FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were treated with 1.8 mg/kg of ADCETRIS intravenously over 30 minutes every 3 weeks for up to 16 cycles or physician's choice for up to 48 weeks.
Croatian: Bolesnici su liječeni s 1,8 mg/kg lijeka ADCETRIS, intravenski tijekom 30 minuta, svaka 3 tjedna do 16 ciklusa ili lijekom po liječnikovom izboru, do 48 tjedana.
English: 37M (58%)/27F (42%)
Croatian: 37M (58%)/27Ž (42%)
English: Twenty patients with relapsed or refractory HL received a starting dose of 1.8 mg/kg and one patient received a starting dose of 1.2 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks.
Croatian: Dvadeset bolesnika s relapsom ili refraktornim HL-om primilo je početnu dozu od 1,8 mg/kg, a jedan bolesnik primio je početnu dozu od 1,2 mg/kg lijeka ADCETRIS primijenjenog intravenski tijekom 30 minuta svaka 3 tjedna.
English: In the clinical trial of ADCETRIS as combination therapy, neutropenia led to dose delays in 24% of patients.
Croatian: U kliničkom ispitivanju lijeka ADCETRIS u kombiniranoj terapiji, primjena sljedeće doze je zbog neutropenije odgođena u 24% bolesnika.
English: IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus, cough, infusion site pain and pyrexia were reported in 9% of patients.
Croatian: Reakcije povezane s infuzijom, kao što su glavobolja, osip, bol u leđima, povraćanje, zimica, mučnina, dispneja, pruritus, kašalj, bol na mjestu primjene infuzije i pireksija, prijavljene su i 9% bolesnika.
English: The usual dose of Adcetris given alone is 1.8 mg/kg, given once every 3 weeks for no more than one year.
Croatian: Uobičajena doza lijeka Adcetris kada se koristi kao samostalna terapija je 1,8 mg/kg jedanput svaka 3 tjedna tijekom najviše godinu dana.
English: See the package leaflets for these medicines for additional information on their use and effects.
Croatian: Za dodatne informacije o uporabi i djelovanju ovih lijekova, pogledajte upute u njihovim pakiranjima.
English: Withhold dose until toxicity returns to ≤ Grade 2 or baseline then resume treatment at the same dose and schedule .
Croatian: Nemojte primijeniti dozu sve dok se vrijednosti neutrofila ne vrate na stupanj toksičnosti ≤ 2 ili na početnu vrijednost, a potom nastavite liječenje istom dozom prema istom rasporedu b.
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.
Croatian: Trenutak modificiranog događaja bio je datum prve PET pretrage nakon završetka prve linije terapije koja je pokazala odsutstvo kompletnog odgovora (CR), definirano Deauvilleovim skorom ≥ 3. Medijan modificiranog PFS-a prema IRF procjeni nije postignut u oba terapijska režima.
English: Alopecia, rash
Croatian: Alopecija, osip a,
English: Bone marrow involvement at time of diagnosis or study entry, n (%)
Croatian: Zahvaćenost koštane srži u vrijeme dijagnoze ili uključivanja u ispitivanje, n (%) B simptomi a, n (%)
English: 18.8 mo (7.4-180.8)
Croatian: 18,7 mj. (6,1-204,0) 18,8 mj. (7,4-180,8)
English: No benefit in terms of PFS or OS has been observed in patients with one risk factor for relapse or progression.
Croatian: U bolesnika s jednim rizičnim čimbenikom za relaps ili progresiju bolesti nije zapažena korist u smislu PFS-a ili OS-a.
English: - are allergic to brentuximab vedotin or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na brentuksimab vedotin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako trenutno primjenjujete bleomicin, antitumorski lijek.
English: Disease stage a at initial diagnosis of HL, n (%)
Croatian: Stadij a bolesti pri dijagnozi HL-a, n (%)
English: - shortness of breath or cough (may affect more than 1 in 10 people) - flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin (may affects up to 1 in 100 people) - a change in feeling or sensitivity, especially in the skin, numbness, tingling, discomfort, a burning sensation, weakness, or pain in the hands or feet (neuropathy; may affect more than 1 in 10 people) - a feeling of weakness (may affect more than 1 in 10 people) - constipation (may affect more than 1 in 10 people) - diarrhoea, vomiting (may affect more than 1 in 10 people) - chills or shivering (may affect up to 1 in 10 people) - feeling tired, frequent urination, increased thirst, increased appetite with unintended weight loss, and irritability (these may be signs of hyperglycaemia, which may affect up to1 in 10 people) - unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (these may be signs of thrombocytopenia which may affect up to 1 in 10 people) - headaches, experience dizziness, look pale (these may be signs of anaemia, which may affect more than 1 in 10 people)
Croatian: Odmah obavijestite svog liječnika ako osjetite neki od sljedećih simptoma zato što neki od njih mogu biti znakovi ozbiljnog ili moguće smrtonosnog stanja: - simptomi progresivne multifokalne leukoencefalopatije (PML) kao što su smetenost, otežano razmišljanje, gubitak pamćenja, zamagljen vid ili gubitak vida, smanjena snaga, smanjena kontrola ili osjet u jednoj ruci ili nozi, promjena u načinu hoda ili gubitak ravnoteže (za detaljnije informacije, pogledajte dio 2) (javlja se u manje od 1 na 100 osoba) - simptomi upale gušterače (pankreatitis), kao što su jaki i uporni bolovi u trbuhu, s ili bez mučnine i povraćanja (može se javiti u do 1 na 100 osoba). - nedostatak zraka ili kašalj (može se javiti u više od 1 na 10 osoba) - simptomi nalik gripi praćeni bolnim crvenim ili ljubičastim osipom koji se širi, te mjehurima, uključujući i opsežno odvajanje kože (može se javiti u do 1 na 100 osoba) - promjena osjeta ili osjetljivosti, osobito kože, utrnulost, trnci, nelagoda, osjećaj žarenja, slabost ili bol u šakama i stopalima (neuropatija; može se javiti u više od 1 na 10 osoba) - osjećaj slabosti (može se javiti u više od 1 na 10 osoba) - zatvor (može se javiti u više od 1 na 10 osoba) - proljev, povraćanje (može se javiti u više od 1 na 10 osoba) - zimica ili drhtanje (može se javiti u do 1 na 10 osoba) - umor, učestalo mokrenje, pojačana žeđ, pojačan apetit s nenamjernim gubitkom tjelesne težine i razdražljivost (ovo mogu biti znakovi hiperglikemije, koja se može javiti u do 1 na 10 osoba) - neuobičajeno krvarenje ili modrice pod kožom, krvarenje koje traje dulje no obično nakon vađenja krvi ili krvarenje iz desni (to mogu biti znakovi trombocitopenije koja se može javiti u do 1 na 10 osoba) - glavobolje, osjećaj omaglice, bljedoća (to mogu biti znakovi anemije, koja se može javiti u do 1 na 10 osoba)
English: A study evaluated the PK of brentuximab vedotin and MMAE after the administration of 1.2 mg/kg of ADCETRIS to patients with mild (n = 4), moderate (n = 3) and severe (n = 3) renal impairment.
Croatian: U ispitivanju je ocijenjena farmakokinetika brentuksimab vedotina i MMAE nakon primjene 1,2 mg/kg lijeka ADCETRIS u bolesnika s blagim (n=4), umjerenim (n=3) i teškim (n=3) oštećenjem bubrega.
English: Seven patients with relapsed sALCL received a starting dose of 1.8 mg/kg and one patient received a starting dose of 1.2 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks.
Croatian: Sedam bolesnika s relapsom sALCL-a primilo je početnu dozu od 1,8 mg/kg, a jedan bolesnik primio je početnu dozu od 1,2 mg/kg lijeka ADCETRIS primijenjenog intravenski tijekom 30 minuta svaka
English: After reconstitution each vial contains 5 mg/ml of brentuximab vedotin
Croatian: Nakon rekonstitucije, jedna bočica sadrži 5 mg/ml brentuksimab vedotina
English: For patients who experienced peripheral neuropathy the median time of onset of peripheral neuropathy was 12 weeks.
Croatian: U bolesnika kod kojih se javila periferna neuropatija medijan vremena do pojave periferne neuropatije bio je 12 tjedana.
English: Table 6: Summary of baseline patient and disease characteristics in the phase 3 HL post-ASCT Study
Croatian: Tablica 6: Sažetak početnih karakteristika bolesnika i bolesti u ispitivanju faze 3 HL-a nakon ASCT-a
English: Cutaneous T-cell lymphoma
Croatian: Kožni limfom T-stanica
English: Bone pain, arthralgia, back pain, myalgia
Croatian: Kostobolja, artralgija, bolovi u leđima, mialgija
English: Pre-specified subgroup analyses of ORR4 per IRF were performed by patients' CTCL subtype, physicians' choice of treatment, baseline ECOG status, age, gender, and geographic region.
Croatian: Unaprijed definirane analize podskupina za objektivnu stopu odgovora koja traje najmanje 4 mjeseca (ORR4) po IRF-u provedene su po bolesnikovoj podvrsti CTCL-a, liječnikovom izboru liječenja, početnom ECOG statusu, dobi, spolu i geografskom području.
English: Disease Characteristics
Croatian: Karakteristike bolesti
English: In the event of either being observed, discard the medicinal product.
Croatian: U slučaju da opazite bilo što od navedenog, bacite lijek.
English: Primary Refractory to frontline therapy Refractory to most recent therapy Relapsed to most recent therapy Baseline B symptoms Stage III at initial diagnosis Stage IV at initial diagnosis a.
Croatian: Primarna refraktorna na prvu liniju liječenja Refraktorna na zadnju terapiju Relaps nakon zadnje terapije Početni B simptomi
English: Stratified Hazard Ratio
Croatian: Stratificirani omjer hazarda
English: In the ITT population, 33% fewer patients treated with ADCETRIS + AVD in the ITT population received subsequent salvage chemotherapy (n = 66) and high-dose chemotherapy and transplant (n = 36) compared with those treated with ABVD (n = 99 and n = 54, respectively).
Croatian: Naknadnu kemoterapiju spasa (n = 66) i kemoterapiju s visokim dozama i transplantaciju (n = 36) je u ITT skupini primilo 33% manje bolesnika koji su koristili ADCETRIS + AVD u usporedbi sa skupinom koja je liječena ABVD-om (n = 99 i n = 54).
English: Table 4: Summary of baseline patient and disease characteristics in the phase 3 previously untreated HL study
Croatian: Tablica 4: Sažeti prikaz početnih karakteristika bolesnika i bolesti u ispitivanju faze 3 u prethodno neliječenih bolesnika
English: Tlf: +47 6676 3030 infonorge@takeda.com
Croatian: Takeda Nycomed AS Tlf: +47 6676 3030 infonorge@takeda.com
English: In combination therapy with AVD, advanced age was a risk factor for febrile neutropenia.When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients regardless of age beginning with the first dose.
Croatian: Kada se ADCETRIS koristi u kombinaciji s AVD-om preporučuje se primjena primarne profilakse sa G-CSF kod svih bolesnika, bez obzira na dob, počevši od prve doze.
English: Pre-specified subgroup analyses of modified PFS per IRF were performed for the ITT population including age, region, cancer stage at baseline, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, Cycle 2 PET assessment, Cycle 2 PET Deauville score, and receipt of alternative first-line medication (AFM).
Croatian: Unaprijed specificirane analize mPFS prema IRF provedene su unutar ITT populacije za podskupine prema starosnoj dobi, lokalizaciji. stadiju bolesti na početku liječenja, ekstranodalnoj zahvaćenosti na početku liječenja, broju IPFP rizičnih čimbenika, B simptomima na početku liječenja, PET ocjeni nakon 2. ciklusa, PET Deauvilleovom skoru nakon 2. ciklusa, te primitku alternativnih terapija iz prve linije (AFM).
English: Table 9: Summary of baseline patient and disease characteristics in the phase 2 relapsed or refractory HL study
Croatian: Tablica 9: Sažeti prikaz karakteristika bolesnika i bolesti na početku ispitivanja faze 2 relapsa ili refraktornog oblika HL
English: = Number of ADCETRIS vials needed
Croatian: Potreban broj bočica lijeka ADCETRIS
English: Musculoskeletal and connective tissue disorders Very common:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često:
English: Immediate and delayed infusion-related reactions (IRR), as well as anaphylactic reactions, have been reported.
Croatian: Zabilježene su rane i kasne reakcije povezane s infuzijom, kao i anafilaktičke reakcije.
English: Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells decreased level of blood platelets decreased level of white blood cells with a fever upper respiratory tract infection decrease in weight infection nausea abdominal pain unusual hair loss or thinning muscle pain joint pain or painful, swollen joints dizziness increased liver enzyme levels decreased appetite not being able to sleep bone pain sore or inflammation in the mouth
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - snižena razina bijelih krvnih stanica - snižena razina trombocita - snižena razina bijelih krvnih stanica s vrućicom - infekcija gornjih dišnih puteva - gubitak težine - infekcija - mučnina - bol u trbuhu - neuobičajeni gubitak ili prorjeđivanje kose - bol u mišićima - bolovi u zglobovima ili bolni, otečeni zglobovi - omaglica - povišene razine jetrenih enzima - smanjen apetit - nesanica - kostobolja - afte ili upale u usnoj šupljivi
English: Typical Cmax and AUC of ADC after a single 1.8 mg/kg in a phase 1 study was approximately 31.98 μg/ mL and 79.41 μg/ mL x day respectively.
Croatian: Cmax ADC-a nakon jedne doze od 1,8 mg/kg u ispitivanju faze 1 obično je iznosio približno 31,98 μg/ml, a AUC 79,41 μg/ml po danu.
English: Patients with hepatic impairment should be closely monitored for adverse events (see section 5.2).
Croatian: Bolesnike s oštećenjem funkcije bubrega mora se pažljivo nadzirati radi nuspojava (vidjeti dio 5.2).
English: Gastrointestinal (GI) complications including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, some with fatal outcomes, have been reported in patients treated with ADCETRIS.
Croatian: U bolesnika liječenih lijekom ADCETRIS zabilježene su gastrointestinalne komplikacije, uključujući intestinalnu opstrukciju, ileus, enterokolitis, neutropenijski kolitis, eroziju, ulkus, perforaciju i krvarenje, neke od njih sa smrtnim ishodom.
English: What Adcetris is and what it is used for What you need to know before you are given Adcetris How Adcetris will be given Possible side effects
Croatian: Što morate znati prije nego počnete primati Adcetris
English: Consider G-CSF or GMCSF in subsequent cycles for patients who develop Grade 3 or Grade 4 neutropenia.
Croatian: Kod bolesnika koji razviju neutropeniju 3. ili 4. stupnja razmotrite upotrebu G-CSF ili GM-CSF u sljedećim ciklusima.
English: 2.88 vials
Croatian: 2,88 bočica
English: No patients aged < 12 years (0 of 11) and 2 patients aged ≥ 12 years (2 of 23) became persistently ADA positive.
Croatian: <12 godina (0 od 11) nije postao trajno pozitivan na protutijela na lijek, dok su trajno pozitivna na protutijela na lijek postala 2 bolesnika u dobi
English: The primary endpoint was objective response rate that lasts at least 4 months (ORR4) (duration from first response to last response ≥ 4 months), as determined by an independent review of the Global Response Score (GRS) consisting of skin evaluations (modified severity weighted assessment tool [mSWAT] as assessed per investigator), nodal and visceral radiographic assessment, and detection of circulating Sézary cells (Olsen 2011).
Croatian: Primarna mjera ishoda bila je objektivna stopa odgovora koja traje najmanje 4 mjeseca (ORR4) (vrijeme od prvog do zadnjeg odgovora ≥ 4 mjeseca), prema nalazima neovisne procjene Rezultata općih odgovora (engl.
English: Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart treatment at a reduced dose of 1.2 mg/kg every 3 weeks
Croatian: Odgodite primjenu doze sve dok se toksičnost ne vrati na stupanj ≤ 1 ili početnu vrijednost, a onda ponovno započnite liječenje smanjenom dozom od 1,2 mg/kg svaka 3 tjedna
English: The efficacy and safety of ADCETRIS as a single agent was evaluated in an open-label, single-arm, multicenter study in 58 patients with relapsed or refractory sALCL.
Croatian: Djelotvornost i sigurnost lijeka ADCETRIS koji se primjenjivao kao monoterapija procijenjene su u otvorenom, multicentričnom ispitivanju s jednom skupinom od 58 bolesnika s relapsom ili refraktornim oblikom sALCL.
English: Такеда България Тел.
Croatian: Takeda France Tel.
English: Each vial contains 50 mg of brentuximab vedotin.
Croatian: Jedna bočica sadrži 50 mg brentuksimab vedotina.
English: Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells upper respiratory tract infection decrease in weight infection nausea abdominal pain itching muscle pain joint pain or painful, swollen joints
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - snižena razina bijelih krvnih stanica - upala gornjih dišnih puteva - gubitak težine - infekcija - mučnina - bol u trbuhu - svrbež - bol u mišićima - bolovi u zglobovima ili bolni, otečeni zglobovi
English: Median Cmax, AUC, and Tmax of MMAE after a single 1.8 mg/kg dose were 3.73 ng/mL, 17.3 ng*day/mL, and 1.92 days, respectively, in patients < 12 years of age and 6.33 ng/mL, 42.3 ng*day/mL, and 1.82 days, respectively, in patients ≥ 12 years of age.
Croatian: Medijan Cmax, AUC i Tmax za MMAE nakon jedne doze od 1,8 mg/kg bili su 3,73 ng/ml, 17,3 ng*dan/ml i 1,92 dana u bolesnika u dobi
English: Adcetris 50 mg powder for concentrate for solution for infusion brentuximab vedotin
Croatian: ADCETRIS 50 mg prašak za koncentrat za otopinu za infuziju brentuksimab vedotin
English: ADCETRIS 50 mg powder for concentrate for solution for infusion brentuximab vedotin
Croatian: Adcetris 50 mg prašak za koncentrat za otopinu za infuziju brentuksimab vedotin
English: The recommended starting dose for the retreatment of patients who have previously responded to treatment with ADCETRIS is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Croatian: Preporučena početna doza za ponovno liječenje bolesnika koji su prethodno postigli odgovor na liječenje lijekom ADCETRIS je 1,8 mg/kg primijenjena kao intravenska infuzija u trajanju od 30 minuta svaka 3 tjedna.
English: Among these 30 patients, the median time to response, defined as the time from first dose to the soonest of PR or CR, was 6 weeks (range, 5 to 39 weeks).
Croatian: Među tih 30 bolesnika, medijan vremena do odgovora, definiran kao vrijeme od prve doze do PR-a ili CR-a, ovisno koji je nastupio prije, bio je
English: For patients who experienced peripheral neuropathy the median time of onset of peripheral neuropathy was 8 weeks.
Croatian: U bolesnika kod kojih se pojavila periferna neuropatija, medijan vremena do pojave periferne neuropatije iznosio je 8 tjedana od početka liječenja.
English: Table 10: Efficacy results in relapsed or refractory Hodgkin lymphoma patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Croatian: Tablica 10: Rezultati djelotvornosti u bolesnika s relapsom ili refraktornim oblikom Hodgkinovog limfoma liječenih dozom od 1,8 mg/kg lijeka ADCETRIS svaka 3 tjedna
English: Patients were treated with 1.8 mg/kg of ADCETRIS or matching placebo intravenously over 30 minutes every 3 weeks for up to 16 cycles.
Croatian: Bolesnici su liječeni s 1,8 mg/kg lijeka ADCETRIS ili odgovarajućeg placeba intravenski tijekom 30 minuta svaka 3 tjedna u do 16 ciklusa.
English: The efficacy and safety of ADCETRIS as a single agent was evaluated in a pivotal open-label, single-arm, multicenter study in 102 patients with relapsed or refractory HL.
Croatian: Djelotvornost i sigurnost lijeka ADCETRIS primijenjenog kao monoterapija procijenjene su u pivotalnom, otvorenom, multicentričnom ispitivanju s jednom skupinom u 102 bolesnika s relapsom ili refraktornim oblikom HL.
English: Study-C25007
Croatian: Ispitivanje C25007
English: 9/L) or Grade 2 (< 1500-1000/mm < 1.5-1.0 x 10
Croatian: ili Stupanj 2 (<1500 - 1000/mm <1,5 - 1,0 x 10 9/l)
English: Adcetris will be given to you together with doxorubicin, vinblastine and dacarbazine which are other chemotherapy medicines used to treat Hodgkin lymphoma.
Croatian: Adcetris ćete primati zajedno s drugim kemoterapijskim lijekovima za liječenje Hodgkinovog limfoma - doksorubicinom, vinblastinom i dakarbazinom
English: total dose divided by reconstituted vial concentration [5 mg/ mL])
Croatian: Ukupni volumen koji treba razrijediti b = ukupna doza podijeljena s koncentracijom rekonstituirane bočice [5 mg/ml])
English: Refer to the summary of product characteristics (SmPC) of chemotherapy agents given in combination with ADCETRIS for patients with previously untreated HL.
Croatian: Pogledajte sažetak opisa svojstava lijeka za kemoterapeutike koji se u bolesnika s prethodno neliječenim HL-om primjenjuju u kombinaciji s lijekom ADCETRIS.
English: Median Cmax, AUC and Tmax of MMAE after a single 1.8 mg/kg of the ADC in a phase 1 study was approximately 4.97 ng/ mL, 37.03 ng/ mL x day and 2.09 days respectively.
Croatian: Medijan Cmax MMAE nakon samo jedne doze od 1,8 mg/kg ADC u fazi 1 ispitivanja bio je približno 4,97 ng/ml, AUC-a 37,03 ng/ml po danu, a Tmax 2,09 dana.
English: 76M (46%)/89F (54%) 97M (59%)/67F (41%)
Croatian: 97M (59%)/67Ž (41%)
English: Progression Free Survival
Croatian: Preživljenje bez progresije bolesti
English: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS.
Croatian: Uz ADCETRIS zabilježeni su Stevens-Johnsonov sindrom (SJS) i toksična epidermalna nekroliza (TEN).
English: Common side effects (may affect up to1 in 10 people) pneumonia sore, creamy-yellow, raised patches in the mouth (thrush) decreased level of blood platelets dizziness blisters which may crust or scab increased level of blood sugar increased liver enzyme levels unusual hair loss or thinning
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - upala pluća - bolne, krem-žute, odignute naslage u ustima (gljivična infekcija kandidom, soor) - snižena razina krvnih pločica - omaglica - mjehurići koji se mogu sušiti i pretvarati u kraste - povišena razina šećera u krvi - povišene vrijednosti jetrenih enzima - neuobičajen gubitak ili stanjivanje kose
English: Takeda Italia S.p.A. Tel: +39 06 502601
Croatian: Tel: +39 06 502601
English: Table 12: Efficacy results in relapsed or refractory sALCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Croatian: Tablica 12: Rezultati djelotvornosti u bolesnika s relapsom ili refraktornim oblikom sALCL liječenih dozom od 1,8 mg/kg lijeka ADCETRIS svaka 3 tjedna
English: (95% CI [0.36, 0.70])b
Croatian: (95% CI [0,36; 0,70])
English: 2.4 vials
Croatian: 2.4 bočica
English: Preparation of Infusion Solution
Croatian: Priprema otopine za infuziju
English: One patient had a baseline ECOG status of 2, which was prohibited by protocol and is captured as Inclusion Criteria Not Met. b. Primary refractory sALCL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Croatian: Jedan je bolesnik imao početni ECOG status od 2, koji je bio zabranjen protokolom pa je prikazan kao Nije zadovoljio kriterije uključenja.
English: Each vial contains 50 mg of brentuximab vedotin
Croatian: Jedna bočica sadrži 50 mg brentuksimab vedotina
English: Patients were treated with ADCETRIS 1.8 mg/kg intravenously over 30 minutes every 3 weeks for up to 16 cycles.
Croatian: Bolesnici su liječeni sa 1,8 mg/kg lijeka ADCETRIS intravenski tijekom 30 minuta svaka 3 tjedna, do 16 ciklusa.
English: Number of Risk Factors ≥ 2
Croatian: Broj čimbenika rizika ≥ 2 Broj čimbenika rizika
English: Patient Characteristics
Croatian: Karakteristike bolesnika
English: Modification of dosing schedule
Croatian: Prilagodba rasporeda doziranja Prilagodba rasporeda doziranja