natgillin/translations-raw huggingface dataset:
Abbreviations: CI=confidence interval; N=number of patients; PFS=progression-free survival; pNET=pancreatic neuroendocrine tumours. 
Okrajšave: IZ = interval zaupanja, N = število bolnikov, PFS = preživetje brez napredovanja bolezni, pNET = nevroendokrini tumorji trebušne slinavke.
Four out of 6 patients (66.7%) experienced Grade 3-4 treatment-related adverse events (Grade 3 hypophosphataemia, neutropenia, and thrombocytopenia in 1 patient each and a Grade 4 neutropenia in 1 patient). 
Pri 4 od 6 bolnikov (66,7 %) so se pojavili z zdravljenjem povezani neželeni učinki 3.-4. stopnje (hipofosfatemija, nevtropenija in trombocitopenija 3. stopnje, vsaka pri 1 bolniku, in nevtropenija 4. stopnje pri 1 bolniku).
Upon disease progression, patients were unblinded and placebo patients were offered access to open-label sunitinib in a separate extension study. 
V primeru napredovanja bolezni so pri bolnikih šifro razkrili, bolnikom, ki so prejemali placebo, pa ponudili vključitev v ločeno razširjeno študijo z odprtim dajanjem zdravila sunitinib.
Fatal gastrointestinal bleeding was reported in 0.98% of patients receiving placebo in the GIST Phase 3 study. 
V študiji 3. faze pri GIST so poročali o smrtnih krvavitvah v prebavilih pri 0,98 % bolnikov, ki so prejemali placebo.
Cases of renal impairment, renal failure and/or acute renal failure, in some cases with fatal outcome, have been reported (see section 4.8). 
Poročali so o primerih zmanjšanega delovanja ledvic, odpovedi ledvic in/ali akutni odpovedi ledvic, v nekaterih primerih s smrtnim izidom (glejte poglavje 4.8).
Diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, and stomatitis/oral pain were the most commonly reported gastrointestinal adverse reactions; oesophagitis events have been also reported (see section 4.8). 
Najpogosteje opisani neželeni učinki na prebavilih so bili diareja, navzea/bruhanje, bolečina v trebuhu, dispepsija in stomatitis/bolečina v ustih; poročali so tudi o ezofagitisu (glejte poglavje 4.8).
- If you have or have had skin and subcutaneous tissue disorders. 
- Če imate ali ste imeli bolezni kože in podkožja.
Tell your doctor if you develop any of the following signs and symptoms: pain in the area of the stomach (upper abdomen), nausea, vomiting, and fever. 
Obvestite zdravnika, če opazite katerega od naslednjih znakov in simptomov: bolečine v predelu želodca (v zgornjem delu trebuha), slabost s siljenjem na bruhanje, bruhanje in vročino.
Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with sunitinib (see section 4.8). 
Bolnikom, zdravljenim s sunitinibom, je treba na začetku vsakega cikla zdravljenja pregledati celotno krvno sliko (glejte poglavje 4.8).
Seizures have been observed in patients with or without radiological evidence of brain metastases (see section 
Konvulzije so opažali pri bolnikih z radiološkimi znaki metastaz v možganih ali brez njih (glejte poglavje 4.4).
Two of these patients on placebo had DVT, 1 with Grade 2 and 1 with Grade 3. 
Dva od bolnikov v skupini s placebom sta imela globoko vensko trombozo, en 2. stopnje in drugi 3. stopnje.
Severe hypertension was reported in 12% of treatment-naïve patients on sunitinib and < 1% of patients on IFN-. 
O hudi hipertenziji so poročali pri 12 % predhodno nezdravljenih bolnikov, ki so prejemali sunitinib, ter pri < 1 % bolnikov, ki so prejemali IFN-.
Median OS in the ITT population was 72.7 weeks and 64.9 weeks (HR: 0.876; 95% CI: 0.679, 1.129; p=0.306), in the sunitinib and placebo arms, respectively. 
Mediano OS v populaciji ITT je bilo 72,7 tedna v skupini s sunitinibom in 64,9 tedna v skupini s placebom (HR: 0,876; 95 % IZ: 0,679; 1,129, p = 0,306).
Cardiac failure congestive Myocardial infarctionm,* Cardiac failure* Cardiomyopathy* 
zmanjšan iztisni delež kongestivno srčno popuščanje miokardni infarkt m,*
Cases of pulmonary haemorrhage, some with a fatal outcome, have been observed in clinical trials and have been reported in postmarketing experience in patients treated with sunitinib for MRCC, GIST, and lung cancer. 
V kliničnih preskušanjih in v obdobju trženja zdravila so poročali o primerih krvavitev v pljučih, nekaterih s smrtnim izidom, pri bolnikih, zdravljenih s sunitinibom pri MRCC, GIST in pljučnem raku.
No specific additional risk factors for sunitinib-induced cardiomyopathy apart from the drug-specific effect have been identified in the treated patients. 
Razen za zdravilo značilnega učinka pri zdravljenih bolnikih niso ugotovili nobenih posebnih dodatnih dejavnikov tveganja za pojav s sunitinibom izzvane kardiomiopatije.
Abbreviations: CI=confidence interval; INF-α=interferon-alfa; ITT=intent-to-treat; N=number of patients; NA=not applicable; OS=overall survival; PFS=progression-free survival. 
Okrajšave: IZ = interval zaupanja, IFN-α = interferon alfa, ITT = populacija z-namenom-zdravljenja, n = število bolnikov, N/A = navedba smiselno ni potrebna (not applicable), OS = celokupno preživetje, PFS = preživetje brez napredovanja bolezni.
Interim 24.1 (11.1, 28.3) 6.0 (4.4, 9.9) 0.333 (0.238, 0.467) < 0.001 Final 
Primarni TTP (tedni) Vmesni Končni Sekundarni: PFS (tedni) Vmesni 24,1 (11,1; 28,3) 6,0 (4,4; 9,9) 0,333 (0,238; 0,467) < 0,001 Končni 22,9 (10,9; 28,0) 6,0 (4,4; 9,7) 0,347 (0,253; 0,475) < 0,001
As a result of the early study closure, remaining patients were unblinded and offered access to open-label sunitinib in an extension study. 
Zaradi zgodnjega zaključka študije so tudi pri preostalih bolnikih šifro razkrili in jim ponudili vključitev v ločeno razširjeno študijo z odprtim dajanjem zdravila sunitinib.
Based on nonclinical findings, male and female fertility may be compromised by treatment with sunitinib (see section 5.3). 
Predklinični izsledki kažejo, da lahko zdravljenje s sunitinibom poslabša plodnost samcev in samic (glejte poglavje 5.3).
The patient should take the usual prescribed dose on the following day. 
Če bolnik pozabi vzeti odmerek, ne sme dobiti dodatnega, temveč naj vzame običajni predpisani odmerek naslednji dan.
No development toxicity was observed at 1 mg/kg/day (approximate exposure ≥ 0.9 times the AUC in patients administered the RDD). 
Pri odmerku 1 mg/kg/dan (približna izpostavljenost ≥ 0,9-kratnik vrednosti AUC pri bolnikih, ki prejemajo RDD) niso opazili nobene razvojne toksičnosti.
• Abnormal tube like passage from one normal body cavity to another body cavity or the skin. 
• nenormalen cevast prehod med dvema votlima organoma ali iz votlega organa na površino kože
Decreases in blood glucose, in some cases clinically symptomatic and requiring hospitalisation due to loss of consciousness, have been reported during sunitinib treatment. 
Med zdravljenjem s sunitinibom so poročali o znižanju ravni glukoze v krvi, ki je bilo v nekaterih primerih klinično simptomatsko in je vodilo do hospitalizacije zaradi izgube zavesti.
T4 increase was reported in 2 (0.8%) patients on sunitinib and 1 (0.4%) patient on capecitabine. 
O zvišanju ravni T4 so poročali pri 2 bolnicah (0,8 %), ki sta prejemali sunitinib, in pri 1 bolnici (0,4 %), ki je prejemala kapecitabin.
Treatment may be resumed once hypertension is appropriately controlled (see section 4.8). 
Ko je hipertenzija ustrezno urejena, je zdravljenje mogoče nadaljevati (glejte poglavje 4.8).
• Abnormal sensation of the skin, itching, flaking and inflammation of the skin, blisters, acne, nail discolouration, hair loss. 
• nenormalni občutki na koži, srbenje, luščenje in vnetje kože, mehurji, akne, obarvanje nohtov,
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules 
Sutent 12,5 mg trde kapsule Sutent 25 mg trde kapsule Sutent 37,5 mg trde kapsule Sutent 50 mg trde kapsule
Pericardial effusion Electrocardiogram QT prolonged 
srčno popuščanje kardiomiopatija izliv v perikard podaljšanje intervala QT
Seven patients (3%) on sunitinib and none on placebo in a Phase 3 GIST study experienced venous thromboembolic events; 5 of the 7 were Grade 3 deep venous thrombosis (DVT) and 2 were Grade 1 or 2. 
V študiji 3. faze pri GIST so se venski trombembolični dogodki pojavili pri 7 bolnikih (3 %), ki so prejemali sunitinib, in pri nobenem od tistih, ki so prejemali placebo; v 5 od teh 7 primerov je šlo za globoko vensko trombozo 3. stopnje, v 2 pa 1. oz. 2. stopnje.
Cases with fatal outcome have been observed in the postmarketing surveillance. 
Smrtne izide so zabeležili v obdobju trženja.
No significant changes in the PK of sunitinib or the primary active metabolite are observed with repeated daily administration or with repeated cycles in the dosing schedules tested. 
Med ponavljajočo se vsakodnevno uporabo in med ponavljanjem ciklov z uporabo testiranih odmernih shem niso opazili pomembnih sprememb v FK sunitiniba ali njegovega primarnega aktivnega presnovka.
Epistaxis was the most common haemorrhagic adverse reaction, having been reported for approximately half of the patients with solid tumours who experienced haemorrhagic events. 
Najpogostejši hemoragični neželeni učinek je bila epistaksa; zabeležili so jo pri približno polovici tistih bolnikov s čvrstimi tumorji, pri katerih se je pojavila kakšna krvavitev.
Sunitinib benefit/risk did not appear to be negatively affected by younger age or lower body size, and was mainly driven by its plasma exposure. 
Nižja starost in manjša velikost telesa nimata negativnega vpliva na razmerje med koristmi in tveganji sunitiniba, na katerega vpliva predvsem izpostavljenost sunitinibu v plazmi.
You should avoid drinking grapefruit juice while on treatment with Sutent. 
Med zdravljenjem z zdravilom Sutent ne pijte grenivkinega soka.
• Dehydration. 
• izsušenost (dehidracija)
Hepatotoxicity has been observed in patients treated with sunitinib. 
Pri bolnikih, ki so se zdravili s sunitinibom, so opažali hepatotoksičnost.
Core radiology assessment was discontinued after the primary endpoint had been met. At the final analysis, the ORR as determined by the investigator's assessment was 46% (95% CI: 41%, 51%) for the sunitinib arm and 12.0% (95% CI: 9%, 16%) for the IFN-α arm (p<0.001). 
Pri končni oceni je bil ORR, kot so ga določili raziskovalci, v skupini s sunitinibom 46 % (95 % IZ: 41 %-51 %) in 12,0 % (95 % IZ: 9 %-16 %) v skupini z IFN- (p < 0,001).
You will usually be taken off Sutent if you are having an operation. 
Če boste imeli operacijo, boste običajno prekinili z jemanjem zdravila Sutent.
Sunitinib therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated. 
Pri bolnikih, pri katerih se pojavi nekrotizirajoči fasciitis, je treba zdravljenje s sunitinibom prekiniti in nemudoma uvesti ustrezno zdravljenje.
Combination with CYP3A4 inducers should therefore be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered. 
Kombinacijam z induktorji CYP3A4 se je torej treba izogibati ali pa izbrati drugo sočasno zdravljenje z minimalnim potencialom za indukcijo CYP3A4 ali brez takšnega potenciala.
Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking Sutent. 
Obvestite zdravnika, če imate vrtoglavico, omedlevico ali nenormalno bitje srca med zdravljenjem z zdravilom Sutent.
In the other study hypothyroidism was reported in a total of 31 (13%) patients on sunitinib and 2 (0.8%) patients on capecitabine. 
V drugi študiji so o hipotiroidizmu poročali pri skupno 31 bolnicah (13 %), ki so prejemale sunitinib, in pri 2 bolnicah (0,8 %), ki sta prejemali kapecitabin.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset stomach, 
• bolečine/draženje v ustih, rane/vnetje v ustih/suha usta, motnje okušanja, težave z želodcem,
Hypothyroidism was reported as an adverse reaction in 7 patients (4%) receiving sunitinib across the 2 cytokine-refractory MRCC studies; in 61 patients (16%) on sunitinib and 3 patients (< 1%) in the IFN- arm in the treatment-naïve MRCC study. 
V dveh študijah MRCC, odpornega proti citokinom, so o hipotiroidizmu kot o neželenem učinku poročali pri 7 bolnikih (4 %), ki so prejemali sunitinib; v študiji še nezdravljenega MRCC pa pri 61 bolnikih (16 %) v skupini s sunitinibom in pri 3 bolnikih (< 1 %) v skupini z IFN-.
A Phase 1 dose-escalation study of oral sunitinib was conducted in 35 patients comprised of 30 paediatric patients (aged 3 years to 17 years) and 5 young adult patients (aged 18 to 21 years), with refractory solid tumours, the majority of whom had a primary diagnosis of brain tumour. 
Študija s povečevanjem odmerka peroralnega sunitiniba 1. faze je potekala pri 35 bolnikih, od katerih je bilo 30 pediatričnih bolnikov (starih od 3 let do 17 let) in 5 mlajših odraslih bolnikov (starih od 18 let do 21 let) z neodzivnimi čvrstimi tumorji, med katerimi je imela večina primarno diagnozo možganskega tumorja.
The majority of cases were reported in patients who had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk. 
Pri bolnikih, ki so se zdravili z zdravilom Sutent, so poročali o primerih osteonekroze čeljustnic; večina teh bolnikov je bila predhodno ali sočasno zdravljena z intravenskimi bisfosfonati, za katere je osteonekroza čeljustnic znano tveganje.
Decreased absolute neutrophil counts of Grade 3 and 4 severities, respectively, were reported in 10% and 1.7% of patients on the Phase 3 GIST study, in 16% and 1.6% of patients on the Phase 3 MRCC study, and in 13% and 2.4% of patients on the Phase 3 pNET study. 
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 o zmanjšanju 3. stopnje pri 16 % bolnikov in 4. stopnje pri 1,6 % bolnikov, in v študiji 3. faze pri pNET pri 13 % oziroma 2,4 % bolnikov.
nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/decrease of appetite. 
slabost s siljenjem na bruhanje, bruhanje, driska, zaprtje, bolečine/otekanje v trebuhu, izguba ali zmanjšanje teka
• Blood clots in the blood vessels. 
• krvni strdki v žilah
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules sunitinib 
Sutent 12,5 mg trde kapsule Sutent 25 mg trde kapsule Sutent 37,5 mg trde kapsule Sutent 50 mg trde kapsule sunitinib
Cases of fistula formation, sometimes associated with tumour necrosis and regression, in some cases with fatal outcomes, have been reported (see section 4.4). 
Poročali so o primerih nastanka fistule, ki so bili včasih povezani z nekrozo in regresijo tumorja, v nekaterih primerih s smrtnim izidom (glejte poglavje 4.4).
A Phase 1 dose-escalation study of oral sunitinib was conducted in 35 patients comprised of 30 paediatric patients (aged 3 years to 17 years) and 5 young adult patients (aged: 18 years to 21 years), with refractory solid tumours, the majority of whom were enrolled with a primary diagnosis of brain tumour. 
Študija s povečevanjem odmerka peroralnega sunitiniba 1. faze je potekala pri 35 bolnikih, od katerih je bilo 30 pediatričnih bolnikov (starih od 3 let do 17 let) in 5 mlajših odraslih bolnikov (starih od 18 let do 21 let) z neodzivnimi čvrstimi tumorji, med katerimi je imela večina ob vključitvi v študijo primarno diagnozo možganskega tumorja.
Gastrointestinal stromal tumour (GIST) 
Gastrointestinalni stromalni tumorji (GIST)
- If you have or have had pancreatic or gallbladder disorders. 
- Če imate ali ste imeli bolezni trebušne slinavke ali žolčnika.
Cases of pyoderma gangrenosum, generally reversible after discontinuation of sunitinib, have been reported. 
Poročali so o primerih gangrenozne pioderme, ki običajno izgine po prekinitvi zdravljenja s sunitinibom.
Hyperthyroidism was reported in no sunitinib-treated patients and 1 (1.0%) patient receiving standard of care. 
O hipertiroidizmu pri bolnicah, ki so prejemale sunitinib, niso poročali, so pa o njem poročali pri 1 bolnici (1,0 %), ki je prejemala standardno zdravljenje.
A pivotal Phase 3, multi-centre, international, randomised, double-blind, placebo-controlled study of single-agent sunitinib was conducted in patients with unresectable pNET. 
Pri bolnikih z neizrezljivim pNET so opravili ključno, multicentrično, mednarodno, randomizirano, dvojno slepo, s placebom nadzorovano študijo 3. faze.
Combination with CYP3A4 inhibitors should therefore be avoided, or the selection of an alternate concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered. 
Kombinaciji z zaviralci CYP3A4 se je torej treba izogibati ali pa izbrati drugo sočasno zdravljenje z minimalnim potencialom za zaviranje CYP3A4 ali brez takšnega potenciala.
Limited information is available on the continued use of sunitinib in patients with fistulae (see section 4.8). 
Podatki o nadaljnji uporabi sunitiniba pri bolnikih s fistulo so omejeni (glejte poglavje 4.8).
In the treatment-naïve MRCC study, 27% of patients on sunitinib and 15% of patients on IFN- had an LVEF value below the lower limit of normal. 
V študiji še nezdravljenega MRCC je imelo LVEF pod spodnjo mejo normale 27 % bolnikov, ki so prejemali sunitinib, in 15 % bolnikov, ki so prejemali IFN-.
Stepwise covariate modelling analyses were performed to evaluate the effect of age and body size (total body weight or body surface area) as well as other covariates on important PK parameters for sunitinib and its active metabolite. 
Za ovrednotenje vpliva starosti in velikosti telesa (skupne telesne mase ali telesne površine), kot tudi drugih sospremenljivk, na pomembne FK parametre sunitiniba in njegovega aktivnega presnovka so izvedli analize postopnega modeliranja sočasnih spremenljivk.
Pyoderma gangrenosum Toxic epidermal necrolysis* 
Stevens-Johnsonov sindrom gangrenozna pioderma toksična epidermalna nekroliza
There were no serious adverse events (SAEs) or Grade 5 adverse drug reactions reported in this study. 
V tej študiji niso poročali o resnih neželenih učinkih ali neželenih učinkih 5. stopnje.
A 6-month, oral gavage carcinogenicity study (0, 8, 25, 75 [reduced to 50] mg/kg/day), with daily dosing was conducted in rasH2 transgenic mice. 
Pri rasH2 transgenskih miših so izvedli 6-mesečno študijo rakotvornosti ob uporabi gastrične sonde z dnevnim odmerjanjem (0, 8, 25, 75 [zmanjšano na 50] mg/kg/dan).
A Phase 1/2 single-arm, study was conducted in 6 paediatric patients (aged 13 years to 16 years) with advanced unresectable GIST. 
faze je potekala pri 6 pediatričnih bolnikih (starih od 13 let do 16 let) z napredovalim neizrezljivim GIST.
If you get any side effects, talk to your doctor. 
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom.
- If you have abnormal heart rhythm changes. 
- Če imate motnje v srčnem ritmu.
Patients who presented with pulmonary embolism within the previous 12 months were excluded from sunitinib clinical studies. 
V klinične študije s sunitinibom niso vključili bolnikov, ki so imeli pljučno embolijo v zadnjih 12 mesecih.
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered. 
Razmisliti je treba o izbiri drugega sočasnega zdravila, ki nima potenciala za indukcijo ali zaviranje CYP3A4 oz. je njegov potencial v tem pogledu minimalen.
Uncommon cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported (see section 4.8). 
Poročali so o občasnih primerih nekrotizirajočega fasciitisa, vključno s prizadetostjo presredka, ki so bili včasih smrtni (glejte poglavje 4.8).
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 times the systemic exposure in humans. 
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 večja od sistemske izpostavljenosti pri ljudeh).
• Pain in the stomach (abdomen) caused by inflammation of the pancreas. 
• bolečina v trebuhu zaradi vnetja trebušne slinavke
• Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. 
• bolečine v ustih, zobeh in/ali čeljusti, otekline ali ranice v ustih, odrevenelost ali občutek teže v čeljusti ali majav zob; to bi lahko bili znaki in simptomi poškodbe kosti v čeljusti (osteonekroza),
Similarly, among 57 patients in the sunitinib arm (including 28 with 1 prior systemic therapy and 29 with 2 or more prior systemic therapies) and 61 patients in the placebo arm (including 25 with 1 prior systemic therapy and 36 with 2 or more prior systemic therapies), the hazard ratio for PFS was 0.456 (95% CI: 0.264, 0.787), p=0.0036. 
Podobno je med bolniki razmerje ogroženosti za PFS znašalo 0,456 (95 % IZ: 0,264, 0,787), p = 0,0036, in sicer med 57 bolniki v skupini, ki je prejemala sunitinib (vključno z 28, ki so bili deležni enega predhodnega sistemskega zdravljenja, in 29, ki so bili deležni dveh ali več predhodnih sistemskih zdravljenj) in 61 bolniki v skupini, ki je prejemala placebo (vključno s 25, ki so bili deležni enega predhodnega sistemskega zdravljenja, in 36, ki so bili deležni dveh ali več predhodnih sistemskih zdravljenj).
Cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported (see also section 4.4). 
Poročali so o primerih nekrotizirajočega fasciitisa, vključno s prizadetostjo presredka, včasih s smrtnim izidom (glejte tudi poglavje 4.4).
Cytokine-refractory metastatic renal cell carcinoma A Phase 2 study of sunitinib was conducted in patients who were refractory to prior cytokine therapy with interleukin-2 or IFN-. 
Proti citokinom odporni metastatski karcinom ledvičnih celic (MRCC) Pri bolnikih, odpornih proti prejšnjemu citokinskemu zdravljenju z interlevkinom-2 ali IFN-, so opravili študijo 2. faze s sunitinibom.
Bleeding events were reported in 18% of patients receiving sunitinib in a Phase 3 GIST study vs 17% of patients receiving placebo. 
V študiji 3. faze pri GIST so o pojavih krvavitev poročali pri 18 % bolnikov, ki so prejemali sunitinib, in pri 17 % bolnikov, ki so prejemali placebo.
• Yellow skin/skin discoloration, excess pigmentation of the skin, hair colour change, rash on the palms of the hands and soles of the feet, rash, dryness of the skin. 
• porumenela koža/obarvanje kože, čezmerna pigmentacija kože, sprememba barve las in dlak,
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.
Cardiovascular events, including heart failure, cardiomyopathy, left ventricular ejection fraction decline to below the lower limit of normal, myocarditis, myocardial ischaemia and myocardial infarction, some of which were fatal, have been reported in patients treated with sunitinib. 
Pri bolnikih, zdravljenih s sunitinibom, so poročali o srčno-žilnih dogodkih, vključno s srčnim popuščanjem, kardiomiopatijo, zmanjšanjem iztisnega deleža levega prekata pod spodnjo mejo normale, miokarditisom, miokardno ishemijo in miokardnim infarktom, v nekaterih primerih s smrtnim izidom.
Cases of pulmonary embolism with fatal outcome have been observed in postmarketing surveillance. 
Med nadzorom v obdobju trženja zdravila so zabeležili primere pljučne embolije s smrtnim izidom.
Weight, performance status 
Telesna masa in stanje zmogljivosti