po procjeni IRF-a bila je 75% (76 od 102 bolesnika u grupi bolesnika predviđenih za liječenje, [ITT, intent-to-treat]), a smanjenje tumora bilo je postignuto u 94% bolesnika.
English: Of the study's 60 patients, 49 patients (82%) received > 1 prior cancer-related treatment and 11 patients (18%) received 1 prior cancer-related treatment.
Croatian: Od 60 bolesnika u ispitivanju, 49 bolesnika (82%) primilo je > 1 prethodno liječenje zbog raka, a 11 bolesnika (18%) primilo je 1 prethodno liječenje zbog raka.
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.
Croatian: Zbog svog mehanizma djelovanja usmjerenog na CD30, brentuksimab vedotin može nadjačati kemorezistenciju jer je CD30 dosljedno izražen u bolesnika koji su refraktorni na više različitih antineoplastičnih lijekova, bez obzira na prethodni transplantacijski status.
English: Patients should be closely monitored for new or worsening neurological, cognitive, or behavioural signs or symptoms, which may be suggestive of PML.
Croatian: Bolesnike treba pažljivo nadzirati zbog mogućih nastanka novih ili pogoršanja postojećih neuroloških, kognitivnih ili bihevioralnih znakova i simptoma koji mogu upućivati na PML.
English: The significance of this finding in stage IV HL patients with no extranodal disease is not established due to small patient numbers and low event rates (14 events).
Croatian: Značaj ovog rezultata za bolesnike sa HL u 4. Stadiju bez ekstranodalne bolesti nije ustanovljen zbog malog broja bolesnika
English: The ORR was 47% in response-evaluable patients with r/r HL, 53% in patients with r/r sALCL and 60% in sALCL patients in first relapse.
Croatian: 47%, u bolesnika s r/r sALCL-om iznosila je 53% te 60% u bolesnika sa sALCL-om u prvom relapsu.
English: The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
Croatian: Rekonstituirana otopina u bočici bistra je do blago opalescentna, bezbojna otopina s konačnim pH od 6,6.
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.
Croatian: Primarna mjera ishoda ispitivanja C25003 je bilo modificirano preživljenje bez progresije bolesti (mPFS), prema skupini za neovisnu procjenu (IRF), definirano vremenom proteklim od randomizacije do progresije bolesti, smrti ili dokaza o nepotpunom odgovoru na terapiju (non-CR) prema IRF nakon završetka primjene prve linije terapije, praćeno sljedećom antitumorskom terapijom.
English: You may be given other medicines such as anti-histamines, corticosteroids or paracetamol to help reduce any of the reactions above if you have already experienced these when receiving this type of medicine.
Croatian: - antihistaminici, kortikosteroidi ili paracetamol radi smanjivanja navedenih simptoma, posebno ako ste već prije imali reakcije na infuziju kada ste primali ovu vrstu lijeka.
English: Patients ≥ 65 years old n (%) Gender n (%)
Croatian: Bolesnici ≥ 65 godina n (%) Spol n (%)
English: Additionally, the population pharmacokinetics of brentuximab vedotin in combination with AVD were examined, including data from 661 patients up to 82 years old (42 patients ≥ 65-< 75 and 17 patients ≥ 75 years of age).
Croatian: Dodatno, ispitana je populacijska farmakokinetika brentuksimab vedotina u kombinaciji s AVD, uključujući podatke o 661 bolesniku u dobi do 82 godine (42 bolesnika ≥ 65-< 75 i 17 bolesnika
English: Herpes zoster, pneumonia, herpes simplex, oral candidiasis
Croatian: Herpes zoster, pneumonija, herpes simplex, oralna kandidijaza
English: Eighteen (18) patients (18%) received 16 cycles of ADCETRIS; and the median number of cycles received was 9 (ranging from 1 to 16).
Croatian: Osamnaest (18) bolesnika (18%) primilo je 16 ciklusa lijeka ADCETRIS, a medijan primljenih ciklusa bio je 9 (u rasponu od 1 do 16).
English: 0.89 mo (0.0-81.4)
Croatian: 0,89 mj. (0,0-81,4)
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.
Croatian: Faza 1 uključila je 3 r/r bolesnika s HL-om liječena s 1,4 mg/kg i 9 bolesnika (7 s r/r HL-om i 2 sa sALCL-om) liječena s 1,8 mg/kg.
English: The Cmax of ADC was typically observed at the end of infusion or the sampling closest to the end of infusion.
Croatian: Cmax za ADC obično je zabilježen na kraju infuzije ili u vremenskoj točki uzimanja uzorka koja je bila najbliža završetku infuzije.
English: Hyperglycaemia has been reported during clinical trials in patients with an elevated Body Mass Index (BMI) with or without a history of diabetes mellitus.
Croatian: Hiperglikemija je zabilježena tijekom kliničkih ispitivanja u bolesnika s povećanim indeksom tjelesne mase (BMI) s dijabetesom melitusom ili bez njega u anamnezi.
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.
Croatian: Bolesnici kod kojih je liječenje prekinuto zbog periferne neuropatije primili su, prije prekida primjene jednog ili više lijekova, kombiniranu terapiju ADCETRIS+AVD (A+AVD) s medijanom broja primijenjenih doza koji je iznosio 8.
English: Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Croatian: Muškarcima koji se liječe ovim lijekom savjetuje se da daju zamrznuti i pohraniti uzroke sperme prije liječenja.
English: 378M (57) 286F (43)
Croatian: 378M (57) 286Ž (43)
English: Median number of prior chemotherapy regimens (range)
Croatian: Medijan broja prethodnih kemoterapijskih režima (raspon)
English: Alanine aminotransferase (ALT) increased
Croatian: Povišena vrijednost alanin aminotransferaze (ALT)
English: Two percent of patients required dose reduction and < 1% discontinued one of more of the study drugs due to neutropenia.
Croatian: U dva posto bolesnika dozu se moralo smanjiti, a u < 1% bolesnika terapija s jednim ili više ispitivanih lijekova je zbog neutropenije prekinuta.
English: PET scan Status prior to ASCT FDG-AVID
Croatian: Status PET snimanja prije ASCT-a NAKUPLJANJE FDG-a NEGATIVAN FDG
English: If you have any other questions on the use of this medicine, ask your doctor.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
English: Psychiatric Disorders Very common:
Croatian: Psihijatrijski poremećaji Vrlo često:
English: CR was 59% (34 of 58 patients in the ITT set) and tumour reduction (of any degree) was achieved in 97% of patients.
Croatian: Potpuna remisija postignuta je u 59% (34 od 58 bolesnika u ITT skupini), a smanjenje tumora (bilo kojeg stupnja) u 97% bolesnika.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Croatian: POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Number of vials needed = total volume to be diluted divided by total volume per vial [10 mL/vial])
Croatian: Broj potrebnih bočica = ukupni volumen koji treba razrijediti podijeljen ukupnim volumenom po bočici [10 ml/bočica])
English: Objective response rate (CR + PR)
Croatian: Stopa objektivnog odgovora (CR + PR)
English: Discontinue treatment
Croatian: Prekinite liječenje
English: IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin (see section 4.8).
Croatian: Reakcije povezane s infuzijom su češće i teže u bolesnika s protutijelima na brentuksimab vedotin (vidjeti dio 4.8).
English: Contributions to the mechanism of action by other antibody associated functions have not been excluded.
Croatian: Nije isključeno da i druge funkcije protutijela pridonose ovom mehanizmu djelovanja.
English: ADCETRIS is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE).
Croatian: ADCETRIS je konjugat protutijela i lijeka kojeg čini monoklonsko protutijelo protiv CD30 (rekombinantni kimerni imunoglobulin G1 [IgG1] proizvedeno tehnologijom rekombinantne DNK na stanicama jajnika kineskog hrčka), koje je kovalentno vezano za antimikrotubularnu tvar monometil auristatin E (MMAE).
English: Cases of pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), some with fatal outcomes, have been reported in patients receiving ADCETRIS.
Croatian: Slučajevi plućne toksičnosti, uključujući pneumonitis, intersticijsku plućnu bolest i akutni respiratorni distres sindrom (ARDS), neki sa smrtnim ishodom, bili su prijavljeni kod bolesnika koji su primali ADCETRIS.
English: Patients with a diagnosis of mycosis fungoides [MF] or primary cutaneous anaplastic large cell lymphoma [pcALCL] were considered eligible for the study.
Croatian: Bolesnici s dijagnozom fungoidne mikoze [MF] ili primarnim kožnim anaplastičnim velikostaničnim limfomom [pcALCL] procijenjeni su kao prikladni za ispitivanje.
English: Extranodal involvement at time of diagnosis, n (%) IPFP
Croatian: Ekstranodalna bolest pri dijagnozi, n (%) IPFP
English: Table 14 includes the results for ORR4 and other key secondary endpoints.
Croatian: Tablica 14 uključuje rezultate objektivne stope odgovora koja traje najmanje 4 mjeseca (ORR4) i druge ključne sekundarne mjere ishoda.
English: Number of Risk Factors ≥ 3
Croatian: Broj čimbenika rizika ≥ 3
English: No differences were observed in quality of life between the treatment and placebo arms.
Croatian: Nisu zapažene razlike u kvaliteti života između skupine koja je primala liječenje i skupine koja je primala placebom.
English: Population pharmacokinetic analysis indicated that the pharmacokinetics of ADCETRIS in combination with AVD were consistent to that in monotherapy.
Croatian: Farmakokinetička analiza populacije pokazala je da je farmakokinetika lijeka ADCETRIS u kombinaciji s AVD odgovara onoj u monoterapiji.
English: 398M (59) 272F (41)
Croatian: 398M (59) 272Ž (41)
English: Primary prophylaxis with growth factor support (G-CSF) is recommended for all patients with previously untreated HL receiving combination therapy beginning with the first dose (see section 4.4).
Croatian: Primarna profilaksa s faktorom rasta (G-CSF) preporučuje se za sve bolesnike s prethodno neliječenim HL-om koji primaju kombiniranu terapiju, počevši od prve doze (vidjeti dio 4.4).
English: Total dose = patient weight multiplied by recommended dose [1.2 mg/kg a])
Croatian: Ukupna doza = težina bolesnika pomnožena s preporučenom dozom [1,2 mg/kg a])
English: Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; see Neutrophils/granulocytes; LLN = lower limit of normal b.
Croatian: Stupnjevanje na temelju verzije 3.0 Zajedničkih terminoloških kriterija za nuspojave (CTCAE) Nacionalnog instituta za rak (NCI); vidjeti neutrofili/granulociti; DGN= donja granica normale b.
English: Reconstituted vial concentration (5 mg/ml)
Croatian: Koncentracija u rekonstituiranoj bočici (5 mg/ml)
English: These patients should be monitored closely and managed according to best medical practice.
Croatian: Ove bolesnike treba pažljivo nadzirati i liječiti sukladno dobroj kliničkoj praksi.
English: Prior chemotherapy Regimens (range) Histologically confirmed CD30-expressing disease Anaplastic lymphoma kinase (ALK)-negative disease Disease characteristics
Croatian: Prethodni kemoterapijski režimi (raspon) Histološki potvrđena bolest s izražavanjem CD30 Bolest s negativnom kinazom anaplastičnog limfoma (ALK) Karakteristike bolesti
English: Overall Survival
Croatian: Ukupno preživljenje
English: Physician's Choice (Methotrexate or Bexarotene) n = 64
Croatian: Izbor liječnika (metotreksat ili beksaroten) n = 64
English: Total dose = patient weight multiplied by recommended dose [1.8 mg/kg a])
Croatian: Ukupna doza = težina bolesnika pomnožena s preporučenom dozom [1,8 mg/kg a])
English: Patients with CTCL should receive up to 16 cycles (see section 5.1).
Croatian: Bolesnici s CTCL-om trebaju primiti do 16 ciklusa (vidjeti dio 5.1).
English: • HL that was refractory to frontline treatment
Croatian: • HL koji je refraktoran na prvu liniju liječenja
English: Grade 3 neutropenia was reported in 13% and Grade 4 neutropenia was reported in 5% of patients.
Croatian: Neutropenija 3. stupnja prijavljena je u 13%, a neutropenija 4. stupnja prijavljena je u 5% bolesnika.
English: 15.8 months (95% CI [8.5, -])
Croatian: 15,8 mjeseci (95% CI [8,5; -])
English: Compared to patients with normal hepatic function, MMAE exposure increased approximately 2.3-fold (90% CI 1.27-4.12-fold) in patients with hepatic impairment.
Croatian: U usporedbi s bolesnicima s normalnom funkcijom jetre, izloženost MMAE povećala se približno 2,3 puta (90% CI 1,27-4,12 puta) u bolesnika s oštećenjem jetre.