FrancophonIA/ELRC3.0 huggingface dataset:
English: Posterior reversible encephalopathy syndrome (see section 4.4)
Croatian: Sindrom reverzibilne posteriorne leukoencefalopatije (vidjeti dio 4.4)
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 infections have been reported in up to 24% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
Croatian: U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa (ispitivanje GOG-0240), infekcije stupnja 3-5 prijavljene su u do 24% bolesnica liječenih bevacizumabom u kombinaciji s paklitakselom i topotekanom u usporedbi s do13% bolesnica liječenih paklitakselom i topotekanom.
English: Overall survival - Follow-up analysis2 Hazard ratio (95% CI)
Croatian: Ukupno preživljenjeAnaliza nakon praćenja2 Omjer hazarda (95% CI)
English: The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka MVASI je 10 mg/kg tjelesne težine jednom svaka 2 tjedna ili 15 mg/kg tjelesne težine jednom svaka 3 tjedna, primijenjeno u obliku intravenske infuzije.
English: Each single use vial contains 400 mg of bevacizumab in 16 mL of concentrate.
Croatian: Jedna bočica za jednokratnu primjenu sadrži 400 mg bevacizumaba u 16 ml koncentrata.
English: * Primary analysis was performed with a data cut-off date of 14 November 2011.
Croatian: * Završni dan prikupljanja podataka za primarnu analizu bio je 14. studenoga 2011. ** Randomizirane bolesnice s mjerljivom bolešću na početku ispitivanja.
English: NETHERLANDS
Croatian: Nizozemska
English: The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab-treated patients in the FOLFOX treatment subgroup, HR = 0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Croatian: Medijan ukupnog preživljenja iznosio je 20,3 mjeseca u bolesnika u podskupini liječenoj protokolom FOLFOX koji su primali placebo, a 21,2 mjeseca u onih liječenih bevacizumabom: HR = 0,94; 97,5% CI = [0,75; 1,16]; p-vrijednost = 0,4937.
English: Pulmonary embolism,
Croatian: Arterijska tromboembolija:
English: Hazard ratiob
Croatian: Omjer hazarda pvrijednost
English: Severe side effects, which may be common (may affect up to 1 in 10 people), include:
Croatian: Teške nuspojave koje mogu biti česte (mogu se javiti u do 1 na 10 osoba) uključuju: • puknuće crijeva,
English: MVASI is also used for treatment of adult patients with advanced kidney cancer.
Croatian: MVASI se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom bubrega.
English: 5-FU/FA + bevacizumabb
Croatian: 5-FU/FA
English: • Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and topotecan 0.75 mg/m2 IV over 30 minutes on days 1-3 plus bevacizumab 15 mg/kg IV on day 1 (q3w)
Croatian: • paklitaksel u dozi od 175 mg/m2 i.v. tijekom 3 sata 1. dana i topotekan u dozi od 0,75 mg/m2 i.v. tijekom 30 minuta od 1. do 3. dana plus bevacizumab u dozi od 15 mg/kg i.v. 1. dana (svaka 3 tjedna)
English: Metastatic carcinoma of the colon or rectum (mCRC) The recommended dose of MVASI, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Croatian: Preporučena doza lijeka MVASI, primijenjenog u obliku intravenske infuzije, iznosi 5 mg/kg ili 10 mg/kg tjelesne težine jednom svaka 2 tjedna, odnosno 7,5 mg/kg ili 15 mg/kg tjelesne težine jednom svaka 3 tjedna.
English: • A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with MVASI treatment.
Croatian: • Liječenje lijekom MVASI, povezano je s rijetkom neurološkom nuspojavom koju nazivamo sindrom reverzibilne posteriorne encefalopatije.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-0240), 1.8% of bevacizumab-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae.
Croatian: U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa (ispitivanje GOG-0240), fistule izvan gastrointestinalnog sustava i to vaginalne, vezikalne ili fistule u ženskom genitalnom traktu, prijavljene su u 1,8% bolesnica liječenih bevacizumabom te u 1,4% bolesnica u kontrolnoj skupini.
English: Efficacy results from study AVF4095g
Croatian: Rezultati djelotvornosti za ispitivanje AVF4095g Preživljenje bez progresije bolesti
English: Trial E2100 efficacy results
Croatian: Rezultati djelotvornosti za ispitivanje E2100
English: The efficacy results of bevacizumab in combination with IFL-chemotherapy are displayed in table 4.
Croatian: Rezultati djelotvornosti bevacizumaba u kombinaciji s IFL kemoterapijom prikazani su u Tablici 4. Tablica 4. Rezultati djelotvornosti za ispitivanje AVF2107g
English: • The protocol-specified analysis of investigator assessed PFS (without censoring for CA-125 progression or non-protocol therapy [NPT]) shows a stratified hazard ratio of 0.71 (95% CI: 0.61-0.83, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 10.4 months in the CPP arm and 14.1 months in the CPB15+ arm.
Croatian: • Protokolom predviđena analiza preživljenja bez progresije bolesti prema procjeni ispitivača (bez cenzuriranja za porast razine CA-125 ili terapiju izvan protokola) pokazuje stratificirani omjer rizika od 0,71 (95% CI: 0,61-0,83; p-vrijednost jednostranog log-rang testa < 0,0001) kada se skupina CPB15+ usporedi sa skupinom CPP, uz medijan preživljenja bez progresije bolesti od 10,4 mjeseca u skupini CPP te 14,1 mjesec u skupini CPB15+.
English: Median OS (months) HR (95% CI) p-value
Croatian: Medijan OS-a (mjeseci) HR (95% CI) p-vrijednost
English: EGFR mutation testing should be performed prior to initiation of treatment with the combination of MVASI and erlotinib.
Croatian: Prije početka liječenja kombinacijom lijeka MVASI s erlotinibom potrebno je provesti testiranje na mutacije EGFR-a.
English: EGFR mutation status was determined for each patient prior to patient screening and 154 patients were randomised to receive either erlotinib + bevacizumab (erlotinib 150 mg oral daily + bevacizumab [15 mg/kg IV every 3 weeks]) or erlotinib monotherapy (150 mg oral daily) until disease progression (PD) or unacceptable toxicity.
Croatian: + bevacizumab (erlotinib 150 mg na dan, peroralno + bevacizumab [15 mg/kg i.v. svaka 3 tjedna]) ili u skupinu koja je primala monoterapiju erlotinibom (150 mg na dan, peroralno) do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: Secondary endpoints Progression-free survival - Primary analysis6 Median PFS (months)1 Hazard ratio [95% CI]
Croatian: - Primarna analiza6 Medijan PFS-a (mjeseci)1 Omjer hazarda [95% CI]
English: 85 mg/m2 IV 2 h
Croatian: 85 mg/m2 i.v. 2 h oksaliplatin 1. dana leukovorin
English: MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Croatian: MVASI se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica.
English: • a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES),
Croatian: • moždani poremećaj čiji simptomi mogu biti konvulzije (napadi nalik epileptičkim napadajima), glavobolja, smetenost i promjene vida (sindrom posteriorne reverzibilne encefalopatije),
English: Progression-free survival*
Croatian: Preživljenje bez progresije bolesti*
English: The recommended dose of MVASI is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka MVASI je 7,5 mg/kg ili 15 mg/kg tjelesne težine, primijenjena jednom svaka 3 tjedna u obliku intravenske infuzije.
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3-weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Croatian: Riječ je o randomiziranom, dvostruko slijepom (za bevacizumab) kliničkom ispitivanju faze III u kojemu se ispitivala primjena bevacizumaba u dozi od 7,5 mg/kg svaka 3 tjedna u kombinaciji s peroralno primijenjenim kapecitabinom i intravenski primijenjenim oksalipaltinom (XELOX), odnosno primjena bevacizumaba u dozi od 5 mg/kg svaka dva tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila, nakon čega je slijedila infuzija 5-fluorouracila uz intravensku primjenu oksaliplatina (FOLFOX-4).
English: The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka MVASI je 10 mg/kg tjelesne težine, primijenjena jednom svaka 2 tjedna u obliku intravenske infuzije.
English: The majority of patients had EOC (87.7%) followed by PPC (6.9%) and FTC (3.7%) or a mixture of the three origins (1.7%).
Croatian: Približno 50% bolesnica imalo je ECOG funkcionalni status 1, dok je 7% bolesnica u svakoj skupini imalo ECOG status 2. Većina bolesnica bolovala je od epitelnog karcinoma jajnika (87,7%), nakon kojega po učestalosti slijede primarni peritonealni karcinom (6,9%) i karcinom jajovoda (3,7%) ili kombinacija tih triju bolesti (1,7%).
English: Median PFS (months)2 Hazard ratio [95% CI]2
Croatian: Medijan PFS (mjeseci)2 Omjer hazarda [95% CI]2
English: Pre-existing hypertension should be adequately controlled before starting MVASI treatment.
Croatian: Prije početka liječenja lijekom MVASI postojeću hipertenziju treba odgovarajuće regulirati.
English: • CPB15+ arm: Five cycles of bevacizumab (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by continued use of bevacizumab (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
Croatian: • skupina CPB15+: pet ciklusa bevacizumaba (15 mg/kg svaka 3 tjedna, počevši od 2. ciklusa) u kombinaciji sa 6 ciklusa karboplatina (AUC 6) i paklitaksela (175 mg/m2), nakon čega je slijedila trajna primjena bevacizumaba (15 mg/kg svaka 3 tjedna) kao jedinog lijeka u ukupnom trajanju do 15 mjeseci liječenja.
English: • Paclitaxel 80 mg/m2 as a 1-hour IV infusion on days 1, 8, 15, and 22 every 4 weeks
Croatian: • Skupina KT (samo kemoterapija): paklitaksel 80 mg/m2 u obliku jednosatne i.v. infuzije 1., 8., 15. i 22. dana svaka 4 tjedna. topotekan 4 mg/m2 u obliku 30-minutne i.v. infuzije 1., 8. i 15. dana svaka 4 tjedna.
English: Relative to control arm. NR = Not Reached.
Croatian: ND = nije dostignuto.
English: Paclitaxel (n = 354)
Croatian: Paklitaksel (n = 354)
English: Mucosal inflammation
Croatian: Krvožilni poremećaji
English: The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until MVASI fails to stop your tumour growing.
Croatian: Trebali biste nastaviti primati ovaj lijek sve dok MVASI uspješno sprječava rast tumora.
English: Paclitaxel/ bevacizumab (n = 252)
Croatian: Paklitaksel/ bevacizumab (n = 252)
English: • fever,
Croatian: • vrućicu,
English: • decreased number of cells in the blood, including white cells that help to fight against infections
Croatian: • smanjen broj krvnih stanica, uključujući bijele krvne stanice koje pomažu u borbi protiv infekcije (može biti praćeno vrućicom) i stanice koje pomažu u zgrušavanju krvi,
English: • GOG-0213 evaluated the efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Croatian: • U ispitivanju GOG-0213 ocijenjene su djelotvornost i sigurnost bevacizumaba u kombinaciji s karboplatinom i paklitakselom, nakon čega se bevacizumab primjenjivao sam, u bolesnica s recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma osjetljivih na platinu.
English: Thromboembolis m (arterial)b,d, Haemorrhageb,d, Deep vein thrombosis
Croatian: Krvožilni poremećaji hipertenzijab,d, tromboembolija (venska)b,d tromboembolija (arterijska)b,d, krvarenjeb,d, duboka venska tromboza bubrežna trombotska mikroangiopatijaa,b aneurizme i disekcije arterije
English: Paclitaxel/ bevacizumab (n = 229)
Croatian: Paklitaksel/ bevacizumab (n = 229)
English: In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab-treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Croatian: U podskupini bolesnika liječenih protokolom XELOX medijan preživljenja bez progresije bolesti je iznosio 7,4 mjeseca u bolesnika koji su primali placebo, u usporedbi s 9,3 mjeseca u bolesnika liječenih bevacizumabom: HR = 0,77; 97,5% CI = [0,63; 0,94]; p-vrijednost = 0,0026.
English: Number of patients Progression-free survival Median (months) Hazard ratio
Croatian: Preživljenje bez progresije bolesti Medijan (mjeseci) Omjer hazarda
English: 7.5 mg/kg IV 30-90 min Day 1, prior to XELOX, q 3 weeks
Croatian: 7,5 mg/kg i.v. 30-90 min
English: • blocking of the veins of the legs by a blood clot,
Croatian: • začepljenje vena nogu zbog krvnog ugruška,
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane dehidracija, hiponatrijemija
English: The analysis of the primary endpoint showed no difference between the bevacizumab + placebo arm and the bevacizumab + erlotinib arm (median PFS 8.5 versus 9.9 months).
Croatian: + erlotinib (medijan PFS 8,5 naprama 9,9 mjeseci).
English: • The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.50-0.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.
Croatian: • Analiza preživljenja bez progresije bolesti prema procjeni neovisnog ocjenjivačkog povjerenstva (cenzurirana za terapiju izvan protokola) pokazuje stratificirani omjer rizika od 0,62 (95% CI: 0,50-0,77; p-vrijednost jednostranog log-rang testa < 0,0001) kada se skupina CPB15+ usporedi sa skupinom CPP, uz medijan preživljenja bez progresije bolesti od 13,1 mjesec u skupini CPP te 19,1 mjesec u skupini CPB15+.
English: • loss of appetite,
Croatian: • gubitak teka,
English: An increased incidence of hypertension was observed in bevacizumab-treated patients.
Croatian: U bolesnika liječenih bevacizumabom opažena je veća incidencija hipertenzije.
English: Number of patients Overall survival Median (months) 95% CI
Croatian: Ukupno preživljenje Medijan (mjeseci) 95% CI
English: Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and cisplatin 50 mg/m2 IV on day 2 (q3w); or Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and cisplatin 50 mg/m2 IV on day 1 (q3w)
Croatian: • paklitaksel u dozi od 135 mg/m2 i.v. tijekom 24 sata 1. dana i cisplatin u dozi od 50 mg/m2 i.v. 2. dana, svaka 3 tjedna; ili paklitaksel u dozi od 175 mg/m2 i.v. tijekom 3 sata 1. dana i cisplatin u dozi od 50 mg/m2 i.v. 2 dana (svaka 3 tjedna); ili paklitaksel u dozi od 175 mg/m2 i.v. tijekom 3 sata 1. dana i cisplatin u dozi od 50 mg/m2 i.v. 1. dana (svaka 3 tjedna)
English: Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with bevacizumab.
Croatian: Kada se liječe bevacizumabom, bolesnici s hipertenzijom mogu biti izloženi povećanom riziku od razvoja proteinurije.
English: • CPB15 arm: Five cycles of bevacizumab (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Croatian: • skupina CPB15: pet ciklusa bevacizumaba (15 mg/kg svaka 3 tjedna, počevši od 2. ciklusa) u kombinaciji sa 6 ciklusa karboplatina (AUC 6) i paklitaksela (175 mg/m2), nakon čega je slijedio samo placebo u ukupnom trajanju do 15 mjeseci liječenja
English: In a randomised phase II study (BO20924) a total of 154 patients aged ≥ 6 months to < 18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by maintenance vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months.
Croatian: U randomiziranom ispitivanju faze II (BO20924) ukupno su 154 bolesnika u dobi od ≥ 6 mjeseci do < 18 godina s novodijagnosticiranim metastatskim rabdomiosarkomom ili sarkomom mekog tkiva koji nije rabdomiosarkom bila liječena standardnom terapijom (uvodno liječenje režimom IVADO/IVA
English: • The primary analysis of investigator assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm.
Croatian: • Primarna analiza preživljenja bez progresije bolesti prema procjeni ispitivača (cenzurirana za porast razine CA-125 i terapiju izvan protokola) pokazuje stratificirani omjer rizika od 0,62 (95% CI: 0,52-0,75; p-vrijednost jednostranog log-rang testa < 0,0001) kada se skupina CPB15+ usporedi sa skupinom CPP, uz medijan preživljenja bez progresije bolesti od 12,0 mjeseci u skupini CPP te 18,2 mjeseca u skupini CPB15+.
English: 5 mg/kg IV 30-90 min Day 1, prior to FOLFOX-4, every 2 weeks
Croatian: 1. dana prije primjene protokola FOLFOX-4, svaka 2 tjedna
English: Placebo + IFNa
Croatian: BO17705 Placebo + IFNa
English: Number of patients Overall survival Median time (months) 95% CI
Croatian: Ukupno preživljenje Medijan vremena (mjeseci) 95% CI
English: Progression-free survival1
Croatian: Preživljenje bez progresije bolesti1
English: a patients with measurable disease at baseline Overall survival Median (months)
Croatian: Broj bolesnika 36 Ukupno preživljenje Medijan vremena (mjeseci)
English: The clinical benefit, as measured by overall survival, was seen in all prespecified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Croatian: uključujući i one određene dobi, spolom, funkcionalnim statusom, sijelom primarnog tumora, brojem zahvaćenih organa i trajanjem metastatske bolesti.
English: The recommended dose of MVASI is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka MVASI je 15 mg/kg tjelesne težine, primijenjena jednom svaka 3 tjedna u obliku intravenske infuzije.
English: Wound healing (see section 4.4)
Croatian: Zacjeljivanje rana (vidjeti dio 4.4)
English: The administration of MVASI should be permanently discontinued if you develop
Croatian: Primjenu lijeka MVASI treba trajno obustaviti
English: Paclitaxel (n = 243)
Croatian: Paklitaksel (n = 243)
English: Hazard ratio (95% CI) p-value
Croatian: Omjer hazarda (95% CI) p - vrijednost
English: Primary analysis Overall survival
Croatian: Primarna mjera ishoda Ukupno preživljenje - Primarna analiza6
English: 200 mg/m2 IV 2 h
Croatian: 200 mg/m2 i.v. 2 h leukovorin 1. i 2. dana
English: Fistulaa,b, Myalgia, Arthralgia, Muscular weakness, Back pain
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva fistulaa,b, mialgija, artralgija, mišićna slabost, bol u leđima osteonekroza čeljustib,c
English: Febrile neutropenia, Leucopenia, Neutropeniaa, Thrombocytope nia
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija, leukopenija, neutropenijab, trombocitopenija anemija, limfopenija
English: • CP arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) every 3 weeks for 6 and up to
Croatian: • skupina CP: karboplatin (AUC 5) i paklitaksel (175 mg/m2 i.v.) svaka 3 tjedna tijekom 6, a najviše 8 ciklusa.
English: • tiredness,
Croatian: • mučnina,
English: Patients may be at increased risk for the development of fistulae when treated with bevacizumab.
Croatian: Kada se liječe bevacizumabom, bolesnici mogu biti izloženi povećanom riziku od nastanka fistula.
English: Hypertensiona,b Thromboembolism arteriala,b,
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurijaa,b,
English: Arm 2
Croatian: Drugi čimbenik
English: Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Nausea,
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija, umor bol, letargija, upala sluznice
English: Progression-free survival Median time (months) Hazard ratio
Croatian: Preživljenje bez progresije bolesti Medijan vremena (mjeseci) Omjer hazarda
English: IRC assessment
Croatian: Procjena neovisnog povjerenstva
English: Cisplatin + Paclitaxel
Croatian: Cisplatin/Gemcitabin + placebo
English: Number of patients Overall survival Median (months) Hazard ratio
Croatian: Ukupno preživljenje Medijan (mjeseci) Omjer hazarda
English: EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens
Croatian: Monoklonska protutijela s djelovanjem na EGFR u kombinaciji s kemoterapijom koja uključuje bevacizumab
English: Arthralgia, Myalgia
Croatian: Omjer hazardac pvrijednost
English: • blocking of the veins by a blood clot,
Croatian: • začepljenje vena zbog krvnog ugruška,
English: Peripheral sensory neuropathyb, Dysarthria, Headache, Dysguesia
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatijab, dizartrija, glavobolja, disgeuzija cerebrovaskularni incident, sinkopa, somnolencija sindrom reverzibilne posteriorne encefalopatijea,b,d hipertenzivna encefalopatijaa
English: Intestinal obstruction, Recto-vaginal fistulaec,d, Gastrointestinal disorder, Stomatitis, Proctalgia
Croatian: Poremećaji probavnog sustava proljev, mučnina, povraćanje, bol u abdomenu perforacija crijeva, ileus, opstrukcija crijeva, rektovaginalna fistulac,d, gastrointestinalni poremećaj, stomatitis, proktalgija gastrointestinalna perforacijaa,b, gastrointestinalni ulkusc, rektalno krvarenje
English: p-value Overall response rate Rate (n) p-value Overall survival* (months) Median HR (95% CI) p-value A total of 154 patients (ECOG Performance Status 0 or 1) were randomised.
Croatian: Ukupno su randomizirana 154 bolesnika (ECOG funkcionalni status 0 ili 1).
English: Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI)
Croatian: Medijan PFS-a (mjeseci) Omjer hazarda (95% CI) Medijan OS-a (mjeseci) Omjer hazarda (95% CI)
English: Paclitaxel (n = 273)
Croatian: Paklitaksel (n = 273)
English: Median PFS (months) Hazard ratio (95% CI)2
Croatian: Medijan PFS (mjeseci) Omjer hazarda (95% CI)2
English: Febrile neutropenia, Leucopenia, Neutropeniab Thrombocytope nia
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija, leukopenija, neutropenijaa, trombocitopenija anemija, limfopenija
English: Cardiac disorders
Croatian: Kongestivno zatajenje srca
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with bevacizumab.
Croatian: Proteinurija stupnja 4 (nefrotski sindrom) primijećena je u najviše 1,4% bolesnika liječenih bevacizumabom.U bolesnika u kojih se razvije nefrotski sindrom (NCI-CTCAE v.3) treba trajno obustaviti liječenje.
English: Gallbladder perforationb,c
Croatian: Poremećaji jetre i žuči perforacija žučnog mjehurab,c
English: Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8)
Croatian: Sindrom reverzibilne posteriorne encefalopatije (vidjeti dio 4.8)
English: Efficacy results for study JO25567
Croatian: Tablica 13. Rezultati djelotvornosti za ispitivanje JO25567 Erlotinib N = 77#