natgillin/translations-raw huggingface dataset:
In these studies, bevacizumab was administered at the following dosing regimens in combination with FOLFOX-4 (5-FU/LV/oxaliplatin), XELOX (capecitabine/oxaliplatin), and fluoropyrimidine/irinotecan and fluoropyrimidine/oxaliplatin:
U tim je ispitivanjima bevacizumab primjenjivan u kombinaciji s protokolima FOLFOX-4 (5FU/LV/oksaliplatin) i XELOX (kapecitabin/oksaliplatin) te fluoropirimidin/irinotekan i fluoropirimidin/oksaliplatin u sljedećim režimima doziranja:
Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the Avastin arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
U 97 bolesnika koji su primali IFN alfa-2a i 131 bolesnika koji je primao Avastin doza interferona alfa-2a smanjena je s 9 milijuna IU na 6 ili 3 milijuna IU tri puta tjedno, kako je prethodno utvrđeno u protokolu ispitivanja.
The majority of patients included in the study were White (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an
Većina bolesnica obuhvaćenih ispitivanjem bila je bijele rase (96%), medijan dobi u obje je skupine iznosio 57 godina, a 25% bolesnica u svakoj skupini imalo je 65 ili više godina.
When used for patients with breast cancer, it will be administered with a chemotherapy medicinal product called paclitaxel or capecitabine.
Kada se koristi za bolesnike s rakom dojke, primjenjuje se uz kemoterapiju lijekovima paklitakselom ili kapecitabinom.
Cap + Pl (n=161)
Kap + pl (n= 161)
60.0 years in the CP arm and 59.0 years in the CPB arm.
Medijan dobi iznosio je 60,0 godina u skupini CP te 59,0 godina u skupini CPB.
In patients in AVF3694g who received treatment with anthracyclines and who had not received anthracyclines before, no increased incidence of all Grade CHF was observed in the anthracycline + bevacizumab group compared to the treatment with anthracyclines only.
U ispitivanju AVF3694g, u bolesnika liječenih antraciklinima koji ranije nisu primali antracikline nije opažena povećana učestalost kongestivnog zatajenja srca bilo kojeg stupnja u skupini koja je primala antraciklin + bevacizumab u odnosu na skupinu koja je liječena samo antraciklinima.
A total of 16 patients (4.4%) were > 75 years old.
Ukupno je 16 bolesnica bilo starije od 75 godina.
Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel, and paronychia with erlotinib.
Primjeri uključuju sindrom palmarno-plantarne eritrodizestezije kod primjene u kombinaciji s pegiliranim liposomalnim doksorubicinom ili kapecitabinom, perifernu senzornu neuropatiju kod primjene u kombinaciji s paklitakselom ili oksaliplatinom, poremećaje noktiju ili alopeciju kod primjene u kombinaciji s paklitakselom te paronihiju kod primjene u kombinaciji s erlotinibom.
(p-value = 0.3113)
(p- vrijednost = 0,3113)
Patients who had received prior therapy with bevacizumab or prior systemic anticancer therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, or hormonal therapy) or previous radiotherapy to the abdomen or pelvis were excluded from the study.
Bolesnice koje su prethodno liječene bevacizumabom ili sustavnom terapijom za liječenje karcinoma jajnika (npr. kemoterapijom, terapijom monoklonskim protutijelom, terapijom inhibitorom tirozin kinaze ili hormonskom terapijom) ili radioterapijom abdomena ili zdjelice bile su isključene iz ispitivanja.
3 95% CI for one sample binomial using Pearson-Clopper method Approximate 95% CI for difference of two rates using Hauck-Anderson method 5 log-rank test (stratified)
4 Približno 95% CI za razliku između dviju stopa primjenom Hauck-Andersonove metode
In a phase III trial in the adjuvant treatment of patients with colon cancer, a substudy with premenopausal women has shown a higher incidence of new cases of ovarian failure in the bevacizumab group compared to the control group.
U okviru ispitivanja faze III adjuvantnog liječenja bolesnika s karcinomom kolona, u podispitivanju žena u predmenopauzi pokazala se veća učestalost novih slučajeva zatajivanja jajnika u skupini koja je primala bevacizumab u odnosu na kontrolnu skupinu.
This study included a blinded treatment phase, an optional open-label post-progression phase, and a survival follow-up phase.
Ovo je ispitivanje obuhvatilo tri faze: slijepu fazu liječenja, neobaveznu otvorenu fazu nakon progresije bolesti te fazu praćenja preživljenja.
Metastatic carcinoma of the colon or rectum (mCRC)
Metastatski karcinom kolona ili rektuma
● presence of protein in your urine accompanied by swelling of your body,
● u slučaju pojave proteina u mokraći i oticanja tijela,
An unstratified analysis of PFS (investigator assessed) was performed that did not censor for nonprotocol therapy prior to disease progression.
Napravljena je nestratificirana analiza preživljenja bez progresije bolesti (prema ocjeni ispitivača) koja nije isključila bolesnike koji su prije progresije bolesti primali terapiju koja nije bila obuhvaćena protokolom.
● 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.
Neinferiornost protokola XELOX u odnosu na protokol FOLFOX-4 u cjelovitoj je usporedbi dokazana s obzirom na preživljenje bez progresije bolesti i ukupno preživljenje u populaciji bolesnika liječenih prema protokolu koje je bilo moguće ocijeniti.
● Periodic Safety Update Reports
Periodička izvješća o neškodljivosti
Grade 3 hypertension was 60.0% in patients treated with Avastin in combination with erlotinib compared to 11.7% in patients treated with erlotinib alone.
Hipertenzija stupnja 3 zabilježena je u 60,0% bolesnika liječenih lijekom Avastin u kombinaciji s erlotinibom u usporedbi s 11,7% bolesnika liječenih samo erlotinibom.
• Infection or inflammation of the eye globe,
● infekcija ili upala očne jabučice,
Avastin will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Avastin će se davati u kombinaciji s kemoterapijom koja sadrži lijek na bazi fluoropirimidina.
The efficacy results are presented in Table 13.
Rezultati djelotvornosti prikazani su u Tablici 13.
• In a single-arm study (PBTC-022), 18 children with recurrent or progressive non-pontine high-grade glioma (including 8 with glioblastoma [WHO Grade IV], 9 with anaplastic astrocytoma [Grade III] and 1 with anaplastic oligodendroglioma [Grade III]) were treated with bevacizumab (10 mg/kg) two weeks apart and then with bevacizumab in combination with CPT-11 (125-350 mg/m²) once every two weeks until progression.
U ispitivanju (PBTC-022) koje je uključivalo jednu skupinu, 18 djece s rekurentnim ili progresivnim gliomom visokog stupnja malignosti koji ne zahvaća pons (uključujući 8 s glioblastomom [stupnja IV prema WHO], 9 s anaplastičnim astrocitomom [stupnja III] i 1 s anaplastičnim oligodendrogliomom [stupnja III]) liječeno je bevacizumabom (10 mg/kg) u razmaku od 2 tjedna i zatim bevacizumabom u kombinaciji s CPT-11 (125-350 mg/m jednom svaka dva tjedna do progresije bolesti.
Table 4 Efficacy results for trial AVF2107g
Tablica 4 Rezultati djelotvornosti za ispitivanje AVF2107g
An overall survival benefit has been demonstrated in trial E4599 with a 15 mg/kg/q3wk dose of bevacizumab.
Korist za ukupno preživljenje dokazana je u ispitivanju E4599 uz primjenu bevacizumaba u dozi od 15 mg/kg svaka 3 tjedna.
In NSABP C-08, a phase III trial of Avastin in adjuvant treatment of patients with colon cancer, the incidence of new cases of ovarian failure, defined as amenorrhoea lasting 3 or more months, FSH level ≥ 30 mIU/mL and a negative serum β-HCG pregnancy test, has been evaluated in 295 premenopausal women.
U ispitivanju NSABP C-08, ispitivanju faze III adjuvantnog liječenja lijekom Avastin bolesnika s karcinomom kolona, u 295 žena u predmenopauzi ispitana je incidencija novih slučajeva zatajenja jajnika, definiranih kao amenoreja u trajanju od tri mjeseca ili više, razina FSH ≥ 30 mIU/ml te negativan serumski β-HCG test na trudnoću.
• The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV every 2 weeks (or bevacizumab 15 mg/kg every 3 weeks if used in combination with topotecan 1.25 mg/m2 on Days 1-5 every 3 weeks).
• odabrana kemoterapija kombinirana je s bevacizumabom primijenjenim u dozi od 10 mg/kg i.v. svaka 2 tjedna (ili s bevacizumabom u dozi od 15 mg/kg svaka 3 tjedna ako se radilo o kombinaciji s topotekanom u dozi od 1,25 mg/m2 od 1. do 5. dana svaka 3 tjedna).
1, the drug could be delivered as a 1-hour infusion.
Nakon 1. ciklusa lijek se mogao primjenjivati u obliku jednosatne infuzije.
In addition, a prespecified analysis of the data censoring for CA-125 progression events was conducted, as well as an independent review of PFS as determined by radiological scans.
Dodatno je provedena i unaprijed određena analiza podataka u koju nisu bili uključeni slučajevi porasta razine CA-125, kao i neovisna procjena preživljenja bez progresije bolesti na temelju radioloških snimaka.
The results of this trial are presented in Table 10.
Rezultati ovog ispitivanja prikazani su u Tablici 10.
The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection.
Treba izvući potrebnu količinu bevacizumaba i razrijediti je otopinom natrijevog klorida 9 mg/ml
p-value (Chi-squared Test) Kaplan-Meier estimates
Kaplan-Meierove procjene
In addition, the primary endpoint was also assessed by an independent review committee (IRC).
Osim toga, primarnu mjeru ishoda ocijenilo je i neovisno ocjenjivačko povjerenstvo.
Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate.
Bevacizumab je u kombinaciji s kapecitabinom indiciran za prvu liniju liječenja odraslih bolesnika s metastatskim karcinomom dojke za koje se liječenje drugim kemoterapijskim protokolima, uključujući taksane odnosno antracikline, ne smatra primjerenim.
In clinical trials across indications, the overall incidence of venous thromboembolic reactions ranged from 2.8% to 17.3% of Avastin-treated patients compared with 3.2% to 15.6% in the control arms.
U kliničkim ispitivanjima u svim indikacijama ukupna se incidencija venskih tromboembolijskih reakcija kretala od 2,8% do 17,3% u bolesnika liječenih lijekom Avastin te od 3,2% do 15,6% u kontrolnim skupinama.
• In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO Grade IV, 9 with Grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m²) every 2 weeks.
Retrospektivnim pregledom u jednoj ustanovi, 12 uzastopno (od 2005. do 2008.) otkrivene djece s relapsirajućim ili progresivnim gliomom visokog stupnja malignosti (3 stupnja IV prema WHO, 9 stupnja III) liječeno je bevacizumabom (10 mg/kg) i irinotekanom (125 mg/m2) svaka 2 tjedna.
The difference in ORR per independent central review was 18% (CI: 0.6%, 35.3%) between the two treatment arms in the few patients who had evaluable tumor at baseline and had a confirmed response prior to receiving any local therapy : 27/75 patients (36.0%, 95% CI: 25.2%, 47.9%) in the Chemo arm and 34/63 patients (54.0%, 95% CI: 40.9%, 66.6%) in the Bv + Chemo arm.
Prema ocjeni neovisnog središnjeg povjerenstva, razlika u ORR-u između dvije liječene skupine iznosila je 18% (CI: 0,6%, 35,3%) u malobrojnih bolesnika koji su na početku ispitivanja imali tumor koji se mogao ocijeniti te potvrđen odgovor prije nego što su primili bilo koju lokalnu terapiju: 27/75 bolesnika (36,0%; 95% CI: 25,2%, 47,9%) u skupini liječenoj kemoterapijom te 34/63 bolesnika (54,0%; 95% CI: 40,9%, 66,6%) u skupini koja je primala bevacizumab + kemoterapiju.
● Superiority of the Avastin-containing arms versus the chemotherapy alone arms in the overall comparison was demonstrated in terms of progression-free survival in the ITT population (Table 7).
● Superiornost protokola koji su obuhvaćali Avastin u odnosu na samu kemoterapiju u cjelovitoj je usporedbi dokazana s obzirom na preživljenje bez progresije bolesti u populaciji bolesnika u kojoj je planirano liječenje (ITT populaciji) (Tablica 7).
Keep the vial in the outer carton
Bočicu čuvati u vanjskom pakiranju
Cerebrovascular accidents (including transient ischaemic attacks) were reported in up to 2.7% of patients treated with Avastin in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
Cerebrovaskularni incidenti (uključujući i tranzitorne ishemijske atake) prijavljeni su u najviše 2,7% bolesnika liječenih lijekom Avastin u kombinaciji s kemoterapijom u odnosu na najviše 0,5% bolesnika liječenih samo kemoterapijom.
• an open sore or hole in the lining of the stomach or small intestine (the signs may include abdominal pain, feeling bloated, black tarry stools or blood in your stools (faeces) or blood in your vomit),
● otvorena rana ili napuknuće u stijenci želuca ili tankog crijeva (znakovi mogu biti bol u trbuhu, osjećaj napuhnutosti, crna katranasta stolica ili krv u stolici te krv kod povraćanja),
Caution should be exercised when treating patients with clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure with Avastin.
Potreban je oprez kad se Avastin primjenjuje u bolesnika s klinički značajnom bolešću srca i krvnih žila, poput postojeće bolesti koronarnih arterija ili kongestivnog zatajenja srca.
Of the 452 patients randomized at baseline, the majority of patients were white (80.0% in the Chemo alone group and 75.3% in the Chemo+Avastin group), had squamous cell carcinoma (67.1% in the Chemo alone group and 69.6% in the Chemo+Avastin group), had persistent/recurrent disease (83.6% in the Chemo alone group and 82.8% in the Chemo+Avastin group), had 1-2 metastatic sites (72.0% in the Chemo alone group and 76.2% in the Chemo+Avastin group), had lymph node involvement (50.2% in the Chemo alone group and 56.4% in the Chemo+Avastin group), and had a platinum free interval ≥ 6 months (72.5% in the Chemo alone group and 64.4% in the Chemo+Avastin group).
Od 452 bolesnice randomizirane na početku ispitivanja većina su bile bjelkinje (80,0% u skupini koja je primala samo kemoterapiju i 75,3% u skupini koja je primala kemoterapiju+Avastin) te su većinom imale planocelularni karcinom (67,1% u skupini koja je primala samo kemoterapiju i 69,6% u skupini koja je primala kemoterapiju+Avastin), perzistentnu/recidivirajuću bolest (83,6% u skupini koja je primala samo kemoterapiju i 82,8% u skupini koja je primala kemoterapiju+Avastin), 1 do 2 metastatska sijela (72,0% u skupini koja je primala samo kemoterapiju i 76,2% u skupini koja je primala kemoterapiju+Avastin), zahvaćene limfne čvorove (50,2% u skupini koja je primala samo kemoterapiju i 56,4% u skupini koja je primala kemoterapiju+Avastin) i interval bez liječenja platinom ≥ 6 mjeseci (72,5% u skupini koja je primala samo kemoterapiju i 64,4% u skupini koja je primala kemoterapiju+Avastin).
Progression-free survival and objective response rate were inferior in the Avastin monotherapy arm compared to the FOLFOX-4 arm.
Preživljenje bez progresije bolesti i stopa objektivnog odgovora bili su lošiji u skupini koja je primala Avastin u monoterapiji nego u skupini liječenoj protokolom FOLFOX-4.
Combination of bevacizumab and sunitinib malate In two clinical trials of metastatic renal cell carcinoma, microangiopathic haemolytic anaemia (MAHA) was reported in 7 of 19 patients treated with bevacizumab (10 mg/kg every two weeks) and sunitinib malate (50 mg daily) combination.
U dva klinička ispitivanja metastatskog karcinoma bubrežnih stanica u 7 od 19 bolesnika liječenih kombinacijom bevacizumaba (10 mg/kg svaka dva tjedna) i sunitinib malata (50 mg dnevno)
Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see Section 5.1).
Bevacizumab je u kombinaciji s paklitakselom i cisplatinom ili, alternativno, paklitakselom i topotekanom u bolesnica koje ne mogu primiti terapiju platinom, indiciran za liječenje odraslih bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa (vidjeti dio 5.1).
If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Ako bolujete od stanja koja uzrokuju upale u trbuhu (npr. divertikulitis, želučani vrijed, kolitis povezan s kemoterapijom),
Hypersensitivity, infusion reactionsa,b,d
Poremećaji imunološkog sustava preosjetljivost, infuzijske reakcijea,b,d
Gall bladder perforation (not known)
Perforacija nosnog septuma (nepoznato)
Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see Section 5.1).
Bevacizumab je u kombinaciji s erlotinibom indiciran za prvu liniju liječenja odraslih bolesnika s neresektabilnim uznapredovalim, metastatskim ili recidivirajućim neskvamoznim karcinomom pluća nemalih stanica s aktivirajućim mutacijama receptora epidermalnog faktora rasta (engl. epidermal growth factor receptor, EGFR) (vidjeti dio 5.1).
Uncommon (≥ 0.1% to < 1%) reports of fistulae that involve areas of the body other than the gastrointestinal tract (e.g. bronchopleural and biliary fistulae) were observed across various indications.
U ispitivanjima u raznim indikacijama manje često (≥ 0,1% i < 1%) su prijavljene fistule u dijelovima tijela izvan gastrointestinalnog trakta (npr. bronhopleuralne i bilijarne fistule).
Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as Grade 1 proteinuria (NCI-CTCAE v.3).
Težina proteinurije kretala se od klinički asimptomatske, kratkotrajne proteinurije u tragovima do nefrotskog sindroma, no u najvećem broju slučajeva radilo se o proteinuriji stupnja 1 (NCI-CTCAE v.3).
Venous thromboembolism: The incidence of venous thromboembolic reactions in clinical trials was similar in patients receiving Avastin in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Venska tromboembolija: Incidencija venskih tromboembolijskih reakcija u kliničkim ispitivanjima bila je slična u bolesnika koji su primali Avastin u kombinaciji s kemoterapijom i bolesnika u kontrolnoj skupini koji su primali samo kemoterapiju.
The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the
Postotak bolesnica s ECOG funkcionalnim statusom 1 odnosno ≥ 2 iznosio je 38,7% odnosno 5,0% u skupini koja je primala KT te 29,8% odnosno 9,0% u skupini koja je primala KT+BV.
Oxaliplatin 130 mg/m2 IV 2 h Oxaliplatin on day 1 Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
130 mg/m i.v. 2 h oksaliplatin 1. dana kapecitabin, peroralno, dva puta na dan tijekom 2 tjedna (slijedi jednotjedni prekid)
Frequency Not Known
Nepoznata učestalost
Most of the patients who experienced CHF had metastatic breast cancer and had received previous treatment with anthracyclines, prior radiotherapy to the left chest wall or other risk factors for CHF were present.
Većina bolesnika s kongestivnim zatajenjem srca imala je metastatski karcinom dojke te su prethodno liječeni antraciklinima, radioterapijom lijeve strane prsnog koša ili su pak postojali drugi čimbenici rizika za kongestivno zatajenje srca.
This was a phase II randomised, double-blind, active-controlled clinical trial evaluating the efficacy and safety of Avastin in combination with 5-FU/FA as first-line treatment for metastatic colorectal cancer in patients who were not optimal candidates for first-line irinotecan treatment.
Riječ je o randomiziranom, dvostruko slijepom, aktivno kontroliranom kliničkom ispitivanju faze II, u kojemu se određivala djelotvornost i sigurnost primjene lijeka Avastin u kombinaciji s protokolom 5-FU/FA kao prve linije liječenja metastatskog kolorektalnog karcinoma u bolesnika koji nisu bili optimalni kandidati za primjenu irinotekana u prvoj liniji liječenja.
Investigator assessed GOG protocol-specified PFS analysis (neither censored for CA-125 progressions nor censored for NPT prior to disease progression) with data cut-off date of 25 February, 2010.
Analiza preživljenja bez progresije bolesti po procjeni ispitivača sukladno protokolu GOG (nije cenzurirana za porast razine CA-125 ni za terapiju izvan protokola prije progresije bolesti), prema podacima do 25. veljače 2010.
In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 Grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in Avastin treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
U kliničkim ispitivanjima u svim indikacijama ukupna incidencija reakcija krvarenja stupnja 3-5 prema NCI-CTCAE iznosila je od 0,4% do 6,9% u bolesnika liječenih lijekom Avastin u odnosu na najviše 4,5% u bolesnika u kontrolnoj skupini liječenoj kemoterapijom.
Patients with NSCLC of known squamous cell histology or mixed cell type with predominant squamous cell histology were excluded from subsequent phase III trials, while patients with unknown tumour histology were included.
mješovitog staničnog tipa s prevladavajućom histologijom skvamoznih stanica nisu bili uključeni u daljnja ispitivanja faze III, dok su bolesnici s tumorom nepoznate histologije bili uključeni.
A third group of 110 patients received bolus 5-FU/FA + Avastin (Arm 3).
Treća skupina sa 110 bolesnika primala je bolus 5FU/FA
The choices of chemotherapy included capecitabine, taxane (protein-bound paclitaxel, docetaxel), and anthracycline-based agents (doxorubicin/ cyclophosphamide, epirubicin/ cyclophosphamide, 5-fluorouracil/ doxorubicin/ cyclophosphamide, 5-fluorouracil/epirubicin/cyclophosphamide) given every three weeks (q3w).
taksan (paklitaksel vezan za proteine, docetaksel) i lijekove na bazi antraciklina (doksorubicin/ciklofosfamid, epirubicin/ciklofosfamid, 5-fluorouracil/doksorubicin/ciklofosfamid, 5-fluorouracil/epirubicin/ciklofosfamid) koji su davani svaka tri tjedna.
Table 2: Severe Adverse Reactions by Frequency System organ class
Tablica 2: Teške nuspojave prema učestalosti
Other reactions with a higher frequency seen in patients over 65 were Grade 3-4 leucopenia and thrombocytopenia (NCI-CTCAE v.3); and all Grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with Avastin (see sections 4.4 and 4.8 under Thromboembolism).
Avastin zabilježene češće u bolesnika starijih od 65 godina u usporedbi s bolesnicima u dobi od ≤ 65 godina bile su leukopenija i trombocitopenija stupnja 3-4 (NCI-CTCAE v.3) te neutropenija, proljev, mučnina, glavobolja i umor bilo kojeg stupnja (vidjeti dijelove 4.4 i 4.8, pod
Proteinuriab,d
hemoptizab,d,
• Study AVF3694g (capecitabine) • Median PFS increase 2.9 months, HR 0.69 (p = 0.0002, 95% CI 0.56; 0.84)
• Medijan produljenja preživljenja bez progresije bolesti: 2,9 mjeseci, HR = 0,69 (p = 0,0002; 95% CI = 0,56; 0,84)