natgillin/translations-raw huggingface dataset:
Most patients had EOC (82% in CPP and CPB15, 85% in CPB15+) followed by PPC (16% in CPP, 15% in CPB15, 13% in CPB15+) and FTC (1% in CPP, 3% in CPB15, 2% in CPB15+).
Sveukupno je približno 50% bolesnica imalo GOG (Gynecologic Oncology Group) funkcionalni status 0 na početku liječenja, njih 43% imalo je GOG funkcionalni status 1, a 7% GOG funkcionalni status 2. Većina bolesnica bolovala je od epitelnog karcinoma jajnika (82% u skupinama CPP i CPB15, a 85% u skupini CPB15+), nakon čega je po učestalosti slijedio primarni peritonealni karcinom (16% u skupini CPP, 15% u skupini CPB15, 13% u skupini CPB15+) te karcinom jajovoda (1% u skupini CPP, 3% u skupini CPB15, 2% u skupini CPB15+).
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with Avastin in combination with paclitaxel and topotecan compared with up to 4.6% of patients treated with paclitaxel and topotecan.
U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa (ispitivanje GOG-0240), reakcije krvarenja stupnja 3-5 prijavljene su u do 8,3% bolesnica liječenih lijekom Avastin u kombinaciji s paklitakselom i topotekanom u usporedbi s do
A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Razgradnja bevacizumaba ovisna o koncentraciji primijećena je pri razrjeđivanju otopinama glukoze
Cases of non-mandibular osteonecrosis have been observed in Avastin treated paediatric patients (see section 4.8, Paediatric population).
U pedijatrijskih bolesnika liječenih lijekom Avastin zabilježeni su slučajevi osteonekroze koja nije zahvaćala čeljust (vidjeti dio 4.8,
EGFR mutation testing should be performed prior to initiation of treatment with the combination of Avastin and erlotinib.
Prije početka liječenja kombinacijom lijeka Avastin s erlotinibom potrebno je provesti testiranje na mutacije EGFR-a.
(p-value = 0.0012)
(p-vrijednost = 0,0012)
Laboratory abnormalities
Odstupanja laboratorijskih nalaza
The results of this study from the final protocol defined analyses for progression free survival and response rates for the independently powered capecitabine cohort of Study AVF3694g are presented in Table 11 Results from an exploratory overall survival analysis which include an additional 7 months of follow-up (approximately 46% of patients had died) are also presented.
Tablici 11 prikazani su rezultati za preživljenje bez progresije bolesti i stope odgovora na liječenje dobiveni analizama prema konačnom protokolu za kapecitabin kohortu iz ispitivanja AVF3694g koja je bila dizajnirana na način da ima neovisnu statističku snagu.
a 10 mg/kg every 2 weeks b
5 mg/kg svaka 2 tjedna b
Effect of antineoplastic agents on bevacizumab pharmacokinetics No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses.
Rezultati analiza populacijske farmakokinetike pokazali su da nema klinički značajnih interakcija istodobno primijenjene kemoterapije na farmakokinetiku bevacizumaba.
• 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.
U ispitivanju AVF4095g ocijenjene su djelotvornost i sigurnost bevacizumaba u kombinaciji s karboplatinom i gemcitabinom, nakon čega se bevacizumab primjenjivao sam, u bolesnica s recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma osjetljivih na platinu.
The primary efficacy endpoint was overall survival.
Primarna mjera ishoda za djelotvornost bilo je ukupno preživljenje.
A reduction of circulating VEGF concentration has been demonstrated following intravitreal antiVEGF therapy.
Nakon intravitrealnog liječenja inhibitorima VEGF zabilježeno je smanjenje koncentracije VEGF-a u cirkulaciji.
PHARMACEUTICAL FORM Concentrate for solution for infusion.
Koncentrat za otopinu za infuziju.
p-value
p -vrijednost
Study MO22224 evaluated the efficacy and safety of bevacizumab in combination with chemotherapy for platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
U ispitivanju MO22224 ocijenjene su djelotvornost i sigurnost bevacizumaba u kombinaciji s kemoterapijom za liječenje recidiva epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma rezistentnih na platinu.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/16 ml
Koncentrat za otopinu za infuziju 1 bočica sa 16 ml 400 mg/16 ml
• clogging of a very small blood vessel(s) in the kidney,
● začepljenje vrlo malih krvnih žila u bubregu,
Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Bevacizumab je u kombinaciji s karboplatinom i paklitakselom indiciran za prvu liniju liječenja odraslih bolesnica s uznapredovalim (International Federation of Gynecology and Obstetrics (FIGO)
Congestive heart failure (CHF) (see section 4.8)
Kongestivno zatajenje srca (vidjeti dio 4.8)
Avastin should be discontinued in patients with life-threatening (Grade 4) thromboembolic reactions,
Primjenu lijeka Avastin treba prekinuti u bolesnika s tromboembolijskim reakcijama opasnima po život (stupanj 4), uključujući plućnu emboliju (NCI-CTCAE v.3).
Fatal outcome was reported in 0.8% of patients receiving Avastin compared to 0.5% in patients receiving chemotherapy alone.
Smrtni je ishod prijavljen u 0,8% bolesnika koji su primali Avastin te u 0,5%
The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
Preporučena doza lijeka Avastin je 10 mg/kg tjelesne težine, primijenjena jednom svaka 2 tjedna u obliku intravenske infuzije.
Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
Konačna analiza ukupnog preživljenja izvršena nakon što je umrlo 46,7% bolesnica, prema podacima do
2 Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
1 Analiza preživljenja bez progresije bolesti po procjeni ispitivača, prema podacima do 30. studenog 2010.
• Paclitaxel 80 mg/m2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 every 4 weeks.
• Skupina KT (samo kemoterapija): • paklitaksel 80 mg/m u obliku jednosatne i.v. infuzije 1., 8., 15. i 22. dana svaka
Congestive heart failure a,b
Srčani poremećaji kongestivno zatajenje srcaa,b,
• sleepiness,
● pospanost,
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.
U podskupini liječenoj protokolom XELOX, medijan ukupnog preživljenja bio je 19,2 mjeseca u bolesnika koji su dobivali placebo, u usporedbi s 21,4 mjeseca u bolesnika liječenih bevacizumabom, HR = 0,84; 97,5% CI = [0,68; 1,04]; p-vrijednost = 0,0698.
Paclitaxel (n=354)
Paklitaksel (n=354)
Treatment of platinum-sensitive recurrent disease: Avastin is administered in combination with either carboplatin and gemcitabine for 6 cycles and up to 10 cycles or in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles, followed by continued use of Avastin as single agent until disease progression.The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Liječenje rekurentne bolesti osjetljive na platinu: Avastin se primjenjuje u kombinaciji s karboplatinom i gemcitabinom tijekom 6, a najviše 10 ciklusa, ili u kombinaciji s karboplatinom i paklitakselom tijekom 6, a najviše 8 ciklusa, nakon čega se Avastin primjenjuje sam do progresije bolesti.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Avastin 25 mg/ml concentrate for solution for infusion Bevacizumab
Uputa o lijeku: Informacije za korisnika Avastin 25 mg/ml koncentrat za otopinu za infuziju bevacizumab
Avastin is also used for treatment of adult patients with advanced kidney cancer.
Avastin se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom bubrega.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
Table 19 PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease 2,3 CP (n = 368)
Tablica 17 Rezultati preživljenja bez progresije bolesti prema stadiju bolesti i statusu smanjenja tumorske mase iz ispitivanja GOG-0218 Randomizirane bolesnice sa stadijem III bolesti uz optimalno smanjenu tumorsku masu2,3 CPP (n = 219)
Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
U kategoriji gastrointestinalno-vaginalnih fistula najčešće su rektovaginalne fistule.
• 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