FrancophonIA/ELRC3.0 huggingface dataset:
English: Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with Avastin therapy are likely to be dose-dependent.
Croatian: Analize kliničkih podataka o sigurnosti primjene upućuju na to da pojava hipertenzije i proteinurije tijekom liječenja lijekom Avastin vjerojatno ovisi o dozi.
English: In all clinical trials, bevacizumab was administered as an IV infusion.
Croatian: U svim je kliničkim ispitivanjima bevacizumab primijenjen u obliku intravenske infuzije.
English: If this happens you should talk to your doctor, pharmacist or nurse immediately.
Croatian: Ako se to dogodi, morate se odmah obratiti liječniku, ljekarniku ili medicinskoj sestri.
English: Table 2 also includes adverse reactions which are considered by the MAH to be clinically significant or severe.
Croatian: U Tablicu 2 su uključene i one nuspojave koje nositelj odobrenja smatra klinički značajnima ili teškima.
English: Table 13 Efficacy results for trial BO17704
Croatian: Tablica 13 Rezultati djelotvornosti za ispitivanje BO17704
English: Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with Avastin treatment.
Croatian: Smanjen broj neutrofila, smanjen broj leukocita i prisutnost proteina u mokraći mogu biti povezani s liječenjem lijekom Avastin.
English: Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, Avastin therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy.
Croatian: Mogući čimbenici rizika obuhvaćaju histološki tip tumora skvamoznih stanica, liječenje antireumatskim/protuupalnim lijekovima, liječenje antikoagulansima, prethodnu radioterapiju, terapiju lijekom Avastin, anamnezu ateroskleroze te središnju lokalizaciju i kavitacije tumora prije ili tijekom liječenja.
English: Prior anthracyclines exposure and/or prior radiation to the chest wall may be possible risk factors for the development of CHF.
Croatian: Prethodna izloženost antraciklinima i/ili zračenje stijenke prsnog koša mogući su čimbenici rizika za razvoj kongestivnog zatajenja srca.
English: Alternatively, a 1.25 mg/m2 dose could be administered over 30 minutes on Days 1-5
Croatian: Alternativno se mogla primjenjivati doza od 1,25 mg/m2 tijekom 30 minuta od 1. do 5. dana svaka 3 tjedna.
English: Recurrence of cancer within the field of prior radiation is an additional important risk factor for the development of GI-vaginal fistulae.
Croatian: Recidiv karcinoma unutar područja koje je prethodno bilo zračeno dodatan je važan čimbenik rizika za razvoj gastrointestinalno-vaginalne fistule.
English: Eye disorder, Lacrimation increased
Croatian: Poremećaji oka poremećaj oka, pojačano suzenje
English: This group of medical terms may involve the same underlying pathophysiology (e.g. arterial thromboembolic reactions include cerebrovascular accident, myocardial infarction, transient ischaemic attack and other arterial thromboembolic reactions).
Croatian: Ovaj skup medicinskih pojmova može imati istu patofiziološku podlogu (npr. arterijske tromboembolijske reakcije uključuju cerebrovaskularni incident, infarkt miokarda, tranzitorne ishemijske atake i druge arterijske tromboembolijske reakcije).
English: New cases of ovarian failure were reported in 2.6% patients in the mFOLFOX-6 group compared to 39% in the mFOLFOX-6 + bevacizumab group.
Croatian: bolesnica u skupini mFOLFOX-6 u usporedbi s 39% njih u skupini mFOLFOX-6 + bevacizumab.
English: Avastin may impair female fertility (see sections 4.6 and 4.8).
Croatian: Avastin može narušiti plodnost u žena (vidjeti dijelove 4.6 i 4.8).
English: In Avastin clinical trials, gastrointestinal fistulae (all grade) have been reported with an incidence of up to 2% in patients with metastatic colorectal cancer and ovarian cancer, but were also reported less commonly in patients with other types of cancer.
Croatian: U kliničkim ispitivanjima lijeka Avastin prijavljena incidencija gastrointestinalnih fistula (svih stupnjeva) iznosila je do 2% u bolesnika s metastatskim kolorektalnim karcinomom i karcinomom jajnika, no one su prijavljene manje često i u bolesnika s drugim oblicima karcinoma.
English: 7.5 mg/kg IV 30-90 min
Croatian: 7,5 mg/kg i.v. 30-90 min
English: The incidence of CNS bleeding in patients with untreated CNS metastases receiving bevacizumab has not been prospectively evaluated in randomised clinical trials.
Croatian: Incidencija krvarenja u SŽS-u u bolesnika s neliječenim metastazama u SŽS-u koji su primali bevacizumab nije prospektivno ocijenjena u randomiziranim kliničkim ispitivanjima.
English: Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor (EGFR).
Croatian: Avastin se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica kada stanice raka imaju specifične mutacije proteina koji se zove receptor epidermalnog faktora rasta (engl. epidermal growth factor receptor, EGFR).
English: The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%,
Croatian: Randomizirano je 649 bolesnika (od kojih je 641 liječen) funkcionalnog statusa po Karnofskom
English: 878 patients were randomised to the two arms.
Croatian: U te je dvije skupine randomizirano 878 bolesnika.
English: The metabolism and elimination of bevacizumab is similar to endogenous IgG i.e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
Croatian: Metabolizam i eliminacija bevacizumaba slični su endogenom IgG-u, tj. primarno se odvijaju putem proteolitičkog katabolizma u čitavom tijelu, uključujući endotelne stanice,
English: Cases of Osteonecrosis of the Jaw (ONJ) have been reported in patients treated with Avastin, most of which occurred in patients who had identified risk factors for ONJ, in particular exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4)
Croatian: Prijavljeni su slučajevi osteonekroze čeljusti u bolesnika liječenih lijekom Avastin, većinom u bolesnika koji su imali poznate čimbenike rizika za osteonekrozu čeljusti, osobito izloženost intravenskim bisfosfonatima i/ili bolest zuba koja je zahtijevala invazivne stomatološke zahvate u anamnezi (vidjeti i dio 4.4).
English: In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving Avastin.
Croatian: U kliničkim je ispitivanjima proteinurija prijavljena u između 0,7% i 54,7% bolesnika koji su primali
English: Paediatric population The safety and efficacy of Avastin in children less than 18 years old have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost primjene lijeka Avastin u djece mlađe od 18 godina nisu ustanovljene.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Read the package leaflet before use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon razrjeđivanja Prije uporabe pročitajte uputu o lijeku
English: Overall approximately 34% of patients were FIGO Stage III optimally debulked with gross residual disease, 40% Stage III sub-optimally debulked, and 26% were Stage IV patients.
Croatian: Približno 34% bolesnica imalo je po FIGO klasifikaciji bolest stadija III uz optimalno odstranjenu tumorsku masu, ali uz velik rezidualni tumor; 40% bolesnica bolest stadija III uz suboptimalno odstranjenu tumorsku masu, a 26% bolesnica bilo je u stadiju IV.
English: ● an abnormal tube-like connection or passage between the windpipe and the gullet, between internal organs and skin, between the vagina and any parts of the gut or between other tissues that are not normally connected (fistula), and are judged by your doctor to be severe,
Croatian: ● u slučaju pojave neuobičajenog spoja ili kanala između dušnika i jednjaka, između unutarnjih organa i kože, između rodnice i bilo kojeg dijela probavnog sustava ili između drugih tkiva koja inače nisu povezana (fistula), a koje Vaš liječnik smatra teškim,
English: In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with Avastin.
Croatian: U izvješćima objavljenima u literaturi zabilježeni su slučajevi osteonekroze koja nije zahvaćala čeljust u bolesnika mlađih od 18 godina liječenih lijekom Avastin.
English: Day 1, prior to XELOX, q 3 weeks
Croatian: 1. dana prije primjene protokola XELOX, svaka 3 tjedna
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake Rok valjanosti ili EXP.
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + Avastin) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression free survival was 8.8 months.
Croatian: 5 mg/kg svaka 2 tjedna b u odnosu na kontrolnu skupinu Za 110 bolesnika randomiziranih u skupinu 3 (5-FU/FA + Avastin) prije prekida uključivanja u tu skupinu medijan ukupnog preživljenja iznosio je 18,3 mjeseca, a medijan preživljenja bez progresije bolesti 8,8 mjeseci.
English: • a hole in the cartilage wall separating the nostrils of the nose,
Croatian: ● otvor u nosnom septumu - koštanoj pregradi koja razdvaja nosnice,
English: • dry mouth in combination with thirst and/or reduced or darkened urine,
Croatian: ● suhoću usta uz osjećaj žeđi i/ili smanjenu količinu mokraće ili tamniju mokraću,
English: Most patients were FIGO Stage III (both 68%) followed by FIGO Stage IV (13% and 14%), FIGO Stage II (10% and 11%) and FIGO Stage I (9% and 7%).
Croatian: Većina bolesnica bila je u FIGO stadiju III bolesti (68% u obje skupine), nakon čega je najčešći bio FIGO stadij IV (13% odnosno 14%), FIGO stadij II (10% odnosno 11%) te FIGO
English: This is consistent with results in patients in other studies of metastatic breast cancer who did not receive concurrent anthracycline treatment (NCI-CTCAE v.3) (see section 4.8).
Croatian: To se podudara s nalazima u bolesnika iz drugih ispitivanja metastatskoga karcinoma dojke koji nisu istodobno liječeni antraciklinima (NCI-CTCAE v.3) (vidjeti dio 4.8).
English: • feeling of numbness or tingling in hands or feet,
Croatian: ● osjećaj utrnulosti ili trnce u šakama ili stopalima,
English: However, patients who developed venous thrombosis while receiving therapy did not appear to have an increased rate of Grade 3 or above bleeding when treated with a full dose of warfarin and Avastin concomitantly (NCI-CTCAE v.3).
Croatian: Međutim, bolesnici u kojih se tijekom liječenja razvila venska tromboza nisu imali povećanu stopu krvarenja stupnja 3 ili višeg stupnja pri istodobnom liječenju punom dozom varfarina i lijekom Avastin (NCI
English: Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with Avastin through:
Croatian: U Tablici 1 navedene su sve nuspojave prema učestalosti za koje je utvrđena uzročna povezanost s primjenom lijeka Avastin:
English: In the Avastin-containing arms, patients could receive Avastin as a single-agent every 3 weeks until disease progression or unacceptable toxicity.
Croatian: U skupinama koje su primale Avastin bolesnici su mogli dobivati Avastin i kao jedini lijek svaka tri tjedna do progresije bolesti ili razvoja neprihvatljive toksičnosti.
English: At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
Croatian: U trenutku završne primarne analize, za primarnu mjeru ishoda - preživljenje bez događaja prema ocjeni neovisnog središnjeg povjerenstva - nije bilo statistički značajne razlike između dvije liječene skupine, uz HR 0,93 (95% CI: 0,61; 1.41; p-vrijednost = 0,72).
English: • Topotecan 4 mg/m2 as a 30-minute IV infusion on Days 1, 8, and 15 every 4 weeks.
Croatian: • topotekan 4 mg/m2 u obliku 30-minutne i.v. infuzije 1., 8. i 15. dana svaka 4 tjedna.
English: An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
Croatian: (p-vrijednost = 0,3360) Eksploracijski multivarijatni Coxov regresijski model sa selekcijom unatrag (engl. “backward selection”) pokazao je da su sljedeći ishodišni prognostički čimbenici izrazito povezani s preživljenjem, neovisno o liječenju: spol, broj bijelih krvnih stanica, trombociti, gubitak tjelesne težine tijekom 6 mjeseci prije uključenja u ispitivanje, broj metastatskih sijela, zbroj najdužeg promjera ciljnih lezija i procjena po Motzeru.
English: Avastin has been developed and made to treat cancer by injecting it into the bloodstream.
Croatian: Avastin je razvijen i proizveden za liječenje raka primjenom u krvotok.
English: Table 21 Progression-free survival by time from last platinum therapy to recurrence Investigator Assessment
Croatian: Tablica 21 Preživljenje bez progresije bolesti prema vremenu od posljednje terapije platinom do recidiva
English: CT (n=182)
Croatian: KT (n=182)
English: Necrotising fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation (rare) (see also section 4.4)
Croatian: Infekcije i infestacije Nekrotizirajući fasciitis, obično kao posljedica komplikacija pri zacjeljivanju rana, gastrointestinalne perforacije ili stvaranja fistule (rijetko) (vidjeti i dio 4.4).
English: 5 mg/kg IV 30-90 min
Croatian: 5 mg/kg i.v. 30-90 min
English: While the incidence of CHF was, in both arms, above that previously observed for doxorubicin therapy, the rate was higher in the R-CHOP plus bevacizumab arm.
Croatian: Dok je incidencija kongestivnog zatajenja srca u obje skupine bila viša od one zabilježene kod liječenja doksorubicinom, stopa je bila veća u skupini koja je primala R-CHOP uz bevacizumab.
English: Cisplatin/Gemcitabine + Avastin
Croatian: Cisplatin/Gemcitabin + Avastin
English: Gastrointestinal perforations have been reported in clinical trials with an incidence of less than 1% in patients with non-squamous non-small cell lung cancer, up to 1.3% in patients with metastatic breast cancer, up to 2.0% in patients with metastatic renal cell cancer or in patients with ovarian cancer, and up to 2.7% (including gastrointestinal fistula and abscess) in patients with metastatic colorectal cancer.
Croatian: Gastrointestinalne perforacije su u kliničkim ispitivanjima prijavljene s incidencijom manjom od 1% u bolesnika s neskvamoznim karcinomom pluća nemalih stanica, najviše 1,3% u bolesnika s metastatskim karcinomom dojke, najviše 2,0% u bolesnika s metastatskim karcinomom bubrežnih stanica ili bolesnica s karcinomom jajnika te u najviše 2,7% (uključujući gastrointestinalne fistule i apsces) bolesnika s metastatskim kolorektalnim karcinomom.
English: In one clinical trial evaluating Avastin in combination with 5-fluorouracil/folinic acid, AVF2192g, patients with metastatic colorectal cancer who were not candidates for treatment with irinotecan were included.
Croatian: U jedno kliničko ispitivanje AVF2192g, u kojem se Avastin ispitivao u kombinaciji s 5-fluorouracilom/ folnom kiselinom, uključeni su bolesnici s metastatskim kolorektalnim karcinomom koji nisu bili kandidati za liječenje irinotekanom.
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of treated patients.
Croatian: Proteinurija stupnja 4 (nefrotski sindrom) zabilježena je u najviše 1,4% liječenih bolesnika.
English: Table 5 Efficacy results for trials AVF0780g and AVF2192g AVF0780g
Croatian: Rezultati djelotvornosti za ispitivanja AVF0780g i AVF2192g
English: Patients who develop GI-vaginal fistulae may also have bowel obstructions and require surgical intervention as well as diverting ostomies.
Croatian: Bolesnice u kojih se pojave gastrointestinalno-vaginalne fistule mogu imati i opstrukciju crijeva, što može zahtijevati kiruršku intervenciju kao i izvođenje preusmjeravajućih stoma.
English: Across clinical trials, the following Grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with Avastin with at least a 2% difference compared to the corresponding control groups: hyperglycaemia, decreased haemoglobin, hypokalaemia, hyponatraemia, decreased white blood cell count, increased international normalised ratio (INR).
Croatian: Sljedeća odstupanja laboratorijskih nalaza stupnja 3 i 4 (NCI-CTCAE v.3) u svim su se kliničkim ispitivanjima javljala s razlikom od najmanje 2% između bolesnika liječenih lijekom Avastin i odgovarajućih kontrolnih skupina: hiperglikemija, snižena razina hemoglobina, hipokalijemija, hiponatrijemija, smanjen broj leukocita, povišena vrijednost INR-a (internacionalni normalizirani omjer).
English: Table 20 Efficacy results from study AVF4095g
Croatian: Tablica 20 Rezultati djelotvornosti za ispitivanje AVF4095g
English: Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar iste kategorije učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: Prior radiation is a major risk factor for the development of GI-vaginal fistulae and all patients with GIvaginal fistulae had a history of prior radiation.
Croatian: Prethodno zračenje značajan je čimbenik rizika za razvoj gastrointestinalno-vaginalne fistule, a sve bolesnice s gastrointestinalnovaginalnom fistulom prethodno su bile liječene zračenjem.
English: Some of the adverse reactions are reactions commonly seen with chemotherapy; however, Avastin may exacerbate these reactions when combined with chemotherapeutic agents.
Croatian: Neke od nuspojava su nuspojave koje se često javljaju uz kemoterapiju međutim, Avastin može pogoršati te nuspojave kada se primjenjuje u kombinaciji s kemoterapijskim lijekovima.
English: Eligible patients had epithelial ovarian, fallopian tube or primary peritoneal cancer that progressed within <6 months of previous platinum therapy consisting of a minimum of 4 platinum therapy cycles.
Croatian: Bolesnice koje su se mogle uključiti u ispitivanje imale su epitelni karcinom jajnika, karcinom jajovoda ili primarni peritonealni karcinom koji je progredirao unutar < 6 mjeseci od prethodne terapije platinom, koja je obuhvaćala najmanje 4 ciklusa terapije platinom.
English: The secondary endpoint of Overall Survival (OS) was not mature .
Croatian: Podaci za sekundarnu mjeru ishoda - ukupno preživljenje - nisu bili zreli.
English: In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the Avastin containing arms compared with up to 14% in the control arms.
Croatian: U kliničkim ispitivanjima, osim u ispitivanju JO25567, ukupna incidencija hipertenzije (svih stupnjeva), dosezala je do 42,1% u skupinama čije je liječenje uključivalo Avastin, u usporedbi s najviše 14% u kontrolnim skupinama.
English: The addition of bevacizumab to fluoropyrimidine-based chemotherapy resulted in a statistically significant prolongation of survival in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen (ITT = 819) (see Table 9).
Croatian: Dodavanje bevacizumaba kemoterapiji na bazi fluoropirimidina dovelo je do statistički značajnog produljenja preživljenja u bolesnika s metastatskim karcinomom kolona ili rektuma u kojih je došlo do progresije bolesti nakon prve linije liječenja koja je sadržavala bevacizumab (ITT = 819) (vidjeti Tablicu 9).
English: A total of 1873 patients were randomised in equal proportions to the following three arms:
Croatian: Ukupno su randomizirane 1873 bolesnice u jednakim omjerima u sljedeće tri skupine:
English: There is no information on the safety profile of Avastin in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting Avastin treatment, as such patients were excluded from clinical trials.
Croatian: Nema podataka o sigurnosnom profilu lijeka Avastin u bolesnika s prirođenom hemoragijskom dijatezom, stečenom koagulopatijom niti u bolesnika koji su prije početka liječenja lijekom Avastin primali punu dozu antikoagulanasa za liječenje tromboembolije jer takvi bolesnici nisu bili uključeni u klinička ispitivanja.
English: A total of 673 patients were randomized in equal proportions to the following two treatment arms:
Croatian: Ukupno su 673 bolesnice randomizirane u jednakim udjelima u sljedeće dvije liječene skupine:
English: • heart failure,
Croatian: ● zatajenje srca,
English: In two subsequent studies in patients with treated brain metastases (which included around 800 patients), one case of Grade 2 CNS haemorrhage was reported in 83 subjects treated with bevacizumab (1.2%) at the time of interim safety analysis (NCI-CTCAE v.3).
Croatian: U dva kasnija ispitivanja u bolesnika s liječenim metastazama na mozgu (koja su obuhvaćala približno 800 bolesnika) u vrijeme međuanalize sigurnosti primjene u 83 bolesnika liječenih bevacizumabom prijavljen je jedan slučaj krvarenja u SŽS-u stupnja 2 (1,2%) (NCI-CTCAE v.3).
English: For dilution and other handling recommendations, see section 6.6.
Croatian: Za preporuke o razrjeđivanju i druga rukovanja lijekom vidjeti dio 6.6.
English: An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Croatian: Preliminarna analiza pokazala je značajno produljenje vremena do progresije bolesti u skupini koja je primala bevacizumab u dozi od 10 mg/kg u usporedbi sa skupinom koja je primala placebo (omjer rizika 2,55; p < 0,001).
English: Three additional studies with bevacizumab have been conducted in mCRC patients: first-line (NO16966), second-line with no previous bevacizumab treatment (E3200), and second-line with previous bevacizumab treatment following disease progression in first-line (ML18147).
Croatian: Provedena su tri dodatna ispitivanja bevacizumaba u bolesnika s metastatskim karcinomom kolona ili rektuma: ispitivanje u prvoj liniji liječenja (NO16966), ispitivanje u drugoj liniji liječenja bez prethodne primjene bevacizumaba (E3200) i ispitivanje u drugoj liniji liječenja nakon progresije bolesti uz prethodnu primjenu bevacizumaba u prvoj liniji liječenja (ML18147).
English: It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity (see section 5.1).
Croatian: Liječenje se preporučuje nastaviti do progresije bolesti ili do pojave neprihvatljive toksičnosti (vidjeti dio 5.1,
English: Bevacizumab has been shown to be embryotoxic and teratogenic when administered to rabbits.
Croatian: Bevacizumab se pokazao embriotoksičnim i teratogenim u istraživanju provedenom na kunićima.
English: Arm 2 IFL + Avastina
Croatian: Skupina 2 IFL + Avastin a
English: The results of these analyses were very similar to the primary PFS results.
Croatian: Rezultati ove analize bili su vrlo slični primarnim rezultatima preživljenja bez progresije.
English: Tlf: +45 - 36 39 99 99
Croatian: Roche a/s Tlf: +45 - 36 39 99 99
English: every 3 weeks.
Croatian: 1. dana (svaka 3 tjedna)
English: How to use Avastin
Croatian: Kako primjenjivati Avastin
English: Approximately 350 patients were randomised into each of the 4 trial arms in the Part II of the trial.
Croatian: U svaku od 4 skupine u dijelu II ispitivanja randomizirano je približno 350 bolesnika.
English: Median overall survival*
Croatian: (procjena ispitivača)** Medijan ukupnog preživljenja*