FrancophonIA/ELRC3.0 huggingface dataset:
English: The anticipated complications of overdose would consist of exacerbation of adverse reactions as bone marrow suppression and gastrointestinal disorders.
Croatian: Očekivane komplikacije predoziranja mogle bi uključivati pogoršanje nuspojava kao što su supresija koštane srži i gastrointestinalni poremećaji.
English: Patients with a history of congestive heart failure, or myocardial infarction within last 6 months, or patients with uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension were not included in the study.
Croatian: Bolesnici s kongestivnim zatajenjem srca u anamnezi, bolesnici koji su preboljeli infarkt miokarda u prethodnih 6 mjeseci te bolesnici s nekontroliranim srčanim aritmijama, anginom pektoris i/ili hipertenzijom nisu bili uključeni u ispitivanje.
English: There is no known antidote to cabazitaxel.
Croatian: Nema poznatog antidota za kabazitaksel.
English: Symptoms such as abdominal pain and tenderness, fever, persistent constipation, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Croatian: Simptomi poput boli i osjetljivosti u abdomenu, vrućice, dugotrajne konstipacije, proljeva, s neutropenijom ili bez nje, mogu biti rane manifestacije ozbiljne gastrointestinalne toksičnosti te ih treba odmah procijeniti i liječiti.
English: Haematuria all grades frequency was 20.8% at 25 mg/m2 in EFC11785 study (see section 5.1).
Croatian: Učestalost hematurije svih stupnjeva bila je 20,8% pri dozi od 25 mg/m2 u EFC11785 ispitivanju (vidjeti dio 5.1).
English: If the treatment is envisaged in patients with moderate hepatic impairment the dose of cabazitaxel should not exceed 15 mg/m2.
Croatian: Ako je liječenje predviđeno za bolesnike s umjerenim oštećenjem jetrene funkcije, doza kabazitaksela ne smije prijeći 15 mg/m2.
English: • antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent),
Croatian: • antihistaminika (deksklorfeniramin 5 mg ili difenhidramin 25 mg ili ekvivalent),
English: The safety profile of cabazitaxel 25 mg/m2 observed in study EFC11785 was qualitatively and quantitatively similar to that observed in the study EFC6193.
Croatian: Sigurnosni profil 25 mg/m2 kabazitaksela zabilježen u ispitivanju EFC11785 bio je kvalitativno i kvantitativno sličan onom zabilježenom u EFC6193 ispitivanju.
English: CAUTION: Two-step dilution required.
Croatian: OPREZ: Potrebno je razrjeđenje u dva koraka.
English: If patients continue to experience any of these reactions at 20 mg/m2, further dose reduction to 15 mg/m2 or discontinuation of JEVTANA may be considered.
Croatian: Ako bolesnici i dalje imaju bilo koju od navedenih nuspojava pri dozi od 20 mg/m2, može se razmotriti daljnje smanjenje doze na 15 mg/m2 ili prekid primjene lijeka JEVTANA.
English: To be taken into account if you are in a high-risk group such as patients with liver disease, or epilepsy.
Croatian: Navedeno treba uzeti u obzir ako pripadate visoko rizičnoj skupini bolesnika, kao što su bolesnici s bolešću jetre ili epilepsijom.
English: • you have severe abnormal liver function,
Croatian: • ako imate teško oštećenu funkciju jetre
English: Required amount of concentrate-solvent mixture
Croatian: Potrebna količina mješavine koncentrata i otapala
English: • JEVTANA will be given to you by a doctor or a nurse.
Croatian: • Lijek JEVTANA će Vam dati liječnik ili medicinska sestra.
English: p-value 1HR estimated using Cox model; a hazard ratio of less than 1 favours JEVTANA
Croatian: Hazard ratio) procijenjen pomoću Coxovog modela; omjer hazarda manji od 1 govori u korist lijeka JEVTANA
English: Cabazitaxel is mainly excreted in the faeces as numerous metabolites (76% of the dose); while renal excretion of cabazitaxel and metabolites account for less than 4% of the dose (2.3% as unchanged medicinal product in urine).
Croatian: Kabazitaksel se uglavnom izlučuje fecesom u obliku brojnih metabolita (76% doze), a izlučivanje kabazitaksela i metabolita bubrezima iznosi manje od 4% doze (2,3% u obliku nepromijenjenog lijeka u urinu).
English: However, in-use storage time can be longer under specific conditions mentioned in section Shelf life and special precautions for storage above.
Croatian: Međutim, vrijeme čuvanja lijeka u primjeni može biti dulje u specifičnim uvjetima navedenim u dijelu Rok valjanosti i posebne mjere za čuvanje lijeka u tekstu iznad.
English: Cabazitaxel demonstrated a broad spectrum of antitumour activity against advanced human tumours xenografted in mice.
Croatian: Kabazitaksel je pokazao širok spektar antitumorskog djelovanja protiv uznapredovalih ljudskih tumora presađenih u miševe.
English: Animal studies showed that cabazitaxel affected reproductive system in male rats and dogs without any functional effect on fertility (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su da kabazitaksel utječe na reproduktivni sustav u mužjaka štakora i pasa, bez funkcionalnog učinka na plodnost (vidjeti dio 5.3).
English: One pack of JEVTANA contains:
Croatian: Jedno pakiranje lijeka JEVTANA sadrži:
English: • Neutrophil counts less than 1,500/mm3.
Croatian: • Broj neutrofila < 1500 stanica/mm3.
English: JEVTANA must not be mixed with any other medicinal products than those mentioned in section 6.6.
Croatian: JEVTANA se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: Cabazitaxel treatment delay or discontinuation may be necessary.
Croatian: Možda će biti potrebno odgoditi ili prekinuti liječenje kabazitakselom.
English: Practical information for handling and administration of JEVTANA for doctors, nurses and pharmacists is provided with this leaflet.
Croatian: Praktične informacije o rukovanju i primjeni lijeka JEVTANA za liječnike, medicinske sestre i ljekarnike uključene su u ovu uputu.
English: After a 1-hour intravenous infusion [14C]-cabazitaxel at 25 mg/m2 in patients, approximately 80% of the administered dose was eliminated within 2 weeks.
Croatian: Nakon jednosatne intravenske infuzije [14C]-kabazitaksela u dozi od 25 mg/m2 oko 80% primijenjene doze eliminirano je u roku od 2 tjedna.
English: JEVTANA should not be used in pregnant women or women of childbearing age not using contraception.
Croatian: JEVTANA se ne smije primjenjivati u trudnica niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: This is because JEVTANA may increase the risk of bleeding or developing holes in the gut wall.
Croatian: Naime, JEVTANA može povećati rizik od krvarenja ili nastanka pukotina u stijenci crijeva.
English: From 20 to 15 mg/m2: 58 (10.0%) From 15 to 12 mg/m2: 9 (1.6%)
Croatian: Od 20 do 15 mg/m2: 58 (10,0%) Od 15 do 12 mg/m2: 9 (1,6%)
English: Of the 595 patients treated with cabazitaxel 25 mg/m2 in the prostate cancer EFC 11785 study, 420 patients were 65 years or over.
Croatian: Od 595 bolesnika liječenih s 25 mg/m2 kabazitaksela u EFC 11785 ispitivanju karcinoma prostate, 420 bolesnika bilo je u dobi od 65 ili više godina.
English: If patients experience nausea or vomiting, they may be treated with commonly used anti-emetics.
Croatian: Ako se u bolesnika pojavi mučnina ili povraćanje, mogu se primijeniti uobičajeni antiemetici.
English: The most common adverse reactions leading to cabazitaxel discontinuation was neutropenia.
Croatian: Najčešća nuspojava koja je uzrokovala prekid liječenja kabazitakselom bila je neutropenija.
English: • you have blood in your urine.
Croatian: • ako imate krv u mokraći.
English: Seven metabolites were detected in plasma (including 3 active metabolites issued form O-demethylations), with the main one accounting for 5% of parent exposure.
Croatian: 7 metabolita (uključujući 3 aktivna metabolita O-demetiliranog oblika), s tim da glavni metabolit čini
English: The median number of cycles was 6 in the JEVTANA group and 4 in the mitoxantrone group.
Croatian: Medijan broja ciklusa bio je 6 u skupini koja je primala lijek JEVTANA, a 4 u skupini koja je primala mitoksantron.
English: An in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) is recommended during administration.
Croatian: Tijekom primjene lijeka preporučuje se korištenje linijskog filtera nominalne veličine pora od 0,22 mikrometra (označava se i kao veličina od 0,2 mikrometra).
English: Caution is advised with treatment of patients most at risk of developing gastrointestinal complications: those with neutropenia, the elderly, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and patients with a prior history of pelvic radiotherapy or gastrointestinal disease, such as ulceration and GI bleeding.
Croatian: Savjetuje se oprez u liječenju bolesnika u kojih postoji najveći rizik od razvoja gastrointestinalnih komplikacija: bolesnika s neutropenijom, starijih osoba, bolesnika koji istodobno primaju NSAIL-e, antitrombocitnu terapiju ili antikoagulanse te bolesnika koji u anamnezi imaju radioterapiju zdjelice ili bolest probavnog sustava, poput ulceracije i gastrointestinalnog krvarenja.
English: The solvent contains 573.3 mg ethanol 96% (15% v/v), equivalent to 14 ml of beer or 6 ml of wine.
Croatian: Otapalo sadrži 573,3 mg 96%-tnog etanola (15% v/v), što odgovara količini od 14 ml piva ili 6 ml vina.
English: In the population pharmacokinetic analysis in 70 patients of 65 years and older (57 from 65 to 75 and 13 patients above 75), no age effect on the pharmacokinetics of cabazitaxel was observed.
Croatian: U populacijskoj farmakokinetičkoj analizi 70 bolesnika u dobi od 65 i više godina (57 bolesnika u dobi od 65 do 75 godina i 13 starijih od 75 godina) nije opažen učinak dobi na farmakokinetiku kabazitaksela.
English: The dose should be reduced in case of febrile neutropenia, or prolonged neutropenia despite appropriate treatment (see section 4.2).
Croatian: Dozu je potrebno smanjiti u slučaju febrilne neutropenije ili produljene neutropenije prisutne usprkos odgovarajućem liječenju (vidjeti dio 4.2).
English: Cabazitaxel may influence the ability to drive and use machines as it may cause fatigue and dizziness.
Croatian: Kabazitaksel može utjecati na sposobnost upravljanja vozilima i rada sa strojevima jer može uzrokovati umor i omaglicu.
English: Based on in vitro studies, the potential risk of inhibition by cabazitaxel at clinically relevant concentrations is possible towards medicinal products that are mainly substrate of CYP3A.
Croatian: Na temelju rezultata ispitivanja in vitro postoji potencijalan rizik da kabazitaksel u klinički relevantnim koncentracijama inhibira djelovanje lijekova koji su većinom supstrati CYP3A.
English: What you need to know before you are given JEVTANA
Croatian: Što morate znati prije nego počnete primati lijek JEVTANA
English: Cabazitaxel did not affect mating performances or fertility of treated male rats.
Croatian: Kabazitaksel nije utjecao na sposobnost parenja niti na plodnost tretiranih mužjaka štakora.
English: This fill volume has been established during the development of JEVTANA to compensate for liquid loss during preparation of the premix.
Croatian: Ovaj volumen punjenja utvrđen je tijekom razvoja lijeka JEVTANA kako bi se nadoknadio gubitak tekućine tijekom pripreme početne otopine.
English: • abnormal feeling or loss of sensation or pain in hands and feet
Croatian: • neuobičajen osjećaj ili gubitak osjeta ili bol u šakama i stopalima
English: Due to potential exposure via seminal liquid, men treated with cabazitaxel should prevent contact with the ejaculate by another person throughout treatment.
Croatian: Zbog moguće izloženosti putem sjemene tekućine muškarci koji se liječe kabazitakselom moraju spriječiti da druge osobe dođu u kontakt s ejakulatom za vrijeme cjelokupnog trajanja liječenja.
English: Cabazitaxel is extensively metabolised in the liver (>95%), mainly by the CYP3A isoenzyme (80% to 90%).
Croatian: Kabazitaksel se većinom metabolizira u jetri (> 95%), uglavnom pomoću izoenzima CYP3A (80% do 90%).
English: Diarrhoea can occur more frequently in patients that have received prior abdomino-pelvic radiation.
Croatian: Proljev se može češće pojaviti u bolesnika u kojih je prethodno zračeno područje abdomena/zdjelice.
English: You may feel tired or dizzy when having this medicine.
Croatian: Možete osjećati umor ili omaglicu tijekom liječenja ovim lijekom.
English: Cabazitaxel induced embryofoetal toxicity in female rats treated intravenously once daily from gestational days 6 through 17 linked with maternal toxicity and consisted of foetal deaths and decreased mean foetal weight associated with delay in skeletal ossification.
Croatian: Kabazitaksel je u ženki štakora tretiranih intravenski jednom dnevno od 6. do 17. dana gestacije izazvao embriofetalnu toksičnost, što je bilo povezano s toksičnošću za majku, a uključivalo je smrt ploda i smanjenu prosječnu težinu ploda povezanu sa zastojem osifikacije kostura.
English: Cabazitaxel did not inhibit in vitro the major biotransformation pathway of warfarin into 7-hydroxywarfarin, which is mediated by CYP2C9.
Croatian: U ispitivanjima in vitro kabazitaksel nije inhibirao glavni put biotransformacije varfarina u 7-hidroksivarfarin, koju posreduje CYP2C9.
English: Carcinogenicity studies have not been conducted with cabazitaxel.
Croatian: Nisu provedena ispitivanja kancerogenosti kabazitaksela.
English: Serum creatinine should be measured at baseline, with each blood count and whenever the patient reports a change in urinary output.
Croatian: Razinu kreatinina u serumu potrebno je izmjeriti na početku liječenja, prilikom svake kontrole krvne slike te uvijek kada bolesnik prijavi promjenu u volumenu urina.
English: • mental confusion
Croatian: • psihička smetenost
English: Available pharmacokinetics data in animals have shown excretion of cabazitaxel and its metabolites in milk (see section 5.3).
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se kabazitaksel i njegovi metaboliti izlučuju u mlijeko (vidjeti dio 5.3).
English: From 25 to 20 mg/m2: 128 (21.5%) From 20 to 15 mg/m2: 19 (3.2%) From 15 to 12 mg/m2: 1 (0.2%)
Croatian: Od 25 do 20 mg/m2: 128 (21,5%) Od 20 do 15 mg/m2: 19 (3,2%) Od 15 do 12 mg/m2: 1 (0,2%)
English: This can occur if you have severe or long-lasting diarrhoea, or fever, or if you are being sick
Croatian: Može se javiti ako imate težak ili dugotrajan proljev ili vrućicu, ili ako povraćate.
English: Cabazitaxel is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Primjena kabazitaksela se ne preporučuje tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: As with other cytotoxic medicinal products, cabazitaxel may cause foetal harm in exposed pregnant women.
Croatian: Kao i drugi citostatici, kabazitaksel može oštetiti fetus kad se daje trudnicama.
English: Patients under treatment with cabazitaxel should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop.
Croatian: Bolesnicima koji se liječe kabazitakselom potrebno je napomenuti da obavijeste svog liječnika prije nastavka liječenja o pojavi simptoma neuropatije, kao što su bol, pečenje, trnci, utrnulost ili slabost.
English: Exposures in animals were similar or lower than those seen in humans receiving clinically relevant doses of cabazitaxel.
Croatian: Izloženost lijeku u životinja bila je slična ili niža od one u ljudi koji primaju klinički relevantne doze kabazitaksela.
English: Caution is recommended in patients with haemoglobin <10 g/dl and appropriate measures should be taken as clinically indicated.
Croatian: U bolesnika s vrijednošću hemoglobina <10 g/dl preporučuje se oprez te je potrebno poduzeti odgovarajuće mjere sukladno kliničkoj slici.
English: The use of G-CSF has been shown to limit the incidence and severity of neutropenia (see sections 4.2 and 4.4).
Croatian: Pokazalo se da primjena G-CSF-a smanjuje incidenciju i težinu neutropenije (vidjeti dijelove 4.2 i 4.4).
English: If JEVTANA, at any step of its handling, should come into contact with the skin, wash immediately and thoroughly with soap and water.
Croatian: Ako lijek JEVTANA u bilo kojoj fazi rukovanja dođe u dodir s kožom, to mjesto treba odmah temeljito isprati sapunom i vodom.
English: This can occur if you have a hole in the stomach, food pipe, gut or bowel (gastrointestinal perforation).
Croatian: To se može dogoditi ako imate pukotinu u želucu, jednjaku ili crijevima (perforaciju u probavnom sustavu).
English: To limit foaming as much as possible when injecting the solvent, direct the needle onto the inside wall of the vial of concentrate solution and inject slowly.
Croatian: Kako biste što više smanjili pjenjenje prilikom ubrizgavanja otapala, usmjerite iglu na unutarnju stijenku bočice s otopinom koncentrata te ubrizgavajte polako.
English: There was no statistical difference between both treatment arms in pain progression and pain response.
Croatian: Među liječenim skupinama bolesnika nisu zabilježene statističke razlike u progresiji boli i učinku liječenja na bol.
English: These medicines include the following: - ketoconazole, rifampicin (for infections); - carbamazepine, phenobarbital or phenytoin (for seizures); - St John's Wort (Hypericum perforatum) (herbal remedy for depression and other conditions); - statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (for reducing the cholesterol in your blood); - valsartan (for hypertension); - repaglinide (for diabetes).
Croatian: Ti lijekovi uključuju: - ketokonazol, rifampicin (za liječenje infekcija), - karbamazepin, fenobarbital ili fenitoin (za liječenje epileptičkih napadaja), - gospinu travu (Hypericum perforatum) (biljni lijek za depresiju i druga stanja), - statine (kao što su simvastatin, lovastatin, atorvastatin, rosuvastatin ili pravastatin) (za snižavanje razine kolesterola u krvi),
English: A population pharmacokinetic analysis was carried out in 170 patients including patients with advanced solid tumours (n=69), metastatic breast cancer (n=34) and metastatic prostate cancer (n=67).
Croatian: 5.2 Farmakokinetička svojstva Populacijska farmakokinetička analiza provedena je u 170 bolesnika, uključujući bolesnike s uznapredovalim solidnim tumorima (n=69), metastatskim karcinomom dojke (n=34) i metastatskim karcinomom prostate (n=67).
English: Table 3 - Efficacy of JEVTANA in EFC6193 study in the treatment of patients with metastatic castration resistant prostate cancer
Croatian: Tablica 3. Djelotvornost lijeka JEVTANA u EFC6193 ispitivanju u liječenju bolesnika s metastatskim karcinomom prostate rezistentnim na kastraciju
English: However a clinical study has shown that cabazitaxel (25 mg/m2 administered as a single 1-hour infusion) did not modify the plasma levels of midazolam, a probe substrate of CYP3A.
Croatian: Međutim, jedno je kliničko ispitivanje pokazalo da kabazitaksel (doza od 25 mg/m2 primijenjena u obliku jednokratne jednosatne infuzije) nije utjecao na razine midazolama, testnog supstrata CYP3A, u plazmi.
English: In addition, cabazitaxel demonstrated activity in tumour models insensitive to chemotherapy including docetaxel.
Croatian: Osim toga, kabazitaskel je pokazao aktivnost u tumorskim modelima neosjetljivim na kemoterapiju koja uključuje docetaksel.
English: Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed.
Croatian: Neophodno je kontrolirati kompletnu krvnu sliku na tjednoj bazi tijekom 1. ciklusa i prije svakog sljedećeg ciklusa liječenja,
English: Cardiac disorders* Atrial fibrillation Tachycardia
Croatian: Srčani poremećaji* fibrilacija atrija tahikardija
English: No dose adjustment is necessary in patients with renal impairment, not requiring hemodialysis.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrežne funkcije kojima nije potrebna hemodijaliza.
English: As for any other antineoplastic agent, caution should be exercised when handling and preparing JEVTANA solutions, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.
Croatian: Kao i kod svih drugih antineoplastičnih lijekova, potreban je oprez prilikom rukovanja i pripreme otopine lijeka JEVTANA, što se odnosi na primjenu mjera zaštite od zagađenja, uporabu osobne zaštitne opreme (npr. rukavice) i postupke pripreme.
English: Therefore, no pharmacokinetic interaction of cabazitaxel on warfarin is expected in vivo.
Croatian: Stoga se ne očekuje farmakokinetička interakcija kabazitaksela i varfarina in vivo.
English: Transaminases increased a based on laboratory values
Croatian: Temeljeno na laboratorijskim vrijednostima
English: Adverse reactions are listed in table 2 according to MedDRA system organ class and frequency categories.
Croatian: Tablični prikaz nuspojava Nuspojave u Tablici 2 navedene su prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
English: The incidence of tachycardia on cabazitaxel was 1.6%, none of which were Grade ≥3.
Croatian: Incidencija tahikardije u bolesnika liječenih kabazitakselom iznosila je 1,6%, a niti jedan slučaj nije bio stupnja ≥ 3.
English: Results of environmental risk assessment studies indicated that use of JEVTANA will not cause significant risk to the aquatic environment (see section 6.6 for disposal of unused product).
Croatian: Rezultati studija procjene rizika za okoliš ukazuju na to da primjena lijeka JEVTANA ne predstavlja značajan rizik za vode u okolišu (za zbrinjavanje neiskorištenog lijeka, vidjeti dio 6.6).
English: Concentrate vial (60 mg - 1.5 ml)
Croatian: (60 mg - 1,5 ml)
English: Studies in animals have shown reproductive toxicity at maternotoxic doses (see section 5.3) and that cabazitaxel crosses the placenta barrier (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost u dozama toksičnim za ženku (vidjeti dio 5.3) kao i činjenicu da kabazitaksel prolazi placentarnu barijeru (vidjeti dio 5.3).
English: See leaflet for further information.
Croatian: Pogledajte Uputu o lijeku za daljnje informacije.
English: Exposures in animals were lower than those seen in humans receiving clinically relevant doses of cabazitaxel.
Croatian: Izloženost lijeku u životinja bila je niža od one u ljudi koji primaju klinički relevantne doze kabazitaksela.
English: The solvent is a clear and colourless solution.
Croatian: Otapalo je bistra i bezbojna otopina.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane od najozbiljnije prema manje ozbiljnima.
English: Concentrate vial: polysorbate 80 and citric acid; Solvent vial: ethanol 96% and water for injections.
Croatian: Bočica s koncentratom: polisorbat 80 i citratna kiselina; Bočica s otapalom: etanol 96% i voda za injekcije.
English: Risk of neutropenia
Croatian: Rizik od neutropenije
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek JEVTANA Lijek čuvajte izvan pogleda i dohvata djece.
English: Data in patients below the 20 mg/m2 dose are limited.
Croatian: Podaci o primjeni u bolesnika s dozom manjom od 20 mg/m2 su ograničeni.
English: Excipient with known effect Each vial of solvent contains 573.3 mg of ethanol 96%.
Croatian: Pomoćna tvar s poznatim učinkom Jedna bočica otapala sadrži 573,3 mg 96%-tnog etanola.
English: Hazard Ratioa versus CBZ25+PRED 1-sided 98.89% UCI 1-sided 95% LCI CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone CI=confidence interval, LCI=lower bound of the confidence interval, UCI=upper bound of the confidence interval a Hazard ratio is estimated using a Cox Proportional Hazards regression model.
Croatian: Omjer hazardaa naspram CBZ25+PRED jednostrano 98,89% UCI jednostrano 95% LCI CBZ20=20 mg/m2 kabazitaksela, CBZ25=25 mg/m2 kabazitaksela, PRED=prednizon/prednizolon CI=interval pouzdanosti, LCI (engl. lower bound of the confidence interval) = donja granica intervala pouzdanosti, UCI (engl. upper bound of the confidence interval) =gornja granica intervala pouzdanosti a Omjer hazarda procijenjen je koristeći Coxov model regresije proporcionalnih hazarda.