natgillin/translations-raw huggingface dataset:
The clinical benefit of bevacizumab as measured by PFS was seen in all pre-specified subgroups tested (including disease-free interval, number of metastatic sites, prior receipt of adjuvant chemotherapy and oestrogen receptor (ER) status). 
Klinična korist bevacizumaba, merjena kot preživetje brez napredovanja bolezni, je bila opažena v vseh preiskovanih, vnaprej določenih podskupinah (vključno z intervalom brez bolezni, številom metastatskih mest, predhodnim prejetjem adjuvantne kemoterapije in statusom estrogenskih receptorjev).
Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections. 
SEZNAM POMOŽNIH SNOVI Trehaloza dihidrat, natrijev fosfat, polisorbat 20, voda za injekcije.
What MVASI looks like and contents of the pack 
Izgled zdravila MVASI in vsebina pakiranja
• AVF2107g: A weekly schedule of irinotecan/bolus 5-fluorouracil/folinic acid (IFL) for a total of 4 weeks of each 6 week-cycle (Saltz regimen). 
• AVF2107g: tedenska shema irinotekana/bolusa 5-fluorouracila/folinske kisline (IFL), ki jo bolnik prejema 4 tedne zapored v 6-tedenskih ciklih (shema Saltz).
The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see table 4). 
Dodatek bevacizumaba k shemi IFL je statistično značilno podaljšal celokupno preživetje, preživetje brez napredovanja bolezni in celokupen odgovor na zdravljenje teh bolnikov (glejte preglednico 4).
Fluoropyrimidine/irinotecan or Fluoropyrimidine/oxaliplatin based chemotherapy + bevacizumaba 
kemoterapija na osnovi fluoropirimidina/irinotekana ali fluoropirimidina/oksaliplatina kemoterapija na osnovi fluoropirimidina/irinotekana ali fluoropirimidina/oksaliplatina + bevacizumaba
In study BO20924 of bevacizumab with current standard of care in metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma, the safety profile of bevacizumab-treated children was comparable with that observed in adults treated with bevacizumab. 
V študiji BO20924 z bevacizumabom v kombinaciji s trenutnim standardnim zdravljenjem metastatskega rabdomiosarkoma in ostalih mehkotkivnih sarkomov je bil varnostni profil bevacizumaba pri zdravljenih otrocih primerljiv s tistim pri odraslih, zdravljenih z bevacizumabom.
Efficacy results from study MO22224 Primary endpoint 
Rezultati učinkovitosti iz študije MO22224
Ovarian failure/fertility 
Okvara jajčnikov/plodnost
Pre-specified PFS analyses were conducted, all with a cut-off date of 29 September 2009. 
Narejene so bile vnaprej določene analize preživetja brez napredovanja bolezni, vse s podatki zbranimi do 29. septembra 2009.
Progression-free survival by time from last platinum therapy to recurrence 
Preživetje brez napredovanja bolezni prikazano glede na čas od zadnjega zdravljenja, ki je vsebovalo platino, do ponovitve bolezni
This does not necessarily mean that these side effects were strictly caused by MVASI. 
To pa ne pomeni, da je neželene učinke povzročilo le zdravilo MVASI.
In clinical trials with bevacizumab, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer. 
V kliničnih preskušanjih z bevacizumabom so kongestivno srčno popuščanje opazili pri vseh indikacijah raka, ki so jih preiskovali do sedaj, pojavilo pa se je predvsem pri bolnikih z metastatskim rakom dojk.
5.8% of the overall randomised patient population had stage IIIB disease. 
5,8 % celotne populacije randomiziranih bolnic je imelo bolezen stadija III B. Glede na kontrolno skupino.
PFS1 results by disease stage and debulking status from study GOG-0218 
Rezultati preživetja brez napredovanja bolezni1, glede na stadij bolezni in stopnjo citoredukcije iz študije GOG-0218
Ovarian failure/fertility (see sections 4.4 and 4.6) 
Okvara jajčnikov/plodnost (glejte poglavji 4.4 in 4.6)
Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, bevacizumab therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy. 
Med možnimi dejavniki tveganja so ploščatocelična histologija, zdravljenje z antirevmatičnimi/protivnetnimi zdravili, zdravljenje z antikoagulanti, predhodna radioterapija, zdravljenje z bevacizumabom, anamneza ateroskleroze, centralna lokalizacija tumorja in razpad tumorjev med zdravljenjem.
• an open sore or hole in the lining of the stomach or small intestine (the signs may include abdominal pain, feeling bloated, black tarry stools or blood in your stools (faeces) or blood in your vomit), 
• odprta rana ali luknja v sluznici želodca ali tankega črevesa (znaki so lahko bolečina v trebuhu, občutek napihnjenosti, črno blato ali kri v blatu ali kri v bruhanju),
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; HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147). 
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 0,518 v študiji E3200; razmerje ogroženosti 0,68 v študiji ML18147).
FOLFOX-4 or XELOX + bevacizumab (n = 699) 
FOLFOX-4 ali XELOX + bevacizumab (n = 699)
Patients may be at increased risk for the development of fistulae when treated with bevacizumab. 
Bolniki so lahko izpostavljeni večjemu tveganju za nastanek fistule, če se zdravijo z bevacizumabom.
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). 
V dveh kasnejših kliničnih preskušanjih, pri bolnikih z zdravljenimi zasevki v možganih (vključenih je bilo okoli 800 bolnikov), so v času vmesne analize varnosti poročali o enem primeru krvavitve v osrednjem živčevju stopnje 2 od 83 bolnikov, zdravljenih z bevacizumabom (1,2 %) (NCI-CTCAE v.3).
In study BO25041, bevacizumab exposure was similar compared to a typical adult at the same dose. 
V študiji BO25041 je bila izpostavljenost bevacizumabu podobna kot pri tipičnem odraslem bolniku, ki je prejemal enak odmerek.
• Infection or inflammation of the eye globe, 
• okužba ali vnetje očesnega zrkla,
Adjustment for these baseline factors resulted in a treatment hazard ratio of 0.78 (95% CI [0.63; 0.96], p = 0.0219), indicating a 22% reduction in the risk of death for patients in the bevacizumab + IFN alfa-2a arm compared to IFN alfa-2a arm. 
Po prilagoditvi glede na izhodiščne dejavnike je bilo razmerje ogroženosti 0,78 (95-% interval zaupanja [0,63; 0,96], p = 0,0219), kar je pomenilo 22 % zmanjšanje tveganja za smrt za bolnike, ki so prejemali bevacizumab in interferon alfa-2a, v primerjavi z bolniki, ki so prejemali interferon alfa-2a.
• clogging of a very small blood vessel(s) in the kidney, 
• strdki v zelo majhni krvni žili (ali žilah) v ledvicah,
Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with bevacizumab therapy are likely to be dose-dependent. 
Podatki o klinični varnosti zdravila kažejo, da je pojav hipertenzije in proteinurije med zdravljenjem z bevacizumabom verjetno odvisen od njegovega odmerka.
• a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES), 
• bolezen možgan s simptomi, ki vključujejo epileptični napad, glavobol, zmedenost in spremembe vida (sindrom posteriorne reverzibilne encefalopatije ali PRES),
Treatment of platinum-resistant recurrent disease: MVASI is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin. 
Zdravljenje ponovitve bolezni, ki je rezistentna na platino: zdravilo MVASI dajemo v kombinaciji z enim od naslednjih zdravil: paklitakselom, topotekanom (s tedenskim odmerjanjem) ali pegiliranim liposomalnim doksorubicinom.
Results from the primary analysis and the follow-up analysis are presented by bevacizumab treatment and by trial treatment in table 24 and 25, respectively. 
Rezultati primarne analize in analize po spremljanju so predstavljeni glede na zdravljenje z bevacizumabom (preglednica 24) in glede na preizkušano zdravljenje (preglednica 25).
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). 
Dodatek bevacizumaba kemoterapiji na osnovi fluoropirimidina je statistično značilno podaljšal preživetje pri bolnikih z metastatskim rakom debelega črevesa in danke, pri katerih je po prvi liniji zdravljenja, ki je vključevalo bevacizumab, bolezen napredovala (ITT = 819) (glejte preglednico 9).
The efficacy results of the study are presented in table 13. 
Rezultati učinkovitosti študije so predstavljeni v preglednici 13.
This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/ vincristine/prednisone (R-CHOP) plus bevacizumab to R-CHOP without bevacizumab. 
V kliničnem preskušanju faze III so primerjali shemo rituksimab/ciklofosfamid/doksorubicin/vinkristin/prednizon (R-CHOP) in bevacizumab s shemo R-CHOP brez bevacizumaba.
Congestive heart failurea,b, Supraventricular tachycardia 
Srčne bolezni kongestivno srčno popuščanjea,b, supraventriku-larna tahikardija
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. 
Sedemindevetdesetim (97) bolnikom iz skupine, ki je prejemala interferon alfa-2a, in 131 bolnikom iz skupine, ki je prejemala bevacizumab, so v skladu s protokolom zmanjšali odmerek interferona alfa-2a z 9 mio i.e. na 6 ali 3 mio i.e. trikrat na teden.
Study JO25567 was a randomised, open-label, multi-centre phase II study conducted in Japan to evaluate the efficacy and safety of bevacizumab used in addition to erlotinib in patients with nonsquamous NSCLC with EGFR activating mutations (exon 19 deletion or exon 21 L858R mutation) who had not received prior systemic therapy for stage IIIB/IV or recurrent disease. 
Študija JO25567 je bila randomizirana, odprta, multicentrična študija faze II, izvedena na Japonskem, v kateri so ocenjevali učinkovitost in varnost bevacizumaba, uporabljenega kot dodatek erlotinibu pri bolnikih z neskvamoznim nedrobnoceličnim rakom pljuč z EGFR-aktivirajočimi mutacijami (delecijo eksona 19 ali mutacijo L858R eksona 21), ki niso prejeli predhodnega sistemskega zdravljenja za stadij IIIB/IV ali pri katerih se je bolezen ponovila.
The study evaluated the effect of adding bevacizumab to carboplatin+paclitaxel and continuing bevacizumab as a single agent until disease progression or unacceptable toxicity compared to carboplatin+paclitaxel alone. 
Študija je ocenjevala učinek dodajanja bevacizumaba h kombinaciji karboplatina in paklitaksela ter nadaljevanja zdravljenja s samim bevacizumabom do napredovanja bolezni ali nesprejemljive toksičnosti v primerjavi z dajanjem samo karboplatina in paklitaksela.
An increased incidence of hypertension was observed in bevacizumab-treated patients. 
Incidenca hipertenzije je bila večja pri bolnikih, zdravljenih z bevacizumabom.
A total of 484 patients with measurable disease were randomised 1:1 to either: 
V dve skupini v razmerju 1:1 so randomizirali skupno 484 bolnic z merljivo boleznijo:
There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder. 
Pri bolnikih, ki so se zdravili z bevacizumabom, so redko poročali o pojavu znakov in simptomov, povezanih s sindromom posteriorne reverzibilne encefalopatije, redko nevrološko motnjo.
• severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure, 
• zelo visok krvni tlak, ki ga ni mogoče uravnati z zdravili za zdravljenje zvišanega krvnega tlaka,
The safety and efficacy of bevacizumab in the front-line treatment of patients with epithelial ovarian, fallopian tube or primary peritoneal cancer were studied in two phase III trials (GOG-0218 and BO17707) that evaluated the effect of the addition of bevacizumab to carboplatin and paclitaxel compared to the chemotherapy regimen alone. 
Varnost in učinkovitost bevacizumaba v prvem zdravljenju bolnic z epitelijskim rakom jajčnikov, karcinomom jajcevodov ali primarnim peritonealnim karcinomom so proučevali v dveh preskušanjih faze III (GOG-0218 in BO17707), kjer so ocenjevali vpliv dodajanja bevacizumaba karboplatinu in paklitakselu v primerjavi s kemoterapijo samo.
Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/mL (0.9%) solution for injection. 
Kemijska in fizikalna stabilnost v 0,9-% (9 mg/ml) raztopini natrijevega klorida za injiciranje pred uporabo je bila dokazana do 48 ur pri temperaturi 2 °C do 30 °C.
Eight hundred and thirteen patients were randomised to receive IFL + placebo (Arm 1) or IFL + bevacizumab (5 mg/kg every 2 weeks, Arm 2). 
Randomiziranih je bilo 813 bolnikov, ki so prejeli IFL + placebo (skupina 1) ali IFL + bevacizumab (5 mg/kg vsaka 2 tedna, skupina 2).
Overall survival results from study GOG-0240 by trial treatment Treatment comparison Other factor 
Rezultati celokupnega preživetja v študiji GOG-0240 glede na preizkušano zdravljenje
The study compared the effect of adding bevacizumab to carboplatin and gemcitabine chemotherapy and continuing bevacizumab as a single agent to progression, to carboplatin and gemcitabine alone. 
Študija je primerjala učinek dodajanja bevacizumaba h kemoterapiji, ki je vsebovala karboplatin in gemcitabin, ter se je nadaljevala s samim bevacizumabom do napredovanja bolezni, z dajanjem samo karboplatina in gemcitabina.
Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with bevacizumab. 
Proteinurijo četrte stopnje (nefrotski sindrom) so opazili pri do 1,4 % bolnikov, zdravljenih z bevacizumabom.
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. 
V kliničnih preskušanjih je bila incidenca arterijskih trombemboličnih neželenih učinkov, vključno s cerebrovaskularnimi neželenimi učinki, tranzitornimi ishemičnimi atakami (TIA) in miokardnimi infarkti, večja pri bolnikih, ki so prejemali bevacizumab v kombinaciji s kemoterapijo v primerjavi s tistimi, ki so prejemali le kemoterapijo.
Patients receiving bevacizumab plus chemotherapy, with a history of arterial thromboembolism, diabetes or age greater than 65 years have an increased risk of developing arterial thromboembolic reactions during therapy. 
Bolniki, ki prejemajo bevacizumab skupaj s kemoterapijo in imajo arterijske trombembolične neželene učinke v anamnezi, sladkorno bolezen ali so stari nad 65 let, imajo med zdravljenjem povečano tveganje za razvoj arterijskih trombemboličnih neželenih učinkov.
(p-value = 0.8910) 
(p-vrednost = 0,8910)
In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with bevacizumab. 
V literaturi so bili objavljeni primeri osteonekroze izven spodnje čeljustnice pri bolnikih, ki so se zdravili z bevacizumabom in so bili mlajši od 18 let.
Placebo or bevacizumab 
placebo ali bevacizumab
regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth. 
Zaradi tega ker preprečuje biološko delovanje VEGF, vaskularizacija tumorja nazaduje, preostala vaskulatura tumorja se normalizira, nastajanje nove vaskulature tumorja pa se prepreči.
In bevacizumab 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. 
V kliničnih preskušanjih bevacizumaba so fistule prebavil (vseh stopenj) pri bolnikih z metastatskim kolorektalnim rakom in rakom jajčnikov zabeležili z incidenco do 2 %, pri bolnikih z drugimi vrstami raka pa so bile zabeležene redkeje.
MVASI in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. 
Zdravilo MVASI je v kombinaciji z interferonom alfa-2a indicirano za prvo linijo zdravljenja odraslih bolnikov z napredovalim in/ali metastatskim rakom ledvičnih celic.
Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed mainly in patients treated with platinumor taxane-based therapies in the treatment of NSCLC and mBC. 
Opazili so večji pojav hude nevtropenije, febrilne nevtropenije ali okužbe s hudo nevtropenijo ali brez nje (vključno s smrtnimi primeri); to so večinoma opazili pri bolnikih, ki so prejemali zdravljenje na osnovi platine ali taksanov pri nedrobnoceličnem raku pljuč ter metastatskem raku dojk.
3.7% of the overall randomised patient population had stage IIIB disease. 
3,7 % celotne populacije randomiziranih bolnic je imelo bolezen stadija III B. Glede na kontrolno skupino.
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. 
V študiji pri bolnicah s ponovitvijo raka jajčnikov, rezistentnega na platino, so poročali tudi o alopeciji, vnetju sluznice, periferni senzorični nevropatiji, proteinuriji in hipertenziji, ki so se pojavili z najmanj 5 % večjo pogostnostjo pri starejših bolnicah ≥ 65 let v primerjavi z bolnicami, mlajšimi od 65 let, v skupini, ki je prejemala kemoterapijo in bevacizumab.
MVASI is not formulated for intravitreal use. 
Zdravilo MVASI ni namenjeno intravitrealni uporabi.
The safety and efficacy of bevacizumab in the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer was studied in three phase III trials (AVF4095g, MO22224 and GOG-0213) with different patient populations and chemotherapy regimens. 
Varnost in učinkovitost bevacizumaba pri zdravljenju ponovitve epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma so proučevali v treh preskušanjih faze III (AVF4095g, MO22224 in GOG-0213) pri različni populaciji bolnic in shemah kemoterapije.
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. 
V študiji AVF3694g je bila pri bolnikih, ki so prejemali antracikline sočasno z bevacizumabom, incidenca kongestivnega srčnega popuščanja stopnje 3 ali več v skupini z bevacizumabom in v kontrolni skupini podobna kot v drugih preskušanjih pri metastatskemu raku dojk: 2,9 % v skupini z antraciklinom in bevacizumabom ter 0 % v skupini z antraciklinom in placebom.
• muscle and joint pain, muscular weakness, 
• bolečine v mišicah in sklepih, šibkost mišic,
Other reactions with a higher frequency seen in patients over 65 were grade 3-4 leucopenia and thrombocytopenia (NCI-CTCAE v.3); and all grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with bevacizumab (see sections 4.4 and 4.8 under Thromboembolism). 
Druge reakcije, ki so jih pri bolnikih, starejših od 65 let, opazili z višjo pogostnostjo v primerjavi z bolniki, starimi 65 let ali manj pri zdravljenju z bevacizumabom, so bile levkopenija in trombocitopenija stopnje 3 do 4 (NCI-CTCAE v.3), vse stopnje nevtropenije, diareja, navzea, glavobol in utrujenost (glejte poglavji 4.4 in 4.8 pod Trombembolija).
The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with bevacizumab. 
Opaženo zvišanje kreatinina v serumu pri bolnikih, zdravljenih z bevacizumabom, ni bilo povezano z višjo incidenco kliničnih manifestacij ledvične okvare.
Detailed information about these post-marketing reactions are provided in table 3. 
Natančnejše informacije o teh neželenih učinkih so v preglednici 3.
Adverse reactions by frequency 
Neželeni učinki po pogostnosti
Fatal outcome was reported in 0.8% of patients receiving bevacizumab compared to 0.5% in patients receiving chemotherapy alone. 
O smrtnem izidu so poročali pri 0,8 % bolnikov, zdravljenih z bevacizumabom, v primerjavi z 0,5 % bolnikov, ki so prejemali le kemoterapijo.
The only variables that showed statistically significant correlations with bleeding were bevacizumab therapy and squamous cell histology. 
Statistično značilno povezavo s krvavitvijo so našli le pri zdravljenju z bevacizumabom in ploščatocelični histologiji.
Topotecan + Paclitaxel 
Topotekan + paklitaksel
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. 
V kliničnih preskušanjih vseh indikacij je celokupna incidenca venskih trombemboličnih neželenih učinkov znašala od 2,8 do 17,3 % pri bolnikih, zdravljenih z bevacizumabom, v primerjavi s kontrolnimi skupinami, kjer je znašala od 3,2 do 15,6 %.
Results are presented in table 11. 
Rezultati so predstavljeni v preglednici 11.
First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy 
Prva linija zdravljenja neskvamoznega nedrobnoceličnega raka pljuč v kombinaciji s kemoterapijo na osnovi platine
MVASI, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). 
Zdravilo MVASI je v kombinaciji z erlotinibom indicirano za prvo linijo zdravljenja odraslih bolnikov z inoperabilnim, napredovalim, metastatskim ali ponavljajočim se neskvamoznim nedrobnoceličnim rakom pljuč z EGFR-aktivirajočimi mutacijami (EGFR - Epidermal Growth Factor Receptor) (glejte poglavje 5.1).
Results are presented in table 22. 
Rezultati so prikazani v preglednici 22.
The safety of reinitiating bevacizumab therapy in patients previously experiencing PRES is not known. 
Varnost ponovne uvedbe zdravljenja z bevacizumabom pri bolnikih, pri katerih se je ta sindrom pojavil, ni znana.
• hole in the gall bladder (symptoms and signs may include abdominal pain, fever, and nausea/vomiting), 
• luknja v žolčniku (simptomi in znaki lahko vključujejo bolečino v trebuhu, povišano telesno temperaturo in slabost/bruhanje),
Primary endpoint Overall survival (OS) 
Celokupno preživetje (OS)
Each vial contains 100 mg bevacizumab in 4 mL of solution or 400 mg bevacizumab in 16 mL of solution. 
Ena viala vsebuje 100 mg bevacizumaba v 4 ml raztopine ali 400 mg bevacizumaba v 16 ml raztopine.
• Seeing flashes of light with floaters, progressing to a loss of some of your vision, 
• bliskanje v vidnem polju z motnjavami, kar vodi do delne izgube vida,