FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who develop signs and symptoms suggestive of pancreatitis should be evaluated and monitored.
Croatian: Bolesnike u kojih se pojave znakovi i simptomi koji ukazuju na pankreatitis treba ocijeniti i pratiti.
English: For recommendations in case of suspected differentiation syndrome see sections 4.2 and 4.4.
Croatian: Za preporuke u slučaju sumnje na sindrom diferencijacije vidjeti dijelove 4.2 i 4.4.
English: This medicinal product does not require any special temperature storage conditions.
Croatian: Lijek ne zahtijeva čuvanje na posebnoj temperaturi.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE54
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori proteinskih kinaza, ATK oznaka: L01XE54
English: QTc interval increased by >30 msec on ECG on day 8 of cycle 1
Croatian: Produljenje QTc intervala za > 30 ms na EKG-u 8. dana 1. ciklusa
English: Patients had the following confirmed mutations: FLT3-ITD alone (88.4%), FLT3-TKD alone (8.4%) or both FLT3-ITD and FLT3-TKD (1.9%).
Croatian: Bolesnici su imali sljedeće potvrđene mutacije: samo FLT3-ITD (88,4%), samo FLT3-TKD (8,4%) ili i FLT3-ITD i FLT3-TKD (1,9%).
English: Your doctor will also regularly check your heart function before and during treatment.
Croatian: Uz to će Vam redovito provjeravati rad srca prije i tijekom liječenja.
English: What Xospata is and what it is used for What you need to know before you take Xospata How to take Xospata
Croatian: Što je Xospata i za što se koristi Što morate znati prije nego počnete uzimati lijek Xospata
English: It is not known if Xospata passes into your breast milk and could harm your baby.
Croatian: Nije poznato izlučuje li se Xospata u majčino mlijeko i može li naškoditi Vašem djetetu.
English: Xospata belongs to a class of cancer medicines called protein kinase inihibitors.
Croatian: Xospata pripada skupini lijekova za liječenje raka koji se zovu inhibitori proteinskih kinaza.
English: Continue treatment at the dose prescribed by your doctor.
Croatian: Nastavite liječenje dozom koju Vam je propisao liječnik.
English: These data indicate gilteritinib distributes extensively outside of plasma, which may indicate extensive tissue distribution.
Croatian: Ti podaci ukazuju na to da se gilteritinib opsežno distribuira izvan plazme, što bi moglo upućivati na opsežnu distribuciju u tkiva.
English: QT prolongation can be observed in the first two months of treatment with gilteritinib.
Croatian: Produljenje QT intervala može se primijetiti tijekom prva dva mjeseca liječenja gilteritinibom.
English: Of the patients who were pre-selected to receive salvage chemotherapy, 60.5% were randomised to high intensity and 39.5% to low intensity.
Croatian: Među bolesnicima koji su unaprijed bili odabrani za primanje spasonosne kemoterapije, njih 60,5% bilo je randomizirano za terapiju visokog intenziteta, a njih 39,5% za terapiju niskog intenziteta.
English: In the event of an overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic and supportive treatment initiated, taking into consideration the long half-life estimated at 113 hours.
Croatian: U slučaju predoziranja bolesnike se mora pažljivo nadzirati zbog moguće pojave znakova ili simptoma nuspojava te treba uvesti odgovarajuće simptomatsko i potporno liječenje, uzimajući u obzir dugi poluvijek lijeka, za koji se procjenjuje da iznosi 113 sati.
English: The primary metabolites in humans include M17 (formed via N-dealkylation and oxidation), M16 and M10 (both formed via N-dealkylation) and were observed in animals.
Croatian: Primarni metaboliti u ljudi uključuju M17 (nastaje N-dealkilacijom i oksidacijom), M16 i M10 (oba nastaju N-dealkilacijom), a ti su metaboliti opaženi i u životinja.
English: The tablets are provided in blisters and are available in packs containing 84 film-coated tablets (4-blisters of 21 film-coated tablets).
Croatian: Tablete dolaze u blisterima i dostupne su u pakiranjima koja sadrže 84 filmom obložene tablete (4 blistera s 21 filmom obloženom tabletom).
English: Twelve percent of patients received previous treatment with another FLT3 inhibitor.
Croatian: Dvanaest posto (12%) bolesnika prethodno se liječilo nekim drugim inhibitorom FLT3.
English: Response may be delayed; therefore, continuation of treatment at the prescribed dose for up to 6 months should be considered to allow time for a clinical response.
Croatian: Budući da odgovor može biti odgođen, treba razmotriti nastavak liječenja propisanom dozom tijekom do 6 mjeseci kako bi se osiguralo dovoljno vremena za postizanje kliničkog odgovora.
English: Other medicines and Xospata
Croatian: Drugi lijekovi i Xospata
English: In the juvenile toxicity study in rats, the minimum lethal dose level (2.5 mg/kg/day) was much lower than that of adult rats (20 mg/kg/day).
Croatian: U ispitivanju toksičnosti na juvenilnim štakorima minimalna letalna doza (2,5 mg/kg na dan) bila je mnogo manja od one u odraslih štakora (20 mg/kg na dan).
English: If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Croatian: Ako koristite hormonski kontraceptiv, morate uz njega koristiti i mehaničku metodu kontracepcije, kao što su prezervativ ili dijafragma.
English: The safety of Xospata was evaluated in 319 patients with relapsed or refractory AML who have received at least one dose of 120 mg gilteritinib.
Croatian: Sigurnost lijeka Xospata ocjenjivala se u 319 bolesnika s relapsirajućim ili refraktornim AML-om koji su primili najmanje jednu dozu od 120 mg gilteritiniba.
English: Your doctor will carry out regular blood tests before and during treatment with Xospata.
Croatian: Vaš će liječnik redovito provoditi krvne pretrage prije i tijekom liječenja lijekom Xospata.
English: In vivo plasma protein binding in humans is approximately 90% and gilteritinib is primarily bound to albumin.
Croatian: Vezivanje za proteine u plazmi ljudi in vivo iznosi približno 90%, pri čemu se gilteritinib prvenstveno vezuje za albumin.
English: Gilteritinib has been associated with differentiation syndrome (see section 4.8).
Croatian: Gilteritinib je povezan sa sindromom diferencijacije (vidjeti dio 4.8).
English: These changes were observed at plasma exposure levels similar to or less than clinical exposure levels.
Croatian: Te su promjene opažene pri razinama izloženosti u plazmi koje su bile slične kliničkim razinama izloženosti ili niže od njih.
English: Covariate analysis indicated that age (20 years to 90 years), and body weight (36 kg to 157 kg) were statistically significant; however predicted change in gilteritinib exposure was less than 2-fold.
Croatian: Analiza kovarijata ukazala je na to da su dob (20 - 90 godina) i tjelesna težina (36 - 157 kg) bili statistički značajni parametri; međutim, predviđena promjena u izloženosti gilteritinibu bila je manje nego dvostruka.
English: - Continue taking Xospata for as long as your doctor tells you.
Croatian: - Nastavite uzimati lijek Xospata onoliko dugo koliko Vam kaže liječnik.
English: If PRES is suspected, it should be confirmed by brain imaging, preferably magnetic resonance imaging (MRI).
Croatian: Ako se sumnja na PRES, treba ga potvrditi oslikavanjem mozga, po mogućnosti magnetskom rezonancijom (MR).
English: Based on in vitro data, gilteritinib is primarily metabolised via CYP3A4.
Croatian: Prema podacima in vitro, gilteritinib se prvenstveno metabolizira putem CYP3A4.
English: Differentiation syndrome occurred as early as two days and up to 75 days after Xospata initiation and has been observed with or without concomitant leukocytosis.
Croatian: Sindrom diferencijacije javljao se u razdoblju od samo 2 dana pa sve do 75 dana nakon uvođenja lijeka Xospata, a opažen je uz popratnu leukocitozu ili bez nje.
English: The MAH shall ensure that in each Member State where Xospata is marketed, haematologists who are expected to prescribe Xospata, and patients who are expected to use Xospata are provided with the following educational materials:
Croatian: Nositelj odobrenja osigurat će da u svakoj državi članici gdje je Xospata stavljena u promet hematolozi za koje se očekuje da će propisivati lijek Xospata i bolesnici za koje se očekuje da će ga uzimati dobiju sljedeće edukacijske materijale:
English: The recommended dose is 120 mg (three tablets) once a day.
Croatian: Preporučena doza je 120 mg (tri tablete) jedanput na dan.
English: Gilteritinib as an inhibitor or inducer
Croatian: Gilteritinib kao inhibitor ili induktor
English: Of the 11 patients who experienced differentiation syndrome, 9 (82%) recovered after treatment or after dose interruption of Xospata.
Croatian: Od 11 bolesnika koji su imali sindrom diferencijacije, njih 9 (82%) oporavilo se nakon liječenja ili privremenog prekida primjene lijeka Xospata.
English: Talk to your doctor, pharmacist or nurse immediately if you have any of the following symptoms:
Croatian: Odmah se obratite svom liječniku, ljekarniku ili medicinskoj sestri ako imate bilo koji od sljedećih simptoma:
English: • Swelling of your arms or legs
Croatian: • oticanje ruku ili nogu
English: In AML, patients develop large numbers of abnormal white blood cells.
Croatian: Kod bolesnika s AML-om nastaje velik broj abnormalnih bijelih krvnih stanica.
English: • Resume treatment with gilteritinib at a reduced dose (80 mg or 120 mgb).
Croatian: • Nastaviti liječenje gilteritinibom u smanjenoj dozi (80 mg ili 120 mg b).
English: Hypokalaemia or hypomagnesaemia may increase the QT prolongation risk.
Croatian: Hipokalijemija ili hipomagnezijemija mogu povećati rizik od produljenja QT intervala.
English: Gilteritinib blocks the action of certain enzymes (kinases) needed for the abnormal cells to multiply and grow, thus preventing the growth of the cancer.
Croatian: Gilteritinib blokira djelovanje određenih enzima (kinaza) koji su potrebni za umnožavanje i rast tih abnormalnih stanica te tako sprječava rast raka.
English: Median tmax was delayed 2 hours when gilteritinib was administered with a high-fat meal.
Croatian: Medijan tmax produljio se za 2 sata kada se gilteritinib primjenjivao uz obrok s visokim udjelom masnoća.
English: Please contact the patient's Haematologist/Oncologist for more information and consult the Product Information for gilteritinib available at https://www.ema.europa.eu/.
Croatian: Molimo da se obratite bolesnikovu hematologu/onkologu za više informacija i pročitate informacije o lijeku za gilteritinib, koje su dostupne na adresi https://www.ema.europa.eu/.
English: If you normally take any of these medicines, your doctor might change it and prescribe a different medicine for you during your treatment with Xospata.
Croatian: Ako inače uzimate bilo koji od tih lijekova, liječnik će ga možda promijeniti i propisati Vam neki drugi lijek dok se liječite lijekom Xospata.
English: No dose adjustment is required in patients ≥65 years of age (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika u dobi od ≥ 65 godina (vidjeti dio 5.2).
English: Treatment should continue until the patient is no longer clinically benefiting from Xospata or until unacceptable toxicity occurs.
Croatian: Liječenje treba nastaviti sve dok bolesnik ne prestane ostvarivati kliničku korist od lijeka Xospata ili do pojave neprihvatljive toksičnosti.
English: Serum creatinine, a marker of renal function, was identified as a statistically significant covariate.
Croatian: Serumski kreatinin, koji je biljeg bubrežne funkcije, pokazao se statistički značajnom kovarijatom.
English: Xospata is not recommended for use in patients with severe (Child-Pugh Class C) hepatic impairment, as safety and efficacy have not been evaluated in this population (see section 5.2).
Croatian: Ne preporučuje se primjena lijeka Xospata u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) jer se sigurnost i djelotvornost nisu ispitivale u toj populaciji (vidjeti dio 5.2).
English: If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, Xospata should be interrupted until signs and symptoms are no longer severe (see sections 4.2 and 4.8).
Croatian: Ako teški znakovi i/ili simptomi potraju dulje od 48 sati nakon uvođenja kortikosteroida, primjenu lijeka Xospata treba prekinuti sve dok znakovi i simptomi više ne budu teški (vidjeti dijelove 4.2 i 4.8).
English: Gilteritinib fumarate is a FLT3 and AXL inhibitor.
Croatian: Gilteritinibfumarat je inhibitor FLT3 i AXL-a.
English: Pregnant women should be informed of the potential risk to a foetus (see sections 4.6 and 5.3).
Croatian: Trudnice treba upozoriti na mogući rizik za plod (vidjeti dijelove 4.6 i 5.3).
English: Therefore, concomitant use of gilteritinib with strong CYP3A4/P-gp inducers should be avoided (see section 4.5).
Croatian: Stoga istodobnu primjenu gilteritiniba sa snažnim induktorima CYP3A4/P-gp-a treba izbjegavati (vidjeti dio 4.5).
English: Additional monitoring during treatment with Xospata
Croatian: Dodatno praćenje tijekom liječenja lijekom Xospata
English: Symptoms have resolved after discontinuation of treatment (see sections 4.2 and 4.4).
Croatian: Simptomi su se povukli nakon obustave liječenja (vidjeti dijelove 4.2 i 4.4).
English: Xospata should be administered at about the same time each day.
Croatian: Lijek Xospata treba uzimati svaki dan u približno isto vrijeme.
English: These may be signs of a condition called differentiation syndrome (may affect up to 1 in 10 people).
Croatian: To mogu biti znakovi stanja koje se zove sindrom diferencijacije (može se javiti u do 1 na 10 osoba).
English: Relapsed or refractory AML
Croatian: Relapsirajući ili refraktorni AML
English: Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated in a timely manner.
Croatian: Sindrom diferencijacije je stanje koje zahvaća krvne stanice, a može biti opasno po život ili dovesti do smrti ako se pravovremeno ne liječi.
English: Gilteritinib did not induce gene mutation or chromosomal aberrations in vitro.
Croatian: Gilteritinib nije inducirao mutaciju gena ni kromosomske aberacije in vitro.
English: The primary efficacy endpoint for the final analysis was OS in the intent-to-treat (ITT) population, measured from the date of randomisation until death by any cause (number of events analysed was 261).
Croatian: Primarna mjera ishoda za djelotvornost u završnoj analizi bilo je ukupno preživljenje (engl. overall survival, OS) u populaciji predviđenoj za liječenje (engl. intent-to-treat, ITT), mjereno od datuma randomizacije do smrti zbog bilo kojeg uzroka (broj analiziranih događaja: 261).
English: LoDAC and azacitidine were given in continuous 4-week cycles until unacceptable toxicity or lack of clinical benefit.
Croatian: LoDAC i azacitidin davali su se u neprekidnim 4-tjednim ciklusima do pojave neprihvatljive toksičnosti ili izostanka kliničke koristi.
English: Gilteritinib inhibits FLT3 receptor signalling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and it induced apoptosis in leukemic cells expressing FLT3-ITD.
Croatian: Gilteritinib inhibira signalizaciju putem receptora FLT3 i njegovu proliferaciju u stanicama koje egzogeno eksprimiraju FLT3, uključujući FLT3-ITD, FLT3-D835Y i FLT3-ITD-D835Y, a inducirao je i apoptozu u leukemijskim stanicama koje eksprimiraju FLT3-ITD.
English: If Xospata is re-introduced at a reduced dose, ECG should be performed after 15 days of dosing, and prior to the start of the next three subsequent months of treatment.
Croatian: Ako se Xospata ponovno uvede u smanjenoj dozi, EKG treba učiniti nakon 15 dana primjene i prije početka sljedeća tri uzastopna mjeseca liječenja.
English: • Interrupt treatment with gilteritinib one week prior to administration of the conditioning regimen for HSCT.
Croatian: • Privremeno prekinuti liječenje gilteritinibom tjedan dana prije primjene protokola za kondicioniranje koji prethodi HSCT-u
English: • Interrupt gilteritinib if severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids.
Croatian: • Privremeno prekinuti primjenu gilteritiniba ako teški znakovi i/ili simptomi potraju dulje od 48 sati nakon uvođenja kortikosteroida.
English: Physician educational material:
Croatian: Edukacijski materijal za liječnike:
English: Co-administration of CYP3A/P-gp inducers may lead to decreased gilteritinib exposure and consequently a risk for lack of efficacy.
Croatian: Istodobna primjena induktora CYP3A/P-gp-a može dovesti do smanjenja izloženosti gilteritinibu i posljedičnog rizika od nedostatne djelotvornosti.
English: Other clinically significant serious adverse reactions included differentiation syndrome (2.2%), electrocardiogram QT prolonged (0.9%) and posterior reversible encephalopathy syndrome (0.6%).
Croatian: Druge klinički značajne ozbiljne nuspojave uključivale su sindrom diferencijacije (2,2%), produljenje QT intervala na elektrokardiogramu (0,9%) i sindrom posteriorne reverzibilne encefalopatije (0,6%).
English: Gilteritinib can cause foetal harm when administered to pregnant women.
Croatian: Gilteritinib može uzrokovati oštećenje ploda kada se primjenjuje u trudnica.
English: Xospata may cause a heart problem called QT prolongation (may affect up to 1 in 10 people).
Croatian: Xospata može uzrokovati srčanu tegobu koja se zove produljenje QT intervala (može se javiti u do 1 na 10 osoba).
English: In the absence of a response (patient did not achieve a CRc) after 4 weeks of treatment, the dose can be increased to 200 mg (five 40 mg tablets) once daily, if tolerated or clinically warranted.
Croatian: U slučaju izostanka odgovora (bolesnik nije postigao objedinjenu potpunu remisiju [engl. composite complete remission, CRc]) nakon 4 tjedna liječenja, doza se može povećati na 200 mg (pet tableta od 40 mg) jedanput na dan ako je bolesnik podnosi ili je to klinički potrebno.
English: Juvenile animal toxicity study
Croatian: Ispitivanja toksičnosti na juvenilnim životinjama
English: Gilteritinib was given orally at a starting dose of 120 mg daily until unacceptable toxicity or lack of clinical benefit.
Croatian: Gilteritinib se primjenjivao peroralno u početnoj dozi od 120 mg na dan do pojave neprihvatljive toksičnosti ili izostanka kliničke koristi.
English: Dose reductions were allowed, to manage adverse reactions, and dose increases were allowed, for those patients who did not respond at the starting dose of 120 mg.
Croatian: Bilo je dopušteno smanjiti dozu radi zbrinjavanja nuspojava ili je povećati u bolesnika koji nisu odgovorili na početnu dozu od 120 mg.
English: - if you have severe pain in the upper abdomen and back, nausea and vomiting.
Croatian: - ako osjećate jaku bol u gornjem dijelu trbuha i leđima, imate mučninu te povraćate.
English: The estimated apparent clearance (CL/F) based on the population PK model is 14.85 L/h.
Croatian: Procijenjeni prividni klirens (CL/F) prema populacijskom farmakokinetičkom modelu iznosi 14,85 l/h.
English: The patient information pack:
Croatian: Paket s informacijama za bolesnike:
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza ‘Rok valjanosti' ili ‘EXP'.
English: Patients included were relapsed or refractory after first line AML therapy and were stratified by response to prior AML treatment and preselected chemotherapy i.e. high or low intensity.
Croatian: Uključeni bolesnici imali su relapsirajuću ili refraktornu bolest nakon prve linije liječenja za AML te su bili stratificirani prema odgovoru na prethodno liječenje za AML i unaprijed odabranoj kemoterapiji, tj. terapiji visokog ili niskog intenziteta.
English: Gilteritinib has minor influence on the ability to drive and use machines.
Croatian: Gilteritinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: If you forget to take Xospata at the usual time, take your usual dose as soon as you remember on the same day and take your next dose at the usual time on the following day.
Croatian: Ako ste zaboravili uzeti lijek Xospata u uobičajeno vrijeme, uzmite dozu koju i inače uzimate istoga dana čim se sjetite, a sljedeću dozu uzmite sutradan u uobičajeno vrijeme.
English: • Trouble Breathing
Croatian: • otežano disanje
English: - Do not break or crush the tablets.
Croatian: - Nemojte lomiti niti drobiti tablete.
English: Treatment with Xospata should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
Croatian: Liječenje lijekom Xospata treba započeti i nadzirati liječnik koji ima iskustva s primjenom protutumorskih terapija.
English: Efficacy was further supported by the rate of complete remission (CR)/complete remission with partial haematologic recovery (CRh) (Table 3, Figure 1).
Croatian: U prilog djelotvornosti dodatno su govorili su i podaci o stopi potpune remisije (engl. complete remission, CR)/potpune remisije uz djelomičan hematološki oporavak (CRh) (Tablica 3, Slika 1).
English: Xospata is used to treat adults with acute myeloid leukaemia (AML), a cancer of certain white blood cells.
Croatian: Xospata se koristi za liječenje odraslih osoba s akutnom mijeloičnom leukemijom (AML), oblikom raka koji zahvaća određenu vrstu bijelih krvnih stanica.
English: The most frequent adverse reactions with gilteritinib were blood creatine phosphokinase increased (93.4%), alanine aminotransferase (ALT) increased (82.1%), aspartate aminotransferase (AST) increased (80.6%), blood alkaline phosphatase increased (68.7%), diarrhoea (35.1%), fatigue (30.4%), nausea (29.8%), constipation (28.2%), cough (28.2%), peripheral oedema (24.1%), dyspnea (24.1%), dizziness (20.4%), hypotension (17.2%), pain in extremity (14.7%), asthenia (13.8%), arthralgia (12.5%) and myalgia (12.5%).
Croatian: Najčešće nuspojave gilteritiniba bile su povišene vrijednosti kreatin fosfokinaze u krvi (93,4%), povišene vrijednosti alanin aminotransferaze (ALT) (82,1%), povišene vrijednosti aspartat aminotransferaze (AST) (80,6%), povišene vrijednosti alkalne fosfataze u krvi (68,7%), proljev (35,1%), umor (30,4%), mučnina (29,8%), konstipacija (28,2%), kašalj (28,2%), periferni edem (24,1%), dispneja (24,1%), omaglica (20,4%), hipotenzija (17,2%), bol u ekstremitetu (14,7%), astenija (13,8%), artralgija (12,5%) i mialgija (12,5%).
English: The pharmacological activity of the metabolites against FLT3 and AXL receptors is unknown.
Croatian: Farmakološko djelovanje tih metabolita na receptore FLT3 i AXL nije poznato.
English: Gilteritinib is primarily metabolised by CYP3A enzymes, which can be induced or inhibited by a number of concomitant medicinal products.
Croatian: Gilteritinib se prvenstveno metabolizira djelovanjem enzima CYP3A, čiju aktivnost može inducirati ili inhibirati niz lijekova koji se primjenjuju istodobno.
English: CYP3A/P-gp Inducers
Croatian: Induktori CYP3A/P-gp-a
English: Other possible side effects Very common (may affect more than 1 in 10 people):
Croatian: Druge moguće nuspojave Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
English: Most patients in the study were Caucasian (59.3%); 27.5% Asian, 5.7% Black, 4% other races and 3.5% unknown.
Croatian: Većina bolesnika u ispitivanju bili su bijelci (59,3%), 27,5% njih bili su Azijci, 5,7% crnci, 4% druge rase, a u 3,5% ispitanika rasa je bila nepoznata.
English: Women of childbearing potential are recommended to use effective contraception (methods that result in less than 1% pregnancy rates) during and up to 6 months after treatment.
Croatian: Ženama reproduktivne dobi preporučuje se da koriste učinkovitu kontracepciju (metode uz koje stopa trudnoće iznosi manje od 1%) tijekom i do 6 mjeseci nakon liječenja.
English: Xospata is for oral use.
Croatian: Xospata je namijenjena za peroralnu primjenu.
English: Median in months (95% CI) Hazard Ratio (95% CI) p-value (1-sided) 1 year survival rate, % (95% CI)
Croatian: Ukupno preživljenje Smrtni slučajevi, n (%) Medijan u mjesecima (95% CI) Omjer hazarda (95% CI) p-vrijednost (jednostrana) 1-godišnja stopa preživljenja, % (95% CI)
English: - Posterior reversible encephalopathy syndrome (PRES).
Croatian: - Sindrom posteriorne reverzibilne encefalopatije (PRES).