natgillin/translations-raw huggingface dataset:
The pharmacokinetics of bevacizumab was well characterized by the paediatric population PK model for 70 patients in Study BO20924 ((1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in Study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Farmakokinetika bevacizumaba je bila dobro opredeljena z uporabo farmakokinetičnega modela pediatrične populacije za 70 bolnikov iz študije BO20294 (1,4 do 17,6 let; 11,6 do 77,5 kg) in za 59 bolnikov iz študije BO25041 (1 do 17 let; 11,2 do 82,3 kg).
0.838 [CI: 0.693, 1.014]
0,838 [IZ: 0,693; 1,014]
Other medicines and Avastin
Druga zdravila in zdravilo Avastin
No AEs leading to death occurred in either treatment arm; all deaths were attributed to disease progression.
V nobeni od zdravljenih skupin ni bilo neželenih učinkov, ki bi bili smrtni; vsi smrtni primeri so bili zaradi napredovanja bolezni.
assessment)**
Ocena IRF**
For additional information refer below within section "Further information on selected serious adverse reactions"
d Za nadaljnje informacije glejte spodnje podpoglavje »Dodatne informacije o določenih resnih neželenih učinkih«.
The efficacy results of Avastin in combination with IFL-chemotherapy are displayed in Table 4.
Rezultate učinkovitosti zdravila Avastin v kombinaciji z IFL-kemoterapijo prikazuje preglednica 4.
In patients who experienced wound healing complications during therapy, treatment should be withheld until the wound is fully healed.
Pri bolnikih, pri katerih je med zdravljenjem prišlo do zapleta pri celjenju ran, dajanje začasno prekinemo, dokler se rana popolnoma ne zaceli.
Efficacy Results for Study ML18147 (ITT population)
Rezultati učinkovitosti za študijo ML18147 (populacija bolnikov, ki so jo nameravali zdraviti)
Grade 3 proteinuria was reported in up to 10.9% of treated patients.
O proteinuriji stopnje 3 so poročali pri največ 10,9 % zdravljenih bolnikov.
In terms of safety, there was a higher overall incidence of Grade 3-5 AEs in study E3200 relative to study ML18147.
Kar se tiče varnosti, je bila v študiji E3200 celokupno večja incidenca neželenih dogodkov stopnje 3-5 glede na študijo ML18147.
The findings ranged from asymptomatic declines in left ventricular ejection fraction to symptomatic CHF, requiring treatment or hospitalisation.
Ti učinki so segali od asimptomatskega zmanjšanja iztisnega deleža levega prekata do simptomatskega kongestivnega srčnega popuščanja, za katerega je bilo potrebno zdravljenje ali hospitalizacija.
An adverse effect on female fertility can however be expected as repeat dose toxicity studies in animals have shown inhibition of the maturation of ovarian follicles and a decrease/absence of corpora lutea and associated decrease in ovarian and uterus weight as well as a decrease in the number of menstrual cycles.
Pričakovan pa je škodljiv učinek na plodnost žensk, saj so študije toksičnosti pri večkratnih odmerkih na živalih pokazale zaviranje zorenja ovarijskih foliklov in zmanjšanje/odsotnost rumenega telesca ter s tem povezano zmanjšanje mase jajčnika in maternice ter zmanjšanje števila menstrualnih ciklov.
Follow-up analysis was performed with a data cut-off date of 07 March 2014 8 p-value displayed for descriptive purpose only
Analizo po spremljanju so opravili s podatki, zajetimi do 7. marca 2014. 8 Vrednost p je napisana samo za deskriptivne namene.
Toxicity and adverse reactions included arterial hypertension and fatigue as well as CNS ischaemia with acute neurological deficit.
Toksičnosti in neželeni učinki so vključevali arterijsko hipertenzijo in utrujenost ter ishemijo centralnega živčnega sistema z akutnim nevrološkim pomanjkanjem.
Avastin infusions should not be administered or mixed with glucose solutions.
Infuzije zdravila Avastin se ne sme dajati ali mešati skupaj z raztopinami glukoze.
An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Vmesna analiza je pokazala, da je čas do napredovanja bolezni pomembno podaljšan v skupini, ki je prejemala 10 mg/kg, v primerjavi s skupino, ki je prejemala placebo (razmerje ogroženosti 2,55; p < 0,001).
Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor (EGFR).
Zdravilo Avastin uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim rakom pljuč, ko imajo rakave celice določene mutacije beljakovine, ki se imenuje receptor epidermalnega rastnega faktorja (EGFR).
FOLFOX-4 or XELOX + placebo (n=701)
FOLFOX-4 ali XELOX + placebo (n = 701)
Statistically significant improvements in progression-free survival were also observed.
Statistično značilno izboljšanje so opazili tudi pri preživetju brez napredovanja bolezni.
IgGs are known to cross the placenta, and Avastin is anticipated to inhibit angiogenesis in the foetus, and thus is suspected to cause serious birth defects when administered during pregnancy.
Znano je, da IgG prehajajo skozi placento, zato predvidevamo, da lahko zdravilo Avastin povzroči zavrtje angiogeneze pri plodu in tako domnevno povzroča resne okvare ploda, če ga jemljejo nosečnice.
● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Posodobljen RMP je treba predložiti: · na zahtevo Evropske agencije za zdravila; · ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Avastin may adversely affect the wound healing process.
Zdravilo Avastin lahko neugodno vpliva na proces celjenja ran.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/001
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/300/001
Recurrence of cancer within the field of prior radiation is an additional important risk factor for the development of GI-vaginal fistulae.
Ponovitev raka v območju predhodnega obsevanja je dodaten pomemben dejavnik tveganja za nastanek fistule med prebavili in nožnico.
5-fluorouracil IV bolus/infusion, each on days 1 and 2
bolus/infuzija, vsak 1. in 2. dan
Conclusions on the impact of bevacizumab on gemcitabine pharmacokinetics cannot be drawn.
O vplivu bevacizumaba na farmakokinetiko gemcitabina ne moremo zagotovo sklepati.
Table 5 Efficacy results for trials AVF0780g and AVF2192g AVF0780g
Rezultati učinkovitosti iz preskušanj AVF0780g in AVF2192g AVF0780g
Response rates (for patients with measurable disease)
Odgovor bolnikov na zdravljenje (pri bolnikih z merljivo boleznijo)
If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive and use machines until symptoms abate.
Bolnikom, pri katerih se pojavijo simptomi, ki vplivajo na vid oziroma koncentracijo ali sposobnost odzivanja, je treba svetovati, naj ne vozijo in upravljajo strojev, dokler simptomi ne izzvenijo.
Avastin will be administered in combination with erlotinib.
Zdravilo Avastin boste prejeli v kombinaciji z erlotinibom.
In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of postoperative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting Avastin.
V kliničnih preskušanjih metastatskega raka debelega črevesa in danke ni bilo povečanega tveganja za pooperativno krvavitev ali zaplete pri celjenju ran pri bolnikih, ki so imeli večjo operacijo 28 do 60 dni pred začetkom zdravljenja z zdravilom Avastin.
The pharmacokinetic results show that the clearance and volume of distribution of bevacizumab were comparable between paediatric and young adult patients when normalised by body weight, with exposure trending lower as body weight decreased.
Farmakokinetični rezultati kažejo, da sta bila po normiranju glede na telesno maso očistek in volumen porazdelitve bevacizumaba med pediatričnimi in mlajšimi odraslimi bolniki primerljiva, z izpostavljenostjo, ki se je z manjšanjem telesne mase zmanjševala.
These efficacy data are consistent with the results from trial AVF2107g.
Dobljeni podatki o učinkovitosti se ujemajo z izsledki preskušanja AVF2107g.
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.
Med fazo slepega zdravljenja so bolniki prejemali kemoterapijo in zdravilo (Avastin ali placebo) vsake 3 tedne do napredovanja bolezni, nesprejemljive toksičnosti ali smrti.
The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/ml to 16.5 mg/ml.
Koncentracija končne raztopine bevacizumaba mora biti od 1,4 do 16,5 mg/ml.
Patients should have had a life expectancy of ≥ 12 weeks and no prior radiotherapy to the pelvis or abdomen.
Bolnice so morale imeti pričakovano preživetje ³ 12 tednov in v preteklosti niso smele prejeti radioterapije medenice ali trebuha.
The efficacy data from trials AVF0780g and AVF2192g investigating Avastin in combination with 5-FU/FA-chemotherapy are summarised in Table 5.
Podatki o učinkovitosti iz preskušanj AVF0780g in AVF2192g, ki sta proučevali zdravilo Avastin v kombinaciji s kemoterapevtsko shemo 5-FU/FA, so povzeti v preglednici 5.
Biotransformation Assessment of bevacizumab metabolism in rabbits following a single IV dose of 125I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Biotransformacija Ocena presnove pri kuncih po enkratnem intravenskem odmerku 125I-bevacizumaba je pokazala, da ima bevacizumab podoben presnovni profil kot pričakovani za nativne molekule IgG, ki se ne vežejo na VEGF.
Patients were treated until disease progression.
Bolniki so bili zdravljeni do napredovanja bolezni.
FOLFOX-4 or XELOX + bevacizumab (n=699)
FOLFOX-4 ali XELOX + bevacizumab (n = 699)
Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast, pancreas and prostate.
Injiciranje bevacizumaba ali njegovega izvornega murinskega protitelesa v ksenotransplantantne modele raka pri golih miškah je povzročilo široko antitumorsko aktivnost v tumorju človeškega izvora, vključno z rakom debelega črevesa, dojke, pankreasa in prostate.
These therapies in combination with Avastin may increase the risk of severe side effects.
Ta zdravila lahko v kombinaciji z zdravilom Avastin povečajo tveganje za pojav hudih neželenih učinkov.
Most patients were FIGO Stage III (both 68%) followed by FIGO Stage IV (13% and 14%), FIGO Stage II (10% and 11%) and FIGO Stage I (9% and 7%).
Večina bolnic je imela po FIGO klasifikaciji bolezen stadija III (v obeh skupinah 68 %), sledile so bolnice s stadijem IV po FIGO klasifikaciji (13 % in 14 %), stadijem II po FIGO klasifikaciji (10 % in 11 %) in stadijem I po FIGO klasifikaciji (9 % in 7 %).
Patients should be monitored for signs and symptoms of CNS bleeding, and Avastin treatment discontinued in cases of intracranial bleeding.
Bolnike je treba spremljati za znake ali simptome krvavitev v osrednjem živčevju in zdravljenje z zdravilom Avastin v primerih intrakranialne krvavitve prekiniti.
Roche Pharma AG Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil-Barell-Str.1, D-79639 Grenzach-Wyhlen
Avastin is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Zdravilo Avastin se uporablja v kombinaciji z eno od naslednjih shem kemoterapije: paklitaksel in cisplatin ali paklitaksel in topotekan.
Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were White.
Večina bolnic tako v skupini CP (80,4 %) kot v skupini CPB (78,9 %) je bila belk.
Bevacizumab binds selectively to a protein called human vascular endothelial growth factor (VEGF), which is found on the lining of blood and lymph vessels in the body.
Bevacizumab se selektivno veže na beljakovino, imenovano humani vaskularni endotelijski rastni faktor (VEGF), ki se nahaja na notranji steni krvnih in limfnih žil v telesu.
The primary efficacy parameter of the trial was overall survival, defined as the time from randomisation to death from any cause.
Primarni parameter učinkovitosti kliničnega preskušanja je bilo celokupno preživetje, opredeljeno kot čas od randomizacije do smrti zaradi katerega koli vzroka.
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.
Bolniki, ki so v okviru adjuvantnega zdravljenja v zadnjih 12 mesecih prejeli sheme, ki so vsebovale taksan ali antraciklin, se ne smejo zdraviti z zdravilom Avastin v kombinaciji s kapecitabinom.
This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
To stanje je ponavadi sekundarno zapletom pri celjenju ran, perforaciji prebavil ali nastanku fistule.
For further information as to HER2 status, please refer to section 5.1.
Za dodatne informacije glede statusa HER2 prosimo glejte poglavje
The primary outcome measure was overall survival defined as the time from randomisation until death from any cause.
Primarni cilj preskušanja je bilo celokupno preživetje, definirano kot čas od randomizacije do smrti iz kateregakoli vzroka.
First-line treatment of non-squamous NSCLC with EGFR activating mutations in combination with erlotinib
Prva linija zdravljenja neskvamoznega nedrobnoceličnega raka pljuč z EGFR-aktivirajočimi mutacijami v kombinaciji z erlotinibom
● you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
· če ste alergični (preobčutljivi) na bevacizumab ali katero koli drugo sestavino tega zdravila
In Part II, treatment assignment was double-blind with respect to Avastin.
delu je bila določitev zdravljenja glede uporabe zdravila Avastin dvojno slepa.
Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Tega zdravila ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki viale poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
• problems with wound healing after surgery,
· težave s celjenjem ran po operaciji,
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 16 ml
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala (16 ml)
The recommended dose is 5 mg, 7.5 mg, 10 mg or 15 mg per kilogram of your body weight.
Priporočeni odmerek je 5 mg; 7,5 mg; 10 mg ali 15 mg na kilogram vaše telesne mase.
● Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe: Opis
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+).
Večina bolnic je imela epitelijski rak jajčnikov (82 % v CPP in CPB15, 85 % v CPB15+ skupini), sledil je primarni peritonealni karcinom (16 % v CPP, 15 % v CPB15, 13 % v CPB15+ skupini) nato pa karcinom jajcevodov (1 % v CPP, 3 % v CPB15 in 2 % v CPB15+ skupini).
The side effects listed below were seen when Avastin was given together with chemotherapy.
Neželene učinke, ki so navedeni spodaj, so opazili, ko so zdravilo Avastin dajali skupaj s kemoterapijo.
Avastin must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Zdravilo Avastin je treba dajati pod nadzorom zdravnika z izkušnjami pri uporabi zdravil za zdravljenje novotvorb.
Avastin has been developed and made to treat cancer by injecting it into the bloodstream.
Zdravilo Avastin so razvili in izdelali za zdravljenje raka in injiciranje v krvni obtok.
Eye disorder, Lacrimation increased
Očesne bolezni bolezni oči, povečano solzenje
Post-marketing adverse reactions are included in both Tables 1 and 2, where applicable.
Neželeni učinki, opisani po prihodu zdravila na trg, so vključeni v preglednico 1 in 2, kjer je ustrezno.
Patients were nephrectomised for primary renal cell carcinoma.
Bolnikom so zaradi primarnega raka ledvičnih celic napravili nefrektomijo.
When events were noted as both all grade and grade 3-5 adverse drug reactions in clinical trials, the highest frequency observed in patients has been reported.
Kadar je bil neželeni učinek v kliničnih preskušanjih vseh stopenj in stopnje 3 do 5, je upoštevana največja pogostnost, opažena pri bolnikih.
Avastin should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
Zdravilo Avastin mora pripraviti zdravstveno osebje v aseptičnih pogojih, da zagotovi sterilnost pripravljene raztopine.
The clinical benefit, as measured by overall survival, was seen in all pre-specified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Klinična korist, katere merilo je bilo celokupno preživetje, se je pokazala pri vseh že prej izbranih podskupinah, vključno s podskupinami, osnovanimi glede na starost, spol, splošno stanje zmogljivosti, lokalizacijo primarnega tumorja, število prizadetih organov in trajanje metastatske bolezni.
Intra-abdominal inflammatory process may be a risk factor for gastrointestinal perforations in patients with metastatic carcinoma of the colon or rectum, therefore, caution should be exercised when treating these patients.
Vnetni proces znotraj trebušne votline je lahko dejavnik tveganja za perforacijo prebavil pri bolnikih z metastatskim rakom debelega črevesa in danke, zato je med zdravljenjem teh bolnikov potrebna previdnost.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Vpliv zdravil za zdravljenje novotvorb na farmakokinetiko bevacizumaba
• allergic reactions (the signs may include difficulty breathing, facial redness, rash, low blood pressure or high blood pressure, low oxygen in your blood, chest pain, or nausea/vomiting),
· alergijske reakcije (znaki lahko vključujejo težave pri dihanju; lahko se pojavi tudi rdečica obraza, izpuščaj, nizek ali visok krvni tlak, nizka raven kisika v vaši krvi, bolečina v prsnem košu ali slabost/bruhanje),
Table 18 Efficacy results from study BO17707 (ICON7)
Rezultati učinkovitosti iz študije BO17707 (ICON7)
Avastin has not been shown to reduce your ability to drive or to use any tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Za zdravilo Avastin se ni izkazalo, da bi zmanjšalo vašo sposobnost za vožnjo ali uporabo orodij oziroma strojev.
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).
Proteinurija je po resnosti obsegala od klinično asimptomatske, prehodne, proteinurije v sledovih vse do nefrotskega sindroma, večinoma pa je bila proteinurija stopnje 1 (NCI-CTCAE v.3).
Monitoring of blood pressure is generally recommended during therapy.
Med zdravljenjem je priporočeno spremljanje vrednosti krvnega tlaka.
Avastin will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Zdravilo Avastin se uporablja v kombinaciji s paklitakselom in cisplatinom ali, alternativno, s paklitakselom in topotekanom pri bolnicah, ki ne morejo dobivati zdravljenja s platino.
In this trial, there were two primary objectives: to show that XELOX was non-inferior to FOLFOX-4 and to show that Avastin in combination with FOLFOX-4 or XELOX chemotherapy was superior to chemotherapy alone.
tem preskušanju sta bila primarna cilja dva: pokazati, da je shema XELOX neinferiorna shemi FOLFOX-4, in da je zdravilo Avastin v kombinaciji s kemoterapevtskima shemama FOLFOX-4 ali XELOX superiorno samostojni kemoterapiji.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Priporočamo, da se zdravljenje nadaljuje, dokler osnovna bolezen ne napreduje ali do nesprejemljive toksičnosti.
Each ml of concentrate contains 25 mg of bevacizumab*.
En ml koncentrata vsebuje 25 mg bevacizumaba*.
• Carboplatin (AUC4, Day 1) and gemcitabine (1000 mg/m2 on Days 1 and 8) and concurrent
· karboplatin (AUC4, dan1) in gemcitabin (1000 mg/m2 na dan 1 in 8) ter sočasno zdravilo
The frequency of GI-vaginal fistulae in the group treated with Avastin + chemotherapy was higher in patients with recurrence within the field of prior radiation (16.7%) compared with patients with no prior radiation and/ or no recurrence inside the field of prior radiation (3.6%).
Pogostnost fistul med prebavili in nožnico v skupini, zdravljeni z zdravilom Avastin in kemoterapijo, je bila večja pri bolnicah s ponovitvijo bolezni v področju predhodnega obsevanja (16,7 %) v primerjavi z bolnicami brez predhodnega obsevanja in/ali brez ponovitve znotraj polja predhodnega obsevanja (3,6 %).
Patients with non-small cell lung cancer treated with Avastin may be at risk of serious, and in some cases fatal, pulmonary haemorrhage/haemoptysis.
Pri bolnikih z nedrobnoceličnim rakom pljuč, ki se zdravijo z zdravilom Avastin, lahko obstaja tveganje za resno in v nekaterih primerih smrtno krvavitev v pljučih/hemoptizo.
In study JO25567, all grade hypertension was observed in 77.3% of the patients who received Avastin in combination with erlotinib as first-line treatment for non-squamous NSCLC with EGFR activating mutations, compared to 14.3% of patients treated with erlotinib alone.
V študiji JO25567 so hipertenzijo vseh stopenj opazili pri 77,3 % bolnikov, ki so prejemali zdravilo Avastin v kombinaciji z erlotinibom v prvi liniji zdravljenja neskvamoznega nedrobnoceličnega raka pljuč z EGFR-aktivirajočimi mutacijami, v primerjavi s 14,3 % bolnikov, zdravljenih samo z erlotinibom.
The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p=0.5076).
Dodatek erlotiniba bevacizumabu ni prispeval k izboljšanju celokupnega preživetja (HR = 1,764; p = 0,1789), trajanja objektivnega odgovora na zdravljenje (6,7 v primerjavi z 9,1 meseca) ali časa do napredovanja simptomov (HR =
HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147).
0,518 v študiji E3200; razmerje ogroženosti 0,68 v študiji ML18147).
While the incidence of CHF was, in both arms, above that previously observed for doxorubicin therapy, the rate was higher in the R-CHOP plus bevacizumab arm.
Medtem ko je bila incidenca kongestivnega srčnega popuščanja v obeh skupinah večja kot incidenca, ki so jo predhodno opazili pri zdravljenju z doksorubicinom, je bil delež večji v skupini, ki je prejemala R-CHOP in bevacizumab.
fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy + Avastina
ML18147 kemoterapija na osnovi fluoropirimidina/irinotekana ali fluoropirimidina/oksaliplatina kemoterapija na osnovi fluoropirimidina/irinotekana ali fluoropirimidina/oksaliplatina + Avastina
Relative to the control arm; stratified hazard ratio.
Glede na kontrolno skupino; stratificirano razmerje ogroženosti.