natgillin/translations-raw huggingface dataset:
• a blood clot in your arteries, 
• krvni strdek v arterijah,
Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents 
Vpliv bevacizumaba na farmakokinetiko drugih zdravil za zdravljenje novotvorb
5-fluorouracil IV bolus/infusion, each on days 1 and 2 
bolus/infuzija, vsak 1. in 2. dan placebo ali bevacizumab
• E3200: bevacizumab 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. 
• E3200: Bevacizumab 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.
Each vial of 16 mL of concentrate contains 400 mg of bevacizumab. 
Ena viala s 16 ml koncentrata vsebuje 400 mg bevacizumaba.
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 tumour 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. 
Po neodvisnem centralnem pregledu je bila razlika v deležu celokupnega odziva med redkimi bolniki iz obeh zdravljenih skupin, ki so imeli ocenljiv tumor v izhodišču in potrjen odziv pred prejemom katerega koli lokalnega zdravljenja, 18 % (interval zaupanja: 0,6 %; 35,3 %): 27/75 bolnikov (36,0 %; 95-% interval zaupanja: 25,2 %; 47,9 %) iz skupine, ki je prejemala kemoterapijo, in 34/63 bolnikov (54,0 %; 95-% interval zaupanja: 40,9 %; 66,6 %) iz skupine, ki je prejemala kombinacijo bevacizumaba in kemoterapije.
GOG-0213, a phase III randomised controlled open label trial, studied the safety and efficacy of bevacizumab 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. 
Randomizirano, kontrolirano, odprto preskušanje faze III GOG-0213 je proučevalo varnost in učinkovitost bevacizumaba 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.
The addition of bevacizumab to IFN alfa-2a significantly increased PFS and objective tumour response rate. 
Dodatek bevacizumaba k interferonu alfa-2a je pomembno podaljšal preživetje brez napredovanja bolezni in pomembno povečal objektivni odgovor na zdravljenje.
Posterior reversible encephalopathy syndrome (see section 4.4) 
Sindrom posteriorne reverzibilne encefalopatije (glejte poglavje 4.4)
5-FU/FA + bevacizumab 
5-FU/FA + bevacizumab b
The primary endpoint was progression-free survival, with secondary endpoints including objective response rate and overall survival. 
Primarni opazovani dogodek je bil preživetje brez napredovanja bolezni, sekundarni opazovani dogodki pa so vključevali objektivni odgovor in celokupno preživetje.
Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category. 
Rektovaginalne fistule so najpogostejše fistule v skupini fistul med prebavili in nožnico.
Sepsis, Abscessb,d, Cellulitis, Infection, Urinary tract infection 
Infekcijske in parazitske bolezni sepsa, abscesb,d, celulitis, okužba, okužba sečil nekrotizirajoči fasciitisa
Bevacizumab was combined with two chemotherapy regimens: 
Bevacizumab so dajali v kombinaciji z dvema kemoterapevtskima shemama zdravljenja:
Each mL of concentrate contains 25 mg of bevacizumab, corresponding to 1.4 to 16.5 mg/mL when diluted as recommended. 
En ml koncentrata vsebuje 25 mg bevacizumaba, kar po priporočeni razredčitvi ustreza koncentraciji od 1,4 mg/ml do 16,5 mg/ml.
• loss of body weight, 
• zvišano telesno temperaturo,
Cisplatin/Gemcitabine + bevacizumab 7.5 mg/kg q 3 weeks 
cisplatin/gemcitabin/ placebo cisplatin/gemcitabin/ bevacizumab 7,5 mg/kg na 3 tedne cisplatin/gemcitabin/ bevacizumab 15 mg/kg na 3 tedne
Oxaliplatin on day 1 
2 h oksaliplatin 1. dan
What MVASI contains 
Kaj vsebuje zdravilo MVASI
• 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). 
• AVF0780g: v kombinaciji z bolusom 5-fluorouracila/folinske kisline (5-FU/FA).
(16.2 vs. 12.0 months; p = 0.1342) 
(16,2 proti 12,0 meseca; p =
Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with bevacizumab through: 
Za te neželene učinke so določili, da imajo vzročno povezavo z bevacizumabom:
• you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies. 
• če ste alergični (preobčutljivi) na celične produkte ovarija kitajskega hrčka (CHO - Chinese
• Each 16 mL vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/mL when diluted as recommended. 
• Ena 16 ml viala vsebuje 400 mg bevacizumaba, kar po priporočeni razredčitvi ustreza koncentraciji 16,5 mg/ml.
• Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. 
• Preobčutljivost za produkte ovarijskih celic kitajskega hrčka (CHO - Chinese Hamster Ovary)
Number of patients Overall survival Median (months) Hazard ratio (95% confidence interval) 
Število bolnikov Celokupno preživetje mediana (meseci) razmerje ogroženosti (95-% interval zaupanja)
(12.0 vs. 15.0 months; 
(12,0 proti 15,0 meseca; p =
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. 
Občasno (≥ 0,1 % do < 1 %) so pri različnih indikacijah poročali o fistulah, ki se v telesu pojavljajo izven prebavil (plevrobronhialna in žolčna fistula).
Severe side effects, which may be common (may affect up to 1 in 10 people), include: 
Hudi neželeni učinki, ki so lahko pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov), vključujejo:
However, sleepiness and fainting have been reported with MVASI use. 
Vendar pa so pri uporabi zdravila MVASI poročali o zaspanosti in omedlevici.
Paclitaxel/ bevacizumab (n = 368) 
paklitaksel/ bevacizumab (n = 368)
This was a phase III randomised, active-controlled, open-label trial investigating bevacizumab 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second-line) with advanced colorectal cancer. 
To je bilo randomizirano, aktivno kontrolirano, odprto preskušanje faze III, ki je proučevalo bevacizumab v odmerku 10 mg/kg v kombinaciji z levkovorinom in bolusom 5-fluorouracila, sledila je infuzija 5-fluorouracila z oksaliplatinom intravensko (shema FOLFOX-4) pri bolnikih z napredovalim rakom debelega črevesa in danke, ki so bili predhodno zdravljeni (druga linija).
Investigator assessed PFS analysis with data cut-off date of 30 November 2010. 
Analiza podatkov preživetja brez napredovanja bolezni, ocenjenih s strani raziskovalca, zbranih do 30. novembra 2010.
(14.9 vs. 11.9 months; p = 0.1061) 
(14,9 proti 11,9 meseca; p =
Bevacizumab may impair female fertility (see sections 4.6 and 4.8). 
Bevacizumab lahko zmanjša plodnost žensk (glejte poglavji 4.6 in 4.8).
Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with bevacizumab. 
Pri bolnikih, ki so prejemali bevacizumab, so redko poročali o nekrotizirajočem fasciitisu, vključno s smrtnimi primeri.
MVASI is also used for the treatment of adult patients with metastatic breast cancer. 
Zdravilo MVASI uporabljamo tudi za zdravljenje odraslih bolnikov z metastatskim rakom dojk.
MVASI in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. 
Zdravilo MVASI je v kombinaciji s paklitakselom indicirano za prvo linijo zdravljenja odraslih bolnikov z metastatskim rakom dojk.
This was a phase III randomised, double-blind, active-controlled clinical trial evaluating bevacizumab in combination with IFL as first-line treatment for metastatic carcinoma of the colon or rectum. 
To je bilo randomizirano, dvojno slepo, aktivno kontrolirano klinično preskušanje faze III, ki je proučevalo bevacizumab v kombinaciji z IFL v prvi liniji zdravljenja metastatskega raka debelega črevesa in danke.
Eligible patients had persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which was not amenable to curative treatment with surgery and/or radiation therapy and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. 
Primerne bolnice so imele histološko skvamozni karcinom, adenoskvamozni karcinom ali adenokarcinom materničnega vratu, pri katerem ni bila možna ozdravitev z operacijo in/ali obsevanjem, ponovitev bolezni ali metastatsko bolezen ter predhodno še niso bile zdravljene z bevacizumabom ali drugimi zaviralci VEGF ali tarčnimi učinkovinami za receptor VEGF.
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. 
To je bilo randomizirano, dvojno slepo (za bevacizumab), klinično preskušanje faze III, v katerem so proučevali bevacizumab v odmerku 7,5 mg/kg v kombinaciji s kapecitabinom peroralno in oksaliplatinom intravensko (shema XELOX), kar so bolniki prejemali na 3 tedne; ali bevacizumab 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).
In cases of internal fistula not arising in the gastrointestinal tract, discontinuation of MVASI should be considered. 
V primerih notranjih fistul izven prebavil je treba razmisliti o ukinitvi zdravljenja z zdravilom MVASI.
• Carboplatin (AUC 4, day 1) and gemcitabine (1,000 mg/m2 on days 1 and 8) and concurrent bevacizumab (15 mg/kg day 1) every 3 weeks for 6 and up to 10 cycles followed by bevacizumab (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity. 
• karboplatin (AUC 4, dan1) in gemcitabin (1.000 mg/m2 na dan 1 in 8) ter sočasno bevacizumab (15 mg/kg, dan 1) vsake 3 tedne, od 6 do največ 10 ciklov, nato je sledil samo bevacizumab (15 mg/kg vsake 3 tedne) do napredovanja bolezni ali nesprejemljive toksičnosti.
Myocardial infarction was reported in up to 1.4% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone. 
O miokardnem infarktu so poročali pri do 1,4 % bolnikov, ki so jih zdravili s kombinacijo bevacizumaba in kemoterapije, v primerjavi z do 0,7 % bolnikov, ki so bili zdravljeni le s kemoterapijo.
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back at least 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, MVASI will be administered in combination with carboplatin and gemcitabine or with carboplatin and paclitaxel. 
Kadar zdravilo uporabljamo pri odraslih bolnicah z napredovalim epitelijskim rakom jajčnikov, karcinomom jajcevodov in primarnim rakom potrebušnice, pri katerih se je bolezen ponovila po 6 ali več mesecih po zadnji prejeti kemoterapiji, ki je vsebovala platino, bo zdravilo MVASI dano v kombinaciji s karboplatinom in gemcitabinom ali s karboplatinom in paklitakselom.
The majority of patients included in the study were white (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an ECOG PS of 2. 
25 % bolnic v vsaki skupini je bilo starih 65 let ali več in približno 50 % bolnic je imelo oceno stanja zmogljivosti (PS, performance status) po ECOG (Eastern Cooperative Oncology Group) 1; 7 % bolnic v vsaki skupini pa 2.
In clinical trials of ovarian cancer, grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3). 
V kliničnih preskušanjih raka jajčnikov so zaplete pri celjenju ran stopnje 3-5 opazili pri do 1,8 % bolnic, ki so prejemale bevacizumab, v primerjavi z do 0,1 % bolnic v kontrolni skupini (NCI-CTCAE v.3).
One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression. 
Randomiziranih je bilo 105 bolnikov, ki so prejeli 5-FU/FA + placebo, in 104 bolniki, ki so prejeli 5-FU/FA + bevacizumab (5 mg/kg vsaka dva tedna).
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 4.6% of patients treated with paclitaxel and topotecan. 
V kliničnem preskušanju pri bolnicah z rakom materničnega vratu, pri katerih je bila bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je bila metastatska (študija GOG-0240), so o krvavitvah stopnje 3 do 5 poročali pri do 8,3 % bolnic, ki so prejemale bevacizumab v kombinaciji s paklitakselom in topotekanom, in pri do 4,6 % bolnic, ki so prejemale paklitaksel in topotekan.
Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with MVASI and all patients with GI perforation had a history of prior radiation. 
Predhodno obsevanje je dejavnik tveganja za perforacije prebavil pri bolnicah 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 MVASI - vse bolnice s perforacijami prebavil so bile predhodno obsevane.
If a dose of MVASI is missed 
Če je bil odmerek zdravila MVASI izpuščen
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. 
154 bolnikov je bilo randomiziranih v skupino, ki je prejemala erlotinib in bevacizumab (erlotinib 150 mg peroralno na dan + bevacizumab [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.
CHF grade 3 or higher reactions were somewhat more frequent among patients receiving bevacizumab in combination with chemotherapy than in patients receiving chemotherapy alone. 
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.
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. 
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.
• Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival and overall survival in the eligible per-protocol population. 
• V populaciji, ki je bila primerna glede na protokol raziskave, je bila v celokupni primerjavi glede na preživetje brez napredovanja bolezni in celokupno preživetje dokazana neinferiornost skupin, ki so se zdravile po shemi XELOX, v primerjavi s skupinami, ki so se zdravile po shemi FOLFOX-4.
FOLFOX-4 or 
FOLFOX-4 ali
Efficacy results for trial AVF2107g 
Rezultati preskušanja AVF2107g glede učinkovitosti AVF2107g
PFS subgroup analyses by disease stage and debulking status are summarised in table 16. 
Analize podskupin preživetja brez napredovanja bolezni, glede na stadij bolezni in stopnjo kirurškega zmanjšanja bolezni, so povzete v preglednici 16.
Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC07. 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe in imunomodulatorji, zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa.
The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarised in table 23. 
Eksplorativne analize preživetja brez napredovanja bolezni in celokupnega preživetja glede na uporabljeno kemoterapijo (paklitaksel, topotekan ali PLD) so povzete v preglednici 23.
Enrolment in Arm 3 was discontinued, as pre-specified, once safety of bevacizumab with the IFL regimen was established and considered acceptable. 
Ko je bila varnost kombinacije IFL in bevacizumaba dokazana in sprejeta, je bilo vključevanje v tretjo skupino prekinjeno, kot je bilo že prej predvideno.
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. 
V kliničnih preskušanjih vseh indikacij je celokupna incidenca krvavitev stopnje 3 do 5 po lestvici NCI-CTCAE v.3 znašala od 0,4 do 6,9 % bolnikov, ki so se zdravili z bevacizumabom.
Sepsis, Cellulitis, Abscessa,b, Infection, Urinary tract infection 
Infekcijske in parazitske bolezni sepsa, celulitis, abscesa,b, okužba, okužba sečil nekrotizirajoči fasciitisc
• decreased number of cells in the blood, including white cells that help to fight against infections 
• zmanjšano število krvnih celic, vključno z belimi krvnimi celicami, ki pomagajo pri boju proti okužbam (ob tem se lahko pojavi zvišana telesna temperatura), in celicami, ki pomagajo strjevati kri,
These results suggest that close clinical observation with appropriate cardiac assessments should be considered for patients exposed to cumulative doxorubicin doses greater than 300 mg/m2 when combined with bevacizumab. 
Ti rezultati nakazujejo, da je treba bolnike, ki prejemajo kumulativne odmerke doksorubicina, višje od 300 mg/m2, v kombinaciji z bevacizumabom, skrbno klinično spremljati in jim ustrezno oceniti srčno funkcijo.
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back before 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, MVASI will be administered in combination with paclitaxel, or topotecan, or pegylated liposomal doxorubicin. 
Kadar zdravilo uporabljamo pri odraslih bolnicah z napredovalim epitelijskim rakom jajčnikov, karcinomom jajcevodov ali primarnim rakom potrebušnice, pri katerih se je bolezen ponovila prej kot po 6 mesecih po zadnji prejeti kemoterapiji, ki je vsebovala platino, bo zdravilo MVASI dano v kombinaciji s paklitakselom ali topotekanom ali pegiliranim liposomalnim doksorubicinom.
When used for patients with breast cancer, it will be administered with a chemotherapy medicinal product called paclitaxel. 
Kadar ga uporabljamo za bolnike z rakom dojk, ga dajemo skupaj s kemoterapijo, to je z zdravilom paklitaksel.
• CPP arm: Five cycles of placebo (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 
• CPP skupina: pet ciklov placeba (z začetkom v ciklu 2) v kombinaciji s karboplatinom (AUC 6) in 6 cikli paklitaksela (175 mg/m2), katerim je sledil samo placebo do skupno 15 mesecev zdravljenja.
Hypersensitivity, Infusion reactionsa,b,d 
Bolezni imunskega sistema preobčutljivost, reakcije pri infundiranjua,b,c
PFS subgroup analyses by disease stage and debulking status are summarised in table 18. 
Analize podskupin preživetja brez napredovanja bolezni, glede na stadij bolezni in stopnjo kirurškega zmanjšanja bolezni so povzete v preglednici 18.
• 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 (q3w) 
• paklitaksel 175 mg/m2 intravensko v 3-urni infuziji 1. dan in topotekan 0,75 mg/m2 intravensko v 30 minutah od 1. do 3. dne (na 3 tedne);
MVASI should be discontinued permanently in patients who experience grade 3 or 4 bleeding during bevacizumab therapy (NCI-CTCAE v.3) (see section 4.8). 
Pri bolnikih, pri katerih se pojavi krvavitev tretje ali četrte stopnje (NCICTCAE v.3) med zdravljenjem z bevacizumabom, zdravilo MVASI opustimo (glejte poglavje 4.8).
CT (n = 182) 
kemoterapija (n = 182)
These clinically significant adverse reactions were reported in clinical trials but the grade 3-5 reactions did not meet the threshold of at least a 2% difference compared to the control arm. Table 2 also includes clinically significant adverse reactions that were observed only in the post-marketing setting, therefore, the frequency and NCI-CTCAE grade is not known. 
O teh klinično pomembnih neželenih učinkih so poročali v kliničnih preskušanjih, a neželeni učinki stopenj 3 do 5 niso dosegli meje - najmanj 2-% razlike v primerjavi s kontrolno skupino.
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). 
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.
In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the bevacizumab-containing arms compared with up to 2.1% in the chemotherapy control arms. 
V kliničnih preskušanjih je bila celokupna incidenca arterijskih trombemboličnih neželenih učinkov pri bolnikih, zdravljenih z bevacizumabom, do 3,8 %, v kontrolnih skupinah, v katerih so prejemali kemoterapijo, pa do 2,1 %.
Nervous system disorders Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8) 
Bolezni živčevja hipertenzivna encefalopatija (zelo redko) (glejte tudi poglavje 4.4 in odstavek Hipertenzija v poglavju 4.8) sindrom posteriorne reverzibilne encefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome) (redko) (glejte tudi poglavje
MVASI is a concentrate for solution for infusion. 
Zdravilo MVASI je koncentrat za raztopino za infundiranje.
4817 ZK Breda 
4817 ZK Breda NIZOZEMSKA
The administration of MVASI should be permanently discontinued if you develop 
Dajanje zdravila MVASI je treba dokončno opustiti, če se pojavi kar koli od naslednjega
Seventy-one patients were randomised to receive bolus 5-FU/FA or 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks). 
Randomiziranih je bilo 71 bolnikov, ki so prejeli bolus 5-FU/FA ali 5-FU/FA + bevacizumab (5 mg/kg vsaka dva tedna).