FrancophonIA/ELRC3.0 huggingface dataset:
English: ● The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Slovenian: · tveganje za pojav krvnih strdkov v arterijah (tip krvne žile) je lahko povečano, če ste starejši od
English: Chemotherapy + Avastin (n=227)
Slovenian: Kemoterapija + Avastin (n = 227)
English: Avastin is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Slovenian: Zdravilo Avastin uporabljamo tudi za zdravljenje odraslih bolnic z napredovalim epitelijskim rakom jajčnikov, karcinomom jajcevodov ali primarnim rakom potrebušnice.
English: 5 Patients with measurable disease at baseline.
Slovenian: 5 Bolnice z merljivo boleznijo na začetku zdravljenja.
English: Caution should be taken when treating these patients with Avastin.
Slovenian: Pri zdravljenju teh bolnikov je zato potrebna previdnost.
English: The 131 patients in the Avastin + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the trial, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving Avastin + IFN alfa-2a.
Slovenian: Pri 131 bolnikih iz skupine, ki je prejemala zdravilo Avastin in interferon alfa-2a, pri katerih so zmanjšali in vzdrževali odmerek interferona alfa-2a med preskušanjem na 6 ali 3 mio i.e., so deleži preživetja brez napredovanja bolezni znašali: po 6 mesecih 73 %, po 12 mesecih 52 % in po 18 mesecih 21 %.
English: Grade 4 hypertension (hypertensive crisis) occurred in up to 1.0% of patients treated with Avastin and chemotherapy compared to up to 0.2% of patients treated with the same chemotherapy alone.
Slovenian: Hipertenzija stopnje 4 (hipertenzivna kriza) se je pojavila pri do 1,0 % bolnikov, ki so se zdravili z zdravilom Avastin in kemoterapijo, v primerjavi z do 0,2 % bolnikov, ki so se zdravili z enako kemoterapijo brez zdravila Avastin.
English: Table 19 PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease 2,3 CP (n = 368)
Slovenian: Rezultati preživetja brez napredovanja bolezni1, glede na stadij bolezni in stopnjo citoredukcije iz študije BO17707 (ICON7) Randomizirane bolnice z optimalno citoredukcijo, stadija III
English: Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaec,d,
Slovenian: ileus, intestinalna obstrukcija, rektovaginalne fistulec,d,
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).
Slovenian: To je skladno z rezultati pri bolnikih v drugih preskušanjih pri metastatskemu raku dojk, ki niso prejemali sočasnega zdravljenja z antraciklini (NCI
English: (16.2 vs. 12.0 months; p = 0.1342)
Slovenian: (16,2 proti 12,0 meseca; p = 0,1342)
English: Investigations Weight decreased
Slovenian: Preiskave zmanjšanje telesne mase
English: Median OS (months) Hazard ratio (95% CI) (eCRF)a
Slovenian: mediana OS (meseci) razmerje ogroženosti (95-% IZ) (eCRF)a
English: Additional endpoints included objective response, duration of response, overall survival and safety.
Slovenian: Ostali cilji so vključevali objektiven odgovor, trajanje odgovora,
English: was initiated prior to documented progression; data from those patients were censored at the last tumour assessment prior to starting NPT.
Slovenian: Podatke teh bolnikov so krnili ob času zadnje ocene tumorja pred začetkom zdravljenja, ki ni bilo v skladu s protokolom.
English: The HR for PFS was 0.47 (95% CI: 0.35, 0.62) and 0.45 (95% CI: 0.31, 0.67) for the < 65 and ≥ 65 subgroups, respectively.
Slovenian: Razmerje ogroženosti za preživetje brez napredovanja bolezni je bilo 0,47 (95-% interval zaupanja: 0,35; 0,62) za mlajše od 65 let in 0,45 (95-% interval zaupanja: 0,31; 0,67) za bolnice, stare 65 let ali več.
English: (11.9 vs.14.3 months; p = 0.4825)
Slovenian: (11,9 proti 14,3 meseca; p = 0,4825)
English: The addition of Avastin to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Slovenian: Dodatek zdravila Avastin k interferonu alfa-2a je pomembno podaljšal preživetje brez napredovanja bolezni in pomembno povečal objektivni odgovor na zdravljenje.
English: Patients treated for persistent, recurrent, or metastatic cervical cancer with Avastin in combination with paclitaxel and cisplatin may be at increased risk of venous thromboembolic events.
Slovenian: Bolnice z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska, in se zdravijo z zdravilom Avastin v kombinaciji s paklitakselom in cisplatinom, imajo lahko večje tveganje za venske trombembolične dogodke.
English: Overall survivalb HR (95% CI) p-value (exploratory) 1000 mg/m oral twice daily for 14 days administered every 3 weeks bStratified analysis included all progression and death events except those where non-protocol therapy (NPT)
Slovenian: 1000 mg/m peroralno dvakrat na dan 14 dni, dano vsake 3 tedne bStratificirana analiza je vključevala vse dogodke napredovanja bolezni in smrti, razen tistih, kjer so pred dokumentiranim napredovanjem bolezni začeli z zdravljenjem, ki ni bilo v skladu s protokolom.
English: Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumabpretreated patients.
Slovenian: V študiji E3200 so uporabljali bevacizumab pri bolnikih, ki ga še niso prejemali, v odmerku, ekvivalentnem 5 mg/kg/teden, medtem, ko so v študiji ML18147 uporabili bevacizumab pri bolnikih, ki so se z njim že zdravili, v odmerku, ekvivalentnem 2,5 mg/kg/teden.
English: Avastin 25 mg/ml concentrate for solution for infusion Bevacizumab
Slovenian: Avastin 25 mg/ml koncentrat za raztopino za infundiranje bevacizumab
English: • ML18147: Avastin 5.0 mg/kg of body weight every 2 weeks or Avastin 7.5 mg/kg of body weight every 3 weeks in combination with fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin in patients with disease progression following first-line treatment with bevacizumab.
Slovenian: · ML18147: zdravilo Avastin 5,0 mg/kg telesne mase enkrat na 2 tedna ali zdravilo Avastin 7,5 mg/kg telesne mase vsake 3 tedne v kombinaciji s fluoropirimidinom/irinotekanom ali fluoropiridinom/oksaliplatinom pri bolnikih, pri katerih je bolezen po prvi liniji zdravljenja z zdravilom Avastin napredovala.
English: Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with Avastin.
Slovenian: Bolnike z anamnezo hipertenzije spremlja večje tveganje za razvoj proteinurije, če jih zdravimo z zdravilom Avastin.
English: GOG-0213, a phase III randomized controlled open label trial, studied the safety and efficacy of Avastin in the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who have not received prior chemotherapy in the recurrent setting.
Slovenian: GOG-0213 Randomizirano, kontrolirano, odprto preskušanje faze III GOG-0213 je proučevalo varnost in učinkovitost zdravila Avastin pri zdravljenju bolnic s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, občutljivega na platino, ki pri ponovnem pojavu bolezni še niso prejele kemoterapije.
English: Hazard ratio [95% CI]
Slovenian: Razmerje ogroženosti [95-% IZ]
English: CHF Grade 3 or higher reactions were somewhat more frequent among patients receiving bevacizumab in combination with chemotherapy than in patients receiving chemotherapy alone.
Slovenian: Neželeni učinki, povezani s kongestivnim srčnim popuščanjem stopnje 3 ali več, so bili nekoliko bolj pogosti pri bolnikih, ki so prejemali bevacizumab v kombinaciji s kemoterapijo, v primerjavi s tistimi, ki so prejemali samo kemoterapijo.
English: Each 16 ml vial contains 400 mg of bevacizumab.
Slovenian: Ena 16 ml viala vsebuje 400 mg bevacizumaba.
English: Response rate
Slovenian: delež odgovorov
English: The incidence of AEs, including Grade ≥ 3 AEs and SAEs, was similar between the two treatment arms.
Slovenian: Incidenca neželenih učinkov, vključno z neželenimi učinki stopnje ³ 3 in resnimi neželenimi učinki, je bila pri obeh zdravljenih skupinah podobna.
English: Patients may be at increased risk for the development of fistulae when treated with Avastin.
Slovenian: Bolniki so lahko izpostavljeni večjemu tveganju za nastanek perforacije prebavil in žolčnika, če se zdravijo z zdravilom Avastin.
English: Anti-tumour activity was not observed in two earlier studies among a total of 30 children aged > 3 years old with relapsed or progressive high-grade glioma when treated with bevacizumab and irinotecan (CPT-11).
Slovenian: V dveh predhodnih študijah pri skupno 30 otrocih, starejših od 3 let, s ponavljajočim se ali napredovalim gliomom visoke stopnje malignosti, ki so bili zdravljeni z bevacizumabom in irinotekanom (CPT-11), protitumorne aktivnosti niso opazili.
English: (p-value < 0.0001)
Slovenian: (p-vrednost < 0,0001)
English: The typical value for central volume (Vc) was 2.73 L and 3.28 L for female and male patients respectively, which is in the range that has been described for IgGs and other monoclonal antibodies.
Slovenian: Porazdelitev Tipična vrednost za volumen osrednjega prostora (Vc) je bila 2,73 l pri bolnicah in 3,28 l pri bolnikih,
English: d Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
Slovenian: d Rektovaginalne fistule so najpogostejše fistule v skupini fistul med prebavili in nožnico.
English: EGFR mutation status was determined for each patient prior to patient screening and 154 patients were randomised to receive either erlotinib + Avastin (erlotinib 150 mg oral daily + Avastin [15 mg/kg IV every 3 weeks]) or erlotinib monotherapy (150 mg oral daily) until disease progression (PD) or unacceptable toxicity.
Slovenian: 154 bolnikov je bilo randomiziranih v skupino, ki je prejemala erlotinib in zdravilo Avastin (erlotinib 150 mg peroralno na dan + Avastin [15 mg/kg intravensko vsake 3 tedne]), ali v skupino, ki je prejemala samostojno zdravljenje z erlotinibom (150 mg peroralno na dan), do napredovanja bolezni ali nesprejemljive toksičnosti.
English: • AVF0780g: In combination with bolus 5-fluorouracil/folinic acid (5-FU/FA) for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen).
Slovenian: · AVF0780g: v kombinaciji z bolusom 5-fluorouracila/folinske kisline (5-FU/FA).
English: PFS^ (months)
Slovenian: Cilji (meseci)
English: Addition of Avastin to standard of care did not demonstrate clinical benefit in clinical trial BO20924, in 71 evaluable children (from age 6 months to less than 18 years old) patients with metastatic Rhabdomyosarcoma and non-Rhabdomyosarcoma Soft Tissue Sarcoma.
Slovenian: V kliničnem preskušanju BO20924 dodatek zdravila Avastin k standardemu zdravljenju ni pokazal klinične koristi pri 71 ocenjenih otrocih, starih od 6 mesecev do 18 let, z metastatskim rabdomiosarkomom in ostalimi mehkotkivnimi sarkomi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: (14.9 vs. 11.9 months; p = 0.1061)
Slovenian: (14,9 proti 11,9 meseca; p = 0,1061)
English: • Bleeding in the eye.
Slovenian: · zvečan tlak v očesu, · krvavitev v očesu.
English: Prior anthracyclines exposure and/or prior radiation to the chest wall may be possible risk factors for the development of CHF.
Slovenian: Predhodno zdravljenje z antraciklini ali predhodno obsevanje prsnega koša ali oboje sta lahko dejavnika tveganja za razvoj kongestivnega srčnega popuščanja.
English: (17.5 vs.15.0 months; p = 0.0584)
Slovenian: (17,5 proti 15,0 meseca; p = 0,0584)
English: There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/kg group and that in the placebo group (hazard ratio, 1.26; p=0.053).
Slovenian: Med skupino, ki je prejemala 3 mg/kg bevacizumaba, in skupino, ki je prejemala placebo, je obstajala majhna, mejna statistično značilna razlika v času do napredovanja bolezni (razmerje ogroženosti 1,26; p = 0,053).
English: PFS subgroup analyses by disease stage and debulking status are summarised in Table 17.
Slovenian: Analize podskupin preživetja brez napredovanja bolezni, glede na stadij bolezni in stopnjo kirurškega zmanjšanja bolezni, so povzete v preglednici 17.
English: Trial BO17704 has demonstrated that both 7.5 mg/kg/q3wk and 15 mg/kg/q3wk bevacizumab doses increase progression free survival and response rate.
Slovenian: Preskušanje BO17704 pa je pokazalo, da oba odmerka, 7,5 mg/kg telesne mase in 15 mg/kg telesne mase, dana enkrat na tri tedne, podaljšata preživetje brez napredovanja bolezni in povečata delež odgovora na zdravljenje.
English: Most patients who developed CHF during mBC trials showed improved symptoms and/or left ventricular function following appropriate medical therapy.
Slovenian: Pri večini bolnikov, pri katerih se je v preskušanjih pri metastatskem raku dojk pojavilo kongestivno srčno popuščanje, so se simptomi in/ali iztisni delež levega prekata izboljšali po ustreznem zdravljenju.
English: ● if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Slovenian: Dajanje tega zdravila je treba začasno opustiti: · če se pojavi zelo visok krvni tlak, ki ga je treba zdraviti z zdravili proti zvišanemu krvnemu tlaku,
English: Paclitaxel/ Avastin (n=368)
Slovenian: paklitaksel/Avastin (n = 368)
English: • NO16966: Avastin 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or Avastin 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
Slovenian: · NO16966: zdravilo Avastin 7,5 mg/kg telesne mase vsake 3 tedne v kombinaciji s kapecitabinom peroralno in oksaliplatinom intravensko (shema XELOX) ali zdravilo Avastin 5 mg/kg telesne mase vsaka 2 tedna v kombinaciji z levkovorinom in bolusom 5-fluorouracila, sledila je infuzija 5-fluorouracila z oksaliplatinom intravensko (shema FOLFOX-4).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Avastin:
Slovenian: Pred začetkom uporabe zdravila Avastin se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: EGFR mutation testing should be performed prior to initiation of treatment with the combination of Avastin and erlotinib.
Slovenian: Pred začetkom zdravljenja s kombinacijo zdravila Avastin in erlotiniba je treba opraviti testiranje za določanje mutacij EGFR.
English: Rectal haemorrhage
Slovenian: Mehkotkivni sarkom
English: Gallbladder perforation b,c
Slovenian: perforacija žolčnikaa,b
English: • In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO Grade IV, 9 with Grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m²) every 2 weeks.
Slovenian: po lestvici SZO, 9 otrok s stopnjo III po lestvici SZO), ki so bili med letom 2005 in 2008 zdravljeni z bevacizumabom (10 mg/kg) in irinotekanom (125 mg/m2) vsaka 2 tedna.
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating Avastin 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3weekly schedule; or Avastin 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.
Slovenian: To je bilo randomizirano, dvojno slepo (za bevacizumab), klinično preskušanje faze III, v katerem so proučevali zdravilo Avastin v odmerku 7,5 mg/kg v kombinaciji s kapecitabinom peroralno in oksaliplatinom intravensko (shema XELOX), kar so bolniki prejemali na 3 tedne; ali zdravilo Avastin v odmerku 5 mg/kg v kombinaciji z levkovorinom in bolusom 5-fluorouracila, čemur je sledila infuzija 5-fluorouracila z oksaliplatinom intravensko (shema FOLFOX-4).
English: Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Slovenian: Bevacizumab je v kombinaciji s karboplatinom in paklitakselom indiciran za prvo zdravljenje odraslih bolnic z napredovalim epitelijskim rakom jajčnikov (Klasifikacija Mednarodnega združenja ginekologov in porodničarjev (FIGO): stadij III B, III C in IV), karcinomom jajcevodov ali primarnim peritonealnim karcinomom (glejte poglavje 5.1).
English: • E3200: Avastin 10 mg/kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4) in bevacizumab-naïve patients.
Slovenian: · E3200: zdravilo Avastin 10 mg/kg telesne mase enkrat na 2 tedna v kombinaciji z levkovorinom in bolusom 5-fluorouracila, sledila je infuzija 5-fluorouracila z oksaliplatinom intravensko (shema FOLFOX-4) pri bolnikih, ki še niso bili zdravljeni z bevacizumabom.
English: Seventy-one patients were randomised to receive bolus 5-FU/FA or 5-FU/FA + Avastin (5 mg/kg every 2 weeks).
Slovenian: Randomiziranih je bilo 71 bolnikov, ki so prejeli bolus 5-FU/FA ali 5-FU/FA + Avastin (5 mg/kg vsaka dva tedna).
English: 95% CI (0.69; 0.93)
Slovenian: 0,80 (p = 0,003) 95-% interval zaupanja (0,69; 0,93)
English: Avastin or placebo was administered at a dose of 15 mg/kg q3w.
Slovenian: Zdravilo Avastin ali placebo so dajali v odmerku 15 mg/kg vsake 3 tedne.
English: * if specified, the frequency has been derived from clinical trial data
Slovenian: (glejte poglavje 4.6) * Kjer je pogostnost navedena, so jo pridobili iz podatkov kliničnih preskušanj.
English: Тел: +359 2 818 44 44
Slovenian: Рош България ЕООД Тел: +359 2 818 44 44
English: The primary analysis of investigator-assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.
Slovenian: Primarna analiza podatkov preživetja brez napredovanja bolezni, ocenjenih s strani raziskovalca, zbranih do 28. februarja 2010 je pokazala nestratificirano razmerje ogroženosti 0,79 (95-% interval zaupanja: 0,68 - 0,91; p-vrednost za dvostranski log rank test= 0,0010) z mediano preživetja brez napredovanja bolezni 16 mesecev v CP skupini in 18,3 meseca v CPB7,5+ skupini.
English: Uncommon (≥ 0.1% to < 1%) reports of fistulae that involve areas of the body other than the gastrointestinal tract (e.g. bronchopleural and biliary fistulae) were observed across various indications.
Slovenian: Občasno (³ 0,1 % do < 1 %) so pri različnih indikacijah poročali o fistulah, ki se v telesu pojavljajo izven prebavil (plevrobronhialna in žolčna fistula).
English: Both the 5 mg/kg/week and 2.5 mg/kg/week equivalent doses of bevacizumab provided a statistically significant benefit with regards to OS (HR 0.751 in study E3200;
Slovenian: Oba odmerka bevacizumaba, ekvivalentna 5 mg/kg/teden in 2,5 mg/kg/teden, sta zagotovila statistično značilno korist v smislu celokupnega preživetja (razmerje ogroženosti 0,751 v študiji E3200; razmerje ogroženosti 0,81 v študiji ML18147) in preživetja brez napredovanja bolezni (razmerje ogroženosti
English: E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating Avastin as first-line treatment of patients with locally advanced (stage IIIb with malignant pleural effusion), metastatic or recurrent NSCLC other than predominantly squamous cell histology.
Slovenian: E4599 E4599 je bilo odprto, randomizirano, aktivno kontrolirano, multicentrično klinično preskušanje, v katerem so proučevali zdravilo Avastin v prvi liniji zdravljenja bolnikov z lokalno napredovalim (stadij IIIB z malignim plevralnim izlivom), metastatskim ali ponavljajočim se neskvamoznim nedrobnoceličnim rakom pljuč.
English: EGFR monoclonal antibodies should not be administered for the treatment of mCRC in combination with bevacizumab-containing chemotherapy.
Slovenian: Monoklonska protitelesa z delovanjem na EGFR se za zdravljenje metastatskega raka debelega črevesa in danke ne smejo dajati v kombinaciji s kemoterapevstko shemo, ki vključuje bevacizumab.
English: Trehalose dihydrate Sodium phosphate Polysorbate 20
Slovenian: 6.1 Seznam pomožnih snovi trehaloza dihidrat natrijev fosfat polisorbat 20 voda za injekcije
English: Only patients with histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that had recurred > 6 months after platinum-based chemotherapy and who had not received chemotherapy in the recurrent setting and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents were included in the study.
Slovenian: V študijo so bile vključene le bolnice s histološko potrjenim karcinomom jajčnikov, primarnim peritonealnim karcinomom ali karcinomom jajcevodov, ki se je pojavil > 6 mesecev po kemoterapiji na osnovi platine, in bolnice, ki niso prejele kemoterapije pri ponovnem zdravljenju ter niso prejele predhodne terapije z bevacizumabom ali drugimi zaviralci VEGF ali zdravili, usmerjenimi proti VEGF receptorju.
English: Hypertension (see section 4.4)
Slovenian: Hipertenzija (glejte poglavje 4.4)
English: Overall Survival - Primary analysis Median (months)1
Slovenian: Primarni opazovani dogodek Celokupno preživetje - primarna analiza Mediana (meseci)
English: Paediatric population The safety and efficacy of Avastin in children less than 18 years old have not been established.
Slovenian: Varnost in učinkovitost zdravila Avastin pri otrocih, mlajših od 18 let, nista bili dokazani.
English: The results of this study from the final protocol defined analyses for progression free survival and response rates for the independently powered capecitabine cohort of Study AVF3694g are presented in Table 11 Results from an exploratory overall survival analysis which include an additional 7 months of follow-up (approximately 46% of patients had died) are also presented.
Slovenian: V študiji AVF3694g je bila za kohorto s kapecitabinom neodvisno določena statistična moč raziskave in rezultati te študije iz analize, opredeljene v končnem protokolu za preživetje brez napredovanja bolezni in deleže odgovorov so predstavljeni v preglednici 11.
English: The trial contained two parts: an initial unblinded 2-arm part (Part I) in which patients were randomised to two different treatment groups (XELOX and FOLFOX-4) and a subsequent 2 x 2 factorial 4-arm part (Part II) in which patients were randomised to four treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + Avastin, FOLFOX-4 + Avastin).
Slovenian: V poznejšem delu, ki so ga sestavljale 4 skupine (del II) s faktorskim načrtom 2 x 2, so bolnike randomizirali v štiri skupine zdravljenja (XELOX + placebo,
English: The study did not meet its primary endpoint of demonstrating a significant improvement of EFS (Central Radiology Review Committee (CRRC)-assessed) when bevacizumab was added to the RT/T
Slovenian: Primarni cilj študije, to je dokazati značilno izboljšanje v preživetju brez dogodka (po oceni centralnega odbora za radiološki pregled (CRRS - Central Radiology Review Committee)) v skupini, zdravljeni z radioterapijo in temozolomidom z dodatkom bevacizumaba, v primerjavi s skupino, zdravljeno z radioterapijo in temozolomidom, ni bil dosežen.
English: Leucovorin 200 mg/m2 IV 2 h 5-Fluorouracil
Slovenian: Levkovorin 200 mg/m2 i.v.
English: Each 4 ml vial contains 100 mg of bevacizumab, corresponding to 1.4 mg/ml when diluted as recommended.
Slovenian: Ena 4 ml viala vsebuje 100 mg bevacizumaba, kar po priporočeni razredčitvi ustreza koncentraciji 1,4 mg/ml.
English: Exfoliative dermatitis, Dry skin, Skin discoloration
Slovenian: eksfoliativni dermatitis, suha koža, obarvanje kože sindrom palmarnoplantarne eritrodistezije