FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 5 patients who experienced VOD/SOS during treatment with inotuzumab ozogamicin but without an intervening HSCT, 2 patients had also received an HSCT before BESPONSA treatment.
Croatian: Od 5 bolesnika koji su doživjeli VOD/SOS tijekom liječenja inotuzumab ozogamicinom, ali bez HSCT intervencije, 2 bolesnika su prije liječenja lijekom BESPONSA prošli i HSCT.
English: The mean (SD) maximum serum concentration (Cmax) of inotuzumab ozogamicin was 308 ng/mL (362).
Croatian: Srednja vrijednost (SD) maksimalne koncentracije u serumu (Cmax) inotuzumab ozogamicina je iznosila 308 ng/ml (362).
English: The median age was 45 years (range 20-79); 76.4% were Salvage status ≥ 2; 31.9% had received a prior HSCT and 22.2% were Ph+.
Croatian: Medijan dobi je bio 45 godina (raspon 20-79); 76,4% su imali status spašavanja ≥2; 31,9% je prethodno prošlo HSCT i 22,2% njih je imalo Ph+ kromosom.
English: In clinical studies of BESPONSA in patients with relapsed or refractory ALL, 7/236 (3%) patients tested positive for anti-inotuzumab ozogamicin antibodies.
Croatian: U kliničkim ispitivanjima lijeka BESPONSA u bolesnika s recidivirajućom ili refraktornom ALL, 7/236 (3%) bolesnika su imali pozitivne nalaze testa na protutijela protiv inotuzumab ozogamicina.
English: In the Phase 2 portion of the study, patients had to have received at least 2 prior treatment regimens for ALL and patients with Ph+ B-cell ALL had to have failed treatment with at least 1 TKI.
Croatian: U dijelu ispitivanja faze II bolesnici su trebali primiti najmanje 2 prethodna režima liječenja za ALL, a bolesnici s Ph+ B-staničnim ALL-om trebali su imati neuspješno liječenje najmanje jednim TKI-om.
English: ECG and electrolytes should be obtained prior to the start of treatment and periodically monitored during treatment (see sections 4.8 and 5.2).
Croatian: Potrebno je napraviti nalaze EKG-a i elektrolita prije početka liječenja te ih periodički pratiti tijekom liječenja (vidjeti dijelove 4.8 i 5.2).
English: If an infusion related reaction occurs, the infusion should be interrupted and appropriate medical management should be instituted.
Croatian: Ako se pojavi reakcija povezana s infuzijom, potrebno je prekinuti infuziju i započeti s odgovarajućim medicinskim zbrinjavanjem.
English: The mean (SD) simulated total area under the concentration-time curve (AUC) per cycle at steady state was 100 mcgh/mL (32.9).
Croatian: Srednja vrijednost (SD) simulirane ukupne površine pod krivuljom (AUC) koncentracija-vrijeme po ciklusu u stanju dinamičke ravnoteže iznosila je 100 µgh/ml (32,9).
English: In the pivotal clinical study (N=164), VOD/SOS was reported in 23 (14%) patients including 5 (3%) patients during study therapy or in follow-up without an intervening HSCT.
Croatian: U ključnom kliničkom ispitivanju (N=164) VOD/SOS je prijavilo 23 (14%) bolesnika uključujući 5 (3%) bolesnika tijekom primjene ispitivane terapije ili u periodu praćenja bez HSCT intervencije.
English: ≥ 14 days
Croatian: ≥ 14 dana
English: Slight foetal growth retardation in rats also occurred at approximately 0.4 times the human clinical exposure based on AUC (see section 4.6).
Croatian: Neznatno usporavanje fetalnog rasta u štakora se isto tako dogodilo i pri izloženosti koja je bila približno 0,4 puta veća od kliničke izloženosti u ljudi na temelju AUC (vidjeti dio 4.6).
English: In patients in whom the serum bilirubin is ≥ ULN prior to HSCT, HSCT post BESPONSA treatment should only be undertaken after careful consideration of the benefit/risk.
Croatian: U bolesnika u kojih je razina bilirubina u serumu ≥ GGN prije HSCT-a, smije se nastaviti s HSCT-om poslije liječenja lijekom BESPONSA samo nakon pažljivog razmatranja koristi i rizika.
English: The maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) also resulted in foetal growth retardation, including decreased foetal weights and delayed skeletal ossification.
Croatian: Toksična maternalna doza (približno 2,3 puta veća od kliničke izloženosti u ljudi na temelju AUC) je isto tako rezultirala usporavanjem fetalnog rasta, uključujući smanjenu fetalnu težinu i zakašnjelu osifikaciju skeleta.
English: Population pharmacokinetic/pharmacodynamic evaluation suggested a correlation between increasing inotuzumab ozogamicin serum concentrations and prolongation of QTc intervals in ALL and non-Hodgkin's lymphoma (NHL) patients.
Croatian: Populacijska farmakokinetička/farmakodinamička procjena ukazala je na korelaciju između povećanja koncentracije inotuzumab ozogamicina u serumu i produljenja QTc-intervala u bolesnika s ALL-om i non-Hodgkinovim limfomom (NHL).
English: In humans, serum N-acetyl-gamma-calicheamicin dimethylhydrazide levels were typically below the limit of quantitation (50 pg/mL), but sporadic measurable levels of unconjugated calicheamicin up to 276 pg/mL occurred in some patients.
Croatian: U ljudi su razine N-acetil-gama-kalikeamicindimetilhidrazida u serumu obično ispod granice kvantifikacije (50 pg/ml), ali u nekih su se bolesnika povremeno pojavile mjerljive razine nekonjugiranog kalikeamicina do 276 pg/ml.
English: • have elevations in amylase or lipase enzymes that may be a sign of problems with your pancreas or liver and gallbladder or bile ducts.
Croatian: • imate povišene razine enzima amilaze ili lipaze koje mogu biti znak problema s gušteračom ili jetrom i žučnim mjehurom ili žučnim vodovima.
English: If these patients do proceed to HSCT, signs and symptoms of VOD/SOS should be monitored closely (see section 4.2).
Croatian: Ako ovi bolesnici ipak nastave s HSCT-om, treba obratiti posebnu pažnju na znakove i simptome VOD/SOS-a (vidjeti dio 4.2).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: • If the medicine works well, but you are not going to receive a stem cell transplant (see section
Croatian: • Ako lijek dobro djeluje, ali Vi nećete ići na transplantaciju matičnih stanica (vidjeti dio 2),
English: Tumour lysis syndrome (2%) Hyperuricaemia (4%)
Croatian: Sindrom lize tumora (2%) Hiperuricemija (4%)
English: In 234 patients with relapsed or refractory ALL, the clearance of inotuzumab ozogamicin at steady state was 0.0333 L/h, and the terminal elimination half-life (t½) at the end of Cycle 4 was approximately 12.3 days.
Croatian: U 234 bolesnika s recidivirajućom ili refraktornom ALL klirens inotuzumab ozogamicina u stanju dinamičke ravnoteže iznosio je 0,0333 l/h, a terminalni poluvijek eliminacije (t½) na kraju 4. ciklusa bio je oko 12,3 dana.
English: Table 8 shows the storage times and conditions for reconstitution, dilution, and administration of BESPONSA.
Croatian: Tablica 8 prikazuje vremena čuvanja i uvjete za rekonstituciju, razrjeđivanje i primjenu lijeka BESPONSA.
English: BESPONSA should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval (see section 4.5) and in patients with electrolyte disturbances.
Croatian: Lijek BESPONSA treba primjenjivati uz oprez u bolesnika koji imaju povijest ili predispoziciju za produljenje QT-intervala, primaju lijekove za koje je poznato da produljuju QT-interval (vidjeti dio 4.5) te u bolesnika s poremećajima elektrolita.
English: BESPONSA significantly increased the risk of VOD/SOS above that of standard chemotherapy regimens in this patient population.
Croatian: U ovoj populaciji bolesnika BESPONSA značajno povećava rizik od VOD/SOS-a iznad onog standardnih režima kemoterapije.
English: • have a history of, or tendency to have, QT interval prolongation (a change in electrical activity of the heart that can cause serious irregular heart rhythms), are taking medicines that are known to prolong QT interval, and/or have abnormal electrolyte (e.g., calcium, magnesium, potassium) levels.
Croatian: • ste već imali ili ste skloni produljenju QT-intervala (promjena u električnoj aktivnosti srca koja može prouzrokovati ozbiljne nepravilne srčane ritmove), uzimate lijekove za koje je poznato da produljuju QT-interval i/ili imate poremećaj razine elektrolita (npr. kalcija, magnezija, kalija).
English: Administration of inotuzumab ozogamicin to female rats at the maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) prior to mating and during the first week of gestation resulted in embryo-foetal toxicity, including increased resorptions and decreased viable embryos.
Croatian: Primjena inotuzumab ozogamicina u ženki štakora u maternalno toksičnoj dozi (približno 2,3 puta veće od kliničke izloženosti u ljudi na temelju AUC) prije parenja i tijekom prvog tjedna gestacije je rezultirala embrio-fetalnom toksičnošću, uključujući povećane resorpcije i smanjeni broj vijabilnih embrija.
English: • have serious ongoing liver disease, e.g., cirrhosis (a condition in which the liver does not function properly due to long-term damage), nodular regenerative hyperplasia (a condition with signs and symptoms of portal hypertension that can be caused by chronic use of medicines), active hepatitis (a disease characterised by inflammation of the liver).
Croatian: • ako trenutno bolujete od ozbiljne bolesti jetre, npr. ciroze (stanja u kojem jetra ne funkcionira kako bi trebala zbog dugotrajnog oštećenja), nodularne regenerativne hiperplazije (stanja sa znakovima i simptomima portalne hipertenzije koje može biti izazvano stalnim uzimanjem lijekova), aktivnog hepatitisa (bolesti koju karakterizira upala jetre).
English: Interrupt treatment until recovery to Grade 1 or pre-treatment grade levels prior to each dose.
Croatian: Prije svake doze, prekinuti liječenje do povratka na 1. stupanj ili razinu stupnja prije liječenja.
English: No Grade ≥ 3 QT interval prolongation or events of Torsades de Pointes were reported.
Croatian: Nisu zabilježena produljenja QT-intervala ≥ 3. stupnja ili slučajevi Torsades de Pointes.
English: Among all 326 randomised patients, the survival probability at 24 months was 22.8% in the BESPONSA arm and 10% in the Investigator's choice of chemotherapy arm.
Croatian: Među svih 326 randomiziranih bolesnika je vjerojatnost preživljenja nakon 24 mjeseca bila 22,8% u skupini s lijekom BESPONSA te 10% u skupini s kemoterapijom po izboru ispitivača.
English: TLS occurred shortly after the end of the inotuzumab ozogamicin infusion and resolved with medical management.
Croatian: TLS se pojavio ubrzo nakon završetka infuzije inotuzumab ozogamicina te je bio riješen medicinskim zbrinjavanjem.
English: No adjustment to the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤ 1.5 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (see section 5.2).
Croatian: Nije potrebna prilagodba početne doze u bolesnika s oštećenjem jetre koje je definirano ukupnim bilirubinom ≤ 1,5 × GGN (gornja granica normale) i aspartat aminotransferazom (AST)/ alanin aminotransferazom (ALT) ≤ 2,5 × GGN (vidjeti dio 5.2).
English: The safety and efficacy of BESPONSA have not been studied in patients with end-stage renal disease.
Croatian: Sigurnost i djelotvornost lijeka BESPONSA nisu ispitivane u bolesnika sa završnim stadijem bubrežne bolesti.
English: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u zdravstvenom kartonu bolesnika.
English: ≥ 7 days
Croatian: ≥ 7 dana
English: In toxicity studies, rats developed oval cell hyperplasia, altered hepatocellular foci, and hepatocellular adenomas in the liver at approximately 0.3 times the human clinical exposure based on AUC.
Croatian: U ispitivanjima toksičnosti, štakori su razvili hiperplaziju ovalnih stanica, izmijenjena hepatocelularna žarišta i hepatocelularne adenome u jetri pri izloženosti dozama koje su približno 0,3 puta veće od kliničke izloženosti u ljudi na temelju AUC.
English: Febrile neutropenia (26%) Neutropenia (49%) Thrombocytopenia (51%) Leukopenia (35%) Lymphopenia (18%) Anaemia (36%)
Croatian: Febrilna neutropenija (26%) Neutropenija (49%) Trombocitopenija (51%) Leukopenija (35%) Limfopenija (18%) Anemija (36%)
English: For instructions on reconstitution and dilution of BESPONSA before administration, see section 6.6.
Croatian: Za upute o rekonstituciji i razrjeđivanju lijeka BESPONSA prije primjene vidjeti dio 6.6.
English: Inotuzumab ozogamicin pharmacokinetics were well characterised by a 2-compartment model with linear and time-dependent clearance components.
Croatian: Farmakokinetika inotuzumab ozogamicina je bila dobro predočena modelom s 2 odjeljka s linearnim i komponentama klirensa koje su ovisne o vremenu.
English: Sucrose Polysorbate 80 Sodium chloride Tromethamine
Croatian: saharoza polisorbat 80 natrijev klorid trometamin
English: Consider permanent discontinuation of BESPONSA.
Croatian: Razmotriti trajni prekid uzimanja lijeka BESPONSA.
English: Abbreviations: ALL=acute lymphoblastic leukaemia; ECG=electrocardiogram; GGT=gamma-glutamyltransferase; HSCT=haematopoietic stem cell transplant.
Croatian: Skraćenice: ALL=akutna limfoblastična leukemija; EKG=elektrokardiogram; GGT=gama-glutamil transferaza; HSCT=transplantacija hematopoetskih matičnih stanica.
English: • have a history of liver problems or liver diseases or if you have signs and symptoms of a serious condition called hepatic venoocclusive disease, a condition in which the blood vessels in the liver become damaged and blocked by blood clots.
Croatian: • imate povijest problema s jetrom ili bolesti jetre ili ako imate znakove i simptome teškog stanja koje se zove venska okluzivna bolest jetre, stanja u kojem krvni ugrušci oštete i začepe krvne žile u jetri.
English: Myelosuppression/cytopenias
Croatian: Mijelosupresija/citopenije
English: This included 70 and 18 patients in the BESPONSA and Investigator's choice of chemotherapy arm, respectively, who proceeded directly to HSCT.
Croatian: To je uključivalo 70 bolesnika na lijeku BESPONSA i 18 bolesnika na kemoterapiji po izboru ispitivača koji su odmah upućeni na HSCT.
English: The storage times and conditions for reconstitution, dilution, and administration of BESPONSA are shown below.
Croatian: Vremena i uvjeti čuvanja za rekonstituciju, razrjeđivanje i primjenu lijeka BESPONSA su navedeni ispod.
English: Withdraw this amount from the vial(s) using a syringe.
Croatian: Ovu količinu treba izvući iz bočice (bočica) pomoću štrcaljke.
English: The median age was 47 years (range: 18-79 years), 206 (63%) patients had a duration of first remission < 12 months, and 55 (17%) patients had undergone an HSCT prior to receiving BESPONSA or Investigator's choice of chemotherapy.
Croatian: Medijan dobi je bio 47 godina (raspon: 18-79 godina), 206 (63%) bolesnika je bilo s vremenom < 12 mjeseci do prve remisije i 55 (17%) bolesnika je prošlo HSCT prije primitka lijeka BESPONSA ili kemoterapije po izboru ispitivača.
English: In the Phase 2 portion of the study, 8/35 (22.9%) patients had a follow-up HSCT.
Croatian: U ispitivanju faze 2 8/35 (22,9%) bolesnika naknadno je prošlo HSCT.
English: However, if the diluted solution is filtered, polyethersulphone (PES)-, polyvinylidene fluoride (PVDF)-, or hydrophilic polysulphone (HPS)-based filters are recommended.
Croatian: Međutim, ako se razrijeđena otopina filtrira, preporučuju se filteri bazirani na polietersulfonu (PES), poliviniliden fluoridu (PVDF) ili hidrofilnom polisulfonu (HPS).
English: If particles or discolouration are observed, do not use.
Croatian: Ako primijetite čestice ili promjenu boje, nemojte ga koristiti.
English: Patients with a history of liver disease should be carefully evaluated (e.g., ultrasound scan, viral hepatitis testing) prior to treatment with BESPONSA to exclude serious ongoing hepatic disease (see section 4.3).
Croatian: Potrebno je pažljivo procijeniti bolesnike s poviješću bolesti jetre (npr. ultrazvučna pretraga, testiranje na virusni hepatitis) prije liječenja lijekom BESPONSA kako bi se isključila mogućnost trenutne ozbiljne bolesti jetre (vidjeti dio 4.3).
English: Dosing regimen for Cycle 1 and subsequent cycles depending on response to treatment Day 1
Croatian: Režim doziranja za 1. ciklus i sljedeće cikluse, ovisno o odgovoru na liječenje 1. dan
English: • The active substance is inotuzumab ozogamicin.
Croatian: • Djelatna tvar je inotuzumab ozogamicin.
English: The primary analysis of CR/CRi and MRD negativity was conducted in the initial 218 randomised patients and the analysis of OS, PFS, DoR, and HSCT rate was conducted in all 326 randomised patients.
Croatian: Primarna analiza CR/CRi-a i negativnog statusa MRD-a provedena je među prvih 218 randomiziranih bolesnika, a analiza OS-a, PFS-a, DoR-a i stope HSCT-a među svih 326 randomiziranih bolesnika.
English: The benefit/risk should be carefully considered before administering BESPONSA to patients in whom the future use of HSCT conditioning regimens containing 2 alkylating agents is likely unavoidable.
Croatian: Potrebno je pažljivo razmotriti omjer koristi i rizika prije primjene lijeka BESPONSA u bolesnika u kojih se primjena režima kondicioniranja prije HSCT-a koji uključuju 2 alkilirajuća agensa u budućnosti vjerojatno neće moći izbjeći.
English: f In the standard definition of PFS, defined as the time from date of randomisation to earliest date of the following events: death, progressive disease (including objective progression and relapse from CR/CRi), the HR was 0.568 (2-sided p-value=0.0002) and median PFS was 5.6 months and 3.7 months in the BESPONSA and Investigator's choice of chemotherapy arm, respectively.
Croatian: U standardnoj definiciji PFS, definiranoj kao vrijeme od datuma randomizacije do najranijeg datuma sljedećih događaja: smrt, progresija bolesti (uključujući objektivnu progresiju i recidiv s CR/CRi), omjer rizika je bio 0,568 (p-vrijednost dvostranog testa=0,0002) i medijan PFS od 5,6 mjeseci uz lijek BESPONSA i 3,7 mjeseci u skupini na kemoterapiji po izboru ispitivača.
English: Once attached to the lymphoblastic leukaemia cells, the medicine delivers a substance into the cells that interferes with the cells' DNA and eventually kills them.
Croatian: Kada se veže na stanice limfoblastične leukemije, lijek u stanice unosi tvar koja ometa DNK stanica te ih na kraju ubija.
English: CD22 expression was assessed using flow cytometry based on bone marrow aspirate.
Croatian: Ekspresija CD22 procjenjivala se protočnom citometrijom na temelju aspirata koštane srži.
English: Medicines given before treatment with BESPONSA
Croatian: Lijekovi koji se daju prije liječenja lijekom BESPONSA
English: For patient-reported outcomes, most functioning and symptom scores were in favour of BESPONSA compared to Investigator's choice of chemotherapy.
Croatian: Kada je riječ o rezultatima koje su prijavili bolesnici, bodovanje funkcioniranja i simptoma je većinom išlo u korist lijeka BESPONSA u usporedbi s ispitivačevim odabirom kemoterapije.
English: • Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
Croatian: • Smanjen broj bijelih krvnih stanica, što može rezultirati općom slabošću i sklonošću dobivanju infekcija
English: Do not use BESPONSA if you:
Croatian: Nemojte primjenjivati lijek BESPONSA:
English: Pancytopeniab (2%)
Croatian: Pancitopenija b (2%)
English: In all patients, liver tests should be monitored, including, ALT, AST, total bilirubin, and alkaline phosphatase, prior to and following each dose of BESPONSA.
Croatian: Potrebno je pratiti jetrene probe, uključujući ALT, AST, ukupnu razinu bilirubina i alkalnu fosfatazu u svih bolesnika prije i nakon svake doze lijeka BESPONSA.
English: Among patients who proceeded to HSCT after BESPONSA treatment, VOD/SOS was reported in 5/11 (46%) patients who received an HSCT both prior to and after BESPONSA treatment and 13/68 (19%) patients who only received an HSCT after BESPONSA treatment.
Croatian: Među bolesnicima u kojih je HSCT napravljen nakon liječenja lijekom BESPONSA, VOD/SOS je bio zabilježen u 5/11 (46%) bolesnika koji su primili HSCT prije i poslije liječenja lijekom BESPONSA i 13/68 (19%) bolesnika koji su primili HSCT samo nakon liječenja lijekom BESPONSA.
English: This medicine should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Ovaj lijek treba vizualno pregledati na prisutnost čestica i promjenu boje prije primjene.
English: In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide was primarily metabolised via nonenzymatic reduction.
Croatian: In vitro je N-acetil-gama-kalikeamicindimetilhidrazid prvenstveno metaboliziran putem neenzimske redukcije.
English: An increase in QTcF interval of > 450 msec was observed in 26/162 (16%) patients.
Croatian: Produljenje QTcF intervala na > 450 ms opaženo je u 26/162 (16%) bolesnika.
English: In the pivotal study (N=164), infections, including serious infections, some of which were life-threatening or fatal, were reported in 79 (48%) patients.
Croatian: U ključnom kliničkom ispitivanju (N=164) infekcije, uključujući ozbiljne infekcije, od kojih neke opasne po život ili fatalne, su bile zabilježene u 79 (48%) bolesnika.
English: In the pivotal study (N=164), infusion related reactions were reported in 17 (10%) patients.
Croatian: U ključnom kliničkom ispitivanju (N=164) reakcije povezane s infuzijom su zabilježene u 17 (10%) bolesnika.
English: 2), you may receive up to a maximum of 6 cycles of treatment.
Croatian: možete primiti do maksimalno 6 ciklusa liječenja.
English: • Reduced number of lymphocytes (a type of white blood cells) which may result in a tendency to develop infections
Croatian: • Smanjen broj limfocita (vrste bijelih krvnih stanica), što može rezultirati sklonošću dobivanju infekcija
English: • A doctor or nurse will give you BESPONSA through a drip in your vein (intravenous infusion) which will run for 1 hour.
Croatian: • Liječnik ili medicinska sestra će Vam davati lijek BESPONSA putem infuzije u venu
English: How BESPONSA is given
Croatian: Kako se BESPONSA daje
English: 2-sided p-value < 0.0001 BESPONSA (N=164)
Croatian: p-vrijednost dvostranog testa < 0,0001 BESPONSA (N=164)
English: In patients with relapsed or refractory ALL treated with inotuzumab ozogamicin at the recommended starting dose of 1.8 mg/m2/cycle (see section 4.2), steady-state exposure was achieved by Cycle 4.
Croatian: U bolesnika s recidivirajućom ili refraktornom ALL liječenih s inotuzumab ozogamicinom u preporučenoj početnoj dozi od 1,8 mg/m2/ciklus (vidjeti dio 4.2), izloženost u stanju dinamičke ravnoteže bila je postignuta do 4. ciklusa.
English: Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment (see Summary of Product Characteristics section 4.2).
Croatian: U svakog bolesnika u kojeg unutar 3 ciklusa nije postignut CR/CRi treba prekinuti terapiju (vidjeti sažetak opisa svojstava lijeka, dio 4.2).
English: Preferred terms were retrieved by applying the Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
Croatian: Medical Dictionary for Regulatory Activities, MedDRA), verzija 19.1.
English: There was a trend in favour of BESPONSA for estimated mean postbaseline scores from the EuroQoL 5 Dimension (EQ-5D) questionnaire, (BESPONSA and Investigator's choice of chemotherapy, respectively) for the EQ-5D index (0.80 versus 0.76, minimally important difference for cancer = 0.06).
Croatian: Trend u prilog lijeku BESPONSA zabilježen je u procijenjenim prosječnim rezultatima nakon početne vrijednosti izmjerene upitnikom EuroQoL 5 Dimension (EQ-5D) (BESPONSA, odnosno ispitivačev odabir kemoterapije) za EQ-5D indeks (0,80 naspram 0,76; najmanja značajna razlika za rak = 0,06).
English: Dosing regimen for Cycle 1 and subsequent cycles depending on response to treatment
Croatian: Režim doziranja za 1. ciklus i sljedeće cikluse, ovisno o odgovoru na liječenje
English: Venoocclusive liver disease (sinusoidal obstruction syndrome) (3% [pre-HSCT]d)
Croatian: Venookluzivna bolest jetre (sindrom sinusoidalne opstrukcije) (3% [prije HSCT-a]