natgillin/translations-raw huggingface dataset:
Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 7.5 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab for up to 18 cycles had a statistically significant improvement in PFS. 
V primerjavi z bolnicami, ki so kot prvo zdravljenje prejele samo kemoterapijo (karboplatin in paklitaksel), so bolnice, ki so prejele bevacizumab v odmerku 7,5 mg/kg telesne mase enkrat na 3 tedne v kombinaciji s kemoterapijo in nadaljevale z do 18 cikli bevacizumaba, imele statistično signifikantno izboljšanje preživetja brez napredovanja bolezni.
NAME OF THE MEDICINAL PRODUCT Avastin 25 mg/ml concentrate for solution for infusion. 
IME ZDRAVILA Avastin 25 mg/ml koncentrat za raztopino za infundiranje
• constipation, 
· srčno popuščanje,
What you need to know before you use Avastin 
Kaj morate vedeti, preden boste uporabili zdravilo Avastin Zdravila Avastin ne smete prejemati:
In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026. 
V podskupini, ki je prejemala zdravljenje po shemi FOLFOX, je bila mediana preživetja brez napredovanja bolezni 8,6 meseca pri bolnikih, ki so prejemali placebo, ter 9,4 meseca pri bolnikih, ki so se zdravili z bevacizumabom; razmerje ogroženosti = 0,89, 97,5-% interval zaupanja = [0,73; 1,08]; p-vrednost = 0,1871.
Progression-free survivalb Investigator Assessment 
Preživetje brez napredovanja bolezni Ocena raziskovalca
Wound healing complications (see section 4.8) 
Zapleti pri celjenju ran (glejte poglavje 4.8)
• diarrhoea, 
Bolezni jeter,
In patients with NSCLC excluding predominant squamous histology, all Grade reactions were seen with a frequency of up to 9.3% when treated with Avastin plus chemotherapy compared with up to 5% in the patients treated with chemotherapy alone. 
Pri bolnikih z nedrobnoceličnim rakom pljuč so, razen pri predominantni skvamozni histologiji, neželene učinke vseh stopenj opazili s pogostnostjo do 9,3 %, če so jih zdravili z zdravilom Avastin in kemoterapijo.
* Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm 
** Primarna analiza kliničnih podatkov zbranih do 31. januarja 2006.
Oxaliplatin 130 mg/m2 IV 2 h Oxaliplatin on day 1 Capecitabine oral bid for 2 weeks (followed by 1 week off treatment) 
2 h oksaliplatin 1. dan kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1-tedenski odmor)
Osteonecrosis of the jawa,b Non-mandibular osteonecrosisa,f 
osteonekroza izven spodnje čeljustnicea,f
● 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
Enrolment in Arm 3 was discontinued, as pre-specified, once safety of Avastin with the IFL regimen was established and considered acceptable. 
Ko je bila varnost kombinacije IFL in zdravila Avastin dokazana in sprejeta, je bilo vključevanje v tretjo skupino prekinjeno, kot je bilo že prej predvideno.
CT (n=182) 
kemoterapija (n = 182)
95% CI 
5,5-NR
The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. 
Priporočeni odmerek zdravila Avastin je 10 mg/kg telesne mase v enkratnem odmerku vsaka 2 tedna ali 15 mg/kg telesne mase v enkratnem odmerku vsake 3 tedne, v obliki intravenske infuzije.
The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab treated patients in the FOLFOX treatment subgroup, HR=0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698. 
Pri podskupini bolnikov, ki so prejemali zdravljenje po shemi XELOX, je mediana celokupnega preživetja znašala 19,2 meseca, če so prejemali placebo, in 21,4 meseca, če so se zdravili z bevacizumabom; razmerje ogroženosti = 0,84; 97,5-% interval zaupanja = [0,68; 1,04]; p-vrednost = 0,0698.
Paclitaxel/ Avastin (n=252) 
paklitaksel/Avastin (n = 252)
As Avastin may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials. 
Bolniki, ki so imeli večjo operacijo v zadnjih 28 dneh pred pričetkom zdravljenja, niso bili vključeni v klinična preskušanja faze III, saj lahko zdravilo Avastin negativno vpliva na celjenje ran.
(p-value = 0.0012) 
(p-vrednost = 0,0012)
In a randomized phase II study (BO25041) a total of 121 patients aged ≥ 3 years to <18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) were treated with post operative radiation therapy (RT) and adjuvant temozolomide (T) with and without bevacizumab: 10 mg/kg every 2 weeks IV. 
V randomizirani študiji faze II (BO25041) so s pooperativno radioterapijo in adjuvantnim temozolomidom v kombinaciji z intravenskim bevacizumabom (v odmerku 10 mg/kg vsaka dva tedna) ali brez njega zdravili skupno 121 bolnikov, starih od ≥ 3 do < 18 let, z novo diagnosticiranim supratentorialnim ali infratentorialnim cerebralnim ali pedunkularnim gliomom visoke stopnje.
The recommended dose of Avastin when used in addition to erlotinib is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. 
Priporočeni odmerek zdravila Avastin, ko ga uporabljamo kot dodatek erlotinibu, je 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
● 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.
• diarrhoea, nausea, vomiting and abdominal pain. 
· utrujenost, · driska, slabost, bruhanje in bolečine v trebuhu.
(p-value = 0.0036) 
(p-vrednost = 0,0036)
Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1). 
7,5 mg/kg telesne mase kot tudi za 15 mg/kg telesne mase (glejte poglavje 5.1).
Gastrointestinal (GI) perforations and Fistulae (see section 4.8) Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with Avastin. 
Venska trombembolija (glejte poglavje 4.8) Med zdravljenjem z zdravilom Avastin so bolniki lahko podvrženi povečanemu tveganju za razvoj venskih trombemboličnih neželenih učinkov, vključno s pljučno embolijo.
• CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus Avastin (7.5 mg/kg q3w) for up to 12 months (Avastin was started at cycle 2 of chemotherapy if treatment was initiated within 4 weeks of surgery or at cycle 1 if treatment was initiated more than 4 weeks after surgery). 
Skupno je bilo randomiziranih 1528 bolnic v enakih razmerjih v naslednji dve skupini: · CP skupina: 6 tritedenskih ciklov karboplatina (AUC 6) in paklitaksela (175 mg/m2) · CPB7,5 + skupina: 6 tritedenskih ciklov karboplatina (AUC 6) in paklitaksela (175 mg/m2) ter zdravila Avastin (7,5 mg/kg telesne mase enkrat na 3 tedne) do 12 mesecev (zdravljenje z zdravilom Avastin se je začelo pri drugem ciklu kemoterapije, če se je s terapijo začelo v prvih 4 tednih po operaciji ali pri prvem ciklu, če se je s terapijo začelo več kot 4 tedne po operaciji).
• AVF4095g evaluated the efficacy and safety of bevacizumab in combination with carboplatin and gemcitabine, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. 
· Preskušanje AVF4095g je ocenjevalo učinkovitost in varnost bevacizumaba v kombinaciji s karboplatinom in gemcitabinom, ki jim je sledil bevacizumab samostojno, pri bolnicah s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, občutljivega na platino.
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,
You could also experience redness or flushing of the skin or a rash, chills and shivering, feeling sick (nausea) or being sick (vomiting). 
Med znaki so lahko: težave pri dihanju ali bolečina v prsnem košu; lahko se pojavi tudi rdečina ali pordevanje kože ali izpuščaj, mrazenje in drgetanje, slabost ali bruhanje.
• MO22224 evaluated the efficacy and safety of bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. 
· Preskušanje MO22224 je ocenjevalo učinkovitost in varnost bevacizumaba v kombinaciji s paklitakselom, topotekanom ali pegiliranim liposomalnim doksorubicinom pri bolnicah s ponovitvijo epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma, rezistentnega na platino.
% pts with objective response p-value 
% bolnic z objektivnim odgovorom p-vrednost
Paclitaxel/ Avastin (n=229) 
paklitaksel/Avastin (n = 229)
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). 
7,8 % bolnikov, ki so jih zdravili s kemoterapijo in bevacizumabom, v primerjavi z do 4,9 % pri bolnikih, ki so jih zdravili samo s kemoterapijo (pri vseh indikacijah, razen pri bolnicah z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska).
Progression-free survival 
Preživetje brez napredovanja bolezni
Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. 
Bevacizumab je v kombinaciji s karboplatinom in gemcitabinom ali v kombinaciji s karboplatinom in paklitakselom indiciran za zdravljenje odraslih bolnic, pri katerih je prišlo do prve ponovitve epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma,
7.5% of patients in the Chemo+Avastin group over the age of 65 years. 
26 % v CPB15+ skupini je bilo starih več kot 65 let.
A GOG PS of 2 at baseline was reported in 0.9% of patients in the CP arm and in 1.2% of patients in the CPB arm.“ The primary efficacy endpoint was overall survival (OS). 
O izhodiščnem stanju zmogljivosti po GOG 2 so poročali pri 0,9 % bolnic v skupini CP in pri 1,2 % bolnic v skupini CPB.
Hazard ratio Best overall response ratea 
razmerje ogroženosti Najboljši celokupni odgovor delež a
Paclitaxel (n=354) 
paklitaksel (n = 354)
Therapy should be permanently discontinued in patients who develop gastrointestinal perforation. 
Zdravljenje opustimo pri bolnikih, pri katerih se je pojavila perforacija prebavil.
An increased incidence of CHF has been observed in a clinical trial of patients with diffuse large Bcell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2. 
V kliničnem preskušanju, ki je vključevalo bolnike z difuznim velikoceličnim B limfomom, ki so prejemali bevacizumab skupaj s kumulativnim odmerkom doksorubicina, ki je presegal 300 mg/m2, so opazili večjo incidenco kongestivnega srčnega popuščanja.
This was a phase II randomised, active-controlled, open-labelled clinical trial investigating Avastin in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer. 
To je bilo randomizirano, aktivno kontrolirano, odprto klinično preskušanje faze II, v katerem so proučevali kombinacijo zdravila Avastin s 5-FU/FA kot prvo linijo zdravljenja metastatskega raka debelega črevesa in danke.
ANNEX III LABELLING AND PACKAGE LEAFLET 
Skupina 1 karboplatin in paklitaksel
• blocking of the arteries by a blood clot, 
· zamašitev arterij s krvnim strdkom, · zamašitev ven s krvnim strdkom,
● Keep this leaflet. 
· Navodilo shranite.
weeks (n=39), 10 mg/kg every 2 weeks; (n=37), or placebo (n=40). 
(n = 37) in v skupino, ki je prejemala placebo (n = 40).
• The primary analysis of investigator-assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm. 
· Primarna analiza preživetja brez napredovanja bolezni, ocenjena s strani raziskovalca (s krnjenimi podatki za napredovanje bolezni glede na CA 125 in zdravljenja, ki ni bilo v skladu s protokolom) kaže stratificirano razmerje ogroženosti 0,62 (95-% interval zaupanja: 0,520,75; p-vrednost za enostranski log rank test < 0,0001) ko primerjamo CPB15+ s CPP, z mediano preživetja brez napredovanja bolezni 12,0 mesecev v CPP skupini in 18,2 meseca v CPB15+ skupini.
• symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure, 
· negativni učinek na zmožnost zanositve (za nadaljnje informacije glejte spodaj), · bolezen možgan s simptomi, ki vključujejo epileptični napad, glavobol, zmedenost in spremembe vida (sindrom posteriorne reverzibilne encefalopatije ali PRES), · simptomi, ki nakazujejo spremembe v normalnem delovanju možganov (glavoboli, spremembe vida, zmedenost ali epileptični napadi) in visok krvni tlak,
In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Avastin. 
Če se pri bolniku pojavi sindrom posteriorne reverzibilne encefalopatije, je poleg prekinitve zdravljenja z zdravilom Avastin priporočljivo zdravljenje specifičnih simptomov, vključno z uravnavo hipertenzije.
The recommended dose of Avastin is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. 
Priporočeni odmerek zdravila Avastin je 7,5 mg/kg telesne mase ali 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
Study JO25567 was a randomized, open-label, multi-center Phase II study conducted in Japan to evaluate the efficacy and safety of Avastin used in addition to erlotinib in patients with non-squamous 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 zdravila Avastin, uporabljenega kot dodatek erlotinibu pri bolnikih z neskvamoznim nedrobnoceličnim rakom pljuč z EGFR-aktivirajočimi mutacijami
Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with Avastin at a dose of 7.5 or 15 mg/kg IV infusion day 1 of every 3-week cycle. 
Randomizirani bolniki so prejeli kemoterapijo na osnovi platine, cisplatin 80 mg/m2 v obliki intravenske infuzije na dan 1 in gemcitabin 1250 mg/m2 v obliki intravenske infuzije na dneva 1 in 8
Median PFS (months) Hazard ratio (95% CI) 
mediana PFS (meseci) razmerje ogroženosti (95-% IZ)
Difference in Response Rates 95% CI for Difference in Response Rates4 
95-% IZ za razliko v deležih odgovora na zdravljenje
Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer. 
Zdravilo Avastin uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim rakom pljuč.
This was a phase III randomised, active-controlled, open-label trial investigating Avastin 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. 
Avastin 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).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Avastin 25 mg/ml concentrate for solution for infusion Bevacizumab 
IME ZDRAVILA IN POT(I) UPORABE Avastin 25 mg/ml koncentrat za raztopino za infundiranje bevacizumab i.v.
Rate (n) p-value 
p-vrednost (eksplorativna)
• stomach and intestinal disorder, 
bolečine v trebuhu perforacija črevesja,
Table 11 Efficacy results for study AVF3694g: - Capecitabinea and Avastin/Placebo (Cap + Avastin/Pl) 
Rezultati učinkovitosti preskušanja AVF3694g: kapecitabina in zdravilo
(p-value5 <0.0001) 
(vrednost p5 < 0,0001)
Hazard ratio (95% CI) > 12 months (n=282) Median 
6-12 mesecev (n = 202) mediana razmerje ogroženosti (95-% interval zaupanja) > 12 mesecev (n = 282) mediana razmerje ogroženosti (95-% interval zaupanja)
Patients treated for persistent, recurrent, or metastatic cervical cancer with Avastin are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae). 
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, imajo večje tveganje za nastanek fistule med nožnico in katerim koli delom prebavil (fistule med prebavili in nožnico).
Severe reactions are defined as adverse events with at least a 2% difference compared to the control arm in clinical studies for NCI-CTCAE Grade 3-5 reactions. 
Hudi neželeni učinki so tisti neželeni učinki stopnje 3 do 5 po lestvici NCI-CTCAE, ki so se pojavili z najmanj 2-% razliko v primerjavi s kontrolno skupino v kliničnih preskušanjih.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 
Vpliv bevacizumaba na farmakokinetiko drugih zdravil za zdravljenje novotvorb
Relative to control arm 
a glede na kontrolno skupino
Hypersensitivity, infusion reactions a,b,c 
reakcije pri infundiranjua,b,c
Wound healing (see section 4.4) 
Celjenje ran (glejte poglavje 4.4)
Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia 
pljučna embolija, hipoksija, disfonijaa pljučna hipertenzijaa, perforacija nosnega pretinaa
Patients were randomised to paclitaxel alone (90 mg/m2 IV over 1 hour once weekly for three out of four weeks) or in combination with Avastin (10 mg/kg IV infusion every two weeks). 
v 1 uri enkrat tedensko tri od štirih tednov) ali v skupino, ki je prejemala kombinacijo paklitaksela in zdravila Avastin (10 mg/kg z intravensko infuzijo vsaka dva tedna).
Progression-Free Survival Median (months) 
Preživetje brez napredovanja bolezni mediana (meseci)
This was a Phase III randomised, controlled, open-label trial investigating Avastin 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a firstline bevacizumab-containing regimen. 
ML18147 To je bilo randomizirano, kontrolirano, odprto preskušanje faze III, s katerim so pri bolnikih z metastatskim rakom debelega črevesa in danke, pri katerih je po prvi liniji zdravljenja z bevacizumabom prišlo do napredovanja bolezni, proučevali zdravilo Avastin v odmerku 5,0 mg/kg telesne mase vsaka 2 tedna ali v odmerku 7,5 mg/kg telesne mase vsake 3 tedne v kombinaciji s kemoterapijo, osnovano na fluoropirimidinu, v primerjavi s samostojno kemoterapijo na osnovi fluoropirimidina.
Gastrointestinal haemorrhages, including rectal bleeding and melaena have been reported in colorectal cancer patients, and have been assessed as tumour-associated haemorrhages. 
Pri bolnikih z rakom debelega črevesa in danke so poročali o krvavitvah v prebavilih, vključno s krvavitvami iz danke in meleno.
An increased incidence of hypertension was observed in Avastin-treated patients. 
Incidenca hipertenzije je bila večja pri bolnikih, zdravljenih z zdravilom Avastin.
Based on a substudy from NSABP C-08 with 295 patients d For additional information refer below within section "Further information on selected serious adverse reactions." 
c Na podlagi podštudije NSABP C-08 z 295 bolnicami.
Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, Avastin therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy. 
predhodna radioterapija, zdravljenjem z Avastinom, anamneza ateroskleroze, centralna lokalizacija tumorja in razpad tumorjev med zdravljenjem.
Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. 
4.1 Terapevtske indikacije Bevacizumab je v kombinaciji s kemoterapijo na osnovi fluoropirimidina indiciran za zdravljenje odraslih bolnikov z metastatskim rakom debelega črevesa in danke.
2 Investigator assessed PFS analysis with data cut-off date of 30 November 2010. 
1 Analiza podatkov preživetja brez napredovanja bolezni, ocenjenih s strani raziskovalca, zbranih do 30. novembra 2010.
• CPB15 arm: Five cycles of Avastin (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy 
· CPB15 skupina: pet ciklov zdravila Avastin (15 mg/kg telesne mase enkrat na 3 tedne, z začetkom v ciklu 2) v kombinaciji s karboplatinom (AUC 6) in 6 cikli paklitaksela
A reduction of circulating VEGF concentration has been demonstrated following intravitreal antiVEGF therapy. 
Po intravitrealnem zdravljenju z zaviralci VEGF se koncentracija VEGF v plazmi zmanjša.
Hazard ratio (95% CI) 
Razmerje ogroženosti (95-% IZ)
The results for all secondary endpoints (investigator assessed EFS, and ORR and OS) were consistent in showing no improvement associated with the addition of bevacizumab to the RT/T arm compared with the RT/T arm alone. 
(preživetje brez dogodka po oceni raziskovalca, delež celokupnega odziva in celokupno preživetje) so bili skladni in niso pokazali izboljšanja, povezanega z dodatkom bevacizumaba v skupini, zdravljeni z radioterapijo in temozolomidom, v primerjavi s skupino, zdravljeno samo z radioterapijo in temozolomidom.
Elderly patients 
Število bolnikov
The primary efficacy variable of the trial was overall survival. 
Primarni cilj preskušanja in merilo za učinkovitost zdravila je bilo celokupno preživetje.
Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with Avastin through: 
Za te neželene učinke so določili, da imajo vzročno povezavo z zdravilom Avastin:
It should not be administered as an intravenous push or bolus. 
Zdravila se ne sme dajati kot hitro infuzijo ali bolus.