natgillin/translations-raw huggingface dataset:
A phase 3, randomized, double-blind, placebo-controlled study of SUTENT was conducted in patients with GIST who were intolerant to, or had experienced disease progression during or following treatment with, imatinib (Median maximum daily dose 800 mg).
Pri bolnikih z GIST, ki so bili odporni proti imatinibu ali jim je bolezen med zdravljenjem ali po zdravljenju z njim napredovala (mediana največjega dnevnega odmerka 800 mg), je bila opravljena randomizirana, dvojno slepa, s placebom kontrolirana študija 3. faze s SUTENTOM.
In this study, 312 patients were randomized (2:1) to receive either 50 mg SUTENT or placebo, orally once daily on Schedule 4/ 2 until disease progression or withdrawal from the study for another reason (207 patients received SUTENT and 105 patients received placebo).
V tej študiji so 312 bolnikov randomizirali (2: 1) na peroralno uporabo 50 mg SUTENTA ali placeba enkrat na dan po shemi 4/ 2; bolnike so spremljali do napredovanja bolezni ali do umika iz študije zaradi kakšnega drugega razloga (SUTENT je dobivalo 207 bolnikov in placebo 105 bolnikov).
The primary efficacy endpoint of the study was TTP, defined as the time from randomization to first documentation of objective tumour progression.
Primarni opazovani dogodek kot merilo učinkovitosti v tej študiji je bil TTP, opredeljen kot čas od randomizacije do prvega dokumentiranega objektivnega napredovanja tumorja.
14 The median TTP on SUTENT was 28.9 weeks (95% CI = 21.3-34.1 weeks) and was statistically significantly longer than the TTP of 5.1 weeks (95% CI = 4.4-10.1 weeks) on placebo.
Mediani TTP je s SUTENTOM znašal 28, 9 tednov (95% IZ:
The difference in overall survival was statistically in favour of SUTENT [hazard ratio:
21, 3– 34, 1 tedna) in je bil statistično pomembno daljši kot s placebom (5, 1 tedna; 95% IZ:
0.491 (95%C. I.
0, 491; 95% IZ:
0.290- 0.831)]; the risk of death was 2 times higher in patients in the placebo arm compared to the SUTENT arm.
0, 290– 0, 0831]; tveganje za smrt je bilo v kraku s placebom 2- krat večje kot v kraku s SUTENTOM.
The percentages of deaths were 14% for SUTENT vs 25% for placebo.
Odstotek smrti je ob SUTENTU znašal 14% in ob placebu 25%.
Median overall survival had not yet been reached in either treatment arm at the time of analysis.
V času analize še v nobenem od obeh krakov ni bilo doseženo mediano celokupno preživetje.
Treatment-naïve Metastatic Renal cell Carcinoma (MRCC) A phase 3 randomized, multicenter, international, study evaluating the efficacy and safety of sunitinib compared with IFN-α in patients with treatment-naïve metastatic RCC was conducted.
Še nezdravljeni metastatski karcinom ledvičnih celic (MRCC) Narejena je bila randomizirana, multicentrična mednarodna študija 3. faze za oceno učinkovitosti in varnosti sunitiniba v primerjavi z IFN- α pri bolnikih s še nezdravljenim MRCC.
Seven hundred and fifty patients were randomized 1:1 to the treatment arms; they received treatment with either sunitinib in repeated 6-week cycles, consisting of 4 weeks of 50 mg daily oral administration followed by 2 weeks of rest (Schedule 4/ 2), or IFN-α, administered as a subcutaneous injection of 3 million units (MU) the first week, 6 MU the second week, and 9 MU the third week and thereafter on 3 non-consecutive days each week.
Zdravljenje
The primary efficacy endpoint was progression free survival (PFS).
Primarni opazovani dogodek kot merilo učinkovitosti je bilo preživetje brez napredovanja bolezni (PFS – progression free survival).
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 hazard ratio was 0.415 (95% CI:
V tej študiji je mediano PFS v skupini, zdravljeni s sunitinibom, znašalo 47, 3 tedna in v skupini, zdravljeni z IFN- α, 22, 0 tednov; razmerje ogroženosti je bilo 0, 415 (95% IZ:
0.320-0.539, p-value < 0.001).
0, 320– 0, 539, vrednost p < 0, 001).
Cytokine-Refractory Metastatic Renal Cell Carcinoma A phase 2 study of SUTENT was conducted in patients who were refractory to prior cytokine therapy with interleukin-2 or interferon-α.
Proti citokinom odporni metastatski karcinom ledvičnih celic Študija 2. faze s SUTENTOM je bila narejena pri bolnikih, odpornih proti prejšnji citokinski terapiji z interlevkinom- 2 ali interferonom- α.
Sixty-three patients received a starting dose of 50 mg of SUTENT orally, once daily for 4 consecutive weeks followed by a 2-week rest period, to comprise a complete cycle of 6 weeks (schedule 4/ 2).
Triinšestdeset bolnikov je dobivalo začetni odmerek 50 mg SUTENTA peroralno enkrat na dan 4 tedne zapored, čemur je sledil 2- tedenski premor, tako da je celotni ciklus trajal 6 tednov (shema 4/ 2).
The primary efficacy endpoint was objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumours (RECIST).
Primarni opazovani dogodek kot merilo učinkovitosti je bil objektivni odziv na zdravljenje (ORR – objective response rate), ocenjen po merilih RECIST (Response Evaluation Criteria in Solid Tumours).
In this study the objective response rate was 36.5% (95% C. I.
V tej študiji je objektivni odziv na zdravljenje znašal 36, 5% (95% IZ:
24.7% - 49.6%) and the median time to progression (TTP) was 37.7 weeks (95% C. I.
24, 7– 49, 6%) in mediani čas do napredovanja (TTP) 37, 7 tedna (95% IZ:
24.0 - 46.4 weeks).
24, 0– 46, 4 tedna).
A confirmatory, open-label, single-arm, multi-centre study evaluating the efficacy and safety of SUTENT was conducted in patients with MRCC who were refractory to prior cytokine therapy.
Potrditveno odprto multicentrično študijo z enim krakom za oceno učinkovitosti in varnosti SUTENTA so opravili pri bolnikih z MRCC, odpornih proti prejšnji citokinski terapiji.
One hundred and six patients received at least one 50 mg dose of SUTENT on schedule 4/ 2.
Stošest bolnikov je dobilo vsaj en 50 mg odmerek SUTENTA po shemi 4/ 2.
The primary efficacy endpoint of this study was Objective Response Rate (ORR).
Primarni opazovani dogodek kot merilo učinkovitosti v tej študiji je bil objektivni odziv na zdravljenje (ORR).
Secondary endpoints included TTP, duration of response (DR) and overall survival (OS).
Med sekundarnimi opazovanimi dogodki so bili TTP, trajanje odziva (DR – duration of response) in celokupno preživetje (OS – overall survival).
In this study the ORR was 35,8% (95% C. I.
ORR v tej študiji je znašal 35, 8% (95% IZ:
26.8% – 47.5%) The median DR and OS had not yet been reached.
Mediani DR in OS še nista dosežena.
The pharmacokinetics of sunitinib and sunitinib malate have been evaluated in 135 healthy volunteers and 266 patients with solid tumours.
Farmakokinetiko sunitiniba in sunitinibijevega malata so ocenili pri 135 zdravih prostovoljcih in 266 bolnikih s čvrstimi tumorji.
Absorption After oral administration of sunitinib, maximum concentrations (Cmax) are generally observed from 6 to 12 hours (Tmax) post-dose.
Absorpcija Po peroralni uporabi sunitinib na splošno doseže največjo koncentracijo (Cmax) od 6 do 12 ur (Tmax) po odmerku.
Distribution Binding of sunitinib and its primary active metabolite to human plasma protein in in vitro assays was 95% and 90%, respectively, with no apparent concentration dependence.
Porazdelitev V preskusih in vitro je bila vezava sunitiniba na beljakovine v človeški plazmi 95%, vezava njegovega primarnega aktivnega presnovka pa 90%; vezavi nista bili odvisni od koncentracije.
The apparent volume of distribution (V/ F) for sunitinib was large – 2230l -, indicating distribution into the tissues.
Navidezni volumen porazdelitve (V/ F) za sunitinib je bil velik - 2230 l - kar kaže, da se sunitinib porazdeli v tkiva.
Metabolism The calculated in vitro Ki values for all CYP isoforms tested (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/ 5 AND CYP4A9/ 11) indicated that sunitinib and its
Presnova Na podlagi izračunanih in vitro vrednosti Ki za vse testirane izooblike CYP (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/ 5 in CYP4A9/ 11) je malo verjetno, da bi sunitinib in njegov primarni aktivni presnovek imela klinično pomembne interakcije z zdravili, ki se presnavljajo s temi encimi.
In-vitro studies also indicate that SUTENT neither induces nor inhibits major CYP enzymes, including CYP3A4.
Študije in vitro kažejo, da SUTENT ne inducira in ne zavira glavnih encimov CYP, vključno s CYP3A4.
Biotransformation Sunitinib is metabolized primarily by CYP3A4, the cytochrome P450 enzyme, which produces its primary active metabolite, which is then further metabolized by CYP3A4.
Biotransformacija Sunitinib se presnovi predvsem s CYP3A4, encimom citokroma P450, ki tvori njegov primarni aktivni presnovek; ta se potem s CYP3A4 presnovi še naprej.
Concurrent administration of SUTENT with the potent CYP3A4 inducer, rifampin, resulted approximately in 56% and 78% reduction in sunitinib Cmax and AUC0-∞, values respectively, after a single dose of SUTENT in healthy volunteers.
Sočasna uporaba SUTENTA z močnim induktorjem CYP3A4 rifampinom je pri zdravih prostovoljcih po posamičnem odmerku SUTENTA zmanjšala Cmax sunitiniba za 56% in AUC0– ∞ sunitiniba za
Administration of SUTENT with other inducers of the CYP3A4 family (e. g. dexamethasone, phenytoin, carbamazepine, phenobarbital or Hypericum perforatum, known also as St.
Uporaba SUTENTA z induktorji družine CYP3A4 (npr. deksametazonom, fenitoinom, karbamazepinom, fenobarbitalom ali Hypericum perforatum, znano tudi kot šentjanževka) lahko zniža koncentracijo sunitiniba.
Elimination Excretion is primarily via faeces (61%) with renal elimination of drug and metabolites accounting for 16% of the administered dose.
Izločanje Izloča se predvsem z blatom (61%); skozi ledvice se v obliki zdravila in presnovkov izloči 16% uporabljenega odmerka.
Sunitinib and its primary active metabolite were the major drug-related compounds identified in plasma, urine and faeces, representing 91.5%, 86.4% and 73.8% of radioactivity in pooled samples, respectively.
73, 8% (blato) radioaktivnosti v kumuliranih vzorcih.
Total oral clearance (CL/ F) was 34-62 l/ hr.
Celotni peroralni očistek (CL/ F) je bil 34– 62 l/ uro.
Organ Functions impairment Hepatic insufficiency:
Okvarjeno delovanje organov Insuficienca jeter:
Systemic exposures after a single dose of SUTENT were similar in subjects with mild or moderate (Child-Pugh Class A and B) hepatic impairment compared to subjects with normal hepatic function.
Sistemska izpostavljenost po enem samem odmerku SUTENTA je v primerjavi z bolniki z normalno jetrno funkcijo pri bolnikih z blago ali zmerno jetrno okvaro (razred A in B po Child- Pughu) podobna.
SUTENT was not studied in subjects with severe (Child-Pugh class C) hepatic impairment.
SUTENT ni bil preizkušen pri bolnikih s hudo jetrno okvaro (razred C po Child- Pughu).
Studies in cancer patients have excluded patients with ALT or AST > 2.5 x ULN (Upper Limit of Normal) or, if due to liver metastasis, > 5.0 x ULN.
Študije pri bolnikih z rakom so izključile bolnike z ALT ali AST > 2, 5 x ZMN (zgornjo mejo normalnega območja) oz., če je šlo za posledico metastaz jeter, > 5, 0 x ZMN.
No clinical studies have been performed in patients with impaired renal function Studies excluded patients with serum creatinine > 2.0 x ULN.
Študije so izključile bolnike s kreatininom v serumu > 2, 0 x ZMN.
Population pharmacokinetic analyses indicated that sunitinib apparent clearance (CL/ F) was not affected by creatinine clearance within the range evaluated (42-347 ml/ min).
Analize farmakokinetike preučevanih bolnikov so pokazale, da se navidezni očistek SUTENTA v območju ocenjevanega delovanja ledvic (od 42 do 347 ml/ min) ne spremeni.
Plasma Pharmacokinetics Following oral administration in healthy volunteers, the elimination half-lives of sunitinib and its primary active desethyl metabolite are approximately 40 - 60 hours, and 80 - 110 hours, respectively.
Plazemska farmakokinetika Razpolovni čas izločanja sunitiniba po peroralni uporabi pri zdravih prostovoljcih je približno 40– 60 ur, njegovega primarnega aktivnega dezetil- presnovka pa približno 80– 110 ur.
With repeated daily administration, sunitinib accumulates 3- to 4-fold and its primary active metabolite accumulates 7- to 10-fold.
S ponavljajočo se dnevno uporabo se sunitinib nakopiči 3 - do 4- kratno, njegov primarni aktivni presnovek pa 7 - do 10- kratno.
By day 14, combined plasma concentrations of sunitinib and is active metabolite are 62.9 - 101 ng/ ml which are target concentrations predicted from preclinical data to inhibit receptor phosphorylation in vitro and result in tumour stasis/ growth reduction in vivo.
To je ciljna koncentracija, ki glede na predklinične podatke predvidoma in vitro zavre fosforilacijo receptorjev, in vivo pa povzroči stazo oz. zmanjšanje rasti tumorja.
The primary active metabolite comprises 23 to 37% of the total exposure.
Primarni aktivni presnovek predstavlja od 23 do 37% celotne izpostavljenosti.
No significant changes in the pharmacokinetics of sunitinib or the primary, active metabolite are observed with repeated daily administration or with repeated cycles in the dosing regimens tested.
Med ponavljajočo se vsakodnevno uporabo in med ponavljanjem ciklusov z uporabo testiranih odmernih shem niso opazili pomembnih sprememb v farmakokinetiki sunitiniba ali njegovega primarnega aktivnega presnovka.
The pharmacokinetics were similar in all solid tumour populations tested and in healthy volunteers.
Farmakokinetika je bila pri vseh testiranih populacijah s čvrstimi tumorji in pri zdravih prostovoljcih podobna.
Population pharmacokinetic analyses of demographic data indicate that no dose adjustments are necessary for weight or ECOG score.
Populacijske farmakokinetične analize demografskih podatkov kažejo, da odmerka ni treba prilagajati glede na telesno maso ali po ECOG.
Available data indicate that females could have about 30% lower apparent clearance (CL/ F) of sunitinib than males: this difference however does not necessitate dose adjustments.
Podatki, ki so na voljo, kažejo, da imajo ženske lahko za približno 30% nižji navidezni očistek (CL/ F) kot moški; ta razlika pa ne zahteva prilagoditve odmerka.
In rat and monkey repeated-dose toxicity studies up to 9-months duration, the primary target organ effects were identified in the gastrointestinal tract (emesis and diarrhoea in monkeys), adrenal gland (cortical congestion and/ or haemorrhage in rats and monkeys, with necrosis followed by fibrosis in rats),
Študije toksičnosti ponavljajočih se odmerkov pri podganah in opicah, ki so trajale do 9 mesecev, so ugotovile učinke na primarnih tarčnih organih v prebavilih (bruhanje in diareja pri opicah), nadledvičnih žlezah (kortikalna kongestija in/ ali krvavitev pri podganah in opicah, pri podganah z nekrozo, ki ji je sledila fibroza), hematolimfopoetskem sistemu (hipercelularnost kostnega mozga ter limfoidno izčrpanje timusa, vranice in bezgavk), eksokrinem pankreasu (degranulacija acinarnih celic z nekrozo posamičnih celic), žlezah slinavkah (acinarna hipertrofija), kosteh in sklepih (zadebelitev rastne ploščice), maternici (atrofija) in jajčnikih (zmanjšano nastajanje foliklov).
Additional effects, observed in other studies included QTc interval prolongation, LVEF reduction, pituitary hypertrophy, and testicular tubular atrophy, increased mesangial cells in kidney, haemorrhage in GI tract and oral mucosa, and hypertrophy of anterior pituitary cells.
Med dodatnimi učinki, opaženimi v drugih študijah, so bili podaljšanje intervala QTc, zmanjšanje LVEF, hipertrofija
Genotoxicity The genotoxic potential of sunitinib was assessed in vitro and in vivo.
Genotoksičnost Genotoksični potencial sunitiniba so ocenili in vitro in in vivo.
The major active metabolite was not evaluated for genetic toxicity potential.
Genotoksični potencial glavnega aktivnega presnovka ni ovrednoten.
Carcinogenicity Carcinogenicity studies with sunitinib malate have not been performed.
Kancerogenost Študije kancerogenosti s sunitinibijevim malatom niso bile izvedene.
Reproductive and Developmental toxicity No effects on male or female fertility were observed in reproductive toxicity studies.
Reprodukcijska in razvojna toksičnost Pri samcih in samicah v študijah vpliva na sposobnost razmnoževanja niso opazili učinkov na plodnost.
However, in repeated- dose toxicity studies performed in rats and monkeys, effects on female fertility were observed in the form of follicular atresia, degeneration of corpora lutea, endometrial changes in the uterus and decreased uterine and ovarian weights at clinically relevant systemic exposure levels.
So pa v študijah toksičnosti ponavljajočih se odmerkov pri podganah in opicah ob klinično pomembni sistemski izpostavljenosti ugotovili učinke na plodnost samic, ki so se kazali kot atrezija foliklov, degeneracija rumenih telesc, spremembe endometrija v maternici in zmanjšanje mase maternice in jajčnikov.
Effects on male fertility in rat were observed in the form of tubular atrophy in the testes, reduction of spermatozoa in epididimes and colloid depletion in prostate and seminal vesicles at plasma exposure levels 18-fold higher than is observed in clinic.
Pri plazemski izpostavljenosti, ki je bila 18- krat večja kot med klinično uporabo, 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.
In rats, embryo-foetal mortality was evident as significant reductions in the number of live foetuses, increased numbers of resorptions increased postimplantation loss, and total litter loss in 8 of 28 pregnant females at plasma exposure levels 5.5-fold higher than is observed in clinic.
Pri podganah se je embrio- fetalna umrljivost kazala s pomembno manjšim številom živih plodov, večjim številom resorpcij, večjimi poimplantacijskimi izgubami ter popolno izgubo legla pri 8 od 28 brejih samic, in sicer pri plazemski izpostavljenosti, ki je bila 5, 5- krat večja kot med klinično uporabo.
In rabbits, reductions in gravid uterine weights and number of live foetuses were due to increases in the number of resorptions, increases in post-implantation loss and complete litter loss in 4 of 6 pregnant females at plasma exposure levels 3-fold higher than is observed in clinic.
Pri kuncih sta bila zmanjšanje gravidne uterine mase in števila živih plodov posledica večjega števila resorpcij, večje poimplantacijske izgube in popolne izgube legla pri 4 od 6 brejih samic, in sicer pri plazemski izpostavljenosti, ki je bila 3- krat večja kot med klinično uporabo.
Sunitinib treatment in rats during organogenesis resulted in developmental effects at ≥ 5 mg/ kg/ day consisting of increased incidence of foetal skeletal malformations, predominantly characterized as retarded ossification of thoracic/ lumbar vertebrae and occurred at plasma exposure levels 6-fold higher than is observed in clinic.
Pri podganah je zdravljenje s sunitinibom med organogenezo povzročilo učinke na razvoj, ki so vključevali večjo incidenco skeletnih malformacij pri plodu, ki so se kazale predvsem kot zapoznelo zakostenevanje prsnih in ledvenih vretenc, pojavile pa so se pri plazemski izpostavljenosti, ki je bila 6- krat večja kot med klinično uporabo.
In rabbits, developmental effects consisted of increased incidence of cleft lip at plasma exposure levels approximately equal to that observed in clinic, and cleft lip and cleft palate at plasma exposure levels 2.7-fold higher than is observed in clinic.
Pri kuncih so učinki na razvoj obsegali večjo incidenco heiloshize (ob plazemski izpostavljenosti, ki je bila približno enaka kot med klinično uporabo) ter heilognatoshize (ob plazemski izpostavljenosti, ki je bila približno 2, 7- krat tolikšna kot med klinično uporabo).
Capsule content Mannitol Croscarmellose Sodium Povidone Magnesium Stearate
Vsebina kapsule manitol premreženi natrijev karmelozat povidon magnezijev stearat
17 Capsule Shell Gelatin Red Iron Oxide (E172) Titanium dioxide (E171)
Ovojnica kapsule želatina rdeči železov oksid (E172) titanov dioksid (E171)
Printing ink Shellac Propylene glycol Sodium hydroxide Povidone Titanium dioxide (E171)
18 Črnilo šelak propilenglikol natrijev hidroksid povidon titanov dioksid (E171)
High-density polyethylene (HDPE) bottles with a polypropylene closure, containing 30 capsules.
Plastenke iz polietilena visoke gostote (HDPE) s polipropilensko zaporko, ki vsebujejo 30 kapsul.
Aclar/ PVC transparent blister with aluminium foil coated with heat seal lacquer containing 28 (4 x 7) hard capsules Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
SUTENT 25 mg hard capsules
SUTENT 25 mg trde kapsule
Each capsule contains sunitinib malate, equivalent to 25.0 mg of sunitinib Excipient(s):
Pomožne snovi:
39.663 mg of mannitol.
39, 663 mg manitola.
Hard capsules Gelatin capsules with caramel cap and orange body, printed with white ink “ Pfizer” on the cap and “ STN 25 mg” on the body and containing yellow to orange granules.
Kapsule vsebujejo rumena do oranžna zrnca.
19 Paediatric use:
20 Uporaba pri otrocih:
The safety and efficacy of SUTENT in paediatric patients have not been established.
Varnost in učinkovitost SUTENTA pri pediatričnih bolnikih nista ugotovljeni.
SUTENT should not be used in paediatric population until further data become available.
V pediatrični populaciji SUTENTA ne smemo uporabljati, dokler ne bo na voljo dodatnih podatkov.
Seven (1.9%) patients on sunitinib malate versus 0% of patients on IFN-α experienced Grade 3 or greater treatment-related bleeding events.
21 28%, med bolniki, ki so dobivali IFN- α, pa 7%.
20 refractory MRCC, 26% experienced bleeding.
Krvavitve so se pojavile pri 26% bolnikov, ki so sunitinibijev malat dobivali za zdravljenje metastatskega karcinoma ledvičnih celic, odpornega proti citokinom.
Gastro-intestinal tract Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred rarely in patients with intra-abdominal malignancies treated with SUTENT.
Prebavila Pri bolnikih z intraabdominalnimi malignomi, ki so dobivali SUTENT, je v redkih primerih prišlo do resnih zapletov na prebavilih (včasih s smrtnim izidom), vključno s perforacijo prebavil.
Haematological Decreased absolute neutrophil counts of grade 3 and 4 severity were reported in 10% and 1.7% of patients on the phase 3 GIST study, respectively and in 16% and 1.6% of patients on the phase 3 MRCC study, respectively.
Hematološke bolezni V študiji 3. faze pri GIST so o zmanjšanju absolutnega števila nevtrofilcev 3. stopnje poročali pri 10% bolnikov, 4. stopnje pa pri 1, 7% bolnikov, v študiji 3. faze pri MRCC pa o zmanjšanju 3. stopnje pri 16% bolnikov in 4. stopnje pri 1, 6% bolnikov.
Decreased platelet counts of grade 3 and 4 severity were reported in 3.7% and 0.4% of patients on the phase 3 GIST study, respectively, and in 8.2% and 1.1% of patients on the phase 3 MRCC study, respectively.
V študiji 3. faze pri GIST so o zmanjšanju števila trombocitov 3. stopnje so poročali pri 3, 7% bolnikov, 4. stopnje pa pri 0, 4% bolnikov, v študiji 3. faze pri MRCC pa o zmanjšanju 3. stopnje pri 8, 2% bolnikov in 4. stopnje pri 1, 1% bolnikov.
21 SUTENT arm experienced fatal cardiac events.
V študiji 3. faze pri še nezdravljenih bolnikih z MRCC pa so se smrtni srčni dogodki pojavili pri 0, 6% bolnikov v kraku z IFN- α ter pri nobenem bolniku v kraku s SUTENTOM.
QT Interval prolongationData from non-clinical (in vitro and in vivo) studies, at doses higher than the recommended human dose, indicate that sunitinib has the potential to inhibit the cardiac action potential repolarization process (e. g. prolongation of QT interval).
Podaljšanje intervala QT Podatki iz nekliničnih študij (in vitro in in vivo) z odmerki, večjimi od priporočenega odmerka za človeka, kažejo, da lahko sunitinib zavre repolarizacijsko fazo srčnega akcijskega potenciala (npr. podaljšanje intervala QT).
No subjects experienced an effect on the QTc inteval greater than Grade 2 (CTCAE version 3.0).
23 nobenem preiskovancu niso ugotovili učinka na interval QTc, ki bi bil večji od stopnje 2 (CTCAE verzija 3. 0).
22 Seven patients (3%) on SUTENT and none on placebo in a phase 3 GIST study experienced venous thromboembolic events; five of the seven were Grade 3 deep venous thrombosis (DVT) and two were Grade 1 or 2.
2. stopnje.