natgillin/translations-raw huggingface dataset:
• decreased number of cells in the blood, including white cells that help to fight against infections 
● smanjen broj krvnih stanica, uključujući bijele krvne stanice koje pomažu u borbi protiv infekcije (može biti praćeno vrućicom) i stanice koje pomažu u zgrušavanju krvi,
• 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 continued use of Avastin (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy. 
• skupina CPB15+: pet ciklusa lijeka Avastin (15 mg/kg svaka 3 tjedna, počevši od 2. ciklusa) u kombinaciji sa 6 ciklusa karboplatina (AUC 6) i paklitaksela (175 mg/m2), nakon čega je slijedila trajna primjena lijeka Avastin (15 mg/kg svaka 3 tjedna) kao jedinog lijeka u ukupnom trajanju do 15 mjeseci liječenja.
When Avastin is administered in combination with topotecan (given on days 1-5, every 3 weeks), the recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. 
Kada se primjenjuje u kombinaciji s topotekanom, (koji se daje od 1. do 5. dana svaka 3 tjedna), preporučena doza lijeka Avastin je
Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 15 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab alone (CPB15+), had a clinically meaningful and statistically significant improvement in PFS. 
bolesnice koje su dobivale 15 mg/kg bevacizumaba svaka tri tjedna u kombinaciji s kemoterapijom te nastavile primati samo bevacizumab (CPB15+) imale su klinički i statistički značajno poboljšano preživljenje bez progresije bolesti.
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. 
Japanu s ciljem utvrđivanja djelotvornosti i sigurnosti lijeka Avastin kao dodatka erlotinibu u bolesnika oboljelih od neskvamoznog NSCLC-a s aktivirajućim mutacijama EGFR-a (delecija eksona 19 ili mutacija L858R u eksonu 21) koji prethodno nisu primali sistemsku terapiju za bolest stadija
Thromboembolism arteriala,b, Haemorrhage a,b 
Krvožilni poremećaji hipertenzija a,b tromboembolija (arterijska)
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-240), 1.8% of Avastin-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae. 
U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa (ispitivanje GOG-0240), fistule izvan gastrointestinalnog sustava i to vaginalne, vezikalne ili fistule u ženskom genitalnom traktu, prijavljene su u 1,8% bolesnica liječenih lijekom Avastin te u
Lethargy 
Erlotinib
The analysis of the primary endpoint showed no difference between the Avastin + Placebo arm and the Avastin + Erlotinib arm (median PFS 8.5 versus 9.9 months). 
Analiza primarne mjere ishoda pokazala je da nema razlike između skupine liječene kombinacijom Avastin + placebo i skupine liječene kombinacijom Avastin +
Overall survivalb HR (95% CI) p-value (exploratory) 1000 mg/m oral twice daily for 14 days administered every 3 weeks bStratified analysis included all progression and death events except those where non-protocol therapy (NPT) 
1000 mg/m peroralno dvaput na dan tijekom 14 dana, svaka 3 tjedna bStratificirana analiza obuhvatila je sve događaje progresije i smrti izuzev tamo gdje je prije nego je utvrđena progresija uvedena terapija koja nije obuhvaćena protokolom ispitivanja; podaci o ovim bolesnicima su izostavljeni kod posljednje procjene tumora prije uvođenja terapije koja nije obuhvaćena protokolom.
Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaec,d, 
bol u abdomenu perforacija crijeva, ileus, opstrukcija crijeva, rektovaginalna fistulac,d gastrointestinalni poremećaj,
Response rate (for patients with measurable disease)b 
Stope odgovora na liječenje (za bolesnike s mjerljivom bolešću) Procjena ispitivača
MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/001 
EU/1/04/300/001
Common (affects 1 to 10 users in 100) side effects, which were not severe, include: • voice changes and hoarseness. 
Česte (javljaju se u 1 do 10 na 100 korisnika) nuspojave koje nisu bile teške uključuju:
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. 
Opažena je povećana incidencija kongestivnog zatajenja srca u kliničkom ispitivanju bolesnika s difuznim velikostaničnim limfomom B-limfocita kada su primali bevacizumab s doksorubicinom u kumulativnoj dozi višoj od 300 mg/m 2. U tom je kliničkom ispitivanju faze III uspoređeno liječenje kombinacijom rituksimab/ciklofosfamid/doksorubicin/vinkristin/prednizon (R-CHOP) uz bevacizumab s protokolom R-CHOP bez bevacizumaba.
• 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 
• skupina CPB15: pet ciklusa lijeka Avastin (15 mg/kg svaka 3 tjedna, počevši od 2. ciklusa) u kombinaciji sa 6 ciklusa karboplatina (AUC 6) i paklitaksela (175 mg/m2), nakon čega je slijedio samo placebo u ukupnom trajanju do 15 mjeseci liječenja
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/oxaliplatinor fluoropyrimidine/irinotecan-based chemotherapy (chemotherapy switched depending on first-line chemotherapy) with or without bevacizumab. 
1:1 da primaju kemoterapiju s fluoropirimidinom/oksaliplatinom ili fluoropirimidinom/irinotekanom (ta je kemoterapija bila promijenjena ovisno o kemoterapiji u prvoj liniji), s bevacizumabom ili bez njega.
• blocking of the veins of the legs by a blood clot, 
● začepljenje vena nogu zbog krvnog ugruška,
• Paclitaxel 135 mg/m2 IV over 24 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2, every 3 
• paklitaksel u dozi od 135 mg/m i.v. tijekom 24 sata 1. dana i cisplatin u dozi od 50 mg/m i.v.
Overall Survival - Primary analysis Median (months)1 
Ukupno preživljenje - Primarna analiza
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg bevacizumab. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 100 mg bevacizumaba.
Median PFS (months) HR (95% CI) p-value 
PFS^ (mjeseci) Medijan HR (95% CI) p-vrijednost
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 postmarketing setting, therefore, the frequency and NCI-CTCAE grade is not known.These clinically significant reactions have therefore been included in Table 2 within the column entitled “Frequency Not Known.” 
Te su klinički značajne nuspojave bile prijavljene u kliničkim ispitivanjima, ali nuspojave stupnja 3-5 nisu prešle zadani prag od barem 2% razlike u odnosu na kontrolnu skupinu.
Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under Avastin treatment. 
U bolesnika koji se liječe lijekom Avastin postoji rizik za razvoj venskih tromboembolijskih reakcija, uključujući plućnu emboliju.
Roche Pharma AG Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen Germany 
1, D-79639 Grenzach-Wyhlen
The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. 
Preporučena doza lijeka Avastin je 15 mg/kg tjelesne težine, primijenjena jednom svaka 3 tjedna u obliku intravenske infuzije.
Metabolism and nutrition disorders 
Poremećaji metabolizma i prehrane dehidracija hiponatrijemija
• headache, 
● glavobolja
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 400 mg bevacizumab. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 400 mg bevacizumaba.
Age was not associated with the pharmacokinetics of bevacizumab when body weight was taken into account. 
Kada se uzela u obzir tjelesna težina, dob nije bila povezana s farmakokinetikom bevacizumaba.
The percentage of patients who received Avastin in the open-label phase was 62.1% in the capecitabine + placebo arm and 49.9% in the capecitabine + Avastin arm. 
Postotak bolesnika koji su u otvorenoj fazi primali Avastin iznosio je 62,1% u skupini kapecitabin
Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaed,e, 
bol u abdomenu gastrointestinalna perforacijab,d perforacija crijeva, ileus, opstrukcija crijeva, rektovaginalna fistulad,e,
• GOG-0213 evaluated the efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. 
U ispitivanju GOG-0213 ocijenjene su djelotvornost i sigurnost bevacizumaba u kombinaciji s karboplatinom i paklitakselom, nakon čega se bevacizumab primjenjivao sam, u bolesnica s recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma osjetljivih na platinu.
Carboplatin/ Paclitaxel + Avastin 15 mg/kg q 3 weeks 
+ Avastin 15 mg/kg svaka 3 tjedna
a,b 
Bv b
Not censored for NPT Median PFS (months) Hazard ratio (95% CI) p -value 
Nije cenzurirano za terapiju izvan protokola Medijan PFS-a (mjeseci) Omjer hazarda (95% CI) p -vrijednost
Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. 
Lijekom Avastin u kombinaciji s kapecitabinom ne smiju se liječiti bolesnici koji su u proteklih 12 mjeseci u okviru adjuvantnog liječenja primali taksane ili antracikline.
p-Value Hazard ratio (95% CI) (registration form)b 
Omjer hazarda (95% CI) (registracijski obrazac)
The primary efficacy parameter of the trial was the duration of progression-free survival. 
Primarni parametar djelotvornosti u ispitivanju bilo je preživljenje bez progresije bolesti (engl.
Information on foetal malformations observed in the post marketing setting are provided in section 4.6 Fertility, Pregnancy and Lactation and 4.8 Undesirable Effects. 
'Trudnoća, dojenje i plodnost' te u dijelu 4.8. 'Nuspojave'.
Arm 2 
2. tromjesečje
Relative to the control arm; stratified hazard ratio. 
2 U odnosu na kontrolnu skupinu, stratificirani omjer rizika 3 p-vrijednost jednostranog log-rang testa
Summarised below are PFS results for the individual chemotherapy agents included in the indication: 
Slijedi sažeti pregled rezultata preživljenja bez progresije bolesti za svaki kemoterapijski lijek obuhvaćen indikacijom:
Avastin/IFN) received a variety of non-specified post-trial anti-cancer therapies, including antineoplastic agents, which may have impacted the analysis of overall survival. 
Velik udio bolesnika (oko 63% za IFN/placebo; 55% za Avastin/IFN) je nakon završetka ispitivanja primao različite nespecificirane antitumorske terapije, uključujući antineoplastičke lijekove, što je moglo utjecati na analizu ukupnog preživljenja.
Dyspnoea, Rhinitis 
mučnina. povraćanje,
Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 (q3w); or Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 (q3w) 
2. dana plus bevacizumab u dozi od 15 mg/kg i.v. 2. dana (svaka 3 tjedna); ili paklitaksel u dozi od 175 mg/m i.v. tijekom 3 sata 1. dana i cisplatin u dozi od 50 mg/m i.v.
Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with Avastin. 
Kada se liječe lijekom Avastin, bolesnici s hipertenzijom mogu biti izloženi povećanom riziku od razvoja proteinurije.
Thromboembolism (see section 4.4) 
Tromboembolija (vidjeti dio 4.4)
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 temelju podataka iz podispitivanja u okviru ispitivanja NSABP C-08 s 295 bolesnica.
Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer. 
Avastin se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica.
Placebo or Avastin 
Paklitaksel/ Avastin
Responders (Response rate 95% CI for Response Rates3 
95% CI za stope odgovora3
Progression-free survival Median (months) Hazard ratio 
Medijan (mjeseci) Omjer hazarda
Table 10 Trial E2100 efficacy results 
Tablica 10 Rezultati djelotvornosti za ispitivanje E2100 Preživljenje bez progresije bolesti
* Primary analysis was performed with a data cut-off date of 14 November 2011. 
* Završni dan prikupljanja podataka za primarnu analizu bio je 14. studenoga 2011. **Randomizirane bolesnice s mjerljivom bolešću na početku ispitivanja.
Therapy should be permanently discontinued in patients who develop gastrointestinal perforation. 
U bolesnika u kojih dođe do gastrointestinalne perforacije liječenje treba trajno obustaviti.
Thromboembolism (arterial)b,d, Haemorrhageb,d, 
Krvožilni poremećaji hipertenzijab,d tromboembolija (venska)b,d tromboembolija (arterijska)b,d, krvarenjeb,d, duboka venska tromboza bubrežna trombotska mikroangiopatijaa,b, aneurizme i disekcije arterije
• 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 preživljenja bez progresije bolesti prema procjeni ispitivača (cenzurirana za porast razine CA-125 i terapiju izvan protokola) pokazuje stratificirani omjer rizika od 0,62 (95% CI: 0,52-0,75; p-vrijednost jednostranog log-rang testa < 0,0001) kada se skupina
Overall Survival (OS) 
Primarna mjera ishoda Ukupno preživljenje (OS)
Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution. 
Jedna bočica sadrži 100 mg bevacizumaba u 4 ml otopine ili
Addition of Avastin to RT/T did not demonstrate clinical benefit in study BO25041 in 60 evaluable children patients with newly diagnosed supratentorial or infratentorial cerebellar or peduncular highgrade glioma (HGG) (See section 4.2 for information on paediatric use). 
60 ocjenjive djece s novodijagnosticiranim supratentorijalnim ili infratentorijalnim cerebelarnim ili pedunkularnim gliomom visokog stupnja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Two large Phase III trials were designed to investigate the treatment effect of Avastin in combination with two individual chemotherapy agents, as measured by the primary endpoint of PFS. A clinically meaningful and statistically significant improvement in PFS was observed in both trials. 
Djelotvornost liječenja lijekom Avastin u kombinaciji s dva zasebna kemoterapijska lijeka ispitana je u dva velika ispitivanja faze III, u kojima je primarna mjera ishoda bilo preživljenje bez progresije bolesti.
AVF2192g: In combination with bolus 5-FU/FA for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen) in patients who were not optimal candidates for first-line irinotecan treatment. 
AVF2107g: tjedna primjena protokola irinotekan/bolus 5-fluorouracila/folne kiseline (IFL) kroz ukupno 4 tjedna tijekom svakog šestotjednog ciklusa (Saltzov protokol) AVF0780g: u kombinaciji s bolusom 5-fluorouracila/folne kiseline (5-FU/FA) kroz ukupno 6 tjedana tijekom svakog osmotjednog ciklusa (Roswell-Park protokol) AVF2192g: u kombinaciji s bolusom 5-FU/FA kroz ukupno 6 tjedana tijekom svakog osmotjednog ciklusa (Roswell-Park protokol) u bolesnika koji nisu bili optimalni kandidati za primjenu irinotekana u prvoj liniji liječenja.
This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating Avastin 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3weekly schedule; or Avastin 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule. 
NO16966 Riječ je o randomiziranom, dvostruko slijepom (za bevacizumab) kliničkom ispitivanju faze III u kojemu se ispitivala primjena lijeka Avastin u dozi od 7,5 mg/kg svaka 3 tjedna u kombinaciji s peroralno primijenjenim kapecitabinom i intravenski primijenjenim oksalipaltinom (XELOX), odnosno primjena lijeka Avastin u dozi od 5 mg/kg svaka dva tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila, nakon čega je slijedila infuzija 5-fluorouracila uz intravensku primjenu oksaliplatina (FOLFOX-4).
Hepatic impairment 
Kongestivno zatajenje srca
Median (months) Hazard ratio [95% CI] 
Medijan (mjeseci) Omjer hazarda [95% CI]
A total of 484 patients with measurable disease were randomised 1:1 to either: • Carboplatin (AUC4, Day 1) and gemcitabine (1000 mg/m2 on Days 1 and 8) and concurrent placebo every 3 weeks for 6 and up to 10 cycles followed by placebo (every 3 weeks) alone until disease progression or unacceptable toxicity 
karboplatin (AUC4, 1. dan) i gemcitabin (1000 mg/m2, 1. i 8. dan) uz placebo svaka 3 tjedna tijekom 6, a najviše 10 ciklusa, a zatim samo placebo (svaka 3 tjedna) do progresije bolesti ili razvoja neprihvatljive toksičnosti, ili karboplatin (AUC4, 1. dan) i gemcitabin (1000 mg/m 2, 1. i 8. dan) uz Avastin (15 mg/kg, 1.
Paclitaxel (n=243) 
Paklitaksel (n=243)
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. 
Avastin u dozi od 5,0 mg/kg svaka 2 tjedna ili 7,5 mg/kg svaka 3 tjedna u kombinaciji s kemoterapijom na bazi fluoropirimidina u usporedbi s primjenom samo kemoterapije na bazi fluoropirimidina u bolesnika s metastatskim karcinomom kolona ili rektuma u kojih je došlo do progresije bolesti nakon prve linije liječenja koja je obuhvaćala bevacizumab.
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. 
AVF0780g Riječ je o randomiziranom, aktivno kontroliranom, otvorenom kliničkom ispitivanju faze II, u kojemu se ispitivala primjena lijeka Avastin u kombinaciji s protokolom 5-FU/FA u prvoj liniji liječenja metastatskog kolorektalnog karcinoma.
Pulmonary hypertensionc, Nasal septum perforationc 
epistaksa, dispneja, hipoksija plućna hipertenzija c, perforacija nosnog septumac
Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia 
hipoksija, disfonijaa plućna hipertenzijaa,
5 mg/kg every 2 weeks. 
15 mg/kg svaka 3 tjedna
Pulmonary haemorrhage/ Haemoptysis a,b 
Poremećaji bubrega i mokraćnog sustava proteinurija a,b
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 u kombinaciji s karboplatinom i gemcitabinom ili u kombinaciji s karboplatinom i paklitakselom indiciran za liječenje odraslih bolesnica s prvim recidivom epitelnog karcinoma jajnika,
It should not be administered as an intravenous push or bolus. 
Lijek se ne smije primijeniti brzom intravenskom injekcijom niti u obliku bolusa.
Difference in Response Rates 95% CI for Difference in Response Rates4 
95% CI za razliku u stopama odgovora p-vrijednost (hi-kvadrat test)
The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Avastin fails to stop your tumour growing. 
Trebali biste nastaviti primati ovaj lijek sve dok Avastin uspješno sprječava rast tumora.
What Avastin looks like and contents of the pack Avastin is a concentrate for solution for infusion. 
Kako Avastin izgleda i sadržaj pakiranja
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; 
I doze bevacizumaba ekvivalentne dozi od 5 mg/kg na tjedan i one ekvivalentne dozi od 2,5 mg/kg na tjedan pružile su statistički značajnu korist s obzirom na ukupno preživljenje (HR 0,751 u ispitivanju E3200; HR 0,81 u ispitivanju ML18147) i preživljenje bez progresije bolesti (HR 0,518 u ispitivanju E3200; HR 0,68 u ispitivanju ML18147).
• tiredness, 
● mučnina,
Palmar-plantar erythrodysaesthesia syndrome 
suha koža, promjena boje kože sindrom palmarnoplantarne eritrodizestezije
performance status of 0, 43% had a value of 1 and 0.4% had a value of 2. 
bolesnika imalo je ECOG funkcionalni status 0, njih 43% status 1, a 0,4% status 2. 15,5% bolesnika prethodno je primilo radioterapiju, a 28,4% kemoterapiju.
• The protocol specified analysis of investigator-assessed PFS (without censoring for CA-125 progression or non-protocol therapy [NPT]) shows a stratified hazard ratio of 0.71 (95% CI: 
• Analiza preživljenja bez progresije bolesti prema procjeni neovisnog ocjenjivačkog povjerenstva (cenzurirana za terapiju izvan protokola) pokazuje stratificirani omjer rizika od 0,62 (95% CI: 0,50-0,77; p-vrijednost jednostranog log-rang testa < 0,0001) kada se skupina
NAME OF THE MEDICINAL PRODUCT Avastin 25 mg/ml concentrate for solution for infusion. 
Avastin 25 mg/ml koncentrat za otopinu za infuziju.
Tel: + 385 1 47 22 333 
Roche d.o.o. Tel: + 385 1 47 22 333
Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Nausea, Vomiting, Abdominal pain 
Poremećaji probavnog sustava rektalno krvarenje, stomatitis, konstipacija, proljev,
Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI) 
Medijan PFS-a (mjeseci) Omjer hazarda (95% CI)* Medijan OS-a (mjeseci) Omjer hazarda (95% CI)*
Reactions (frequency*) 
Nuspojave (učestalost*)
Dehydration 
Krvarenje
Bevacizumab addition to multimodal standard of care treatment seemed to be tolerated in this paediatric population. 
Čini se da ova pedijatrijska populacija dobro podnosi dodavanje bevacizumaba multimodalnom standardnom liječenju.
Randomised patients with stage III suboptimally debulked disease3 
Randomizirane bolesnice sa stadijem III bolesti uz suboptimalno smanjenu tumorsku masu CPP (n = 253)
Results are presented in Table 12. 
Rezultati su prikazani u Tablici 22.
HR (95% CI) p-value 
HR (95% CI)
Number of patients Overall survival Median (months) 95% CI 
Medijan (mjeseci) 95% CI
● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with Avastin treatment. 
Liječenje lijekom Avastin, povezano je s rijetkom neurološkom nuspojavom koju nazivamo sindrom reverzibilne posteriorne encefalopatije.
• blocking of the veins by a blood clot, 
● začepljenje vena zbog krvnog ugruška,
Foetal abnormalitiesa,b 
+ Avastin b
Metastatic breast cancer (mBC) 
Metastatski karcinom dojke
How to store Avastin 
Moguće nuspojave Kako čuvati Avastin
Median OS (months) HR (95% CI) p-value 
Medijan PFS-a (mjeseci) HR (95% CI) p-vrijednost
The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0. 
Primarna mjera ishoda ispitivanja bilo je preživljenje bez progresije bolesti po procjeni ispitivača prema RECIST-u.
Gallbladder perforation b,c 
Omjer hazarda b
• Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516) 
(p < 0,0001; 95% CI = 0,343; 0,516)