FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, the incidence of arterial thromboembolic reactions including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs) was higher in patients receiving bevacizumab in combination with chemotherapy compared to those who received chemotherapy alone.
Croatian: U kliničkim je ispitivanjima incidencija arterijskih tromboembolijskih reakcija, uključujući cerebrovaskularne incidente (CVI), tranzitorne ishemijske atake (TIA) te infarkte miokarda (IM), bila viša u bolesnika koji su primali bevacizumab u kombinaciji s kemoterapijom u usporedbi s bolesnicima koji su primali samo kemoterapiju.
English: The efficacy results are presented in Table 12.
Croatian: Rezultati djelotvornosti prikazani su u tablici 12.
English: There is no relevant use of bevacizumab in the paediatric population in the indications for treatment of cancers of the colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix and kidney.
Croatian: Nema relevantne primjene bevacizumaba u pedijatrijskoj populaciji za indikacije liječenja raka kolona, rektuma, dojke, pluća, jajnika, jajovoda, peritoneuma, cerviksa i bubrega.
English: Patients with NSCLC of known squamous cell histology or mixed cell type with predominant squamous cell histology were excluded from subsequent phase III trials, while patients with unknown tumour histology were included.
Croatian: Bolesnici koji su imali rak pluća nemalih stanica s poznatom histologijom skvamoznih stanica ili rak pluća nemalih stanica mješovitog staničnog tipa s prevladavajućom histologijom skvamoznih stanica nisu bili uključeni u daljnja ispitivanja faze III, dok su bolesnici s tumorom nepoznate histologije bili uključeni.
English: In patients in AVF3694g who received treatment with anthracyclines and who had not received anthracyclines before, no increased incidence of all Grade CHF was observed in the anthracycline + bevacizumab group compared to the treatment with anthracyclines only.
Croatian: U ispitivanju AVF3694g, u bolesnika liječenih antraciklinima koji ranije nisu primali antracikline nije opažena povećana incidencija kongestivnog zatajenja srca bilo kojeg stupnja u skupini koja je primala antraciklin + bevacizumab u usporedbi sa skupinom koja je liječena samo antraciklinima.
English: You may be advised to have a dental check-up before you start treatment with Zirabev.
Croatian: Možda će Vam biti preporučeno da prije početka liječenja lijekom Zirabev obavite stomatološki pregled.
English: In study BO25041 of bevacizumab added to postoperative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
Croatian: U ispitivanju BO25041, u kojem se ispitivao bevacizumab kao dodatak poslijeoperacijskoj radioterapiji (RT) uz istodobnu i adjuvantnu primjenu temozolomida u pedijatrijskih bolesnika s novodijagnosticiranim supratentorijalnim, infratentorijalnim, cerebelarnim ili pedunkularnim gliomom visokog stupnja, sigurnosni profil bio je usporediv s onim opaženim kod drugih vrsta tumora u odraslih liječenih bevacizumabom.
English: In a phase III trial in the adjuvant treatment of patients with colon cancer, a substudy with premenopausal women has shown a higher incidence of new cases of ovarian failure in the bevacizumab group compared to the control group.
Croatian: U okviru ispitivanja faze III adjuvantnog liječenja bolesnika s rakom kolona, u podispitivanju žena u predmenopauzi pokazala se veća incidencija novih slučajeva zatajivanja jajnika u skupini koja je primala bevacizumab u odnosu na kontrolnu skupinu.
English: Table 3 Adverse reactions reported in post-marketing setting
Croatian: Tablica 3. Nuspojave prijavljene nakon stavljanja lijeka u promet
English: Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Croatian: Zirabev je u kombinaciji s kemoterapijom na bazi fluoropirimidina indiciran za liječenje odraslih bolesnika s metastatskim karcinomom kolona ili rektuma.
English: Overall survival - primary analysis Hazard ratio (95% CI)
Croatian: Ukupno preživljenje - primarna analiza Omjer hazarda (95 % CI)
English: 400 mg/m2 intravenous bolus,
Croatian: 400 mg/m2 intravenski bolus
English: Zirabev is for intravenous use.
Croatian: Zirabev je namijenjen za intravensku primjenu.
English: Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of bevacizumabtreated patients.
Croatian: U svim je kliničkim ispitivanjima mukokutano krvarenje zabilježeno u do 50 % bolesnika liječenih bevacizumabom.
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 središnjem živčanom sustavu stupnja 2 (1,2 %) (NCI-CTCAE v.3).
English: In a study of platinum-resistant recurrent ovarian cancer patients, alopecia, mucosal inflammation, peripheral sensory neuropathy, proteinuria and hypertension were also reported and occurred at a rate at least 5% higher in the CT + BV arm for bevacizumab-treated patients ≥ 65 years of age compared with bevacizumab-treated patients aged < 65 years.
Croatian: U ispitivanju recidiva raka jajnika rezistentnog na platinu prijavljene su i alopecija, upala sluznice, periferna senzorna neuropatija, proteinurija i hipertenzija, a stopa njihova pojavljivanja u skupini koja je primala kemoterapiju i bevacizumab bila je najmanje 5 % veća u bolesnica liječenih bevacizumabom u dobi od ≥ 65 godina nego u bolesnica liječenih bevacizumabom u dobi od < 65 godina.
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 arm compared with RT/T alone (HR = 1.44; 95% CI: 0.90, 2.30).
Croatian: Ispitivanje nije postiglo primarnu mjeru ishoda, tj. nije pokazalo značajno poboljšanje preživljenja bez događaja (prema ocjeni središnjeg povjerenstva za radiološku ocjenu) nakon dodavanja bevacizumaba kombinaciji RT/T u odnosu na skupinu koja je primala samo RT/T (HR = 1,44; 95 % CI: 0,90; 2,30).
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.
English: Table 8 Efficacy results for trial E3200
Croatian: Rezultati djelotvornosti za ispitivanje E3200
English: Grade 3 hypertension was 60.0% in patients treated with bevacizumab in combination with erlotinib compared to 11.7% in patients treated with erlotinib alone.
Croatian: Hipertenzija stupnja 3 zabilježena je u 60,0 % bolesnika liječenih bevacizumabom u kombinaciji s erlotinibom u usporedbi s 11,7 % bolesnika liječenih samo erlotinibom.
English: In NSABP C-08, a phase III trial of bevacizumab in adjuvant treatment of patients with colon cancer, the incidence of new cases of ovarian failure, defined as amenorrhoea lasting 3 or more months, FSH level ≥ 30 mIU/mL and a negative serum β-HCG pregnancy test, has been evaluated in 295 premenopausal women.
Croatian: U ispitivanju NSABP C-08, ispitivanju faze III adjuvantnog liječenja bevacizumabom bolesnika s rakom kolona, u 295 žena u predmenopauzi ispitana je incidencija novih slučajeva zatajenja jajnika, definiranih kao amenoreja u trajanju od 3 mjeseca ili više, razina FSH ≥ 30 mIU/ml te negativan serumski β-HCG test na trudnoću.
English: Peripheral s ensory neuropathy b,
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija b,
English: Zirabev is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Croatian: Zirabev je lijek koji se koristi za liječenje odraslih bolesnika s uznapredovalim rakom debelog crijeva, tj. kolona ili rektuma.
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: The administration of Zirabev should be temporarily discontinued
Croatian: Primjenu lijeka Zirabev treba privremeno prekinuti
English: Patients with renal impairment The safety and efficacy have not been studied in patients with renal impairment (see section 5.2).
Croatian: Bolesnici s oštećenjem funkcije jetre Sigurnost i djelotvornost nisu ispitivane u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: In some cases underlying intra-abdominal inflammation was present, either from gastric ulcer disease, tumour necrosis, diverticulitis, or chemotherapy-associated colitis.
Croatian: U nekim slučajevima bila je prisutna latentna intraabdominalna upala, uzrokovana ulkusom želuca, nekrozom tumora, divertikulitisom ili kolitisom povezanim s kemoterapijom.
English: Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as Grade 1 proteinuria (NCI-CTCAE v.3).
Croatian: Težina proteinurije kretala se od klinički asimptomatske, prolazne proteinurije u tragovima do nefrotskog sindroma, ali u najvećem broju slučajeva radilo se o proteinuriji stupnja 1 (NCI-CTCAE v.3).
English: Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the bevacizumab arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Croatian: U 97 bolesnika koji su primali IFN alfa-2a i 131 bolesnika koji je primao bevacizumab doza interferona alfa-2a smanjena je s 9 milijuna IU na 6 ili 3 milijuna IU tri puta tjedno, kako je prethodno utvrđeno u protokolu ispitivanja.
English: Grade 3-5 (NCI-CTCAE v.3) venous thromboembolic reactions have been reported in up to 7.8% of patients treated with chemotherapy plus bevacizumab compared with up to 4.9% in patients treated with chemotherapy alone (across indications, excluding persistent, recurrent, or metastatic cervical cancer).
Croatian: Venske tromboembolijske reakcije stupnja 3-5 (NCI-CTCAE v.3) prijavljene su u najviše 7,8% bolesnika liječenih kemoterapijom i bevacizumabom u usporedbi s najviše 4,9% u bolesnika liječenih samo kemoterapijom (u svim indikacijama osim perzistentnog, recidivirajućeg ili metastatskog raka cerviksa).
English: Prior radiation is a major risk factor for the development of GI-vaginal fistulae and all patients with GI- vaginal fistulae had a history of prior radiation.
Croatian: Prethodno zračenje značajan je čimbenik rizika za nastanak gastrointestinalno-vaginalnih fistula te su sve bolesnice s gastrointestinalno-vaginalnim fistulama prethodno bile liječene zračenjem.
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: (p-value = 0.3113)
Croatian: (p-vrijednost = 0,3113)
English: In the post-marketing setting, cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.8).
Croatian: Nakon stavljanja lijeka u promet primijećeni su slučajevi abnormalnosti fetusa u žena liječenih bevacizumabom samostalno ili u kombinaciji s poznatim embriotoksičnim kemoterapeuticima (vidjeti dio 4.8).
English: Arm 2
Croatian: Skupina 2
English: Cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.6 )
Croatian: Primijećeni su slučajevi abnormalnosti fetusa u žena liječenih bevacizumabom samostalno ili u kombinaciji s poznatim embriotoksičnim kemoterapeuticima (vidjeti dio 4.6).
English: assessment)**
Croatian: Medijan PFS-a**
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Croatian: Reakcije preosjetljivosti/reakcije povezane s infuzijom (vidjeti dio 4.4 i „Iskustvo nakon stavljanja lijeka u promet“ u nastavku)
English: In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Zirabev.
Croatian: U bolesnika u kojih se razvije PRES, uz prekid primjene lijeka Zirabev preporučuje se i liječenje specifičnih simptoma uključujući kontrolu hipertenzije.
English: Hypersensitivity reactions/infusion reactions (see section 4.8)
Croatian: Reakcije preosjetljivosti/reakcije povezane s infuzijom (vidjeti dio 4.8)
English: Severe reactions are defined as adverse reactions with at least a 2% difference compared to the control arm in clinical studies for NCI-CTCAE Grade 3-5 reactions.
Croatian: Teške nuspojave su definirane kao nuspojave s razlikom od najmanje 2 % u odnosu na kontrolnu skupinu u kliničkim ispitivanjima nuspojava stupnja 3-5 prema NCI-CTCAE.
English: Zirabev should be discontinued in patients with life-threatening (Grade 4) thromboembolic reactions, including pulmonary embolism (NCI-CTCAE v.3).
Croatian: Primjenu lijeka Zirabev treba prekinuti u bolesnika s tromboembolijskim reakcijama opasnima po život (stupanj 4), uključujući plućnu emboliju (NCI-CTCAE v.3).
English: Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with bevacizumab.
Croatian: Bolesnici mogu biti izloženi povećanom riziku od nastanka gastrointestinalne perforacije i perforacije žučnog mjehura tijekom liječenja bevacizumabom.
English: Zirabev has been developed and made to treat cancer by injecting it into the bloodstream.
Croatian: Lijek Zirabev je razvijen i proizveden za liječenje raka primjenom u krvotok.
English: ● Zirabev can also increase the risk of developing blood clots in your veins (a type of blood vessel).
Croatian: Zirabev može povećati i rizik od nastanka krvnih ugrušaka u venama (vrsta krvnih žila).
English: Serious wound healing complications, including anastomotic complications, with a fatal outcome have been reported.
Croatian: Prijavljene su ozbiljne komplikacije pri zacjeljivanju rana, uključujući komplikacije vezane uz anastomozu, sa smrtnim ishodom.
English: Permanently discontinue Zirabev in patients with tracheoesophageal (TE) fistula or any Grade 4 fistula [US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.3)].
Croatian: Potrebno je trajno obustaviti primjenu lijeka Zirabev u bolesnika s traheoezofagealnom fistulom ili bilo kojom fistulom stupnja 4 [prema Općim terminološkim kriterijima za štetne događaje Nacionalnog instituta za rak SAD-a, verzija 3 (engl.
English: Most of the patients who experienced CHF had metastatic breast cancer and had received previous treatment with anthracyclines, prior radiotherapy to the left chest wall or other risk factors for CHF were present.
Croatian: Većina bolesnika u kojih je nastupilo kongestivno zatajenje srca imala je metastatski rak dojke te su prethodno liječeni antraciklinima, radioterapijom lijeve strane prsnog koša ili su pak postojali drugi čimbenici rizika za kongestivno zatajenje srca.
English: XELOX or XELOX + bevacizumab
Croatian: XELOX ili XELOX + bevacizumab oksaliplatin kapecitabin
English: Thromboembolism (arterial)
Croatian: b,d tromboembolija (arterijska)
English: Four patients had objective (partial) response, and all of these had received the 10 mg/kg dose bevacizumab; the ORR for the 10 mg/kg dose was 10%.
Croatian: U četiri bolesnika, koji su primali bevacizumab u dozi od 10 mg/kg, postignut je objektivan (djelomičan) odgovor, a stopa ukupnog odgovora na liječenje za dozu od 10 mg/kg iznosila je 10 %.
English: Zirabev is a concentrate for solution for infusion.
Croatian: Zirabev je koncentrat za otopinu za infuziju.
English: Patients with histologically confirmed mCRC and disease progression were randomised 1:1 within 3 months after discontinuation of bevacizumab first-line therapy to receive fluoropyrimidine/oxaliplatin- or fluoropyrimidine/irinotecan-based chemotherapy (chemotherapy switched depending on first-line chemotherapy) with or without bevacizumab.
Croatian: Bolesnici s histološki potvrđenim metastatskim karcinomom kolona ili rektuma i progresijom bolesti su unutar 3 mjeseca od prekida primjene bevacizumaba u prvoj liniji liječenja randomizirani u omjeru 1:1 da primaju kemoterapiju na bazi fluoropirimidina/oksaliplatina ili fluoropirimidina/irinotekana (ta je kemoterapija bila promijenjena ovisno o kemoterapiji u prvoj liniji), s bevacizumabom ili bez njega.
English: How to use Zirabev
Croatian: Kako čuvati Zirabev
English: The difference in ORR per independent central review was 18% (CI: 0.6%, 35.3%) between the two treatment arms in the few patients who had evaluable tumor at baseline and had a confirmed response prior to receiving any local therapy: 27/75 patients (36.0%, 95% CI: 25.2%, 47.9%) in the Chemo arm and 34/63 patients (54.0%, 95% CI: 40.9%, 66.6%) in the Bv +Chemo arm.
Croatian: Prema ocjeni neovisnog središnjeg povjerenstva, razlika u ORR-u između dvije liječene skupine iznosila je 18 % (CI: 0,6 %; 35,3 %) u malobrojnih bolesnika koji su na početku ispitivanja imali tumor koji se mogao ocijeniti te potvrđen odgovor prije nego što su primili bilo koju lokalnu terapiju: 27/75 bolesnika (36,0 %; 95 % CI: 25,2 %; 47,9 %) u skupini liječenoj kemoterapijom te 34/63 bolesnika (54,0 %; 95 % CI: 40,9 %; 66,6 %) u skupini koja je primala bevacizumab + kemoterapiju.
English: For further information please refer to Table 3 ‘Adverse reactions reported in post-marketing setting.'
Croatian: Za dodatne informacije vidjeti tablicu 3 „Nuspojave prijavljene nakon stavljanja lijeka u promet“.
English: Progression-free survival and objective response rate were inferior in the bevacizumab monotherapy arm compared to the FOLFOX-4 arm.
Croatian: Preživljenje bez progresije bolesti i stopa objektivnog odgovora bili su lošiji u skupini koja je primala bevacizumab u monoterapiji nego u skupini liječenoj režimom FOLFOX-4.
English: Hazard ratioc p-value
Croatian: Omjer hazarda p-vrijednost
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 + bevacizumab, FOLFOX-4 + bevacizumab).
Croatian: U sljedećem dijelu (dio II) sastavljenom od 4 skupine prema faktorijalnom nacrtu 2 x 2 bolesnici su bili randomizirani u četiri terapijske skupine (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, FOLFOX-4 + bevacizumab).
English: In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 Grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in bevacizumab treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
Croatian: U kliničkim ispitivanjima u svim indikacijama ukupna incidencija reakcija krvarenja stupnja 3-5 prema NCI-CTCAE v.3 kretala se u rasponu od 0,4 % do 6,9 % u bolesnika liječenih bevacizumabom u odnosu na najviše 4,5 % u bolesnika u kontrolnoj skupini liječenoj kemoterapijom.
English: In clinical trials across indications, the overall incidence of venous thromboembolic reactions ranged from 2.8% to 17.3% of bevacizumab-treated patients compared with 3.2% to 15.6% in the control arms.
Croatian: U kliničkim ispitivanjima u svim indikacijama ukupna se incidencija venskih tromboembolijskih reakcija kretala u rasponu od 2,8 % do 17,3 % u bolesnika liječenih bevacizumabom te u rasponu od 3,2 % do 15,6 % u kontrolnim skupinama.
English: In patients developing PRES, early recognition of symptoms with prompt treatment of specific symptoms including control of hypertension (if associated with severe uncontrolled hypertension) is recommended in addition to discontinuation of bevacizumab therapy.
Croatian: U bolesnika u kojih se razvije PRES, uz obustavu terapije bevacizumabom preporučuje se rano prepoznavanje simptoma i brzo liječenje specifičnih simptoma, uključujući kontrolu hipertenzije (ako je sindrom povezan s teškom neliječenom hipertenzijom).
English: Table 2 provides the frequency of severe adverse reactions.
Croatian: U tablici 2 navedene su učestalosti teških nuspojava.
English: Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Croatian: Zirabev je u kombinaciji s interferonom alfa-2a indiciran za prvu liniju liječenja odraslih bolesnika s uznapredovalim i/ili metastatskim rakom bubrežnih stanica.
English: Table 5
Croatian: Tablica 5.
English: For patients in study AVF3694g who received anthracyclines concomitantly with bevacizumab, the incidences of Grade 3 or higher CHF for the respective bevacizumab and control arms were similar to those in the other studies in metastatic breast cancer: 2.9% in the anthracycline + bevacizumab arm and 0% in the anthracycline + placebo arm.
Croatian: U bolesnica iz ispitivanja AVF3694g koje su primale antracikline istodobno s bevacizumabom, incidencija kongestivnog zatajenja srca stupnja 3 ili višeg stupnja bila je i u skupini na bevacizumabu i u kontrolnoj skupini slična incidenciji u drugim ispitivanjima metastatskog raka dojke: 2,9 % u skupini koja je primala antraciklin + bevacizumab te 0% u skupini koja je primala antraciklin + placebo.
English: Fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy
Croatian: Kemoterapija na bazi fluoropirimidina/irinotekana ili fluoropirimidina/oksaliplatina
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 središnjem živčanom sustavu u bolesnika s neliječenim metastazama u središnjem živčanom sustavu koji su primali bevacizumab nije prospektivno ocijenjena u randomiziranim kliničkim ispitivanjima.
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.
Croatian: U ispitivanjima u raznim indikacijama manje često (≥ 0,1 % i < 1 %) su prijavljene fistule u dijelovima tijela izvan gastrointestinalnog trakta (npr. bronhopleuralne i bilijarne fistule).
English: These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitritis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular haemorrhage such as vitreous haemorrhage or retinal haemorrhage and conjunctival haemorrhage.
Croatian: Te su reakcije uključivale infektivni endoftalmitis, intraokularnu upalu poput sterilnog endoftalmitisa, uveitisa i vitritisa, odvajanje mrežnice, kidanje pigmentnog epitela mrežnice, povišen očni tlak, intraokularno krvarenje poput vitrealnog krvarenja ili krvarenja mrežnice te krvarenje konjunktive.
English: Trial E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating bevacizumab in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease.
Croatian: Ispitivanje E2100 bilo je otvoreno, randomizirano, aktivno kontrolirano multicentrično kliničko ispitivanje u kojemu se ispitivala primjena bevacizumaba u kombinaciji s paklitakselom u liječenju lokalno recidivirajućeg ili metastatskog raka dojke u bolesnica koje prethodno nisu primale kemoterapiju za lokalno recidivirajuću ili metastatsku bolest.