natgillin/translations-raw huggingface dataset:
This event is generally reversible after sunitinib discontinuation. 
Ti simptomi običajno izginejo, ko z zdravljenjem s sunitinibom prekinete.
HDPE BOTTLE - 37.5 MG CAPSULES 
PLASTENKA IZ HDPE - 37,5 mg KAPSULE
BLISTER - 37.5 MG CAPSULES 
PRETISNI OMOTI - 37,5 mg KAPSULE
BLISTER - 50 MG CAPSULES 
PRETISNI OMOTI - 50 mg KAPSULE
Hypertension was a very common adverse reaction reported in clinical trials. 
V kliničnih preskušanjih so o hipertenziji kot neželenem učinku poročali zelo pogosto.
Method of administration Sutent is for oral administration. 
Način uporabe Zdravilo Sutent se uporablja peroralno.
• Hot flushes. 
• vročinski oblivi
37.5 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate 
37,5 mg trde kapsule vsebina kapsule manitol (E421) premreženi natrijev karmelozat povidon (K-25) magnezijev stearat ovojnica kapsule želatina titanov dioksid (E171) rumeni železov oksid (E172)
Treatment-naïve metastatic renal cell carcinoma 
Še nezdravljeni metastatski karcinom ledvičnih celic (MRCC)
Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib. 
Ena kapsula vsebuje 37,5 mg sunitiniba v obliki sunitinibijevega malata.
Abbreviations: CI=confidence interval; ITT=intent-to-treat; NA=not applicable; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; TTP=time-to-tumour progression. 
Okrajšave: IZ = interval zaupanja, ITT = populacija z-namenom-zdravljenja, ORR = objektivni odziv na zdravljenje, OS = celokupno preživetje, PFS = preživetje brez napredovanja bolezni, TTP = čas do napredovanja tumorja a Rezultati dvojno slepega zdravljenja so iz populacije ITT in z uporabo centralne radiološke meritve, kot je primerno.
Renal failure* Renal failure acute* Chromaturia Proteinuria 
Bolezni sečil odpoved ledvic akutna odpoved ledvic kromaturija proteinurija krvavitev v sečilih nefrotski sindrom
Pancreatitis has been observed uncommonly (< 1%) in patients receiving sunitinib for GIST or MRCC. No treatment-related pancreatitis was reported in the Phase 3 pNET study (see section 4.4). 
V študiji 3. faze pri pNET niso poročali o nobenem primeru pankreatitisa, ki bi bil povezan z zdravljenjem (glejte poglavje 4.4).
Effects on male fertility in rat were observed in the form of tubular atrophy in the testes, reduction of spermatozoa in epididymides, and colloid depletion in prostate and seminal vesicles at plasma exposure levels 25 times the systemic exposure in humans. 
Pri plazemski izpostavljenosti, ki je bila 25-krat večja od sistemske izpostavljenosti pri ljudeh, so ugotovili učinke na plodnost podganjih samcev, ki so se kazali kot atrofija tubulov v modih, manjše število semenčic v obmodkih ter koloidno izčrpanje prostate in seminalnih vezikul.
Abdominal distension Abdominal discomfort Rectal haemorrhage Gingival bleeding Mouth ulceration Proctalgia 
Bolezni živčevja omotica glavobol motnje okušanja periferna nevropatija parestezija hipestezija hiperestezija krvavitev v možganih cerebrovaskularni insult prehodna možganska ishemija sindrom reverzibilne posteriorne encefalopatije
Each capsule contains sunitinib malate equivalent to 12.5 mg sunitinib. 
Ena kapsula vsebuje 12,5 mg sunitiniba v obliki sunitinibijevega malata.
Transient ischaemic attack 
Srčne bolezni miokardna ishemija k,*
• Weight loss. 
• izguba telesne mase
• Back pain, joint pain. 
• bolečine v hrbtu, bolečine v sklepih
- Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide 
- Ovojnica kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172) in črni železov oksid (E172).
The primary efficacy endpoint was PFS. A planned interim analysis showed a statistically significant advantage for sunitinib over IFN-α, in this study, the median PFS for the sunitinib-treated group was 47.3 weeks, compared with 22.0 weeks for the IFN-α-treated group; the HR was 0.415 (95% CI: 0.320, 0.539; p-value < 0.001). 
Načrtovana vmesna analiza je pokazala statistično pomembno prednost sunitiniba v primerjavi z IFN-, v tej študiji je mediano PFS v skupini, zdravljeni s sunitinibom, znašalo 47,3 tedna in v skupini,
12.5 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate 
12,5 mg trde kapsule vsebina kapsule manitol (E421) premreženi natrijev karmelozat povidon (K-25) magnezijev stearat ovojnica kapsule želatina rdeči železov oksid (E172) titanov dioksid (E171)
BLISTER - 25 MG CAPSULES 
PRETISNI OMOTI - 25 mg KAPSULE
Patients who presented with cardiac events within 12 months prior to sunitinib administration, such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischaemic attack, or pulmonary embolism were excluded from all sunitinib clinical studies. 
V nobeno klinično študijo sunitiniba niso bili vključeni bolniki, ki so imeli v 12 mesecih pred aplikacijo sunitiniba kakšen srčni dogodek, npr. miokardni infarkt (vključno s hudo/nestabilno angino pektoris),
h Thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and haemolytic uraemic syndrome. 
Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija anemija levkopenija limfopenija pancitopenija trombotična mikroangiopatija h,*
n Oropharyngeal and pharyngolaryngeal pain. 
Bolezni jeter, žolčnika in žolčevodov
Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules. 
Na pokrovčku je z belim črnilom natisnjeno "Pfizer", na telesu pa "STN 12.5 mg".
Gastroduodenal carcinomas, an increased incidence of background haemangiosarcomas, and/or gastric mucosal hyperplasia were observed at doses of ≥ 25 mg/kg/day following 1- or 6-months duration (≥ 7.3 times the AUC in patients administered the recommended daily dose RDD). 
Pri odmerkih ≥ 25 mg/kg/dan, ki so jih dajali 1 mesec ali 6 mesecev (≥ 7,3-kratnik vrednosti AUC pri bolnikih, ki prejemajo priporočene dnevne odmerke RDD - recommended daily dose), so opažali karcinome na želodcu in dvanajstniku, povečano pogostnost pojavljanja hemangiosarkomov v ozadju in/ali hiperplazijo želodčne sluznice.
Metabolic interactions 
Interakcije pri presnovi
Oedemay 
• omotica
Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib. 
Ena kapsula vsebuje 25 mg sunitiniba v obliki sunitinibijevega malata.
Musculoskeletal pain Muscle spasms Myalgia 
Bolezni mišično-skeletneg a sistema in vezivnega tkiva bolečine v udih artralgija bolečina v hrbtu mišično-skeletna bolečina mišični krči mialgija mišična šibkost osteonekroza čeljustnic fistula rabdomioliza miopatija
Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib. 
Ena kapsula vsebuje 50 mg sunitiniba v obliki sunitinibijevega malata.
Other endpoints included OS, ORR, PROs, and safety. 
Drugi opazovani dogodki so vključevali celokupno preživetje (OS), objektivni odziv na zdravljenje (ORR), izide o katerih so poročali bolniki (PRO - patient-reported outcomes) in varnost.
Gastrointestinal stromal tumours 
levostransko srčno popuščanje Torsade de pointes
Kidney disorders. 
Motnje v delovanju ledvic.
Tumour haemorrhage* 
• vnetje žleze ščitnice
HDPE BOTTLE OUTER CARTON - 37.5 MG CAPSULES 
ŠKATLA ZA PLASTENKO IZ HDPE - 37,5 mg KAPSULE
Summary of overall survival Subject not known to have died [n (%)] Subject observed to have died [n (%)] OS (weeks) 
Povzetek pri celokupnem preživetju (populacija ITT) Preskušanec, za katerega ne vemo, da je umrl [n (%)] Preskušanec, za katerega vemo, da je umrl [n (%)] OS (tedni)
HDPE BOTTLE OUTER CARTON - 12.5 MG CAPSULES 
ŠKATLA ZA PLASTENKO IZ HDPE - 12,5 mg KAPSULE
Gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, and containing yellow to orange granules. 
Na pokrovčku je z belim črnilom natisnjeno "Pfizer", na telesu pa "STN 25 mg".
Gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, and containing yellow to orange granules. 
Na pokrovčku je z belim črnilom natisnjeno "Pfizer", na telesu pa "STN 50 mg".
Cholecystitis and acalculous cholecystitis. 
Bolezni jeter, žolčnika in žolčevodov odpoved delovanja jeter holecistitis s,*
Hepatic impairment 
nenormalno delovanje jeter hepatitis
Rhabdomyolysis* Myopathy 
• ketokonazol, itrakonazol - za zdravljenje glivičnih okužb
Gastro-oesophageal reflux disease Dysphagia Gastrointestinal haemorrhage* Oesophagitis* 
Presnovne in prehranske motnje zmanjšanje teka dehidracija hipoglikemija sindrom lize tumorja*
Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation were reported in patients with intra-abdominal malignancies treated with sunitinib. 
Pri bolnikih z intraabdominalnimi malignomi, ki so prejemali sunitinib, so poročali o resnih zapletih na prebavilih (včasih s smrtnim izidom), vključno z gastrointestinalno perforacijo.
Haematological disorders (e.g., neutropenia, thrombocytopenia, and anaemia) are amongst the most common adverse drug reactions. 
Med najpogostejšimi neželenimi učinki so hematološke motnje (npr. nevtropenija, trombocitopenija in anemija).
HDPE BOTTLE OUTER CARTON - 25 MG CAPSULES 
ŠKATLA ZA PLASTENKO IZ HDPE - 25 mg KAPSULE
Red iron oxide (E172) Titanium dioxide (E171) Yellow iron oxide (E172) Black iron oxide (E172) 
25 mg trde kapsule vsebina kapsule manitol (E421) premreženi natrijev karmelozat povidon (K-25) magnezijev stearat ovojnica kapsule želatina rdeči železov oksid (E172) titanov dioksid (E171) rumeni železov oksid (E172) črni železov oksid (E172)
HDPE BOTTLE OUTER CARTON - 50 MG CAPSULES 
ŠKATLA ZA PLASTENKO IZ HDPE - 50 mg KAPSULE
Table 1. 
V študiji 1./2.
Skin hyperpigmentation Skin lesion Hyperkeratosis Dermatitis Nail disorderw 
Bolezni kože in podkožja obarvanje kože sindrom palmarno-plantarne eritrodizestezije izpuščaj obarvanje las in dlak suha koža luščenje kože kožne reakcije ekcem mehurji eritem alopecija akne srbenje hiperpigmentacija kože kožne lezije hiperkeratoza dermatitis bolezen nohtov multiformni eritem
• Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives, swelling of body parts, and trouble breathing. 
• pretiran imunski odgovor na alergen, vključno s senenim nahodom, kožnim izpuščajem, srbečico,
The CHMP considers that: 
Odbor CHMP meni:
Scientific conclusions and grounds for refusal of the variation presented by the European Medicines Agency 
Znanstveni zaključki in podlaga za zavrnitev spremembe, ki jo je predstavila Evropska agencija za zdravila
• Safety issues 
• Vprašanja glede varnosti
This is in agreement with the conclusions of the Scientific Advisory Group (SAG) consulted. 
To je v skladu z zaključki znanstvene svetovalne skupine, s katero je bilo opravljeno posvetovanje.
The applicant presented his rationale in writing and at an oral explanation. 
Predlagatelj je predstavil svoja izhodišča v pisni dokumentaciji in ustni obrazložitvi.
The CHMP assessed all the detailed grounds for re-examination and argumentations presented by the applicant. 
Odbor CHMP je ocenil vse podrobne razloge za ponoven pregled in utemeljitve, ki jih je predložil predlagatelj.
Recommendations following re-examination 
Priporočila po ponovnem pregledu
Summary of the applicant's response to the grounds for re-examination: 
Povzetek odgovora predlagatelja za zahtevo za ponoven pregled:
However, there are no established methods of analysis that can remedy this after cross-over has occurred. 
Vendar ne obstajajo nobene sprejete metode analize, ki lahko to vprašanje rešijo po tem, ko je prišlo do prehoda.
However, in this analysis, progressive disease (which suffers of the limitations described above) was included as a deterioration event. 
Vendar je bila v to analizo napredujoča bolezen (ki je predmet zgoraj navedenih pomanjkljivosti) vključena kot dogodek poslabšanja.
In addition, some assessments may have been influenced by knowledge of progression status. 
Poleg tega je na nekatere ocene morda vplivalo poznavanje stanja napredovanja.
Disease progression was assessed using adapted Macdonald criteria (Chinot et al., 2013). 
Napredovanje bolezni so ocenili po merilih po Macdonaldu (Chinot et al., 2013).
This analysis resulted in an estimated benefit of smaller magnitude, based on an analysis that, necessarily but problematically, introduces some informative censoring. 
Ta analiza je povzročila ocenjeno korist manjše razsežnosti na podlagi analize, ki nujno, vendar problematično, uvaja nekaj informativnega cenzuriranja.
These analyses should be interpreted with caution since relevant data were not collected systematically after disease progression and the consequent impact of (potentially informative) censoring on the results is unclear. 
Te analize je treba tolmačiti previdno, saj ustrezni podatki niso bili zbrani sistematično po napredovanju bolezni in posledični vpliv (morebitno informativnega) cenzuriranja na rezultate ni jasen.
Finally, the applicant provided a post-hoc analysis in line with the RANO criteria (Wen et al., 2010), which are the current standard used in clinical trials. 
Nazadnje je predlagatelj predložil naknadno analizo po merilih RANO (Wen et al., 2010), ki so trenutni standard v kliničnih preskušanjih.
According to this analysis, 84% of the PFS events could be considered unequivocal. 
Po podatkih omenjene analize bi lahko 84 % dogodkov preživetja brez napredovanja bolezni šteli za nedvoumne.
These apparent responses are not always necessarily indicative of a true antiglioma effect. 
Ti očitni odzivi pa ne kažejo nujno na pravi učinek proti gliomu.
In particular, the applicant did not clearly justify how the criteria chosen to exclude specific patients or events in the various sensitivity analyses were able to address the biases/uncertainties around the assessment of progression. 
Še posebno predlagatelj ni jasno utemeljil, kako so merila, izbrana za izključitev določenih bolnikov ali dogodkov v različnih občutljivostnih analizah, obravnavala odstopanja/negotovosti glede ocene napredovanja.
While the Applicant acknowledged that limited data was captured beyond the time of progression, they contended that this does not diminish the value of the data captured on study. 
Čeprav se je predlagatelj strinjal, da so bili omejeni podatki zajeti po času napredovanja bolezni, je zatrjeval, da to ne zmanjša vrednosti podatkov, zajetih s študijo.
Other endpoints including corticosteroid use, and sign and symptoms of GMB also need special consideration in light of the nature of the mechanism of bevacizumab. 
Druge končne točke, vključno z uporabo kortikosteroidov, ter znake in simptome glioblastoma je treba prav tako posebej obravnavati kar zadeva naravo mehanizma bevacizumaba.
Nominally, statistically significant results were retained for some parameters when PD was not counted as a deterioration event. 
Nominalno so se statistično pomembni rezultati ohranili za nekatere parametre, kadar se napredujoča bolezen ni štela za dogodek poslabšanja.
Changes in corticosteroid use, normally considered indicative for disease progression are confounded by the overlapping physiological effects of corticosteroids and bevacizumab. 
Spremembe pri uporabi kortikosteroidov, ki običajno kažejo na napredovanje bolezni, dopolnjujejo prekrivajoči se fiziološki vplivi kortikosteroidov in bevacizumaba.
Although standard response assessment criteria have been further developed (RANO criteria) aiming to minimise this issue and inform treatment decisions, validation of these criteria as clinical benefit endpoints is still ongoing (Wen et al., 2010). 
Čeprav so nadalje razvili merila za oceno standardnega odziva (merila RANO), s katerimi bi zmanjšali to težavo in vplivali na odločitve v zvezi z zdravljenjem, potrditev teh meril kot končnih točk za klinične koristi še poteka (Wen et al., 2010).
• Efficacy issues 
• Vprašanja glede učinkovitosti
Based on the arguments of the applicant and all the supporting data on safety and efficacy, the CHMP re-examined its initial opinion and in its final opinion concluded by majority decision that the efficacy of the above mentioned medicinal product is not sufficiently demonstrated, and, therefore maintains its recommendation for the refusal of the variation of the Marketing Authorisation for the above mentioned medicinal product. 
Na podlagi utemeljitev predlagatelja in vseh podpornih podatkov o varnosti in učinkovitosti je odbor CHMP ponovno pregledal svoje prvotno mnenje in z večino sprejel končno mnenje, da učinkovitost zgoraj navedenega zdravila ni bila zadovoljivo dokazana, zaradi česar ostaja pri svojem priporočilu za zavrnitev vloge za spremembo dovoljenja za promet z zdravilom za zgoraj navedeno zdravilo.
All the additional analyses cannot exclude the possibility of important bias and the estimated effect is not regarded as sufficiently reliable to conclude that a clinically relevant therapeutic efficacy has been established. 
Vse dodatne analize ne izključujejo možnosti pomembnega odstopanja, ocenjeni učinek pa ni zadostno zanesljiv, da bi zaključili, da je bila dokazana klinično pomembna terapevtska učinkovitost.
Regarding the MRI evaluation of disease progression, the CHMP maintained the view that the impact of the use of adapted criteria in Study BO21990 remains unclear. 
Kar zadeva oceno napredovanja bolezni z magnetnoresonančnim slikanjem je odbor CHMP ostal pri svojem mnenju, da ostaja vpliv uporabe prilagojenih meril v študiji BO21990 nejasen.
The analyses of the secondary endpoint health-related quality of life (HRQoL) did not show an advantage of addition of bevacizumab to standard treatment. 
Analiza sekundarne končne točke, tj. z zdravjem povezane kakovosti življenja (HRQoL), ni pokazala prednosti dodatka bevacizumaba k standardnemu zdravljenju.
• In the absence of established efficacy, a positive benefit-risk balance has not been established. 
• zaradi odsotnosti dokazane učinkovitosti pozitivno razmerje med tveganji in koristmi ni bilo dokazano.
Similar limitations apply to the determination of performance status. 
Podobne pomanjkljivosti veljajo za poslabšanje stanja zmogljivosti.
Following the above CHMP opinion, the applicant requested re-examination and submitted on 22 July 2014 its detailed grounds for the request for re-examination of the CHMP opinion recommending the refusal of the granting of the marketing authorisation. 
Po zgornjem mnenju odbora CHMP je predlagatelj zahteval ponoven pregled in 22. julija 2014 predstavil podrobne razloge za zahtevo za ponoven pregled mnenja, v katerem je odbor CHMP priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom.
The applicant concluded that despite the obvious flaws and biases of the exploratory survival analyses these analyses indicated a beneficial effect of bevacizumab. 
Zato je zaključil, da te analize kljub očitnim napakam in odstopanjem raziskovalnih analiz preživetja kažejo na koristen učinek bevacizumaba.
Bevacizumab was administered at a dose of 10 mg/kg every two weeks in the concurrent phase and the maintenance phase, and at a dose of 15 mg/kg every three weeks in the monotherapy phase. 
Bolniki so prejeli 10 mg/kg bevacizumaba vsaka dva tedna v fazi sočasnega zdravljenja in v fazi vzdrževanja ter 15 mg/kg bevacizumaba vsake tri tedne v fazi zdravljenja z enim zdravilom.
Radiotherapy and TMZ were administered in line with standard regimens used in the setting of newly diagnosed glioblastoma (Stupp et al., 2005). 
Radioterapijo in temozolomid so prejemali skladno s standardnimi režimi zdravljenja novopostavljene diagnoze glioblastoma (Stupp et al., 2005).
While the applicant acknowledged that there is an on-going evolution of the criteria used to assess disease progression in brain tumours, they contended that the criteria used in Avaglio study represent the most advanced and accepted technology in line with expert recommendations. 
Čeprav se je strinjal, da se merila za oceno napredovanja bolezni pri možganskih tumorjih še vedno razvijajo, pa je zatrjeval, da predstavljajo merila, ki so jih uporabili v študiji Avaglio, najbolj napredno in sprejeto tehnologijo v skladu s priporočili strokovnjakov.
However, the CHMP concluded that the positive effects claimed by the applicant are mainly driven by the inclusion of PD as an event in these analyses, and therefore, they cannot provide independent support or insight into the clinical benefits of delaying progression. 
Vendar je zaključil, da so pozitivni učinki, ki jih navaja predlagatelj, v glavnem posledica vključitve napredujoče bolezni kot dogodka v te analize in zato ne zagotavljajo neodvisne podpore ali vpogleda v klinične koristi odložitve napredovanja.
It has not been established that the most likely cause for the failure to demonstrate an OS benefit is confounded by post-progression treatments (including crossover to bevacizumab) rather than lack of an effect. 
Ni bilo dokazano, da je nezmožnost prikaza koristi za celokupno preživetje posledica zdravljenj po napredovanju bolezni (vključno s prehodom na bevacizumab) in ne pomanjkanja učinka.
The demonstration of efficacy was based on a randomized, double-blind, placebo controlled, multicenter phase III trial (study BO21990, “AVAglio”) of bevacizumab, temozolomide and radiotherapy (concomitant phase) followed by bevacizumab and temozolomide (maintenance phase) followed by bevacizumab (monotherapy phase) versus placebo, temozolomide (TMZ) and radiotherapy followed by placebo and temozolomide followed by placebo in patients with newly diagnosed glioblastoma (GBM). 
Dokazovanje učinkovitosti je temeljilo na randomiziranem, dvojno slepem, s placebom nadzorovanem, multicentričnem preskušanju III. faze (študija BO21990, „AVAglio“) bevacizumaba, temozolomida in radioterapije (faza sočasnega zdravljenja), čemur so sledila preskušanja bevacizumaba in temozolomida (faza vzdrževanja), bevacizumaba (faza zdravljenja z enim zdravilom) in placeba, temozolomida (TMZ) in radioterapije, placeba in temozolomida ter nato še placeba pri bolnikih z novopostavljeno diagnozo glioblastoma (GBM).
• The efficacy of bevacizumab in combination with radiotherapy and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma has not been sufficiently demonstrated; 
• učinkovitost bevacizumaba v kombinaciji z radioterapijo in temozolomidom za zdravljenje odraslih bolnikov z novopostavljeno diagnozo glioblastoma ni bila zadovoljivo dokazana;
At the time of disease progression, the data indicated a trend for deterioration in functional status and HRQoL compared to the assessments prior to progression, which underscores the clinical importance for the patients of delaying the time until disease progression. 
V času napredovanja bolezni so podatki kazali težnjo za poslabšanje funkcijskega stanja in z zdravjem povezane kakovosti življenja v primerjavi z ocenami pred napredovanjem bolezni, kar poudarja klinični pomen odloga do napredovanja bolezni za bolnika.
Study methodology including imaging and disease assessment criteria: The applicant considered that the pivotal study (Avaglio) was designed using standard methodology in GBM for the assessment of tumour growth and followed the current clinical practice. 
Metodologija študije, vključno z merili za slikanje in oceno bolezni: predlagatelj je menil, da je bila ključna študija (Avaglio) zasnovana z uporabo standardne metodologije pri glioblastomu za oceno rasti tumorja in da je študija sledila trenutni klinični praksi.
The median PFS was estimated to be 10.6 months in the bevacizumab arm and 6.2 months in the placebo arm. 
Mediana preživetja brez napredovanja bolezni je bila ocenjena na 10,6 meseca v skupini, ki je prejemala bevacizumab, in 6,2 meseca v skupini, ki je prejemala placebo.
Reliability of PFS: The applicant considered that the robustness and reliability of the primary analysis of PFS was confirmed in a number of predefined and post-hoc sensitivity analyses. 
Zanesljivost preživetja brez napredovanja bolezni: predlagatelj je menil, da je bila robustnost in zanesljivost primarne analize preživetja brez napredovanja bolezni potrjena v številnih predhodno določenih in naknadnih občutljivostnih analizah.