FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy results for study 301
Slovenian: Preglednica 4: Rezultati učinkovitosti iz študije 301
English: Daunorubicin per dose
Slovenian: Daunorubicin na odmerek
English: Observe the patient carefully over time for signs of cardiotoxicity and provide appropriate supportive therapy as clinically indicated.
Slovenian: Bolnika dovolj dolgo natančno spremljajte; posebej pozorni bodite na znake kardiotoksičnosti in zagotovite ustrezno podporno zdravljenje, kot je klinično indicirano.
English: It contains two active substances, called ‘daunorubicin' and ‘cytarabine', in the form of tiny particles known as ‘liposomes'.
Slovenian: Vsebuje dve učinkovini, »daunorubicin« in »citarabin«, v obliki drobnih delcev, ki se imenujejo »liposomi«.
English: Cardiotoxicity is a known risk of anthracycline treatment.
Slovenian: Kardiotoksičnost je znano tveganje pri zdravljenju z antraciklini.
English: The safety and efficacy of Vyxeos liposomal in children aged 0-18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Vyxeos liposomski pri otrocih, starih od 0 do 18 let, nista dokazani.
English: Post-remission therapy with haematopoietic stem cell transplantation (HSCT) was permitted either in place of or after consolidation chemotherapy.
Slovenian: Zdravljenje s presaditvijo krvotvornih matičnih celic (HSCT, haematopoietic stem cell transplantation) po remisiji je bilo dovoljeno bodisi namesto konsolidacijske kemoterapije bodisi po njej.
English: • on days 1, 3, and 5 as the first course of induction therapy.
Slovenian: • na 1., 3. in 5. dan kot prvi krog indukcijskega zdravljenja,
English: • slow, fast, or irregular heartbeat, chest pain (which may be a sign of infection)
Slovenian: • počasen, hiter ali nereden srčni utrip, bolečine v prsnem košu (to so lahko znaki okužbe);
English: Name and address of the manufacturer(s) responsible for batch release Jazz Pharmaceuticals Ireland Limited 5th Floor
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Jazz Pharmaceuticals Ireland Limited
English: • if you have had problems with your kidneys or liver.
Slovenian: • če ste kdaj imeli težave z delovanjem ledvic ali jeter.
English: Pneumonia, sepsis and bacteriaemia were the most frequently seen serious infection ADRs in the clinical studies population.
Slovenian: Pljučnica, sepsa in bakteriemija so bile najpogosteje opažene resne okužbe v okviru neželenih učinkov pri populaciji v kliničnih študijah.
English: Vyxeos liposomal demonstrated superiority in overall survival in the ITT population compared with the comparator 7+3 treatment regimen (Figure 1).
Slovenian: Zdravilo Vyxeos liposomski je izkazalo superiornost glede skupnega preživetja pri populaciji z namenom zdravljenja (ITT) v primerjavi s primerjalnim režimom odmerjanja 7 + 3 (slika 1).
English: Each pack contains 1 vial, 2 vials or 5 vials.
Slovenian: Vsako pakiranje vsebuje 1, 2 ali 5 vial.
English: The medicinal product name and dose should be verified prior to administration to avoid dosing errors.
Slovenian: Pred uporabo je treba preveriti ime zdravila in odmerek, da ne pride do napak pri odmerjanju.
English: Cardiotoxicity (72) Arrhythmia a
Slovenian: Zelo pogosti Kardiotoksičnost (72) Aritmija a
English: The randomised patients had a median age of 68 (range 60-75 years), 61% were male, and 88% had an ECOG performance status of 0-1.
Slovenian: Mediana starost randomiziranih bolnikov je bila 68 let (razpon od 60 do 75 let), 61 % je bilo moških in 88 % je imelo telesno zmogljivost (ECOG) 0-1.
English: Your doctor or nurse will work out your dose of the medicine based on your weight and height.
Slovenian: Zdravnik ali medicinska sestra bosta izračunala ustrezni odmerek zdravila glede na vašo telesno maso in višino.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki kategoriji pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: There may be residual product remaining in the vial.
Slovenian: Nekaj zdravila bo morda ostalo v viali.
English: Environmental risk assessment has shown that Vyxeos liposomal is not anticipated to have the potential to be persistent, bioaccumulative, or toxic to the environment.
Slovenian: Glede na oceno tveganja za okolje se ne pričakuje, da bo zdravilo Vyxeos liposomski obstojno, bioakumulativno ali strupeno za okolje.
English: Incidence of fatal cardiotoxicity events is 0.5%.
Slovenian: Incidenca kardiotoksičnih učinkov s smrtnim izidom je bila 0,5 %.
English: If myelosuppressive complications occur, appropriate supportive measures should be used, e.g., anti-infectives, colonystimulating factors, transfusions.
Slovenian: Če pride do mielosupresivnih zapletov, je treba uporabiti primerne podporne ukrepe, npr. zdravila proti okužbam, kolonije stimulirajoče faktorje in transfuzije.
English: Repeat-dose toxicity of Vyxeos liposomal was tested in two-cycle intravenous infusion toxicity studies with 28-day recovery periods conducted in rats and dogs.
Slovenian: Toksičnost zdravila Vyxeos liposomski pri ponavljajočih odmerkih je bila preskušena v študijah toksičnosti z dvema krogoma intravenske infuzije in 28-dnevnimi obdobji okrevanja, ki so jih izvedli pri podganah in psih.
English: Both cytarabine and daunorubicin, tested separately, showed teratogenic and embryotoxic effects in animal studies.
Slovenian: Citarabin in daunorubicin, ki sta bila preskušena ločeno, sta pokazala teratogene in embriotoksične učinke v študijah na živalih.
English: Total cumulative exposure of daunorubicin has been described in the table below.
Slovenian: Skupna kumulativna izpostavljenost daunorubicinu je opisana v spodnji preglednici.
English: There were 153 patients randomised to Vyxeos liposomal and 156 patients randomised to the 7+3 control arm.
Slovenian: V skupino z zdravilom Vyxeos liposomski je bilo randomiziranih 153 bolnikov in v kontrolno skupino 7 + 3 je bilo randomiziranih 156 bolnikov.
English: The attainment of a normal-appearing bone marrow may require more than one induction course.
Slovenian: Za dosego normalnega videza kostnega mozga bo morda potreben več kot en krog indukcijskega zdravljenja.
English: Night sweats (8.3) Alopecia (3.2)
Slovenian: Nočno znojenje (8,3) Alopecija (3,2)
English: Immunosuppressant effects/Increased susceptibility to infections Administration of live or live-attenuated vaccines in patients that are immunocompromised by chemotherapeutic agents may result in serious or fatal infections.
Slovenian: Imunosupresivni učinki/povečana dovzetnost za okužbe Dajanje živih ali oslabljenih cepiv bolnikom, ki imajo zaradi zdravljenja s kemoterapevtskimi učinkovinami poslabšan imunski sistem, lahko povzroči resne ali smrtne okužbe.
English: Vyxeos liposomal may also cause heart problems and damage to the heart muscle.
Slovenian: Poleg tega lahko zdravilo Vyxeos liposomski povzroči težave s srcem in poškoduje srčno mišico.
English: • bleeding or bruising without injury
Slovenian: • krvavitve ali nastanek podplutb, ne da bi se poškodovali;
English: Assessment of cardiac function prior to start of treatment is recommended, especially in patients with a high risk of cardiac toxicity.
Slovenian: Pred začetkom zdravljenja je priporočljivo oceniti delovanje srca, zlasti pri bolnikih z visokim tveganjem za kardiotoksične učinke.
English: A subsequent course of induction may be administered in patients who do not show disease progression or unacceptable toxicity.
Slovenian: Dodaten krog indukcijskega zdravljenja se lahko uporabi pri bolnikih, ki nimajo znakov napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
English: Pharmacotherapeutic group: other antineoplastic agents, combinations of antineoplastic agents, ATC code: L01XY01.
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, kombinacije zdravil z delovanjem na novotvorbe; oznaka ATC: L01XY01.
English: You will receive a first course of treatment and your doctor will decide if you will receive further courses of treatment depending on how you respond to treatment and any side effects you get.
Slovenian: Po prvem krogu zdravljenja bo vaš zdravnik presodil, ali boste nadaljevali z dodatnimi krogi, odvisno od tega, kako se boste odzvali na zdravljenje in ali boste imeli kakšne neželene učinke.
English: Daunorubicin has antimitotic and cytotoxic activity, which is achieved by forming complexes with DNA, inhibiting topoisomerase II activity, inhibiting DNA polymerase activity, affecting regulation of gene expression, and producing DNA-damaging free radicals.
Slovenian: Daunorubicin deluje antimitotično in citotoksično, kar doseže z oblikovanjem kompleksov z DNK, zaviranjem aktivnosti topoizomeraze II, zaviranjem aktivnosti DNK-polimeraze, vplivom na uravnavanje izražanja genov in z ustvarjanjem prostih radikalov, ki poškodujejo DNK.
English: Women of childbearing potential should not receive treatment until pregnancy is excluded.
Slovenian: Ženske v rodni dobi se ne smejo zdraviti s tem zdravilom, dokler možnost nosečnosti ni izključena.
English: • Carefully swirl the contents of the vial for 5 minutes while gently inverting the vial every 30 seconds.
Slovenian: • 5 minut previdno sukajte vsebino viale in vsakih 30 sekund vialo previdno obrnite na glavo.
English: Treatment with Vyxeos liposomal should be permanently discontinued.
Slovenian: Zdravljenje z zdravilom Vyxeos liposomski je treba trajno opustiti.
English: Your doctor will assess how you respond to treatment after each course.
Slovenian: Zdravnik bo po vsakem krogu ocenil, kako se odzivate na zdravljenje.
English: If a planned dose of Vyxeos liposomal is missed, the dose should be administered as soon as possible and the dosing schedule adjusted accordingly, maintaining the treatment interval.
Slovenian: Če se načrtovan odmerek zdravila Vyxeos liposomski izpusti, je treba odmerek čim prej aplicirati in ustrezno prilagoditi časovni razpored odmerjanja, da se ohrani interval med posameznimi krogi zdravljenja.
English: • problems with your sight, blurred vision
Slovenian: • težave z vidom, zamegljen vid;
English: • Do not use this medicine after the expiry date which is stated on the carton and the vial after
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake »EXP:«.
English: A single dose of cytarabine in rats, administered on day 14 of gestation, reduced prenatal and postnatal brain size and caused permanent impairment of learning ability.
Slovenian: Enkraten odmerek citarabina pri podganah, ki so ga uporabili na 14. dan brejosti, je zmanjšal prenatalno in postnatalno velikost možganov ter povzročil trajno zmanjšanje učnih sposobnosti.
English: Cardiotoxicity (18.7)
Slovenian: Zelo pogosti Kardiotoksičnost (18,7)
English: Hypertension (6.9) Hypotension (4.5)
Slovenian: Hipertenzija (6,9) Hipotenzija (4,5)
English: The most frequently reported hypersensitivity ADRs were rash and the majority of these were not serious (38.9%).
Slovenian: Najpogosteje opisani preobčutljivostni neželeni učinek je bil izpuščaj, vendar ti dogodki večinoma niso bili resni (38,9 %).
English: Insufficient pharmacokinetic data were collected in paediatric patients to draw conclusions.
Slovenian: Pediatrična populacija Podatki o farmakokinetiki pri pediatričnih bolnikih ne zadostujejo za kakršne koli zaključke.
English: • Do not use this medicine if you notice any particles in the diluted solution.
Slovenian: • To zdravilo se ne sme uporabiti, če so v razredčeni raztopini vidni kakršni koli delci.
English: Cytarabine caused the transformation of hamster embryo cells and rat H43 cells in vitro.
Slovenian: Citarabin je povzročil transformacijo embrionalnih celic hrčkov in podganjih celic H43 in vitro.
English: Hepatic or renal impairment may increase the risk of toxicity associated with daunorubicin and cytarabine.
Slovenian: Okvara jeter ali ledvic lahko poveča tveganje za toksičnost, povezano z daunorubicinom in citarabinom.
English: Plasma concentration-time profiles obtained from 13 to 26 patients who received Vyxeos liposomal 100 units/m
Slovenian: Profili koncentracije v plazmi po času, ugotovljeni pri 13-26 bolnikih, ki so dobivali zdravilo Vyxeos liposomski v odmerku 100 enot/m
English: An in-line membrane filter may be used for the intravenous infusion of Vyxeos liposomal, provided the minimum pore diameter of the filter is greater than or equal to 15 µm.
Slovenian: Linijski membranski filter se za intravensko infuzijo zdravila Vyxeos liposomski lahko uporablja, če je najmanjši premer por filtra večji ali enak 15 µm.
English: The overall rate of HSCT was 34% (52/153) in the Vyxeos liposomal arm and 25% (39/156) on the control arm.
Slovenian: Skupni delež HSCT je bil 34 % (52/153) v skupini z zdravilom Vyxeos liposomski in 25 % (39/156) v kontrolni skupini.
English: The relationship between cumulative Vyxeos liposomal dose and the risk of cardiac toxicity has not been determined.
Slovenian: V kakšnem razmerju sta kumulativni odmerek zdravila Vyxeos liposomski in tveganje za kardiotoksičnost, še ni ugotovljeno.
English: • During your first course - you will have an infusion on days 1, 3, and 5.
Slovenian: • V prvem krogu zdravljenja boste dobili infuzijo na 1., 3. in 5. dan.
English: The most frequently reported serious ADRs were decreased ejection fraction and congestive cardiac failure.
Slovenian: Resna neželena učinka, o katerih so najpogosteje poročali, sta bila zmanjšan iztisni delež in kongestivno srčno popuščanje.
English: FLT3 mutation was identified in 15% (43/279) of patients tested and NPM1 mutation was identified in 9% (25/283) patients tested.
Slovenian: Pri 15 % (43/279) testiranih bolnikov so ugotovili mutacijo FLT3 in pri 9 % (25/283) mutacijo NPM1.
English: Concurrent use of cardiotoxic agents may increase the risk of cardiotoxicity.
Slovenian: Ob sočasni uporabi kardiotoksičnih učinkovin se lahko poveča tveganje za kardiotoksične učinke.
English: The product is intended for single use only.
Slovenian: Zdravilo je namenjeno samo za enkratno uporabo.
English: Hepatotoxic medicinal products may impair liver function and increase the toxicity.
Slovenian: Hepatotoksična zdravila lahko poslabšajo delovanje jeter in povečajo toksičnost.
English: • if you have ever had a condition known as Wilson's disease or other copper-related disorder, as Vyxeos liposomal contains an ingredient known as 'copper gluconate'.
Slovenian: • če ste kdaj imeli bolezen, ki se imenuje Wilsonova bolezen, ali drugo bolezen, povezano z bakrom, saj zdravilo Vyxeos liposomski vsebuje sestavino »bakrov glukonat«;
English: It is unlikely that you will be given too much, however, tell your doctor or nurse if you have any concerns.
Slovenian: Verjetnost, da dobite preveliko količino zdravila, je zelo majhna, vendar povejte zdravniku ali medicinski sestri, če vas kar koli skrbi.
English: • Determine the dose and number of vials of Vyxeos liposomal based on the individual patient's BSA as outlined in section 4.2.
Slovenian: • Izračunajte ustrezni odmerek in število vial zdravila Vyxeos liposomski na podlagi telesne površine posameznega bolnika, kot je navedeno v poglavju 4.2.
English: The incidence of fatal haemorrhage was 2.1%.
Slovenian: Incidenca krvavitev s smrtnim izidom je bila 2,1 %.
English: From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo porabiti takoj, razen če se metoda odpiranja/rekonstitucije/redčenja izključuje nevarnost mikrobiološke kontaminacije.
English: It is not known whether Vyxeos liposomal is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Vyxeos liposomski izloča v materino mleko.
English: History of Wilson's disease or other copper-related disorder Each vial contains 100 mg of copper gluconate, which corresponds to 14 mg of elemental copper.
Slovenian: Anamneza Wilsonove bolezni ali druge bolezni, povezane z bakrom Ena viala vsebuje 100 mg bakrovega glukonata, kar ustreza 14 mg elementarnega bakra.
English: Daunorubicin has been associated with local tissue necrosis at the site of medicinal product extravasation.
Slovenian: Daunorubicin je povezan z lokalno nekrozo tkiva na mestu ekstravazacije zdravila.
English: Preparation instructions
Slovenian: Navodila za pripravo
English: Care should be taken to ensure there is no extravasation to prevent the risk of tissue necrosis.
Slovenian: Paziti je treba, da ne pride do ekstravazacije, ki bi lahko povzročila nekrozo tkiva.
English: Total cumulative doses of non-liposomal daunorubicin greater than 550 mg/m have been associated with an increased incidence of treatment-induced congestive heart failure.
Slovenian: Skupni kumulativni odmerki neliposomskega daunorubicina, večji od 550 mg/m2, so povezani s povečano incidenco kongestivnega srčnega popuščanja, povzročenega z zdravljenjem.
English: If this applies to you, your doctor may check your heart before starting, and during treatment.
Slovenian: Če to velja za vas, bo zdravnik pred začetkom zdravljenja in med zdravljenjem morda preverjal, kako deluje vaše srce;
English: Prior therapy with anthracyclines (including patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride), pre-existing cardiac disease (including impaired cardiac function), previous radiotherapy of the mediastinum, or concomitant use of cardiotoxic products may increase the risk of daunorubicin-induced cardiac toxicity.
Slovenian: Predhodno zdravljenje z antraciklini (vključno z bolniki, ki so že dobivali največje priporočene kumulativne odmerke doksorubicina ali daunorubicinijevega klorida), že obstoječa bolezen srca (vključno s poslabšanim delovanjem srca), predhodno zdravljenje z obsevanjem mediastinuma ali sočasna uporaba kardiotoksičnih zdravil lahko poveča tveganje za kardiotoksične učinke daunorubicina.
English: Patients may be pre-medicated for nausea and vomiting.
Slovenian: Bolniki lahko dobijo predhodna zdravila proti navzei in bruhanju.
English: While you are receiving treatment with Vyxeos liposomal your doctor will perform regular blood tests to assess how you respond to the treatment and to check it is well tolerated.
Slovenian: Med zdravljenjem z zdravilom Vyxeos liposomski bo zdravnik z rednimi krvnimi preiskavami preverjal, kako se odzivate na zdravljenje in ali zdravilo dobro prenašate.
English: A baseline cardiac evaluation with an electrocardiogram (ECG) and a multi-gated radionuclide angiography (MUGA) scan or an echocardiography (ECHO) is recommended, especially in patients with risk factors for increased cardiac toxicity.
Slovenian: Priporočena je izhodiščna ocena delovanja srca z elektrokardiografom (EKG) in večvhodno radionuklidno angiografijo (MUGA) ali ehokardiografijo (ECHO), zlasti pri bolnikih z dejavniki tveganja za povečano kardiotoksičnost.
English: • chest pain or leg pain
Slovenian: • bolečine v prsih ali nogah;
English: While cytarabine is not a carcinogen, daunorubicin is a possible carcinogen, hence, Vyxeos liposomal may be associated with a carcinogenic potential.
Slovenian: Medtem ko citarabin ni karcinogen, pa ima daunorubicin karcinogeni potencial, zato je lahko zdravilo Vyxeos liposomski povezano s karcinogenim potencialom.
English: • Gently invert each vial 5 times prior to withdrawing the concentrate for dilution.
Slovenian: • Vialo 5-krat previdno obrnite na glavo, preden odvzamete koncentrat, ki ga boste razredčili.
English: Blood counts should be regularly monitored until recovery (see section 4.8).
Slovenian: Vse do okrevanja je treba redno preverjati krvno sliko (glejte poglavje 4.8).
English: • if you are allergic to the active substances (daunorubicin or cytarabine) or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na učinkovini (daunorubicin ali citarabin) ali katero koli sestavino tega zdravila
English: The potential effects of severe renal impairment (CrCL 15 mL/min ≥ to ≤ 29 mL/min, C-G) and end-stage renal disease on the pharmacokinetics of daunorubicin and cytarabine administered as Vyxeos liposomal are unknown (see section 4.2).
Slovenian: Morebitni učinki hude okvare ledvic (CrCL od ≥ 15 ml/min do ≤ 29 ml/min, C-G) in končne odpovedi ledvic na farmakokinetiko daunorubicina in citarabina, kadar se dajeta kot zdravilo Vyxeos liposomski, niso znani (glejte poglavje 4.2).
English: The fatal infections experienced were sepsis and pneumonia (see section 4.4).
Slovenian: Te smrtne okužbe so bile sepsa in pljučnica (glejte poglavje 4.4).
English: Vyxeos liposomal treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products.
Slovenian: Zdravljenje z zdravilom Vyxeos liposomski mora uvesti in spremljati zdravnik, ki ima izkušnje z uporabo kemoterapevtskih zdravil.
English: • Do not heat, vortex, or shake vigorously.
Slovenian: • Ne segrevajte, ne vrtinčite in ne stresajte premočno.
English: Cytarabine is metabolised by cytidine deaminase to the inactive metabolite 1-β (beta)-D-arabinofuranosyluracil (AraU).
Slovenian: Citidin-deaminaza presnovi citarabin v neaktivni presnovek 1-β (beta)-D-arabinofuranoziluracil (AraU).
English: Infection (58.7)
Slovenian: Zelo pogosti Okužba (58,7)
English: Second induction
Slovenian: Druga indukcija
English: Infection (78.1)
Slovenian: Zelo pogosti Okužba (78,1)
English: • Then, reconstitute each vial with 19 mL of sterile water for injections using a 20 mL syringe and immediately thereafter start a 5-minute timer.
Slovenian: • Nato z uporabo 20 ml brizge rekonstituirajte vsako vialo z 19 ml sterilne vode za injekcije in takoj zatem nastavite časovnik na 5 minut.
English: • medicines that can affect your liver.
Slovenian: • zdravila, ki lahko vplivajo na delovanje jeter.
English: • a fall in the number of platelets (cells that help blood to clot) which may cause bruising or bleeding
Slovenian: • zmanjšanje števila krvnih ploščic (celic, ki pomagajo pri strjevanju krvi), ki lahko povzroči podplutbe ali krvavitve;
English: The concentration of the reconstituted solution is 44 mg/20 mL (2.2 mg/mL) daunorubicin and 100 mg/20 mL (5 mg/mL) cytarabine.
Slovenian: Koncentracija rekonstituirane raztopine je 44 mg/20 ml (2,2 mg/ml) daunorubicina in 100 mg/20 ml (5 mg/ml) citarabina.
English: The most serious and frequently occurring ADRs were infection (58.7%), cardiotoxicity (18.7%) and haemorrhage (13.1%).
Slovenian: Najresnejši pogosti neželeni učinki so bili okužba (58,7 %), kardiotoksičnost (18,7 %) in krvavitev
English: Adverse effects of Vyxeos liposomal occurred at all tested dose levels (low to null safety margins as based on systemic exposures) and were generally consistent with those known for non-liposomal daunorubicin and/or cytarabine, comprising mainly findings of gastrointestinal and hematological toxicity.
Slovenian: Neželeni učinki zdravila Vyxeos liposomski so se pojavili pri vseh preskušanih ravneh odmerkov (nizke do ničelne varnostne meje na podlagi sistemske izpostavljenosti), so bili na splošno skladni z znanimi neželenimi učinki neliposomskega daunorubicina in/ali citarabina ter so v glavnem obsegali prebavne in hematološke toksične učinke.
English: Vyxeos liposomal is administered by intravenous infusion over a period of 90 minutes.
Slovenian: Zdravilo Vyxeos liposomski se daje v obliki intravenske infuzije, ki traja 90 minut.
English: Delirium (2.4)
Slovenian: Pogosti Delirij (2,4)
English: The median survival for the Vyxeos liposomal treatment group was 9.56 months compared with 5.95 months for the 7+3 treatment group (Hazard Ratio = 0.69, 95% CI = 0.52, 0.90, two-sided log-rank test p = 0.005).
Slovenian: Mediano preživetje v skupini, zdravljeni z zdravilom Vyxeos liposomski, je bilo 9,56 meseca v primerjavi s 5,95 meseca v skupini 7 + 3 (razmerje tveganja = 0,69; 95 % IZ = 0,52; 0,90; dvostranska vrednost log-rank p = 0,005).