natgillin/translations-raw huggingface dataset:
In study BO20924 of Avastin with current standard of care in rhabdomyosarcoma and nonrhabdomyosarcoma soft tissue sarcoma, the safety profile of Avastin treated children was comparable with that observed in adults treated with Avastin.
U ispitivanju BO20924, u kojem se ispitivao Avastin s trenutnom standardnom terapijom u liječenju metastatskog rabdomiosarkoma i sarkoma mekog tkiva koji nije rabdomiosarkom, sigurnosni profil lijeka u djece liječene lijekom Avastin bio je usporediv s onim primijećenim u odraslih osoba liječenih lijekom Avastin.
Gastrointestinal ulcera
proktalgija gastrointestinalni ulkusa
The HR for PFS was 0.47 (95% CI: 0.35, 0.62) and 0.45 (95% CI: 0.31, 0.67) for the < 65 and ≥ 65 subgroups, respectively.
Omjer hazarda za preživljenje bez progresije bolesti iznosio je 0,47 (95% CI: 0,35; 0,62) za podskupinu bolesnica mlađih od 65 godina, odnosno 0,45 (95% CI: 0,31; 0,67) za podskupinu u dobi od ≥ 65 godina.
If this is well-tolerated the second infusion may be given over 60 minutes.
Ako je dobro podnesete, druga infuzija može trajati 60 minuta.
• inflammation of the moist lining of mouth and gut, lungs and air passages, reproductive, and urinary tracts,
● upalu sluznice usta i crijeva, pluća i dišnih putova, spolnog i mokraćnog sustava,
The risk of Avastin-associated hypertension did not correlate with the patients' baseline characteristics, underlying disease or concomitant therapy.
Rizik od hipertenzije vezane uz Avastin nije bio u korelaciji s bolesnikovim karakteristikama na početku liječenja, bolešću koja se liječi ili popratnom terapijom.
During the blinded treatment phase, patients received chemotherapy and medicinal product (Avastin or placebo) every 3 weeks until disease progression, treatment-limiting toxicity, or death.
Tijekom slijepe faze liječenja bolesnici su primali kemoterapiju i lijek (Avastin odnosno placebo) svaka 3 tjedna do nastupa progresije bolesti,
Enrolment in Arm 3 was discontinued, as pre-specified, once safety of Avastin with the IFL regimen was established and considered acceptable.
Prema planu ispitivanja uključivanje u treću skupinu prekinuto je čim je utvrđena i prihvatljivom ocijenjena sigurnost primjene lijeka Avastin u kombinaciji s protokolom IFL.
Secondary efficacy endpoints included progression-free survival and objective response rate.
Sekundarne mjere ishoda uključivale su preživljenje bez progresije bolesti i stopu objektivnog odgovora.
Cap + Avastin (n=325)
Kap + Avastin (n= 325)
You could also experience redness or flushing of the skin or a rash, chills and shivering, feeling sick (nausea) or being sick (vomiting).
Također se mogu javiti crvenilo ili crvenilo uz osjećaj vrućine ili osip kože, zimica i tresavica, mučnina ili povraćanje.
Avastin therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
U bolesnika u kojih se razvije nekrotizirajući fasciitis terapiju lijekom Avastin treba prekinuti i odmah započeti s odgovarajućim liječenjem.
When used for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, it will be administered in combination with carboplatin and paclitaxel.
Kada se koristi za bolesnice s uznapredovalim epitelnim rakom jajnika, rakom jajovoda ili primarnim peritonealnim rakom, primjenjuje se u kombinaciji s karboplatinom i paklitakselom.
Patients treated with Avastin have an increased risk of haemorrhage, especially tumour-associated haemorrhage.
Bolesnici liječeni lijekom Avastin izloženi su povećanom riziku od krvarenja, a osobito krvarenja povezanog s tumorom.
Cases of ONJ have been reported in cancer patients treated with Avastin, the majority of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Prijavljeni su slučajevi osteonekroze čeljusti u bolesnika s malignom bolešću liječenih lijekom Avastin, od kojih je većina prethodno ili istodobno primala intravenske bisfosfonate, kod čije primjene osteonekroza čeljusti predstavlja poznat rizik.
need to be closely monitored (NCI-CTCAE v.3).
(NCI-CTCAE v.3).
Seventy-one patients were randomised to receive bolus 5-FU/FA or 5-FU/FA + Avastin (5 mg/kg every 2 weeks).
Randomiziran je 71 bolesnik, ili za bolus 5-FU/FA ili za 5-FU/FA + Avastin (5 mg/kg svaka 2 tjedna).
If the first infusion is well tolerated, the second infusion may be administered over 60 minutes.
Ako bolesnik dobro podnese prvu infuziju, drugu je moguće primijeniti tijekom 60 minuta.
Oxaliplatin 85 mg/m2 IV 2 h Oxaliplatin on day 1 Leucovorin on day 1 and 2
85 mg/m i.v. 2 h oksaliplatin 1. dana leukovorin 1. i 2. dana 5-fluorouracil i.v. bolus/infuzija, oboje 1. i 2. dana leukovorin
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.
U randomiziranom ispitivanju faze II (BO25041) ukupno je 121 bolesnik u dobi od ≥ 3 godine do < 18 godina s novodijagnosticiranim supratentorijalnim ili infratentorijalnim cerebelarnim ili pedunkularnim gliomom visokog stupnja bio liječen poslijeoperacijskom radioterapijom (RT) i adjuvantnim temozolomidom (T) u kombinaciji s bevacizumabom i bez njega: 10 mg/kg svaka 2 tjedna intravenski.
Final overall survival analysis performed when 46.9% of the patients had died.
Bolesnice s mjerljivom bolešću na početku ispitivanja Finalna analiza ukupnog preživljenja izvršena je nakon što je umrlo 46,9% bolesnica.
● serious infections of the skin or deeper layers under the skin,
● u slučaju ozbiljne infekcije kože ili dubljih potkožnih slojeva
● Keep this leaflet.
Sačuvajte ovu uputu.
Gastrointestinal disorders
gastrointestinalni poremećaj,
This study was designed as an open-label, randomized, two-arm Phase III evaluation of bevacizumab plus chemotherapy (CT+BV) versus chemotherapy alone (CT).
Ispitivanje je osmišljeno kao otvoreno, randomizirano ispitivanje faze III u dvije skupine, u kojem se ocjenjivala primjena bevacizumaba i kemoterapije (KT+BV) naspram primjene samo kemoterapije (KT).
Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Bevacizumab je u kombinaciji s kemoterapijom na bazi fluoropirimidina indiciran za liječenje odraslih bolesnika s metastatskim karcinomom kolona ili rektuma.
Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Bevacizumab je u kombinaciji s interferonom alfa-2a indiciran za prvu liniju liječenja odraslih bolesnika s uznapredovalim i/ili metastatskim karcinomom bubrežnih stanica.
5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks
a 5,0 mg/kg svaka 2 tjedna ili 7,5 mg/kg svaka 3 tjedna
Overall response rate Rate (percent) 95% CI p-value
Ukupna stopa odgovora Stopa (postotak) 95% CI p-vrijednost
Treatment was given until progressive disease or unacceptable toxicity.
Liječenje se nastavilo do progresije bolesti ili do pojave neprihvatljive toksičnosti.
The primary endpoint of this trial was progression free survival (PFS), based on trial investigators' assessment of disease progression.
Primarna mjera ishoda ovog ispitivanja bilo je preživljenje bez progresije bolesti, na temelju ispitivačeve procjene progresije bolesti.
In clinical trials with Avastin, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer.
U kliničkim ispitivanjima lijeka Avastin kongestivno zatajenje srca zabilježeno je u svim dosad ispitivanim onkološkim indikacijama, no najčešće se javljalo u bolesnika s metastatskim rakom dojke.
An independent review of the primary endpoint was also conducted.
Provedena je i neovisna procjena primarne mjere ishoda.
Results from the randomised phase III studies, PACCE and CAIRO-2, in patients with mCRC suggest that the use of anti-EGFR monoclonal antibodies panitumumab and cetuximab, respectively, in combination with bevacizumab plus chemotherapy, is associated with decreased PFS and/or OS, and with increased toxicity compared with bevacizumab plus chemotherapy alone.
Rezultati randomiziranih ispitivanja faze III PACCE i CAIRO-2 u bolesnika s metastatskim karcinomom kolona ili rektuma ukazuju na to da je primjena monoklonskih protutijela protiv EGFR-a, panitumumaba i cetuksimaba, u kombinaciji s kemoterapijom i bevacizumabom povezana s kraćim preživljenjem bez progresije bolesti i/ili ukupnim preživljenjem te s povećanom toksičnošću u usporedbi s primjenom samo bevacizumaba i kemoterapije.
The trial contained two parts: an initial unblinded 2-arm part (Part I) in which patients were randomised to two different treatment groups (XELOX and FOLFOX-4) and a subsequent 2 x 2 factorial 4-arm part (Part II) in which patients were randomised to four treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + Avastin, FOLFOX-4 + Avastin).
U sljedećem dijelu (dio II) sastavljenom od 4 skupine prema faktorijalnom nacrtu 2 x 2 bolesnici su randomizirani u četiri terapijske skupine (XELOX + placebo, FOLFOX-4 + placebo, XELOX +
● a blood clot in your arteries,
● u slučaju krvnog ugruška u arterijama,
These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitritis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular haemorrhage such as vitreous haemorrhage or retinal haemorrhage and conjunctival haemorrhage.
Ti su događaji obuhvaćali infektivni endoftalmitis, intraokularnu upalu poput sterilnog endoftalmitisa, uveitisa i vitritisa, odvajanje mrežnice, kidanje pigmentnog epitela mrežnice, povišen očni tlak, intraokularno krvarenje poput vitrealnog krvarenja ili krvarenja mrežnice te krvarenje konjunktive.
In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of Avastin.
U bolesnika u kojih se razvije PRES, uz prekid primjene lijeka Avastin preporučuje se i liječenje specifičnih simptoma uključujući kontrolu hipertenzije.
RECIST criteria (Revised RECIST guideline (version 1.1).
1 Završna analiza 2 Ocjene tumora i procjene odgovora provodili su ispitivači na temelju GOG RECIST kriterija (Revidirana RECIST smjernica (verzija 1.1).
Each 4 ml vial contains 100 mg of bevacizumab, corresponding to 1.4 mg/ml when diluted as recommended.
Jedna bočica od 4 ml sadrži 100 mg bevacizumaba, što odgovara 1,4 mg/ml kada se razrijedi sukladno preporuci.
Avastin may impair female fertility.
Avastin može štetno djelovati na plodnost žena.
Table 25 Efficacy results from study GOG-0240 by Avastin Treatment
Tablica 25 Rezultati djelotvornosti za ispitivanje GOG-0240 prema terapiji lijekom Avastin Kemoterapija (n=225)
CHF Grade 3 or higher reactions were somewhat more frequent among patients receiving bevacizumab in combination with chemotherapy than in patients receiving chemotherapy alone.
Kongestivno zatajenje srca stupnja 3 ili višeg stupnja bilo je nešto češće u bolesnika koji su primali bevacizumab u kombinaciji s kemoterapijom nego u bolesnika koji su primali samo kemoterapiju.
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.
Teške nuspojave su definirane kao štetni događaji stupnja 3-5 prema NCI-CTCAE s razlikom od barem 2% u odnosu na kontrolnu skupinu u kliničkim ispitivanjima.
• CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration
• skupina CP: karboplatin (AUC 6) i paklitaksel (175 mg/m 2) u 6 trotjednih ciklusa
Pulmonary haemorrhage/haemoptysis
Plućno krvarenje/hemoptiza
Table 16 Efficacy results from study GOG-0218
Tablica 16 Rezultati djelotvornosti za ispitivanje GOG-0218:
The GOG-0218 study was a phase III multicentre, randomised, double-blind, placebo-controlled, three arm study evaluating the effect of adding Avastin to an approved chemotherapy regimen (carboplatin and paclitaxel) in patients with advanced ( Stages IIIB, IIIC and IV according to FIGO staging version dated 1988) epithelial ovarian, fallopian tube or primary peritoneal cancer.
Ispitivanje GOG-0218 bilo je multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze III u tri skupine, koje je procjenjivalo učinak dodavanja lijeka Avastin odobrenom kemoterapijskom protokolu (karboplatin i paklitaksel) u bolesnica s uznapredovalim (stadiji IIIB, IIIC i IV prema FIGO klasifikaciji, verzija iz 1988.) epitelnim karcinomom jajnika, karcinomom jajovoda ili primarnim peritonealnim karcinomom.
Until mature OS results and safety data are available no definitive conclusion can be drawn on the benefit/risk balance.
Ne može se donijeti definitivan zaključak o omjeru koristi i rizika.
Advanced and/or metastatic renal cell cancer (mRCC)
Uznapredovali i/ili metastatski karcinom bubrežnih stanica
Dose-reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of Avastin and IFN alfa-2a based on PFS event free rates over time, as shown by a sub-group analysis.
Analiza podskupina pokazala je da smanjenje doze IFN alfa-2a nije utjecalo na djelotvornost kombinacije lijeka Avastin i IFN alfa-2a, sudeći po udjelima preživljenja bez progresije bolesti u promatranom vremenu.
Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
U usporedbi s tipičnim bolesnikom s medijanom vrijednosti albumina i tumorskog opterećenja, klirens bevacizumaba bio je oko 30% brži u bolesnika s niskom koncentracijom serumskog albumina i 7% brži u ispitanika s visokim tumorskim opterećenjem.
Due date the MAH should discuss any further outcome data on the combination of bevacizumab + erlotinib in this indication (e.g. data from the ongoing ACCRU study, NCT number NCT01532089) (due date: Q2 2019)
podatke iz ispitivanja ACCRU, koje je u tijeku; identifikacijski NCT broj: NCT01532089) (rok: 2. tromjesečje 2019.)
Table 26 Overall survival results from study GOG-0240 by Trial Treatment Treatment
Tablica 26 Rezultati ukupnog preživljenja za ispitivanje GOG-0240 prema ispitivanom lije če nju
The primary endpoint was progression-free survival (PFS) based on independent review assessment.
Primarna mjera ishoda bilo je preživljenje bez progresije bolesti (PFS) prema ocjeni neovisnog ocjenjivačkog povjerenstva.
Patients with non-small cell lung cancer treated with Avastin may be at risk of serious, and in some cases fatal, pulmonary haemorrhage/haemoptysis.
Bolesnici koji boluju od karcinoma pluća nemalih stanica i liječe se lijekom Avastin izloženi su riziku od teškog, a u nekim slučajevima smrtonosnog plućnog krvarenja/hemoptize.
Prespecified PFS analyses were conducted, all with a cut-off date of 29 September 2009.
Provedene su unaprijed određene analize preživljenja bez progresije bolesti; u svima je završni datum prikupljanja podataka bio 29. rujna 2009.
(p-value = 0.0185)
(p-vrijednost = 0,0185)
Study AVF3694g was a Phase III, multicentre, randomised, placebo-controlled trial designed to evaluate the efficacy and safety of Avastin in combination with chemotherapy compared to chemotherapy plus placebo as first-line treatment for patients with HER2-negative metastatic or locally recurrent breast cancer.
AVF3694g Ispitivanje AVF3694g bilo je multicentrično, randomizirano, placebom kontrolirano kliničko ispitivanje faze III u kojemu se ispitivala djelotvornost i sigurnost primjene lijeka Avastin u kombinaciji s kemoterapijom u odnosu na kemoterapiju plus placebo, u prvoj liniji liječenja bolesnika s HER2 negativnim metastatskim ili lokalno recidivirajućim karcinomom dojke.
Cervical Cancer
Karcinom cerviksa
• ML18147: Avastin 5.0 mg/kg of body weight every 2 weeks or Avastin 7.5 mg/kg of body weight every 3 weeks in combination with fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin in patients with disease progression following first-line treatment with bevacizumab.
• ML18147: Avastin u dozi od 5,0 mg/kg tjelesne težine svaka 2 tjedna ili Avastin u dozi od 7,5 mg/kg tjelesne težine svaka 3 tjedna u kombinaciji s fluoropirimidinom/irinotekanom ili fluoropirimidinom/oksaliplatinom u bolesnika u kojih je došlo do progresije bolesti nakon liječenja bevacizumabom u prvoj liniji.
Trial E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating Avastin in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease.
Ispitivanje E2100 bilo je otvoreno, randomizirano, aktivno kontrolirano multicentrično kliničko ispitivanje u kojemu se ispitivala primjena lijeka Avastin u kombinaciji s paklitakselom u liječenju lokalno recidivirajućeg ili metastatskog karcinoma dojke u bolesnika koji prethodno nisu primali kemoterapiju za lokalno recidivirajuću ili metastatsku bolest.
• diarrhoea, nausea, vomiting and abdominal pain.
● proljev, mučninu, povraćanje i bol u trbuhu.
Grade 3-5 reactions have been observed in up to 2.3% of patients treated with Avastin plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Krvarenja stupnja 3-5 opažena su u do 2,3% bolesnika liječenih kombinacijom kemoterapije i lijeka Avastin u usporedbi s < 1% u bolesnika liječenih samo kemoterapijom (NCI-CTCAE v.3).
Table 2 provides the frequency of severe adverse reactions.
Tablici 2 su navedene učestalosti teških nuspojava.
Table 12 Efficacy results for trial E4599
Rezultati su prikazani u Tablici 12. Tablica 12 Rezultati djelotvornosti za ispitivanje E4599
(16.2 vs 17.5 months; p = 0.3769)
(16,2 naspram 17,5 mjeseci; p = 0,3769)
Response rate
Stopa odgovora
Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Plućna hipertenzija (nepoznato) Disfonija (često)
Hazard ratiob
Omjer hazarda
Avastin 25 mg/ml concentrate for solution for infusion Bevacizumab
Avastin 25 mg/ml koncentrat za otopinu za infuziju bevacizumab
In situations where early discontinuation of chemotherapy was required, treatment with Avastin as a single agent continued until disease progression.
U situacijama u kojima je bilo potrebno prije vremena prekinuti kemoterapiju, nastavljena je monoterapija lijekom Avastin do progresije bolesti.
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), GI perforations (all grade) were reported in 3.2% of patients, all of whom had a history of prior pelvic radiation.
U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa (ispitivanje GOG-0240), gastrointestinalne perforacije (svih stupnjeva) prijavljene su u 3,2% bolesnica, a u svih njih prethodno je provedeno zračenje zdjelice.
Ovarian failure/fertility
Zatajivanje jajnika/plodnost
FOLFOX-4 or FOLFOX-4 + Avastin
FOLFOX-4 ili FOLFOX-4 + Avastin oksaliplatin
The rates of discontinuation due to adverse events in the subgroup of patients > 65 years old were 8.8% in the CT arm and 50.0% in the CT + BV arm.
Stope prekida ispitivanja zbog nuspojava u podskupini bolesnica starijih od 65 godina iznosile su 8,8% u skupini KT
● If you have any further questions, ask your doctor, pharmacist or nurse.
Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF Grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with Avastin in combination with chemotherapy compared with up to 0.9% in the control arms.
U četiri ispitivanja faze III (AVF2119g, E2100, BO17708 i AVF3694g) u bolesnika s metastatskim karcinomom dojke, kongestivno zatajenje srca stupnja 3 ili višeg stupnja (NCI-CTCAE v.3)
Patients treated for persistent, recurrent, or metastatic cervical cancer with Avastin in combination with paclitaxel and cisplatin may be at increased risk of venous thromboembolic events.
Bolesnice koje se liječe lijekom Avastin u kombinaciji s paklitakselom i cisplatinom zbog perzistentnog, recidivirajućeg ili metastatskog karcinoma cerviksa mogu biti izložene povećanom riziku od venskih tromboembolijskih događaja.
A total of 361 patients were enrolled into this study and administered either chemotherapy (paclitaxel, topotecan, or pegylated liposomal doxorubicin (PLD) alone or in combination with bevacizumab:
Bolesnice su primale ili samo kemoterapiju (paklitaksel, topotekan ili pegilirani liposomalni doksorubicin (PLD)) ili kemoterapiju u kombinaciji s bevacizumabom:
In patients who only received bevacizumab in combination with chemotherapy and did not continue to receive bevacizumab alone (CPB15), no clinically meaningful benefit in PFS was observed.
U bolesnica koje su primale bevacizumab samo u kombinaciji s kemoterapijom te nisu nastavile primati samo bevacizumab (CPB15) nisu uočena klinički značajna poboljšanja u preživljenju bez progresije bolesti.
(p-value < 0.0001)
(p-vrijednost < 0,0001)
(p-value = 0.0188)
(p-vrijednost = 0,0188)
The study evaluated the effect of adding Avastin to carboplatin+paclitaxel and continuing Avastin as a single agent until disease progression or unacceptable toxicity compared to carboplatin+paclitaxel alone.
U ovom se ispitivanju ocjenjivao učinak dodavanja lijeka Avastin karboplatinu i paklitakselu i zatim nastavka primjene samo lijeka Avastin do progresije bolesti ili razvoja neprihvatljive toksičnosti u odnosu na terapiju samo karboplatinom i paklitakselom.
(16.2 vs. 12.0 months; p = 0.1342)
(16,2 nasrpam 12,0 mjeseci; p = 0,1342)
This has mainly been seen in combination with platinum- or taxane-based therapies in the treatment of NSCLC, mBC, and in combination with paclitaxel and topotecan in persistent, recurrent, or metastatic cervical cancer.
To je uglavnom uočeno kod kombinacije s terapijama na bazi platinskog spoja ili taksana u liječenju karcinoma pluća nemalih stanica, metastatskog karcinoma dojke te kod kombinacije s paklitakselom i topotekanom u liječenju perzistentnog, recidivirajućeg ili metastatskog karcinoma cerviksa.
Avastin is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Avastin se koristi i za liječenje odraslih bolesnica s uznapredovalim epitelnim rakom jajnika, rakom jajovoda ili primarnim peritonealnim rakom.
The incidence of AEs, including Grade ≥ 3 AEs and SAEs, was similar between the two treatment arms.
Incidencija štetnih događaja, uključujući štetne događaje stupnja ≥ 3 i ozbiljne štetne događaje, bila je slična u obje liječene skupine.
In most clinical trials of Avastin, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
stupnja II-IV nisu bili uključeni u većinu kliničkih ispitivanja lijeka Avastin pa stoga nema dostupnih informacija o riziku za razvoj kongestivnog zatajenja srca u toj populaciji bolesnika.
The efficacy results of the study are presented in Table 14.
Rezultati djelotvornosti za ovo ispitivanje prikazani su u Tablici 14.
These results demonstrate robustness of the primary analysis of PFS as shown in Table 18.
Ti rezultati pokazuju robusnost analize preživljenja bez progresije bolesti koja je prikazana u Tablici 18.
(17.5 vs.15.0 months; p = 0.0584)
(17,5 naspram.15,0 mjeseci; p = 0,0584)
weeks (n=39), 10 mg/kg every 2 weeks; (n=37), or placebo (n=40).
Jedna je skupina primala bevacizumab u dozi od 3 mg/kg svaka 2 tjedna (n = 39), druga u dozi od 10 mg/kg svaka 2 tjedna (n = 37), a treća je skupina primala placebo (n = 40).