FrancophonIA/ELRC3.0 huggingface dataset:
English: A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), race, geographic region, disease site, endocrine therapy resistance, presence of measurable disease, progesterone receptor status, and menopausal status.
Croatian: U nizu unaprijed specificiranih analiza PFS-a po podskupinama opaženi su dosljedni rezultati u svim podskupinama bolesnica, uključujući podskupine prema dobi (< 65 ili ≥ 65 godina), rasi, geografskoj regiji, sijelu bolesti, rezistenciji na endokrinu terapiju, prisutnosti mjerljive bolesti, statusu progesteronskog receptora i menopauzalnom statusu.
English: However, based on the in vitro inhibition of P-gp and breast cancer resistance protein (BCRP) observed with abemaciclib, in vivo interactions of abemaciclib with narrow therapeutic index substrates of these transporters, such as digoxin or dabigatran etexilate, may occur.
Croatian: Međutim, s obzirom na opaženu inhibiciju P-gp-a i proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP) kod primjene abemacikliba in vitro, moguće su in vivo interakcije abemacikliba sa supstratima tih prijenosnika koji imaju uzak terapijski indeks, kao što su digoksin ili dabigatran eteksilat.
English: Pregnancy You should not use Verzenios if you are pregnant.
Croatian: Ne smijete uzimati lijek Verzenios ako ste trudni.
English: Abemaciclib was not mutagenic in a bacterial reverse mutation (Ames) assay, was not clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes, and was not clastogenic in an in vivo rat bone marrow micronucleus assay.
Croatian: Abemaciklib nije bio mutagen u bakterijskom testu reverzne mutacije (Amesov test) te nije bio klastogen u in vitro testu kromosomskih aberacija na limfocitima iz periferne ljudske krvi kao ni u mikronukleusnom testu na koštanoj srži štakora in vivo.
English: If strong CYP3A4 inhibitors cannot be avoided, the abemaciclib dose should be reduced to 100 mg twice daily.
Croatian: Ako se istodobna primjena snažnih inhibitora CYP3A4 ne može izbjeći, dozu abemacikliba potrebno je smanjiti na 100 mg dvaput na dan.
English: Abemaciclib is metabolised in the liver.
Croatian: Abemaciklib se metabolizira u jetri.
English: Randomised Phase 3 Study MONARCH 3: Verzenios in combination with aromatase inhibitors
Croatian: Randomizirano ispitivanje faze 3 MONARCH 3: Verzenios u kombinaciji s inhibitorima aromataze
English: NR (18.05, NR)
Croatian: ND (18,05; ND)
English: Genotoxicity
Croatian: Genotoksičnost
English: Developmental toxicity
Croatian: Razvojna toksičnost
English: In breast cancer xenograft models, abemaciclib dosed daily without interruption at clinically relevant concentrations alone or in combination with anti-oestrogens resulted in reduction of tumour size.
Croatian: U ksenograft modelima raka dojke, neprekidna svakodnevna primjena abemacikliba u klinički značajnim koncentracijama, bilo samostalno ili u kombinaciji s anti-estrogenima, dovela je do smanjenja veličine tumora.
English: In oestrogen receptor-positive breast cancer cell lines, sustained target inhibition with abemaciclib prevented rebound of Rb phosphorylation resulting in cell senescence and apoptosis.
Croatian: staničnim linijama raka dojke pozitivnog na estrogenske receptore održana inhibicija ciljnih molekula abemaciklibom spriječila je ponovnu uspostavu fosforilacije Rb-a, što je dovelo do stanične senescencije i apoptoze.
English: Verzenios is used to treat women with certain types of breast cancer (hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)) which have spread beyond the original tumour and/or to other organs.
Croatian: Verzenios se koristi za liječenje žena s određenim vrstama raka dojke (pozitivan na hormonske receptore (HR+), negativan na receptor humanog epidermalnog faktora rasta 2 (HER2-)) koji se proširio izvan prvotnog tumora i/ili na druge organe.
English: In vivo interactions of abemaciclib with clinically relevant substrates of these transporters, such as dofetilide or creatinine, may occur (see section 4.8).
Croatian: Moguće su in vivo interakcije abemacikliba s klinički značajnim supstratima navedenih prijenosnika, kao što su dofetilid ili kreatinin (vidjeti dio 4.8).
English: The median age of patients enrolled was 60 years (range, 32-91 years).
Croatian: Medijan dobi bolesnica uključenih u ispitivanje iznosio je 60 godina (raspon: 32 - 91 godina).
English: The HR was 0.854 (95% CI: 0.598, 1.221), p=0.3886.
Croatian: HR je iznosio 0,854 (95% CI: 0,598; 1,221), p = 0,3886.
English: Patients should be monitored for signs and symptoms of infection and treated as medically appropriate.
Croatian: Bolesnice treba nadzirati zbog mogućih znakova i simptoma infekcije te liječiti sukladno medicinskoj indikaciji.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
English: Diarrhoea is the most common adverse reaction.
Croatian: Proljev je najčešća nuspojava.
English: Venous thromboembolic events were reported in 5.3% of patients treated with abemaciclib plus fulvestrant or aromatase inhibitors, compared to 0.8% of patients treated with placebo plus fulvestrant or aromatase inhibitors.
Croatian: Slučajevi venske tromboembolije prijavljeni su u 5,3% bolesnica liječenih abemaciklibom u kombinaciji s fulvestrantom ili inhibitorima aromataze u usporedbi s 0,8% bolesnica koje su primale placebo plus fulvestrant ili inhibitore aromataze.
English: These results correspond to a clinically meaningful reduction in the risk of disease progression or death of 44.7% and a 7.2 month improvement in median PFS for patients treated with Verzenios plus fulvestrant.
Croatian: Navedeni rezultati odgovaraju klinički značajnom smanjenju rizika od progresije bolesti ili smrti za 44,7% te povećanju medijana PFS-a za 7,2 mjeseca u bolesnica liječenih lijekom Verzenios u kombinaciji s fulvestrantom.
English: Effects of abemaciclib on the pharmacokinetics of other medicinal products
Croatian: Učinci abemacikliba na farmakokinetiku drugih lijekova
English: 59% of patients had most recent endocrine therapy in the (neo)adjuvant setting, and 38% in metastatic setting.
Croatian: 59% bolesnica posljednji je put endokrinu terapiju primalo u sklopu (neo)adjuvantnog liječenja, a njih 38% za liječenje metastatske bolesti.
English: Verzenios contains lactose
Croatian: Verzenios sadrži laktozu
English: Management recommendations for non-haematologic toxicities (excluding diarrhoea and increased aminotransferases)
Croatian: Tablica 5. Preporuke za zbrinjavanje nehematoloških toksičnosti (izuzev proljeva i povišenih vrijednosti aminotransferaza)
English: Grade 1 (>ULN-3.0 x ULN) Grade 2 (>3.0-5.0 x ULN)
Croatian: 1. stupanj (> GGN - 3,0 x GGN) 2. stupanj (> 3,0 - 5,0 x GGN)
English: These results correspond to a clinically meaningful reduction in the risk of disease progression or death of 46% for patients treated with abemaciclib plus an aromatase inhibitor.
Croatian: Navedeni rezultati odgovaraju klinički značajnom smanjenju rizika od progresije bolesti ili smrti za 46% u bolesnica liječenih abemaciklibom u kombinaciji s inhibitorom aromataze.
English: Verzenios is available in calendar blister packs of 14, 28, 42, 56, 70 and 168 film-coated tablets and perforated unit dose blisters of 28 x 1 film-coated tablets.
Croatian: Verzenios je dostupan u kalendarskim blister pakiranjima sa 14, 28, 42, 56, 70 i 168 filmom obloženih tableta te perforiranim blisterima s jediničnim dozama koji sadrže 28 x 1 filmom obloženu tabletu.
English: This was not considered to be clinically relevant.
Croatian: Navedeni se učinci nisu smatrali klinički značajnima.
English: This was found to be due to reduced renal secretion with unaffected glomerular filtration.
Croatian: Utvrđeno je da je ono posljedica smanjenog izlučivanja putem bubrega uz nepromijenjenu glomerularnu filtraciju.
English: • Inflamation of the mouth and lips, nausea (feeling sick), vomiting,
Croatian: • upala usta i usana, mučnina, povraćanje
English: Take Verzenios continuously for as long as your doctor tells you to.
Croatian: Koliko dugo uzimati Verzenios Verzenios uzimajte neprekidno, onoliko dugo koliko Vam kaže liječnik.
English: Steady state was achieved within 5 days following repeated twice daily dosing, and abemaciclib accumulated with a geometric mean accumulation ratio of 3.7 (58% CV) and 5.8 (65% CV) based on Cmax and AUC, respectively.
Croatian: Nakon ponovljene primjene dvaput na dan stanje dinamičke ravnoteže postignuto je unutar 5 dana, a abemaciklib se akumulirao uz omjer akumulacije od 3,7 (58% CV) na temelju omjera geometrijskih srednjih vrijednosti Cmax, odnosno 5,8 (65% CV) na temelju omjera geometrijskih srednjih vrijednosti AUC-a.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Verzenios Lijek čuvajte izvan pogleda i dohvata djece.
English: The median age of patients enrolled was 63 years (range 32-88).
Croatian: Medijan dobi bolesnica uključenih u ispitivanje iznosio je 63 godine (raspon: 32 - 88).
English: 22.4 (18.3, NR )
Croatian: 22,4 (18,3; ND)
English: In cancer patients, abemaciclib inhibits CDK4 and CDK6 as indicated by inhibition of phosphorylation of Rb and topoisomerase II alpha, which results in cell cycle inhibition upstream of the G1 restriction point.
Croatian: U bolesnica s rakom abemaciklib inhibira CDK4 i CDK6, na što upućuje inhibicija fosforilacije Rb-a i topoizomeraze II alfa, te tako dovodi do inhibicije staničnog ciklusa uzvodno od restrikcijske točke u
English: In each treatment arm the majority of patients were white, and had not received chemotherapy for metastatic disease.
Croatian: U obje su liječene skupine bolesnice većinom bile bijele rase te prethodno nisu primale kemoterapiju za metastatsku bolest.
English: Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Croatian: b Infekcije uključuju sve preporučene pojmove koji su obuhvaćeni organskim sustavom „Infekcije i infestacije“
English: Based on the level of ALT or AST elevation, abemaciclib may require dose modification (see section 4.2).
Croatian: Ovisno o razini povišenja vrijednosti ALT-a ili AST-a, možda će biti potrebna prilagodba doze abemacikliba (vidjeti dio 4.2).
English: Tiredness and dizziness are very common side effects.
Croatian: Umor i omaglica vrlo su česte nuspojave.
English: Elderly No dose adjustment is required based on age (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu s obzirom na dob (vidjeti dio 5.2).
English: Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters without affecting glomerular function (as measured by iohexol clearance) (see section 4.5).
Croatian: Pokazalo se da abemaciklib povisuje serumsku razinu kreatinina zbog inhibicije prijenosnika koji posreduju u bubrežnoj tubularnoj sekreciji, ne utječući pritom na glomerularnu funkciju (mjerenu klirensom ioheksola) (vidjeti dio 4.5).
English: Complete blood counts should be monitored prior to the start of Verzenios therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated.
Croatian: Potrebno je kontrolirati kompletnu krvnu sliku prije uvođenja lijeka Verzenios, svaka dva tjedna tijekom prva dva mjeseca liječenja, jednom mjesečno tijekom sljedeća dva mjeseca te sukladno kliničkoj indikaciji.
English: Although not an adverse reaction, abemaciclib has been shown to increase serum creatinine in 98.3% of patients (based on laboratory findings), 1.9% Grade 3 or 4 (based on laboratory findings).
Croatian: Iako se ne radi o štetnom učinku, pokazalo se da abemaciklib povisuje serumsku vrijednost kreatinina u 98,3% bolesnica (na temelju laboratorijskih nalaza), a u 1,9% bolesnica ta su povišenja bila
English: Patients were randomised in a 2:1 ratio to receive Verzenios 150 mg twice daily plus fulvestrant 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose, versus placebo plus fulvestrant according to the same schedule.
Croatian: Bolesnice su bile randomizirane u omjeru 2:1 za liječenje lijekom Verzenios u dozi od 150 mg dvaput na dan u kombinaciji s fulvestrantom u dozi od 500 mg koji se primjenjivao u razmacima od mjesec dana, uz dodatnu dozu od 500 mg primijenjenu dva tjedna nakon početne doze, odnosno za primanje placeba plus fulvestranta primijenjenog prema istom rasporedu.
English: Abemaciclib plus endocrine therapya All Grades Toxicity
Croatian: Abemaciklib plus endokrina terapijaa
English: In addition, Ndesethyl and N-desethylhydroxy metabolites circulate at AUCs that are 39% and 15% of parent drug.
Croatian: Nadalje, N-dezetil i N-dezetilhidroksi metabolit cirkuliraju uz AUC koji iznosi 39% odnosno
English: 14 film-coated tablets 168 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets 56 film-coated tablets 42 film-coated tablets 70 film-coated tablets
Croatian: 14 filmom obloženih tableta 168 filmom obloženih tableta 28 x 1 filmom obložena tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 42 filmom obložene tablete 70 filmom obloženih tableta
English: In an exposure-response analysis in healthy subjects at exposures comparable to a 200 mg twice-daily dose, abemaciclib did not prolong the QTcF interval to any clinically relevant extent.
Croatian: U analizi odgovora u odnosu na izloženost u zdravih ispitanica pri razinama izloženosti koje su bile usporedive s onima nakon primjene doze od 200 mg dvaput na dan abemaciklib nije doveo do klinički značajnog produljenja QTcF intervala.
English: The HR was 1.057 (95% CI: 0.683, 1.633), p=0.8017.
Croatian: HR je iznosio 1,057 (95% CI: 0,683; 1,633), p = 0,8017.
English: No dose adjustments are necessary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnica s blagim (Child-Pugh stadij A) ili umjerenim (ChildPugh stadij B) oštećenjem jetrene funkcije.
English: Refer to Section 2 for more information on any of the possible effects listed above.
Croatian: Za više informacija o svim gore navedenim mogućim nuspojavama pogledajte dio 2.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, Nizozemska.
English: First dose adjustment
Croatian: Prva prilagodba doze
English: Co-administration of abemaciclib with CYP3A4 inhibitors can increase plasma concentrations of abemaciclib.
Croatian: Istodobna primjena abemacikliba s inhibitorima CYP3A4 može povećati plazmatske koncentracije abemacikliba.
English: Concomitant use of strong CYP3A4 inducers (including, but not limited to: carbamazepine, phenytoin, rifampicin and St. John's wort) should be avoided due to the risk of decreased efficacy of abemaciclib.
Croatian: Treba izbjegavati istodobnu primjenu snažnih induktora CYP3A4 (uključujući, između ostalih: karbamazepin, fenitoin, rifampicin i gospinu travu) zbog rizika od smanjene djelotvornosti abemacikliba.
English: Keep the blister card intact
Croatian: Pazite da ne oštetite blister karticu.
English: In healthy subjects, co-administration of abemaciclib and the P-glycoprotein (P-gp) substrate loperamide resulted in an increase in loperamide plasma exposure of 9% based on AUC0-∞ and 35% based on Cmax.
Croatian: U zdravih je ispitanica istodobna primjena abemacikliba i supstrata P-glikoproteina (P-gp) loperamida dovela do povećanja plazmatske izloženosti loperamidu za 9% na temelju vrijednosti AUC0-∞ te za
English: A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), disease site, disease setting (de novo metastatic vs recurrent metastatic vs locally advanced recurrent), presence of measurable disease, progesterone receptor status, and baseline ECOG performance status.
Croatian: U nizu unaprijed specificiranih analiza PFS-a po podskupinama opaženi su dosljedni rezultati u svim podskupinama bolesnica, uključujući podskupine prema dobi (< 65 ili ≥ 65 godina), sijelu bolesti, tipu bolesti (de novo metastatska bolest naspram rekurentne metastatske bolesti naspram lokalno uznapredovale rekurentne bolesti), prisutnosti mjerljive bolesti, statusu progesteronskih receptora i početnom funkcionalnom ECOG statusu.
English: Patients should be monitored for signs and symptoms of deep vein thrombosis and pulmonary embolism and treated as medically appropriate.
Croatian: Bolesnice treba nadzirati zbog mogućih znakova i simptoma duboke venske tromboze i plućne embolije te liječiti sukladno medicinskoj indikaciji.
English: Eli Lilly Benelux S.A./N.V.
Croatian: Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V.
English: Management recommendations for haematologic toxicities
Croatian: Tablica 2. Preporuke za zbrinjavanje hematoloških toksičnosti
English: If the CYP3A4 inhibitor is discontinued, the abemaciclib dose should be increased to the dose used prior to the initiation of the CYP3A4 inhibitor (after 3 to 5 half-lives of the CYP3A4 inhibitor).
Croatian: U slučaju prestanka primjene inhibitora CYP3A4 dozu abemacikliba treba (nakon 3 - 5 poluvjekova inhibitora CYP3A4) povećati na dozu koja se primjenjivala prije uvođenja inhibitora CYP3A4.
English: Film coating
Croatian: Film ovojnica
English: Medicinal products that are substrates of transporters Abemaciclib and its major active metabolites inhibit the renal transporters organic cation transporter 2 (OCT2), multidrug and extrusion toxin protein (MATE1), and MATE2-K.
Croatian: Abemaciklib i njegovi glavni aktivni metaboliti inhibiraju bubrežne prijenosnike: prijenosnik organskih kationa 2 (engl. organic cation transporter 2, OCT2) te prijenosnike za izlučivanje više lijekova i toksina MATE1 i MATE2-K.
English: Co-administration of abemaciclib with the strong CYP3A4 inducer rifampicin decreased the plasma concentration of abemaciclib by 95% and unbound potency adjusted plasma concentration of abemaciclib plus its active metabolites by 77% based on AUC0-∞.
Croatian: Istodobna primjena abemacikliba sa snažnim induktorom CYP3A4 rifampicinom smanjila je plazmatsku koncentraciju abemacikliba za 95%, dok je plazmatsku koncentraciju abemacikliba i njegovih aktivnih metabolita prilagođenu za potentnost nevezane frakcije smanjila za 77%, na temelju vrijednosti AUC0-∞.
English: 100 mg twice daily
Croatian: 100 mg dvaput na dan
English: NR (NR, NR)
Croatian: ND (ND, ND)
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: 27.39 (25.74, NR)
Croatian: 27,39 (25,74; ND)
English: Second dose adjustment
Croatian: Druga prilagodba doze
English: Abemaciclib is primarily metabolised by CYP3A4.
Croatian: Abemaciklib se prvenstveno metabolizira posredstvom enzima CYP3A4.
English: Abemaciclib is metabolised to several metabolites primarily by cytochrome P450 (CYP) 3A4.
Croatian: Abemaciklib se metabolizira u nekoliko metabolita, prvenstveno djelovanjem enzima 3A4 citokroma P450 (CYP3A4).
English: If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced (see section 4.2), followed by careful monitoring of toxicity.
Croatian: Ako je istodobna primjena inhibitora CYP3A4 neophodna, dozu abemacikliba treba smanjiti (vidjeti dio 4.2), a nakon toga pažljivo nadzirati bolesnice zbog moguće toksičnosti.
English: Before treatment initiation, absolute neutrophil counts (ANC) ≥1500/mm3, platelets ≥100,000/mm3, and haemoglobin ≥8 g/dL are recommended.
Croatian: iznosi ≥ 1500/mm3, broj trombocita ≥ 100 000/mm3, a razina hemoglobina ≥ 8 g/dl.
English: There are no data regarding abemaciclib administration in patients with severe renal impairment, end stage renal disease, or in patients on dialysis (see section 5.2).
Croatian: Nema podataka o primjeni abemacikliba u bolesnica s teškim oštećenjem bubrežne funkcije, bolesnica u terminalnoj fazi bubrežne bolesti ili bolesnica na dijalizi (vidjeti dio 5.2).
English: Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
Croatian: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: Verzenios may: - reduce the number of your white blood cells, and you may be at greater risk of getting an infection.
Croatian: - smanjiti broj bijelih krvnih stanica, zbog čega možete biti izloženi većem riziku od infekcija.
English: It is not known if Verzenios passes into breast milk.
Croatian: Nije poznato izlučuje li se Verzenios u majčino mlijeko.
English: The efficacy and safety of Verzenios in combination with fulvestrant was evaluated in MONARCH 2, a randomised, double-blind, placebo-controlled phase 3 study in women with HR positive, HER2 negative locally advanced or metastatic breast cancer.
Croatian: Djelotvornost i sigurnost lijeka Verzenios u kombinaciji s fulvestrantom ocjenjivale su se u ispitivanju MONARCH 2, koje je bilo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 3 provedeno u žena s HR pozitivnim, HER2 negativnim lokalno uznapredovalim ili metastatskim rakom dojke.
English: Creatinine
Croatian: Kreatinin
English: Mild and moderate renal impairment had no effect on the exposure of abemaciclib.
Croatian: Blago i umjereno oštećenje bubrežne funkcije nije utjecalo na izloženost abemaciklibu.
English: Icepharma hf. Sími + 354 540 8000
Croatian: Sími + 354 540 8000
English: In patients who have had their dose reduced to 50 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose may be continued with close monitoring of signs of toxicity.
Croatian: U bolesnica kojima je doza abemacikliba već smanjena na 50 mg dvaput na dan i u kojih se ne može izbjeći istodobna primjena snažnog inhibitora CYP3A4, može se nastaviti s primjenom iste doze abemacikliba uz pomno praćenje mogućih znakova toksičnosti.
English: Toxicitya
Croatian: Toksičnost
English: Other side effects with Verzenios may include:
Croatian: Druge nuspojave lijeka Verzenios mogu uključivati:
English: Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Croatian: Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
English: • Tablet core: colloidal hydrated silica, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate.
Croatian: • Jezgra tablete: koloidni hidratizirani silicijev dioksid, umrežena karmelozanatrij, laktoza hidrat, mikrokristalična celuloza, natrijev stearilfumarat.
English: Median [months] (95% CI) Hazard ratio (95% CI) and p-value
Croatian: Medijan [mjeseci] (95% CI) Omjer hazarda (95% CI) i p-vrijednost
English: Objective response rateb [%] (95% CI) Complete response, (%) Partial response, (%)
Croatian: Stopa objektivnog odgovorab [%] (95% CI) Potpun odgovor, (%)
English: In the following tables, adverse reactions are listed in order of MedDRA body system organ class and frequency.
Croatian: U sljedećim su tablicama nuspojave popisane prema MedDRA organskom sustavu i učestalosti pojavljivanja.
English: No dose adjustment required.
Croatian: Nije potrebno prilagođavati dozu.
English: Hazard ratio (95% CI) and p-value
Croatian: Omjer hazarda (95% CI) i p-vrijednost
English: Grade 3, recurrent; or Grade 4
Croatian: Rekurentna toksičnost 3. stupnja ili 4. stupanj
English: Persistent or recurrent Grade 2 toxicity that does not resolve with maximal supportive measures to baseline or Grade 1 within 7 days
Croatian: Perzistentna ili rekurentna toksičnost 2. stupnja koja se uz maksimalne potporne mjere ne ublaži do početne razine ili
English: 150 mg twice daily
Croatian: 150 mg dvaput na dan
English: Objective response rateb [%] (95% CI) Duration of response [months] (95% CI)
Croatian: Stopa objektivnog odgovorab [%] (95% CI) Trajanje odgovora [mjeseci] (95% CI)
English: Serious or life-threatening infections are uncommon (may affect up to 1 in 100 people).
Croatian: Ozbiljne ili po život opasne infekcije javljaju se manje često (mogu se javiti u do 1 na