natgillin/translations-raw huggingface dataset:
Male patients (including those who have had vasectomies) should use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose of pazopanib to avoid potential exposure to the medicinal product for pregnant partners and female partners of reproductive potential. 
Muški bolesnici (uključujući one koji su imali vazektomiju) trebaju koristiti prezervative tijekom spolnog odnosa dok uzimaju pazopanib i najmanje 2 tjedna nakon posljednje doze pazopaniba kako bi se izbjegla potencijalna izloženost lijeku trudnih partnerica ili ženskih partnerica reproduktivnog potencijala.
In clinical studies with pazopanib, events of hypertension including newly diagnosed symptomatic episodes of elevated blood pressure (hypertensive crisis) have occurred. 
Tijekom kliničkih ispitivanja pazopaniba zabilježeni su slučajevi hipertenzije, uključujući novodijagnosticirane simptomatske epizode povišenog krvnog tlaka (hipertenzivna kriza).
It is not known whether the ingredients in Votrient pass into breast milk. 
Nije poznato prelaze li sastojci lijeka Votrient u mlijeko.
The effect of Votrient during pregnancy is not known. 
Nije poznat utjecaj lijeka Votrient tijekom trudnoće.
Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. 
Terapiju lijekom Votrient smije započeti samo liječnik koji ima iskustva u primjeni antitumorskih lijekova.
It cannot be excluded that pazopanib will affect the pharmacokinetics of other statins (e.g. atorvastatin, fluvastatin, pravastatin, rosuvastatin). 
Ne može se isključiti da pazopanib može utjecati na farmakokinetiku drugih statina (npr. atorvastatin, fluvastatin, pravastatin, rosuvastatin).
Pazopanib has been shown to be embryotoxic and teratogenic when administered to rats and rabbits at exposures more than 300-fold lower than the human exposure (based on AUC). 
Pokazano je da je pazopanib embriotoksičan i teratogen u štakora i zečeva pri izloženosti koja je više od 300 puta manja od ljudske izloženosti (temeljem AUC-a).
In such cases there should be close attention to adverse drug reaction, and further dose reduction may be considered if possible drug-related adverse events are observed. 
U takvim slučajevima treba pomno pratiti nuspojave te ukoliko se zabilježe nuspojave moguće povezane s lijekom razmisliti o daljnjem smanjenju doze.
Votrient can have side effects that may affect your ability to drive or use machines. 
Votrient može uzrokovati nuspojave koje mogu utjecati na Vašu sposobnost upravljanja vozilom ili korištenja strojeva.
Pazopanib is a UGT1A1 inhibitor. 
Pazopanib je inhibitor UGT1A1.
It is not known whether pazopanib or its metabolites are excreted in human milk. 
Nije poznato izlučuje li se pazopanib ili njegovi metaboliti u majčino mlijeko u ljudi.
The safety and efficacy of pazopanib in RCC were evaluated in a randomised, double-blind, placebo-controlled multicentre study. 
Sigurnost primjene i djelotvornost pazopaniba u RCC-u procjenjivani su u randomiziranom, dvostruko slijepom, multicentričnom ispitivanju koje je bilo kontrolirano placebom.
It can occur in muscles, blood vessels, fat tissue or other tissues that support, 
Može se pojaviti u mišićima, krvnim žilama, masnom tkivu ili drugim tkivima koja potpomažu, okružuju i štite organe.
Votrient may cause blood clots in the small blood vessels in the kidneys and brain accompanied by a decrease in red blood cells and cells involved in clotting (thrombotic microangiopathy, TMA). 
Votrient može uzrokovati krvne ugruške u malim krvnim žilama u bubrezima i mozgu koji su praćeni smanjenim brojem crvenih krvnih stanica i stanica uključenih u zgrušavanje krvi (trombotička mikroangiopatija, TMA).
Do not use this medicine after the expiry date (EXP) which is stated on the bottle and the carton. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i na kutiji iza oznake „EXP“.
There are no animal data on the excretion of pazopanib in animal milk. 
Ne postoje podaci o izlučivanju pazopaniba u životinjskom mlijeku.
Patients were stratified by the factors of WHO performance status (WHO PS) (0 or 1) at baseline and the number of lines of prior systemic therapy for advanced disease (0 or 1 vs. 2+). 
Bolesnici su stratificirani prema „performance status“ SZO kriterijima (WHO PS) (0 ili 1) na početku ispitivanja i po broju prethodnih linija sistemske terapije za uznapredovalu bolest (0 ili 1 naspram 2+).
Following reintroduction of pazopanib, if transaminase elevations >3 x ULN recur, then pazopanib should be permanently discontinued. 
Ako nakon ponovnog uvođenja pazopaniba ponovno dođe do porasta transaminaza na >3 x GGN, treba trajno prekinuti liječenje pazopanibom.
Of note, patients with adipocytic sarcoma were excluded from the pivotal Phase III study as in a preliminary Phase II study (VEG20002) activity (PFS at week 12) observed with pazopanib in adipocytic did not meet the prerequisite rate to allow further clinical testing. 
Uz to, bolesnici s adipocitnim sarkomom bili su izostavljeni iz ključnog ispitivanja faze III, kao i iz preliminarnog ispitivanja faze II (VEG20002), zabilježena aktivnost pazopaniba u adipocitnom sarkomu (PFS u 12. tjednu) nije dosegla prethodno zadanu stopu da bi dopustila daljnje kliničko ispitivanje.
Combination with strong P-gp or BCRP inhibitors should be avoided, or selection of an alternate concomitant medicinal product with no or minimal potential to inhibit P-gp or BCRP is recommended. 
Treba izbjegavati kombiniranje s jakim inhibitorima P-gp-a ili BCRP-a, ili se preporučuje odabir istodobne alternativne terapije lijekovima koji ne inhibiraju ili imaju minimalni potencijal za inhibiciju P-gp-a ili BCRP-a.
No significant difference in OS was observed between the two treatment arms at the final OS analysis performed after 76% (280/369) of the events had occurred (HR 0.87, 95% CI 0.67, 1.12 p=0.256). 
Nije zabilježena značajna razlika u OS-u između dva kraka ispitivanja u završnoj analizi ukupnog preživljenja izvedenoj nakon što je zabilježeno 76% (280/389) događaja (HR 0,87; 95% CI 0,67; 1,12 p=0,256).
Systemic exposure to pazopanib is increased when administered with food. 
Sistemska izloženost pazopanibu se povećava pri uzimanju s hranom.
Your doctor will be checking your liver enzymes while you are taking Votrient. 
Vaš liječnik će provjeravati Vaše jetrene enzime za vrijeme uzimanja lijeka Votrient.
A similar improvement in PFS based on investigator assessments was observed in the pazopanib arm compared with the placebo arm (in the overall ITT population HR: 0.39; 95% CI, 0.30 to 0.52, p <0.001). 
Slično poboljšanje u PFS-u na temelju procjene ispitivača zabilježeno je u kraku s pazopanibom u usporedbi s placebo krakom (u sveukupnoj ITT populaciji HR: 0,39; 95% CI, 0,30 do 0,52; p <0,001).
Human paediatric patients are at increased risk for bone and teeth effects as compared to adults, as these changes, including inhibition of growth (shortened limbs), fragile bones and remodelling of teeth, were present in juvenile rats at ≥10 mg/kg/day (equal to approximately 0.1-0.2 times the clinical exposure based on AUC in adult humans) (see section 4.4). 
Djeca su u povećanom riziku za učinak na kost i zube u usporedbi s odraslim ljudima, jer su ove promjene, uključujući inhibiciju rasta (skraćeni udovi), krhke kosti i remodeliranje zuba, bile prisutne u mladih štakora pri ≥10 mg/kg/dan (jednako kao približno 0,1-0,2 puta kliničke izloženosti na temelju AUC-a u odraslih ljudi) (vidjeti dio 4.4).
Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family (e.g. itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase pazopanib concentrations. 
Istovremena primjena pazopaniba s drugim jakim inhibitorima obitelji CYP3A4 (npr. itrakonazol, klaritromicin, atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, vorikonazol) može povećati koncentracije pazopaniba.
Based on safety and tolerability data, the dose of pazopanib should be reduced to 200 mg once daily in subjects with moderate hepatic impairment (see section 4.2). 
Temeljem podataka o sigurnosti i podnošljivosti, dozu pazopaniba treba smanjiti na 200 mg jednom dnevno u osoba s umjerenim oštećenjem funkcije jetre (vidjeti dio 4.2).
PRES/RPLS can present with headache, hypertension, seizure, lethargy, confusion, blindness and other visual and neurological disturbances, and can be fatal. 
PRES/RPLS mogu se prezentirati kao glavobolja, hipertenzija, epileptički napadaji, letargija, konfuzija, sljepoća ili neki drugi poremećaj vida ili neurološki poremećaj, a mogu imati i smrtni ishod.
When using pazopanib, baseline and periodic monitoring of electrocardiograms and maintenance of electrolytes (e.g. calcium, magnesium, potassium) within normal range is recommended. 
Kod uzimanja pazopaniba preporučuje se početno mjerenje i povremeno praćenje elektrokardiograma kao i održavanje elektrolita (npr. kalcij, magnezij, kalij) unutar raspona normalnih vrijednosti.
Results from population pharmacokinetic modelling (data from subjects with baseline CLCR values ranging from 30.8 ml/min to 150 ml/min) indicated that renal impairment is unlikely to have clinically relevant effect on pazopanib pharmacokinetics. 
Rezultati populacijskog farmakokinetičkog modeliranja (podaci od ispitanika s inicijalnim vrijednostima klirensa kreatinina u rasponu od 30,8 ml/min do 150 ml/min) ukazuju da oštećenje bubrega vjerojatno nema klinički značajan učinak na farmakokinetiku pazopaniba.
VEG108844 achieved its primary endpoint of PFS and demonstrated that pazopanib was non-inferior to sunitinib, as the upper bound of the 95% CI for the hazard ratio was less than the protocol-specified non-inferiority margin of 1.25. 
Ispitivanje VEG 108844 postiglo je PFS primarnu mjeru ishoda, i pokazalo je da je pazopanib neinferioran sunitinibu, uz gornju granicu intervala pouzdanosti od 95% za omjer hazarda koji je bio manji od onog definiranog planom ispitivanja s marginom neinferiornosti postavljenoj kao 1,25.
If the concomitant use of a proton-pump inhibitor (PPI) is medically necessary, it is recommended that the dose of pazopanib be taken without food once daily in the evening concomitantly with the PPI. 
Ukoliko je istodobna primjena inhibitora protonske pumpe (IPP) medicinski neophodna, preporučuje se uzeti pazopanib bez hrane jednom dnevno, navečer, istodobno s inhibitorom protonske pumpe.
In each treatment group, there was a slightly greater percentage of subjects in the 2+ lines of prior systemic therapy for advanced disease (58% and 55%, respectively, for placebo and pazopanib treatment arms) compared with 0 or 1 lines of prior systemic therapy (42% and 45%, respectively, for placebo and pazopanib treatment arms). 
U svakoj terapijskoj skupini, bio je malo veći postotak ispitanika s 2+ linije prethodne sistemske terapije za uznapredovalu bolest (58% i 55% za placebo i pazopanib krakove) u usporedbi s 0 ili 1 linijom prethodne sistemske terapije (42% odnosno 45% za placebo odnosno pazopanib krakove).
Median (weeks) 
Medijan (tjedni)
Group 
Grupa
In vitro studies with human liver microsomes showed that pazopanib inhibited CYP enzymes 1A2, 3A4, 2B6, 2C8, 2C9, 2C19, and 2E1. 
Ispitivanja in vitro na ljudskim mikrosomima jetre pokazala su da pazopanib inhibira CYP enzime 1A2, 3A4, 2B6, 2C8, 2C9, 2C19, i 2E1.
Elimination is primarily via faeces with renal elimination accounting for <4% of the administered dose. 
Eliminacija je primarno putem stolice dok na eliminaciju putem bubrega otpada <4% primijenjene doze.
Effects of pazopanib on other medicinal products 
Učinci pazopaniba na druge lijekove
QT prolongation and torsade de pointes 
Produljenje QT intervala i „torsade de pointes“
In a randomised study comparing pazopanib and sunitinib in RCC (VEG108844), subjects had baseline and follow up LVEF measurements. 
U randomiziranom ispitivanju u kojem su se uspoređivali pazopanib i sunitinib u liječenju RCC-a (VEG108844), ispitanicima se mjerio LVEF na početku liječenja te u periodu praćenja.
Overall Survival Median (months) (95% CI) 
Ukupno preživljenje Medijan (mjeseci) (95% CI)
Clinical pharmacology studies, using pazopanib 800 mg once daily, have demonstrated that pazopanib does not have a clinically relevant effect on the pharmacokinetics of caffeine (CYP1A2 probe substrate), warfarin (CYP2C9 probe substrate), or omeprazole (CYP2C19 probe substrate) in cancer patients. 
Klinička farmakološka ispitivanja s jednom dnevnom dozom pazopaniba od 800 mg pokazala su da pazopanib nema klinički značajan učinak na farmakokinetiku kofeina (probni supstrat za CYP1A2), varfarina (probni supstrat za CYP2C9), ili omeprazola (probni supstrat za CYP2C19) u bolesnika oboljelih od raka.
All patients had clear cell histology or predominantly clear cell histology. 
Svi bolesnici imali su histološki karcinom svijetlih stanica (engl. clear cell) ili predominantno karcinom svijetlih stanica.
Proliferative hepatic lesions (eosinophilic foci and adenoma) were seen in female mice at exposures 2.5 times human exposure based on AUC. 
Proliferativne jetrene lezije (eozinofilni fokusi i adenomi) zabilježeni su u ženskih miševa pri izloženosti 2,5 puta većoj od one u ljudi prema AUC-u.
Liver function should be monitored in all subjects receiving pazopanib, regardless of genotype or age (see section 5.1). 
Jetrenu funkciju treba pratiti u svih ispitanika koji uzimaju pazopanib, neovisno o genotipu ili dobi (vidjeti dio 5.1).
A total of 369 patients with advanced STS were randomised to receive pazopanib 800 mg once daily or placebo. 
Ukupno 369 bolesnika s uznapredovalim STS-om randomizirano je kako bi primili pazopanib 800 mg jednom dnevno ili placebo.
Normal hepatic function 
Normalna funkcija jetre
The primary analysis of the primary endpoint PFS is based on disease assessment by independent radiological review in the entire study population (treatment-naïve and cytokine pre-treated). 
Primarna analiza primarne mjere ishoda PFS temeljena je na neovisnoj radiološkoj evaluaciji bolesti za cijelu ispitivanu populaciju (bez ranije terapije i s ranijom terapijom citokinima).
Pazopanib did not cause genetic damage when tested in genotoxicity assays (Ames assay, human peripheral lymphocyte chromosome aberration assay and rat in vivo micronucleus). 
Pazopanib nije uzrokovao genetička oštećenja pri testovima genotoksičnosti (Amesov test, test kromosomskih aberacija u humanim perifernim limfocitima te in vivo mikronukleusima štakora).
- if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall. 
- ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile.
Blurry or impaired vision 
Zamagljeni ili oslabljeni vid
In two-year carcinogenicity studies with pazopanib, there were increased numbers of liver adenomas noted in mice and duodenal adenocarcinomas noted in rats. 
U dvogodišnjim ispitivanjima kancerogenosti pazopaniba zabilježen je povećan broj adenoma jetre u miševa i adenokarcinoma duodenuma u štakora.
Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medicinal products that may prolong QT interval and in patients with relevant pre-existing cardiac disease. 
Pazopanib se treba koristiti s posebnim oprezom u bolesnika koji su ranije već imali produljenje QT intervala, u bolesnika koji primaju terapiju antiaritmicima ili drugim lijekovima koji mogu produljiti QT interval i u bolesnika s od ranije poznatom značajnom bolesti srca.
What Votrient contains - The active substance is pazopanib (as hydrochloride). 
Što Votrient sadrži - Djelatna tvar je pazopanib (u obliku pazopanibklorida).
200 mg OD 9.4 
200 mg JD 9,4
In repeat dose studies in rodents, effects in a variety of tissues (bone, teeth, nail beds, reproductive organs, haematological tissues, kidney and pancreas) appear related to the pharmacology of VEGFR inhibition and/or disruption of VEGF signalling pathways, with most effects occurring at plasma exposure levels below those observed in the clinic. 
U ispitivanjima s ponovljenim dozama na glodavcima čini se da su učinci na različita tkiva (kost, zubi, baze noktiju, reproduktivni organi, hematološka tkiva, bubrezi i gušterača) povezani s farmakologijom inhibicije VEGFR-a i/ili poremećajem signalnih puteva VEGF-a, s najviše učinaka pri nižim razinama izloženosti u plazmi od onih kliničkih.
The primary objective of the study was to evaluate and compare the two treatment arms for progression-free survival (PFS) and the principle secondary endpoint was overall survival (OS). 
Primarna mjera ishoda ispitivanja bila je procijeniti i usporediti dvije terapijske skupine prema preživljenju bez progresije bolesti (PFS od engl. progression-free survival), a glavna sekundarna mjera ishoda bilo je sveukupno preživljenje (OS od engl. overall survival).
Some patients however may have systemic pazopanib exposure greater than what has been observed after administration of 800 mg pazopanib alone. 
Međutim, u nekih bolesnika sistemska izloženost pazopanibu može biti veća nego što je zabilježena nakon primjene samog pazopaniba u dozi od 800 mg jednom na dan.
Patients should be carefully monitored for clinical signs or symptoms of congestive heart failure. 
Bolesnike treba pomno nadzirati radi uočavanja kliničkih znakova i simptoma kongestivnog zatajenja srca.
In VEG108844, patients (N = 1110) with locally advanced and/or metastatic RCC who had not received prior systemic therapy, were randomised to receive either pazopanib 800 mg once daily continuously or sunitinib 50 mg once daily in 6-week cycles of dosing with 4 weeks on treatment followed by 2 weeks without treatment. 
U ispitivanju VEG108844, bolesnici (N = 1110) s lokalno uznapredovalim metastazirajućim RCC-om, a koji ranije nisu primali sistemsku terapiju, randomizirani su u skupinu koja je primala ili kontinuirano 800 mg pazopaniba jednom dnevno, ili 50 mg sunitiniba u ciklusima od šest tjedana, a unutar ciklusa terapija je bila dozirana tijekom 4 tjedna nakon čega su slijedila 2 tjedna bez terapije.
The decision to resume pazopanib after surgery should be based on clinical judgement of adequate wound healing. 
Odluku o nastavku terapije nakon kirurškog zahvata treba temeljiti na kliničkoj procjeni odgovarajućeg cijeljenja rane.
Endpoints / study population 
Mjere ishoda / studijska populacija
Permanently discontinue pazopanib. 
Trajno prekinuti liječenje pazopanibom.
In juvenile toxicity studies, when pre-weaning rats were dosed from day 9 post partum through to day 14 post partum, pazopanib caused mortalities and abnormal organ growth/maturation in kidney, lung, liver and heart, at a dose approximately 0.1 times the clinical exposure based on AUC in adult humans. 
U ispitivanjima juvenilne toksičnosti, kada su štakori dozirani od 9. do 14. dana nakon rođenja, pazopanib je uzrokovao smrtnost i abnormalan rast/sazrijevanje organa bubrega, pluća, jetre i srca, pri dozi od približno 0,1 puta kliničke izloženosti na temelju AUC-a u odraslih ljudi.
Pazopanib should be discontinued if there is evidence of hypertensive crisis or if hypertension is severe and persists despite anti-hypertensive therapy and pazopanib dose reduction. 
Liječenje pazopanibom treba trajno prekinuti u slučaju dokazane hipertenzivne krize ili teške hipertenzije koja traje unatoč antihipertenzivnoj terapiji i smanjenju doze pazopaniba.
Therefore, no dose adjustment is required in patients with creatinine clearance above 30 ml/min. 
Stoga, nije potrebna prilagodba doze u bolesnika s klirensom kreatinina većim od 30 ml/min.
Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. 
Votrient je indiciran za liječenje odraslih bolesnika s određenim podtipovima uznapredovalog sarkoma mekih tkiva (STS; engl. soft tissue sarcoma) koji su prethodno primili kemoterapiju za metastatsku bolest ili su imali progresiju unutar 12 mjeseci nakon (neo)adjuvantne terapije.
Dosing recommendations in hepatically impaired patients are based on pharmacokinetic studies of pazopanib in patients with varying degrees of hepatic dysfunction (see section 5.2). 
Preporuke za doziranje u bolesnika s oštećenjem jetre se temelje na farmakokinetičkim ispitivanjima pazopaniba u bolesnika s različitim stupnjevima poremećaja funkcije jetre (vidjeti dio 5.2).
Disease characteristics at initial diagnosis and at screening were balanced between the treatment arms with the majority of patients having clear cell histology and Stage IV disease. 
Svojstva bolesti pri inicijalnoj dijagnozi kao i pri probiru raspoređene su između terapijskih krakova tako da je većina bolesnika histološki imala karcinom svijetlih stanica i bolest IV stadija.
How to store Votrient 
Kako čuvati Votrient
CYP3A4, P-gp, BCRP inducers 
Induktori CYP3A4, P-gp-a, BCRP-a
In preclinical experiments, pazopanib dose-dependently inhibited ligand-induced auto-phosphorylation of VEGFR-2, c-Kit and PDGFR- receptors in cells. 
U pretkliničkim pokusima, pazopanib je ovisno o dozi u stanicama inhibirao autofosforilaciju induciranu ligandom VEGFR-2, c-Kit i PDGFR- receptora.
Symptoms include: - loss of speech - change of vision - seizure (fits) - confusion - high blood pressure 
Simptomi uključuju: - gubitak sposobnosti govora - promjene vida - napadaje - smetenost - visoki krvni tlak
Cardiac dysfunction/heart failure, heart attack 
Disfunkcija srca/zatajenje srca, srčani udar
Selection of an alternative concomitant medication with no or minimal enzyme or transporter induction potential is recommended. 
Preporučuje se odabir istodobne alternativne terapije lijekovima bez ili s minimalnim potencijalom stimuliranja enzima ili prijenosa.
Transaminase elevation between 3 and 8 x ULN 
Porast vrijednosti transaminaza na 3-8 x GGN
In a rat male fertility study, there was no effect on mating or fertility, but decreased testicular and epididymal weights were noted with reductions in sperm production rates, sperm motility, and epididymal and testicular sperm concentrations observed at exposures 0.3 times human exposure based on AUC. 
U ispitivanju muške plodnosti u štakora nije bilo učinaka na parenje ili plodnost, ali zabilježene su smanjene težine testisa i epididimisa kao i smanjenje brzine proizvodnje sperme, motilitet spermatozoida i smanjenje koncentracije sperme u epididimisu i testisima i to pri izloženosti od 0,3 puta vrijednosti izloženosti u ljudi temeljem AUC-a.
Pazopanib is an orally administered, potent multi-target tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, platelet-derived growth factor (PDGFR) -α and -β, and stem cell factor receptor (c-KIT), with IC50 values of 10, 30, 47, 71, 84 and 74 nM, respectively. 
Pazopanib je lijek za peroralnu primjenu koji je snažni višestruki inhibitor tirozin kinaze receptora vaskularnog endotelnog čimbenika rasta (VEGFR)-1, -2, i -3, receptora trombocitnog čimbenika rasta (PDGFR) -α i -β, odnosno receptora čimbenika matičnih stanica (c-KIT), s vrijednostima IC50 od 10, 30, 47, 71, 84 odnosno 74 nM.
Interstitial lung disease (ILD)/Pneumonitis 
Intersticijska bolest pluća/pneumonitis
Pooled data from the pivotal STS study (VEG110727, n=369) and the supportive Phase II study (VEG20002, n=142) was evaluated in the overall evaluation of safety and tolerability of pazopanib (total safety population n=382) in subjects with STS (see section 5.1). 
Združeni podaci iz ključnog ispitivanja STS-a (VEG110727, n=369) i pratećeg ispitivanja faze II (VEG20002, n=142) procijenjeni su u sveukupnoj procjeni sigurnosti i podnošljivosti pazopaniba (sveukupna populacija za procjenu sigurnosti n=382) u ispitanika s STS-om (vidjeti dio 5.1).