FrancophonIA/ELRC3.0 huggingface dataset:
English: • During the infusion, the intravenous bag or syringes needs to be protected from light using a light (including ultraviolet light) blocking cover.
Croatian: • Tijekom infuzije potrebno je zaštititi intravensku vrećicu ili štrcaljke od svjetla korištenjem pokrova koji blokira svjetlo (uključujući ultraljubičasto svjetlo).
English: No dose adjustment is required in elderly patients (≥ 65 years) (see section 5.2).
Croatian: Nije potrebna prilagodba doze u starijih bolesnika (≥ 65 godina) (vidjeti dio 5.2).
English: Increased embryolethality was also observed in the presence of maternal toxicity.
Croatian: Povećana embrionalna smrtnost isto je tako zabilježena u prisutnosti toksičnosti za majku.
English: What MYLOTARG is and what it is used for 2.
Croatian: Što je MYLOTARG i za što se koristi 2.
English: Therefore, caution should be exercised when driving or operating machines.
Croatian: Stoga je potreban oprez pri upravljanju vozilima ili strojevima.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 April 2018
Croatian: Datum prvog odobrenja: 19. travnja 2018.
English: What MYLOTARG looks like and contents of the pack
Croatian: Kako MYLOTARG izgleda i sadržaj pakiranja
English: • Your doctor may change your dose, interrupt, or completely stop treatment with MYLOTARG if you have certain side effects.
Croatian: • Liječnik Vam može promijeniti dozu, privremeno prekinuti ili potpuno prekinuti liječenje lijekom MYLOTARG ako imate određene nuspojave.
English: Contact your doctor immediately if you or your partner becomes pregnant while taking this medicine.
Croatian: Odmah obavijestite svog liječnika ako Vi zatrudnite / Vaša partnerica zatrudni za vrijeme uzimanja ovog lijeka.
English: This includes the time required for reconstitution, dilution, and administration.
Croatian: To uključuje vrijeme potrebno za rekonstituciju, razrjeđivanje i primjenu.
English: • are allergic to gemtuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na gemtuzumab ozogamicin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Both men and women should seek advice on fertility preservation before treatment.
Croatian: I muškarci i žene bi trebali potražiti savjet o očuvanju plodnosti prije liječenja.
English: MYLOTARG must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus.
Croatian: Lijek MYLOTARG se ne smije primjenjivati tijekom trudnoće osim u slučaju kada potencijalna korist za majku premašuje mogući rizik za fetus.
English: Limitations of this analysis include the small sample size of some studies, heterogeneity of the studies, and the lack of control data in this setting.
Croatian: Ograničenja ove analize uključuju malu veličinu uzorka kod nekih ispitivanja, heterogenost ispitivanja i nedostatak kontrolnih podataka u ovom okruženju.
English: Previously untreated AML
Croatian: Prethodno neliječeni AML
English: Treatment-related death due to septic shock was reported in 1 (0.8%) patients.
Croatian: Smrt povezana s liječenjem, koja je nastupila zbog septičkog šoka, zabilježena je u 1 (0,8 %) bolesnika.
English: See section 2, “MYLOTARG contains sodium”.
Croatian: Pogledajte dio 2, „MYLOTARG sadrži natrij.“
English: Because of this limited data collection, laboratory data from the combination therapy study are included in Table 5.
Croatian: Zbog ovog ograničenog prikupljanja podataka, laboratorijski podaci iz ispitivanja kombiniranog liječenja prikazani su u tablici 5.
English: Protect from light and do not freeze.
Croatian: Zaštitite od svjetlosti i ne zamrzavajte.
English: • Excessive accumulation of fluid in the abdomen/stomach
Croatian: • pretjerano nakupljanje tekućine u abdomenu/trbuhu
English: There is no information on fertility in patients.
Croatian: Nema podataka o plodnosti u bolesnika.
English: For patients who proceed to HSCT, close monitoring of liver tests is recommended during the post-HSCT period, as appropriate.
Croatian: Bolesnicima koji nastavljaju s HSCT-om preporučuje se pažljivo praćenje jetrenih testova tijekom razdoblja nakon HSCT-a, prema potrebi.
English: Dose and schedule modifications
Croatian: Prilagodba doze i rasporeda
English: One of these patients experienced VOD 25 days after the subsequent HSCT.
Croatian: Jedan od tih bolesnika razvio je VOD 25 dana nakon naknadnog HSCT-a.
English: There is no information regarding the presence of gemtuzumab ozogamicin or its metabolites in human milk, the effects on the breast-fed child, or the effects on milk production.
Croatian: Nema podataka o prisutnosti gemtuzumab ozogamicina ili njegovih metabolita u majčinom mlijeku, učincima na dojenče ili učincima na proizvodnju mlijeka.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC05
Croatian: Farmakoterapijska skupina: Antineoplastici, monoklonska antitijela, ATK oznaka: L01XC05
English: One VOD event occurred more than 28 days of last dose of gemtuzumab ozogamicin; with 1 of these events occurring a few days after having started an HSCT conditioning regimen.
Croatian: Jedan događaj VOD-a pojavio se nakon više od 28 dana od zadnje doze gemtuzumab ozogamicina, dok se 1 od tih događaja pojavio nekoliko dana nakon početka režima kondicioniranja za HSCT.
English: Effects on male rat reproductive organs were partially reversible or not reversible (see section 4.6).
Croatian: Učinci na reproduktivne organe mužjaka štakora bili su djelomično reverzibilni ili uopće nisu bili reverzibilni (vidjeti dio 4.6).
English: Treatment of MYLOTARG overdose should consist of general supportive measures.
Croatian: Liječenje predoziranja lijekom MYLOTARG se treba sastojati od općih potpornih mjera.
English: The median time from the last gemtuzumab ozogamicin dose to onset of VOD was 9 days (range: 2-298 days).
Croatian: Medijan vremena od zadnje doze gemtuzumab ozogamicina do pojave VOD-a iznosio je 9 dana (raspon: 2-298 dana).
English: c. 2-sided p-value from the log-rank test.
Croatian: p-vrijednost dvostranog log-rank testa.
English: Determination of PK parameters for unconjugated calicheamicin was limited due to the low systemic concentration levels.
Croatian: Određivanje farmakokinetičkih parametara za nekonjugirani kalikeamicin bilo je ograničeno zbog niskih razina sistemskih koncentracija.
English: c: Rates across studies were estimated using inverse variance weighting with fixed effects.
Croatian: c: Stope u svim ispitivanjima procijenjene su primjenom inverzne varijance ponderiranjem s fiksnim učincima.
English: Patients should be monitored until signs and symptoms completely resolve.
Croatian: Bolesnike je potrebno pratiti dok se znakovi i simptomi potpuno ne povuku.
English: MYLOTARG is intended for the treatment of AML for patients age 15 years and above who have not tried other treatments.
Croatian: MYLOTARG je namijenjen liječenju AML-a u bolesnika u dobi od 15 godina i više koji nisu isprobali druga liječenja.
English: • Infections (signs of a low number of white blood cells known as neutrophils) Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening.
Croatian: • Infekcije (znakovi niskog broja bijelih krvnih stanica poznatih kao neutrofili) Neke infekcije mogu biti ozbiljne i nastati zbog virusa, bakterija ili drugih uzroka koji mogu biti opasni po život.
English: Nervous system effects have not been observed in animals after administration of MYLOTARG.
Croatian: Učinci na živčani sustav nisu primijećeni u životinja nakon primjene lijeka MYLOTARG.
English: Seek advice regarding fertility preservation before treatment.
Croatian: Potražite savjet o očuvanju plodnosti prije terapije.
English: b. Estimated from Kaplan-Meier curve.
Croatian: Procijenjeno iz Kaplan-Meierove krivulje.
English: What you need to know before you are given MYLOTARG
Croatian: Što morate znati prije nego počnete primati MYLOTARG
English: The primary endpoint was event-free survival (EFS).
Croatian: Primarna mjera ishoda bila je preživljenje bez događaja (engl. event-free survival, EFS).
English: When male rats were mated again after a 9-week non-dosing period, effects on sperm and fertility were worse but there was partial recovery of the lower spermatogonia and spermatocytes in the testes.
Croatian: Kada su se mužjaci štakora ponovno parili nakon razdoblja od 9 tjedana bez doziranja, učinci na spermu i plodnost bili su veći, ali postojao je djelomičan oporavak smanjenog broja spermatogonija i spermatocita u testisima.
English: Infections and bleeding/haemorrhagic reactions were reported, some of which were life-threatening or fatal.
Croatian: Prijavljene su infekcije i reakcije krvarenja/hemoragije od kojih su neke bile opasne po život ili smrtonosne.
English: • A doctor or nurse will give you MYLOTARG through a drip in your vein (intravenous infusion [IV]) gradually over 2 hours.
Croatian: • Liječnik ili medicinska sestra davat će Vam lijek MYLOTARG putem infuzije u venu (intravenska infuzija) postupno tijekom 2 sata.
English: Other severe or life-threatening non-haematologic toxicities
Croatian: Druge teške ili životno opasne nehematološke toksičnosti
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: Response rate (by Investigator)
Croatian: Stopa odgovora (prema ispitivaču)
English: If you feel unusually tired, dizzy or have a headache (these are very common side effects of MYLOTARG) you should not drive or use machines.
Croatian: Ako osjećate neuobičajen umor, omaglicu ili imate glavobolju (ovo su vrlo česte nuspojave lijeka MYLOTARG), ne biste smjeli upravljati vozilima ili strojevima.
English: Nervous system alterations were identified in rats with other antibody-calicheamicin conjugates.
Croatian: Promjene na živčanom sustavu bile su utvrđene u štakora s drugim konjugatima antitijela-kalikeamicina.
English: See Table 1 for dose recommendations for consolidation course.
Croatian: Vidjeti tablicu 1 za preporučeno doziranje za ciklus konsolidacije.
English: Monitoring only total bilirubin may not identify all patients at risk of VOD/SOS.
Croatian: Praćenje samo ukupne razine bilirubina ne mora nužno identificirati sve bolesnike s povećanim rizikom od VOD/SOS-a.
English: The ALFA-0701 trial was not designed to prospectively evaluate the benefit of MYLOTARG in subgroups; analysis are presented for descriptive purposes only.
Croatian: Ispitivanje ALFA-0701 nije namijenjeno prospektivnoj procjeni koristi lijeka MYLOTARG u podskupinama; analiza je predstavljena samo u deskriptivne svrhe.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving MYLOTARG.
Croatian: Ženama reproduktivne dobi treba savjetovati da izbjegavaju trudnoću dok primaju lijek MYLOTARG.
English: Dose modification of MYLOTARG is recommended based on individual safety and tolerability (see section 4.4).
Croatian: Promjene doze lijeka MYLOTARG preporučuju se ovisno o individualnoj sigurnosti i podnošljivosti (vidjeti dio 4.4).
English: Signs and symptoms of infusion related reactions may include fever and chills, and less frequently hypotension, tachycardia, and respiratory symptoms that may occur during the first 24 hours after administration.
Croatian: Znakovi i simptomi reakcija povezanih s infuzijom mogu uključivati vrućicu i zimicu te manje često hipotenziju, tahikardiju i respiratorne simptome koji se mogu pojaviti tijekom prva 24 sata nakon primjene.
English: Withdraw this amount from the vial using a syringe.
Croatian: Ovu količinu treba izvući iz bočice pomoću štrcaljke.
English: Combinationa
Croatian: Kombinacija
English: Some of the side effects could be serious and may occur during or after treatment with MYLOTARG.
Croatian: Neke od nuspojava mogu biti ozbiljne i mogu se pojaviti tijekom ili nakon liječenja lijekom MYLOTARG.
English: Infections and infestations Very common
Croatian: Infekcije i infestacije Vrlo često
English: The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su prikazane prema klasifikaciji organskih sustava i kategorijama učestalosti, definiranim prema sljedećoj podjeli: vrlo često ( 1/10), često ( 1/100 i < 1/10), manje često ( 1/1000 i < 1/100), rijetko ( 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: What MYLOTARG is and what it is used for
Croatian: Što je MYLOTARG i za što se koristi
English: In vitro, the binding N-acetyl gamma calicheamicin dimethyl hydrazide to human plasma proteins is approximately 97%.
Croatian: In vitro vezanje N-acetil-gama-kalikeamicindimetilhidrazida na proteine ljudske plazme iznosi približno 97%.
English: It is supplied as white to off-white cake or powder.
Croatian: Dostupan je kao bijeli do gotovo bijeli kolačić ili prašak.
English: The safety and efficacy of MYLOTARG in patients less than 15 years of age has not been established.
Croatian: Sigurnost i djelotvornost lijeka MYLOTARG u bolesnika mlađih od 15 godina nisu ustanovljene.
English: Consolidation
Croatian: Konsolidacija
English: In patients, the total volume of distribution of hP67.6 antibody (sum of V1 [10 L] and V2 [15 L]) was found to be approximately 25 L.
Croatian: Ustanovilo se da ukupan volumen distribucije hP67.6 antitijela (zbroj V1 [10 l] i V2 [15 l]) u bolesnika iznosi približno 25 l.
English: Pregnant women, or patients becoming pregnant whilst receiving gemtuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the foetus.
Croatian: Trudnice ili bolesnice koje zatrudne dok primaju gemtuzumab ozogamicin, odnosno liječene muške bolesnike kao partnere trudnica, treba upozoriti na moguću opasnost za fetus.
English: Relapsed or refractory AML
Croatian: Recidivni ili refraktorni AML
English: Additional findings included effects on the testes, epididymides and mammary gland as well as fertility.
Croatian: Dodatni nalazi uključivali su učinke na testise, epididimise i mliječnu žlijezdu, kao i na plodnost.
English: • Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
Croatian: • žuta boja kože ili bjeloočnica uzrokovana problemima s jetrom ili krvi (žutica)
English: 38.6 [24.4, NE]
Croatian: 38,6 [24,4; NP]
English: Consolidation Course 2a,b
Croatian: 2. ciklus konsolidacije a,b
English: MYLOTARG was given as monotherapy in 47.1%, part of a combination in 23.5%, and in both settings in 29.4% of the studies.
Croatian: Lijek MYLOTARG bio je primijenjen kao monoterapija u 47,1 %, kao dio kombinacije u 23,5 % i u oba oblika primjene u 29,4 % ispitivanja.
English: The number of patients with persistent thrombocytopenia remained similar across treatment courses (8 [7.4%] patients at the induction phase and 8 [8.5%] patients at the consolidation 1 phase and 10 [13.2%] patients at the consolidation 2 phase).
Croatian: Broj bolesnika s perzistirajućom trombocitopenijom ostao je sličan tijekom različitih ciklusa liječenja (8 [7,4 %] bolesnika u fazi uvodnog liječenja i 8 [8,5 %] bolesnika u 1. fazi konsolidacije te 10 [13,2 %] bolesnika u 2. fazi konsolidacije).
English: • Abnormal liver function
Croatian: • abnormalna funkcija jetre
English: MYLOTARG has moderate influence on the ability to drive and use machines.
Croatian: MYLOTARG umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: No clinical PK data have been collected using the fractionated regimen; however, the PK have been simulated using the population PK model.
Croatian: Nisu prikupljeni nikakvi klinički farmakokinetički podaci na temelju režima podijeljenog doziranja; međutim, farmakokinetika je simulirana upotrebom populacijskog farmakokinetičkog modela.
English: MYLOTARG is for intravenous use and must be reconstituted and diluted before administration (see section 6.6).
Croatian: MYLOTARG je za intravensku primjenu i mora se rekonstituirati i razrijediti prije primjene (vidjeti dio 6.6).
English: The relevance of these animal findings to humans is uncertain.
Croatian: Značaj ovih nalaza za ljude nije poznat.
English: For these reasons, comparison of incidence of antibodies to gemtuzumab ozogamicin with the incidence of antibodies to other products may be misleading.
Croatian: Zbog ovih razloga usporedba incidencije pojave antitijela na gemtuzumab ozogamicin s incidencijom pojave antitijela na druge lijekove može navesti na krivi zaključak.
English: • Interstitial pneumonia (inflammation of the lungs causing coughing and difficulty breathing)
Croatian: • intersticijska upala pluća (upala pluća koja uzrokuje kašljanje i otežano disanje)
English: ALFA-0701 study of previously untreated patients with de novo AML
Croatian: Ispitivanje ALFA-0701 prethodno neliječenih bolesnika s de novo AML-om
English: Hepatotoxicity, including hepatic VOD/SOS
Croatian: Hepatotoksičnost, uključujući jetreni VOD/SOS
English: • Changes in the levels of different enzymes in the blood (may show in your blood tests)
Croatian: • promjene u razinama različitih enzima u krvi (mogu se vidjeti pomoću krvnih pretraga)
English: • Toxic waste disposal procedures prescribed for anticancer medicinal products must be used.
Croatian: • Potrebno je provesti postupke za zbrinjavanje toksičnog otpada propisane za lijekove protiv raka.
English: If you need treatment with MYLOTARG, you must stop breast-feeding during treatment and for at least 1 month after treatment.
Croatian: Ako Vam je potrebna terapija lijekom MYLOTARG, morate prestati dojiti za vrijeme terapije i ne dojiti najmanje 1 mjesec nakon terapije.
English: Patients in the Phase 2 trials did not develop antidrug antibodies (ADAs) and only 2 patients in a Phase 1 trial developed antibodies against the calicheamicin-linker complex, 1 of whom had reduced hP67.6 plasma concentrations.
Croatian: Bolesnici u ispitivanjima faze 2 nisu razvili antitijela na lijek (engl. antidrug antibody, ADA) i samo su 2 bolesnika tijekom ispitivanja faze 1 razvila antitijela na kompleks kalikeamicin-povezivač, od kojih je 1 smanjio koncentracije hP67.6 u plazmi.
English: Overall, the incidence rate of ADA development after MYLOTARG treatment was < 1% across the 4 clinical studies with ADA data.
Croatian: Sveukupno je stopa incidencije razvoja ADA-e nakon liječenja lijekom MYLOTARG bila < 1 % u 4 klinička ispitivanja s podacima o ADA-i.
English: Symptoms may also include feeling sick (nausea) and/or vomiting.
Croatian: Simptomi mogu uključivati osjećaj mučnine i/ili povraćanja.
English: Saturation of a high percentage of CD33 antigenic sites is presumed to be required for maximum delivery of calicheamicin to leukaemic blast cells.
Croatian: Smatra se da je saturacija visokog postotka antigenih mjesta CD33 potrebna za maksimalnu dostavu kalikeamicina do stanica leukemijskih blasta.
English: Gemtuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody which specifically recognises human CD33.
Croatian: Gemtuzumab je humanizirani imunoglobulin razreda G podtipa 4 (IgG4), antitijelo koje posebno prepoznaje ljudski CD33.
English: No definitive relationship was found between VOD and time of HSCT relative to higher MYLOTARG monotherapy doses, however, the ALFA-0701 study recommended an interval of 2 months between the last dose of MYLOTARG and HSCT.
Croatian: Nije pronađena definitivna veza između VOD-a i vremena provedbe HSCT-a s obzirom na veće doze lijeka MYLOTARG kao monoterapije, međutim, ispitivanje ALFA-0701 preporučuje razmak od 2 mjeseca između zadnje doze lijeka MYLOTARG i HSCT-a.
English: MYLOTARG should be administered under the supervision of a physician experienced in the use of anticancer medicinal products and in an environment where full resuscitation facilities are immediately available.
Croatian: MYLOTARG se mora primjenjivati pod nadzorom liječnika s iskustvom u primjeni lijekova protiv raka te u okruženju gdje je odmah dostupna puna oprema za reanimaciju.
English: Consolidation Course 1a,b
Croatian: 1. ciklus konsolidacije a,b
English: MYLOTARG should not be administered as an intravenous push or bolus (see section 6.6).
Croatian: MYLOTARG se ne smije primijeniti kao brza intravenska injekcija ili bolus (vidjeti dio 6.6).
English: • Signs of an enlarged liver (hepatomegaly), such as an enlarged belly
Croatian: • simptomi povećane jetre (hepatomegalija), kao što je povećan trbuh
English: Proportions were transformed using Freeman-Tukey double arcsine transformation prior to combining studies, and the estimated combined rate was back-transformed using the harmonic mean of study sample sizes.
Croatian: Udjeli su bili transformirani primjenom Freeman-Tukeyjeve duple transformacije arkus sinusa prije kombiniranja ispitivanja i procijenjena kombinirana stopa bila je povratno transformirana primjenom harmonijske srednje vrijednosti veličina ispitivanih uzoraka.
English: Both of these patients experienced VOD more than 28 days after the last dose of gemtuzumab ozogamicin.
Croatian: Oba navedena bolesnika razvila su VOD više od 28 dana nakon zadnje doze gemtuzumab ozogamicina.
English: Overall, the median age of patients was 62 years (range 50 to 70 years) and most patients (87.8%) had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at baseline.
Croatian: Sveukupno, medijan dobi bolesnika bio je 62 godine (u rasponu od 50 do 70 godina) te je većina bolesnika (87,8 %) imala funkcionalni status prema Istočnoj kooperativnoj onkološkoj skupini (engl.
English: Persistent neutropenia
Croatian: Perzistirajuća neutropenija
English: Overall, 29 (5.5%) of patients in the MYLOTARG arm and 15 (2.8%) patients in the comparator arm died during remission.
Croatian: Sveukupno, 29 (5,5%) bolesnika u skupini koja je primala MYLOTARG i 15 (2,8%) bolesnika u skupini koja je primala usporedni lijek umrlo je tijekom remisije.
English: Across all studies, near maximal peripheral CD33 saturation was observed post-MYLOTARG dose at all dose levels of 2 mg/m² and above, suggesting that a low dose of gemtuzumab ozogamicin is sufficient to bind all available CD33 sites.
Croatian: U svim je ispitivanjima gotovo maksimalna periferna saturacija CD33 primijećena nakon doze lijeka MYLOTARG pri svim razinama doza od 2 mg/m² i više, što ukazuje na to da je niska doza gemtuzumab ozogamicina dovoljna za vezivanje na sva dostupna mjesta CD33.
English: • Prior to reconstitution, allow the vial to reach room temperature (below 25°C) for approximately 5 minutes.
Croatian: • Prije rekonstitucije pustite bočicu da dosegne sobnu temperaturu (ispod 25 °C) oko 5 minuta.
English: Infusion of MYLOTARG should be performed under close clinical monitoring, including pulse, blood pressure, and temperature.
Croatian: Infuziju lijeka MYLOTARG treba provoditi uz pažljivo kliničko praćenje, uključujući praćenje pulsa, krvnog tlaka i temperature.
English: CD33 expression on AML blasts by flow cytometry harmonised from local laboratory results was determined in 194/271 (71.6%) patients overall.
Croatian: Ekspresija CD33 na blastima AML-a procijenjena pomoću protočne citometrije te usklađena s rezultatima lokalnih laboratorija utvrđena je u ukupno 194/271 (71,6 %) bolesnika.
English: Reconstituted and diluted solution: Following reconstitution and dilution, the solution should be protected from light and should be used immediately.
Croatian: Rekonstituirana i razrijeđena otopina: Nakon rekonstitucije i razrjeđivanja otopinu treba zaštititi od svjetlosti te je treba primijeniti odmah.
English: Based on the primary definition of EFS: event dates (induction failure, relapse, or death) determined by investigator assessment.
Croatian: Na temelju osnovne definicije vjerojatnosti preživljenja bez događaja: datumi događaja (neuspjeh uvodnog liječenja, recidiv ili smrt) određeni su prema procjeni ispitivača.
English: 45.6 [25.5, NE]
Croatian: 45,6 [25,5; NP]