FrancophonIA/ELRC3.0 huggingface dataset:
English: In general, the tolerability of Erivedge in repeat-dose toxicity studies in rats and dogs was limited by nonspecific manifestations of toxicity including decreased body weight gain and food consumption.
Croatian: U načelu je podnošljivost lijeka Erivedge u ispitivanjima toksičnosti ponovljenih doza na štakorima i psima bila ograničena nespecifičnim manifestacijama toksičnosti koje su uključivale smanjen prirast tjelesne težine i smanjen unos hrane.
English: Dedicated studies to assess the potential of vismodegib to affect post-natal development have not been performed.
Croatian: Nisu provedena posebna ispitivanja kojima bi se procijenio mogući učinak vismodegiba na postnatalni razvoj.
English: Specific instructions (the Erivedge Pregnancy Prevention Programme), given to you by your doctor contain information particularly on the effects of Erivedge on unborn babies.
Croatian: Posebne upute (Program sprječavanja trudnoće pri primjeni lijeka Erivedge) koje će Vam dati liječnik sadrže informacije osobito u vezi s učincima lijeka Erivedge na nerođenu djecu.
English: • Women who are pregnant or breast-feeding (see sections 4.4 and 4.6).
Croatian: ● Trudnice i dojilje (vidjeti dijelove 4.4 i 4.6).
English: The most common adverse drug reactions (ADR) occurring in ≥ 30 % of patients, were muscle spasms (74.6 %), alopecia (65.9%), dysgeusia (58.7%), weight decreased (50.0%), fatigue (47.1%), nausea (34.8 %) and diarrhea (33.3%).
Croatian: Najčešće nuspojave lijeka koje su se javile u ≥ 30% bolesnika bile su: grčevi mišića (74,6%), alopecija (65,9%), disgeuzija (58,7%), smanjena tjelesna težina (50,0%), umor (47,1%), mučnina (34,8%) i proljev (33,3%).
English: Treatment interruptions of up to 4 weeks were allowed based on individual tolerability.
Croatian: Ovisno o individualnoj podnošljivosti, bili su dopušteni prekidi u liječenju u trajanju do najviše 4 tjedna.
English: If the patient has developed any of these reactions with the use of vismodegib, treatment with vismodegib must not be restarted in this patient at any time.
Croatian: Ako se u bolesnika kod primjene vismodegiba pojavi bilo koja od tih reakcija, tom se bolesniku više nikada ne smije ponovno uvesti liječenje vismodegibom.
English: *** Observed in patients during a post-approval study with 1215 safety evaluable patients.
Croatian: *** Opažene u bolesnika tijekom ispitivanja nakon dobivanja odobrenja koje je obuhvatilo 1215 bolesnika u kojih se mogla ocijeniti sigurnost primjene.
English: Epiphyses premature fusion****
Croatian: prijevremeno spajanje epifiza****
English: • Coadministration of St John's wort (Hypericum perforatum) (see section 4.5).
Croatian: Istodobna primjena gospine trave (Hypericum perforatum) (vidjeti dio 4.5).
English: PD = progressive disease, SD = stable disease, PR = partial response.
Croatian: PB = progresivna bolest, SB = stabilna bolest, DO = djelomičan odgovor.
English: • Obligations of the health care professional in relation to the prescribing of Erivedge
Croatian: ● obveze zdravstvenoga radnika povezane s propisivanjem lijeka Erivedge
English: For women taking Erivedge
Croatian: Za žene koje uzimaju Erivedge
English: In addition, in the vismodegib general toxicity studies up to 26-week in sexually mature rats and dogs, no effects on male reproductive organs were observed.
Croatian: Osim toga, u ispitivanjima opće toksičnosti vismodegiba u spolno zrelih štakora i pasa, koja su trajala do 26 tjedana, nisu primijećeni učinci na reproduktivne organe mužjaka.
English: No malignant tumors were identified in either species tested.
Croatian: Ni kod jedne od ispitivanih vrsta nisu pronađeni zloćudni tumori.
English: Benign hair follicle tumors have not been reported in clinical trials with Erivedge, and the relevance of this finding to humans is uncertain.
Croatian: Dobroćudni tumori folikula dlake nisu prijavljeni u kliničkim ispitivanjima lijeka Erivedge, pa je nepoznat značaj tog nalaza za ljude.
English: Metabolic pathways of vismodegib in humans include oxidation, glucuronidation, and an uncommon pyridine ring cleavage.
Croatian: Metabolički putovi vismodegiba u ljudi uključuju oksidaciju, glukuronidaciju i neuobičajeno cijepanje piridinskog prstena.
English: • Erivedge exposes a teratogenic risk to the unborn child,
Croatian: ● Erivedge može biti teratogen za nerođeno dijete,
English: Erivedge can pass into semen.
Croatian: Erivedge se može izlučivati u spermu.
English: The use of Erivedge in children and adolescents under the age of 18 years is not recommended.
Croatian: Ne preporučuje se primjena lijeka Erivedge u djece i adolescenata mlađih od 18 godina.
English: The findings of premature fusion of the epiphyses indicate a potential risk for short stature and tooth deformities to infants and children (see section 5.3).
Croatian: Nalazi preuranjenog spajanja epifiza ukazuju na mogući rizik od niskog rasta i deformacije zuba u dojenčadi i djece (vidjeti dio 5.3).
English: Post-natal development
Croatian: Postnatalni razvoj
English: Premature fusion of the epiphyses and precocious puberty have been reported in paediatric patients exposed to Erivedge.
Croatian: Preuranjeno spajanje epifiza i prijevremeni pubertet su zabilježeni u pedijatrijskih bolesnika koji su bili izloženi lijeku Erivedge.
English: If you take more Erivedge than you should If you take more Erivedge than you should, talk to your doctor.
Croatian: Ako uzmete više lijeka Erivedge nego što ste trebali, obratite se svom liječniku.
English: Erivedge is used to treat adults with a type of skin cancer called advanced basal cell carcinoma.
Croatian: Erivedge se koristi za liječenje odraslih osoba s jednom vrstom raka kože koji se naziva uznapredovalim karcinomom bazalnih stanica.
English: Erivedge contains lactose and sodium
Croatian: Erivedge sadrži laktozu i natrij
English: On the basis of the scientific conclusions for vismodegib the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vismodegib is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za vismodegib, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) vismodegib nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Vismodegib concentrations are strongly correlated with AAG levels, showing parallel fluctuations of AAG and total vismodegib over time and consistently low unbound vismodegib levels.
Croatian: Koncentracije vismodegiba u snažnoj su korelaciji s koncentracijama AAG-a te postoji usporedna fluktuacija AAG-a i ukupnog vismodegiba kroz vrijeme, dok je koncentracija nevezanog vismodegiba konstantno niska.
English: Four patients did not have lesion measurements and were not included in the plot.
Croatian: U 4 bolesnika nisu izmjerene lezije pa oni nisu uključeni u grafikon.
English: Each hard capsule contains 71.5 mg lactose monohydrate per capsule.
Croatian: Jedna tvrda kapsula sadrži i 71,5 mg laktoza hidrata po kapsuli.
English: Basal cell carcinoma develops when DNA in normal skin cells becomes damaged and the body cannot repair the damage.
Croatian: Karcinom bazalnih stanica nastaje kada dođe do oštećenja deoksiribonukleinske kiseline DNK u normalnim stanicama kože, koje tijelo ne može popraviti.
English: Vismodegib and associated metabolic products are eliminated primarily by the hepatic route.
Croatian: Vismodegib i povezani metabolički proizvodi eliminiraju se prvenstveno putem jetre.
English: In an embryo-foetal development study in which pregnant rats were administered vismodegib daily during organogenesis, vismodegib crossed the placenta and was severely toxic to the conceptus.
Croatian: U istraživanju embriofetalnog razvoja u kojem je u skotnih ženki štakora doza vismodegiba primjenjivana svakodnevno tijekom organogeneze, vismodegib je prošao kroz placentu i bio izrazito toksičan za plod.
English: As shown in the waterfall plots in figures 1 and 2, which chart maximum reduction in target lesion(s) size for each patient, the majority of patients in both cohorts experienced tumour shrinkage as assessed by the IRF.
Croatian: Kao što se može iščitati iz stupčanih grafikona na Slikama 1 i 2, koji prikazuju maksimalno smanjenje veličine ciljne lezije (lezija) za svakog pojedinog bolesnika, prema procjeni neovisnog ocjenjivačkog tijela u većine je bolesnika u obje kohorte došlo do smanjenja tumora.
English: The apparent half-life of vismodegib at steady-state is estimated to be 4 days with continuous daily dosing.
Croatian: Prividni poluvijek vismodegiba u stanju dinamičke ravnoteže procjenjuje se na 4 dana uz kontinuirano svakodnevno doziranje.
English: CYP2C9 appears to contribute in part to vismodegib metabolism in vivo.
Croatian: Čini se da CYP2CP djelomično pridonosi metabolizmu vismodegiba in vivo.
English: WCBP, whose periods are irregular or stopped, must follow all the advice on effective contraception.
Croatian: Žena generativne dobi kojoj su menstruacije neredovite ili ih uopće nema mora slijediti sve savjete o djelotvornoj kontracepciji.
English: ******Cases of SCAR (including SJS/TEN, DRESS and AGEP) have been reported in patients during post-marketing use.
Croatian: ****** Slučajevi teških kožnih nuspojava (uključujući SJS/TEN, DRESS i AGEP) zabilježeni su u bolesnika nakon stavljanja lijeka na tržište.
English: The bottle cap material is Polypropylene.
Croatian: Zatvarač boce je od polipropilena.
English: • pain in your chest, back or side,
Croatian: ● bol u prsnom košu, leđima ili slabinama,
English: After continuous once-daily dosing, the pharmacokinetics of vismodegib appears to be nonlinear due to saturable absorption and saturable protein binding.
Croatian: Čini se da je nakon kontinuiranog doziranja jedanput na dan farmakokinetika vismodegiba nelinearna zbog saturabilne apsorpcije i saturabilnoga vezanja za proteine.
English: Results from a clinical study demonstrated no clinically significant PK interaction between vismodegib and itraconazole (a strong P-glycoprotein inhibitor) in healthy volunteers.
Croatian: Rezultati jednog kliničkog ispitivanja nisu pokazali klinički značajnu farmakokinetičku interakciju između vismodegiba i itrakonazola (snažnog inhibitora P-glikoproteina) u zdravih dobrovoljaca.
English: • She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic,
Croatian: ● mora imati negativan nalaz testa na trudnoću svakog mjeseca tijekom liječenja, čak i ako je nastupila amenoreja,
English: Population pharmacokinetic analyses suggest that age did not have a clinically significant impact on steady-state concentration of vismodegib.
Croatian: Populacijske farmakokinetičke analize pokazale su da dob nema klinički značajnog učinka na koncentraciju vismodegiba u stanju dinamičke ravnoteže.
English: • use 2 methods of contraception, one highly effective method and one barrier method (please see the examples below)
Croatian: ● morate primjenjivati 2 metode zaštite od trudnoće - jednu metodu visoke djelotvornosti i jednu metodu barijere (pogledajte primjere u nastavku)
English: Mild and moderate renal impairment is not expected to impact the elimination of vismodegib and no dose adjustment is needed.
Croatian: Ne očekuje se da će blago i umjereno oštećenje bubrežne funkcije utjecati na eliminaciju vismodegiba pa nije potrebno prilagođavati dozu.
English: It is not known if Erivedge can pass into your breast milk and harm your baby.
Croatian: Nije poznato može li se Erivedge izlučivati u majčino mlijeko i tako naškoditi Vašem djetetu.
English: **Includes preferred terms: liver function test abnormal, blood bilirubin increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, alkaline phosphatase increased, liver hepatic enzyme increased.
Croatian: **Uključuje preferirane pojmove: poremećeni nalazi jetrenih proba, povišene vrijednosti bilirubina u krvi, povišene vrijednosti gama-glutamil transferaze, povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti alkalne fosfataze, povišene vrijednosti jetrenih enzima.
English: • The need to ensure all patients complete and sign the Erivedge Verification of Counselling Form which is to be present in the healthcare professional educational material
Croatian: ● zdravstveni radnik mora se pobrinuti da svi bolesnici ispune i potpišu Obrazac potvrde o savjetovanju o lijeku Erivedge, koji se mora nalaziti u edukacijskom materijalu za zdravstvene radnike
English: In addition, in the vismodegib general 26-week toxicity study, decreased number of corpora lutea was observed at 100 mg/kg/day; the effect was not reversed by the end of an 8 week recovery period.
Croatian: Osim toga, u 26-tjednom ispitivanju opće toksičnosti vismodegiba primijećen je smanjen broj žutih tijela uz dozu od 100 mg/kg/dan; taj se učinak do kraja 8-tjednog razdoblja oporavka nije pokazao reverzibilnim.
English: • Local contact details for reporting of any suspected pregnancy
Croatian: ● lokalni kontakt podaci za prijavljivanje sumnje na trudnoću
English: In case of pregnancy or missed menstrual periods If the patient does become pregnant, misses a menstrual period, or suspects for any reason that she may be pregnant, she must notify her treating physician immediately.
Croatian: Ako bolesnica zatrudni, ako joj izostane menstruacija ili iz bilo kojeg razloga sumnja da bi mogla biti trudna, mora o tome odmah obavijestiti svog liječnika.
English: Post approval study results
Croatian: Rezultati ispitivanja nakon dobivanja odobrenja
English: Concomitant treatment with strong CYP inducers (e.g. rifampicin, carbamazepine or phenytoin) should be avoided, as a risk for decreased plasma concentrations and decreased efficacy of vismodegib cannot be excluded (see also section 4.5).
Croatian: Treba izbjegavati istodobno liječenje snažnim induktorima CYP izoenzima (npr. rifampicinom, karbamazepinom ili fenitoinom) jer se ne može isključiti rizik od smanjenih koncentracija u plazmi i smanjene djelotvornosti vismodegiba (vidjeti i dio 4.5).
English: In vitro studies indicate that vismodegib has the potential to act as an inhibitor of breast cancer resistance protein (BCRP).
Croatian: Ispitivanja in vitro ukazuju na to da vismodegib može djelovati kao inhibitor proteina koji uzrokuje rezistenciju raka dojke na lijekove (BCRP).
English: • Red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Croatian: ● proširen crveni, ljuskavi osip s potkožnim kvržicama i mjehurićima, koji je praćen vrućicom, a javlja se na početku liječenja (akutna generalizirana egzantematozna pustuloza)
English: PD = progressive disease, SD = stable disease, R = response, * = complete resolution of ulceration(s).
Croatian: PB = progresivna bolest, SB = stabilna bolest, O = odgovor, * = potpuno povlačenje ulceracije(a).
English: Patients who present with amenorrhoea during treatment with Erivedge should continue monthly pregnancy testing while on treatment.
Croatian: Bolesnice u kojih tijekom liječenja lijekom Erivedge nastupi amenoreja moraju nastaviti provoditi mjesečne testove na trudnoću tijekom liječenja.
English: Due to the risk of embryo-foetal death or severe birth defects caused by vismodegib, women taking Erivedge must not be pregnant or become pregnant during treatment and for 24 months after the final dose (see sections 4.3 and 4.4).
Croatian: Zbog rizika od smrti embrija/fetusa ili teških prirođenih oštećenja prouzročenih vismodegibom, žene koje uzimaju Erivedge ne smiju biti trudne niti zatrudnjeti tijekom liječenja i unutar 24 mjeseca nakon uzimanja posljednje doze lijeka (vidjeti dijelove 4.3 i 4.4).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • The need to keep Erivedge capsules out of sight and reach of children
Croatian: ● upozorenje da se Erivedge kapsule moraju držati izvan pogleda i dohvata djece
English: Fertility impairment in human males is not expected (see Section 5.3).
Croatian: Ne očekuje se smanjenje plodnosti u muškaraca (vidjeti dio 5.3).
English: • Vasectomy,
Croatian: ● vazektomija,
English: • To return unused capsules at the end of the treatment (disposal will depend on local requirements)
Croatian: ● upozorenje da neiskorištene kapsule treba vratiti na kraju liječenja (odlaganje ovisi o lokalnim propisima)
English: Contraception - for men and women
Croatian: Zaštita od trudnoće - za muškarce i žene
English: Results from a clinical study demonstrated a 57% increase in vismodegib unbound drug concentrations on day 7 after co-treatment with 400 mg fluconazole (a moderate CYP2C9 inhibitor) daily, but this interaction is not expected to be clinically significant.
Croatian: Rezultati jednog kliničkog ispitivanja pokazali su povećanje koncentracije nevezanog vismodegiba za 57% nakon 7 dana istodobnog liječenja flukonazolom (umjerenim inhibitorom CYP2C9) u dozi od 400 mg na dan, ali ne očekuje se da će ta interakcija biti klinički značajna.
English: • Reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes.
Croatian: ● crvenkaste mrlje nalik metama ili kružne mrlje, često s mjehurima u sredini, koje se javljaju na trupu, ljuštenje kože, vrijedovi u ustima, grlu i nosu te na spolnim organima i očima.
English: HDPE bottle with a child-resistant closure containing 28 hard capsules.
Croatian: Boca od polietilena visoke gustoće (HDPE), sa sigurnosnim zatvaračem za djecu, koja sadrži 28 tvrdih kapsula.
English: In clinical trials with aBCC, approximately 40 % of patients were of geriatric age (≥ 65 years).
Croatian: U kliničkim ispitivanjima uznapredovalog karcinoma bazalnih stanica približno 40% bolesnika bilo je starije dobi (≥ 65 godina).
English: Additional findings at clinically relevant exposures included faecal changes; skeletal muscle twitching or tremors; alopecia; swelling, follicular hyperkeratosis, and inflammation in paw pads; and increased LDL and HDL cholesterol.
Croatian: Dodatni nalazi pri klinički značajnim razinama izloženosti uključivali su promjene u fecesu; tremor ili trzanje skeletnih mišića; alopeciju; oticanje, folikularnu hiperkeratozu i upalu jastučića šape; te povećane vrijednosti LDL i HDL kolesterola.
English: Dysgeusia Ageusia
Croatian: Poremećaji živčanog sustava disgeuzija ageuzija hipogeuzija
English: Erivedge may cause severe birth defects.
Croatian: Erivedge može izazvati teške prirođene mane.
English: A post-approval, open-label, non-comparative, multicenter, phase II clinical trial (MO25616) was conducted in 1232 patients with advanced BCC, of whom 1215 patients were evaluable for efficacy and safety with laBCC (n = 1119) or mBCC (n = 96).
Croatian: Otvoreno, nekomparativno, multicentrično kliničko ispitivanje faze II nakon dobivanja odobrenja (MO25616) provedeno je s 1232 uključena bolesnika s uznapredovalim karcinomom bazalnih stanica, od kojih su se u 1215 bolesnika mogle ocijeniti djelotvornost i sigurnost u liječenju lokalno uznapredovalog karcinoma bazalnih stanica (n = 1119) ili metastatskog karcinoma bazalnih stanica (n = 96).
English: • Requirements in the event of pregnancy
Croatian: ● uvjete koje treba ispuniti u slučaju trudnoće
English: *Of the 138 patients with advanced BCC, 10 were WCBP.
Croatian: *Od 138 bolesnika s uznapredovalim karcinomom bazalnih stanica njih 10 bile su žene generativne dobi.
English: Paediatric population There are insufficient pharmacokinetic data in paediatric patients.
Croatian: Ne postoji dovoljno farmakokinetičkih podataka o primjeni u pedijatrijskih bolesnika.
English: • He will tell his healthcare provider if his female partner becomes pregnant while he is taking
Croatian: ● mora obavijestiti zdravstvenog djelatnika ako njegova partnerica zatrudni dok on uzima
English: 3 patients had a best percent change in tumour size of 0; these are represented by minimal positive bars in the figure.
Croatian: U 3 je bolesnika vrijednost najboljeg postotka promjene veličine tumora iznosila 0; oni su na grafikonu prikazani stupcima s najmanjom pozitivnom vrijednošću.
English: Results from a clinical study demonstrated a 33% decrease in vismodegib unbound drug concentrations after 7 days co-treatment with 20 mg rabeprazole (a proton pump inhibitor) given 2 h before each vismodegib administration.
Croatian: Rezultati jednog kliničkog ispitivanja pokazali su smanjenje koncentracije nevezanog vismodegiba za 33% nakon 7 dana istodobnog liječenja rabeprazolom (inhibitorom protonske pumpe) u dozi od 20 mg koji se davao 2 sata prije svake primjene vismodegiba.
English: • you need to continue contraception for 24 months after your final dose of this medicine because Erivedge may remain in your body for up to 24 months after your final dose.
Croatian: ● morate nastaviti s primjenom metoda zaštite od trudnoće još 24 mjeseca nakon uzimanja posljednje doze lijeka jer se Erivedge u Vašem tijelu može zadržati do 24 mjeseca nakon uzimanja posljednje doze
English: Posology The recommended dose is one 150 mg capsule taken once daily.
Croatian: Doziranje Preporučena doza je jedna kapsula od 150 mg jedanput na dan.
English: The initial prescription and dispensing of Erivedge should occur within a maximum of 7 days of a negative pregnancy test (day of pregnancy test = day 1).
Croatian: Ograničenja za propisivanje i izdavanje lijeka ženi generativne dobi Erivedge se mora prvi puta propisati i izdati unutar najviše 7 dana od negativnog testa na trudnoću (dan testa na trudnoću = dan 1).
English: • loss of monthly periods in women of childbearing age,
Croatian: ● gubitak mjesečnice u žena koje mogu zanijeti,
English: Erivedge is an anti-cancer medicine that works by controlling one of the key proteins involved in basal cell carcinoma.
Croatian: Erivedge je lijek za liječenje raka koji djeluje tako da kontrolira jedan od glavnih proteina koji imaju ulogu u rastu karcinomu bazalnih stanica.
English: Roche Slovensko, s.r.o.
Croatian: Slovenská republika Roche Slovensko, s.r.o.
English: Malformations, including craniofacial anomalies, open perineum, and absent and/or fused digits, were observed in foetuses of dams at a dose which corresponded to 20 % of the typical steady-state exposure in patients, and a 100 % incidence of embryolethality was observed at higher doses.
Croatian: Malformacije, uključujući kraniofacijalne anomalije, otvoren perineum te nedostatak prstiju i/ili spojeni prsti, primijećene su u plodova ženki kod doze koja je odgovarala 20%-tnoj uobičajenoj izloženosti u bolesnika u stanju dinamičke ravnoteže, dok je pri višim dozama opažena stopostotna (100%) smrtnost embrija.
English: Any unused medicinal product at the end of treatment must immediately be disposed of by the patient in accordance with local requirements (if applicable, e.g. by returning the capsules to the pharmacist or physician).
Croatian: Neiskorišteni lijek na kraju liječenja bolesnik mora odmah zbrinuti sukladno nacionalnim propisima (ako je primjenjivo, npr. vratiti kapsule ljekarniku ili liječniku).
English: Metastatic BCC was defined as BCC that had spread beyond the skin to other parts of the body, including the lymph nodes, lung, bones and/or internal organs.
Croatian: Metastatski karcinom bazalnih stanica bio je definiran kao karcinom bazalnih stanica koji se proširio s kože u druge dijelove tijela, uključujući limfne čvorove, pluća, kosti i/ili unutarnje organe.
English: When vismodegib is administered with CYP inducers (rifampicin, carbamazepine, phenytoin, St. John´s wort), exposure to vismodegib may be decreased (see sections 4.3 and 4.4).
Croatian: Kada se vismodegib primjenjuje s induktorima CYP enzima (rifampicinom, karbamazepinom, fenitoinom, gospinom travom), izloženost vismodegibu može biti smanjena (vidjeti dijelove 4.3 i 4.4).
English: Roche Products Ltd.
Croatian: United Kingdom Roche Products Ltd.
English: The primary endpoint was objective response rate (ORR) as assessed by an independent review facility (IRF) as summarised in Table 2.
Croatian: Primarni ishod bila je stopa objektivnog odgovora prema procjeni neovisnog ocjenjivačkog tijela, kako je prikazano u Tablici