FrancophonIA/ELRC3.0 huggingface dataset:
English: QTc interval prolongation was investigated in a trial in 24 patients, ages 20-87 years, with advanced malignancies.
Croatian: Produljenje QTc-intervala proučavalo se u ispitivanju s 24 bolesnika s uznapredovalim zloćudnim bolestima, u dobi od 20 do 87 godina.
English: Interim 6.8 (3.7, 11.1)
Croatian: ORR (%) Interim 6,8 (3,7; 11,1)
English: Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, and metastatic progression of cancer.
Croatian: Suntinib inhibira višestruke receptorske tirozin kinaze (RTK) koje imaju ulogu u rastu tumora, neoangiogenezi i metastatskoj progresiji karcinoma.
English: The EMA has waived the obligation to submit the results of the studies with Sutent in all subsets of the paediatric population for the treatment of gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, and phaeochromocytoma) (see section 4.2).
Croatian: EMA je izuzela obvezu podnošenja rezultata ispitivanja lijeka Sutent u svim podskupinama pedijatrijske populacije u liječenju gastroenteropankreatičnih neuroendokrinih tumora (osim neuroblastoma, neuroganglioblastoma i feokromocitoma) (vidjeti dio 4.2).
English: Risk factors for TLS include high tumour burden, pre-existing chronic renal insufficiency, oliguria, dehydration, hypotension, and acidic urine.
Croatian: Faktori rizika za TLS uključuju visoko opterećenje tumorom, postojeću kroničnu bubrežnu insuficijenciju, oliguriju, dehidraciju, hipotenziju i kiseli urin.
English: Eight of these patients had DVT; 1 with Grade 1, 2 with Grade 2, 4 with Grade 3, and 1 with Grade 4.
Croatian: Osam od tih bolesnika imalo je DVT; 1 bolesnik 1. stupnja, 2 bolesnika 2. stupnja, 4 bolesnika 3. i 1 bolesnik 4. stupnja.
English: With repeated daily administration, sunitinib accumulates 3- to 4-fold and its primary active metabolite accumulates 7- to 10-fold.
Croatian: Nakon ponovljene svakodnevne primjene kumulacija sunitiniba je trostruka do četverostruka, a kumulacija njegova primarnog aktivnog metabolita sedmerostruka do deseterostruka.
English: • Life-threatening infection of the soft tissue including the ano-genital region (see section 2).
Croatian: • Po život opasne infekcije mekog tkiva, uključujući i područje spolnih organa i anusa (pogledajte dio 2.).
English: These may be caused by inflammation of the pancreas or gallbladder.
Croatian: Njihov uzrok može biti upala gušterače ili žučnog mjehura.
English: 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.
Croatian: U ispitivanju prethodno neliječenog MRCC-a, 27% bolesnika liječenih sunitinibom i 15% bolesnika koji su primali IFN-α imalo je vrijednost LVEF-a ispod donje granice normalnih vrijednosti.
English: In a pancreatic islet cell tumour cohort of 66 patients, the primary endpoint of response rate was 17%.
Croatian: U kohorti od 66 bolesnika s tumorom stanica otočića gušterače stopa odgovora na liječenje, što je bila primarna mjera ishoda, iznosila je 17%.
English: Steady-state concentrations of sunitinib and its primary active metabolite are achieved within 10 to 14 days.
Croatian: Koncentracije sunitiniba i njegova primarnog aktivnog metabolita dosežu stanje dinamičke ravnoteže unutar 10 do 14 dana.
English: Primary TTP (weeks) Interim 27.3 (16.0, 32.1) 6.4 (4.4, 10.0) 0.329 (0.233, 0.466) < 0.001 Final
Croatian: Primarna TTP (tjedni) Interim 27,3 (16,0; 32,1) 6,4 (4,4; 10,0) 0,329 (0,233;
English: Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
Croatian: Metastatski karcinom bubrežnih stanica (engl. metastatic renal cell carcinoma, MRCC) Sutent je indiciran za liječenje uznapredovalog/metastatskog karcinoma bubrežnih stanica (MRCC-a) u odraslih bolesnika.
English: All thyroid-related events reported were Grade 1-2 (see section 4.4).
Croatian: Svi zabilježeni događaji povezani sa štitnjačom bili su 1.do 2. stupnja (vidjeti dio 4.4).
English: Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations.
Croatian: Primjena sunitiniba sa snažnim inhibitorima CYP3A4 (npr. ritonavirom, itrakonazolom, eritromicinom, klaritromicinom, sokom od grejpa) može povećati koncentracije sunitiniba.
English: A hazard ratio favouring sunitinib was observed in all subgroups of baseline characteristics evaluated, including an analysis by number of prior systemic therapies.
Croatian: 4. Omjer hazarda u prilog sunitinibu zabilježen je u svim podskupinama ocijenjenima na temelju početnih obilježja, uključujući i analizu prema broju prethodnih sustavnih terapija.
English: • Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
Croatian: • Neuobičajeno oštećenje mišićnih vlakana koje može dovesti do problema s bubrezima (rabdomioliza).
English: 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.
Croatian: Čini se da na omjer koristi i rizika sunitiniba nisu negativno utjecali mlađa dob i manja tjelesna veličina, i uglavnom je zavisio o izloženosti lijeku u plazmi.
English: • Abnormal blood tests including pancreatic and liver enzymes.
Croatian: • Poremećene krvne pretrage, uključujući enzime gušterače i jetre.
English: Cases of ONJ have been reported in patients treated with Sutent, most of which occurred in patients who had identified risk factors for ONJ, in particular, exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4).
Croatian: Prijavljeni su slučajevi osteonekroze čeljusti u bolesnika liječenih lijekom Sutent, većinom u onih koji su imali poznate faktore rizika za osteonekrozu čeljusti, osobito izloženost intravenskim bisfosfonatima i/ili bolest zuba koja je zahtijevala invazivne stomatološke zahvate (vidjeti i dio 4.4).
English: Sunitinib should be used with caution in patients with a known history of QT interval prolongation, patients who are taking antiarrhythmics or medicinal products that can prolong QT interval, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances.
Croatian: Sunitinib treba primjenjivati uz oprez u bolesnika koji su već imali produljenje QT-intervala, bolesnika koji uzimaju antiaritmike ili lijekove koji mogu produljiti QT interval te bolesnika s relevantnim postojećim srčanim bolestima, bradikardijom ili poremećajima ravnoteže elektrolita.
English: Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking Sutent.
Croatian: Obavijestite liječnika ako imate omaglicu, nesvjesticu ili neuobičajene otkucaje srca dok uzimate Sutent.
English: - If you have or have had 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, tell your doctor and dentist immediately.
Croatian: - Ako osjećate ili ste osjećali bol u ustima, zubima i/ili čeljusti, ako imate oteklinu ili bol u usnoj šupljini, ako osjećate utrnulost ili težinu čeljusti ili Vam se klima zub, odmah se obratite liječniku i stomatologu.
English: • Decreased in the amount of blood pumped by the heart.
Croatian: • Smanjena količina krvi koju srce istisne.
English: Among age and bodysize related covariates tested, age was a significant covariate on apparent clearance of sunitinib (the younger the age of the paediatric patient, the lower the apparent clearance).
Croatian: Od testiranih varijabli povezanih s dobi i veličinom tijela, dob je bila značajna varijabla za prividni klirens sunitiniba (što je mlađa dob pedijatrijskih bolesnika, to je niži prividni klirens).
English: Hepatic dysfunction has been reported and may include Liver Function Test abnormalities, hepatitis, or liver failure (see section 4.4).
Croatian: Prijavljen je poremećaj jetrene funkcije koji može uključivati odstupanja rezultata testova jetrene funkcije, hepatitis ili zatajenje jetre (vidjeti dio 4.4).
English: - If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Croatian: - ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile.
English: • Blood clots in the blood vessels.
Croatian: • Stvaranje ugrušaka u krvnim žilama.
English: Table 4 - pNET efficacy results from the Phase 3 study Efficacy parameter
Croatian: Tablica 4. Rezultati djelotvornosti kod pNET-a u ispitivanju faze III
English: Call your doctor immediately if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness while on treatment with Sutent.
Croatian: Odmah se javite svom liječniku ako tijekom liječenja lijekom Sutent nastupe simptomi poput boli ili stezanja u prsima, bolova u rukama, leđima, vratu ili čeljusti, nedostatka daha, obamrlosti ili slabosti na jednoj strani tijela, poteškoća s govorom, glavobolje ili omaglice.
English: IFN- (N = 375)
Croatian: IFN-α (N = 375)
English: The results of this study demonstrated that sunitinib had an effect on QTc interval (defined as a mean placebo-adjusted change of > 10 msec with a 90% confidence interval [CI] upper limit > 15 msec) at therapeutic concentration (Day 3) using the within-day baseline correction method,
Croatian: Rezultati tog ispitivanja pokazali su da sunitinib ima učinak na QTc-interval (definiran kao srednja vrijednost promjene od > 10 ms korigirane za placebo, uz gornju granicu 90%-tnog intervala pouzdanosti od > 15 ms) pri terapijskoj koncentraciji (3. dana) uz primjenu unutardnevne metode korekcije u odnosu na početne vrijednosti te pri koncentraciji većoj od terapijske (9. dana) uz primjenu obiju metoda korekcije u odnosu na početne vrijednosti.
English: The major active metabolite was not evaluated for genotoxic potential.
Croatian: Nije ispitivan genotoksični potencijal glavnog aktivnog metabolita.
English: 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.
Croatian: Obavijestite liječnika ako razvijete bilo koji od sljedećih znakova i simptoma: bol u području trbuha (u gornjem dijelu trbuha), mučninu, povraćanje i vrućicu.
English: Ninety-seven patients were enrolled at various doses and schedules; 55 patients received 50 mg at the recommended treatment Schedule 4 weeks on /2 weeks off (“Schedule 4/2”).
Croatian: U ispitivanje je uključeno 97 bolesnika koji su primali različite doze i sheme doziranja; 55 bolesnika je primalo dozu od 50 mg prema preporučenoj shemi liječenja: 4 tjedna primjene lijeka/2 tjedna bez lijeka („shema 4/2“).
English: In the Phase 1/2 study, stable disease and disease progression was observed in 3 out of 6 patients each (1 patient received neo adjuvant and 1 patient received adjuvant imatinib, respectively).
Croatian: U ovom ispitivanju faze 1/2 stabilna bolest i progresija bolesti opažene su svaka u 3 od 6 bolesnika (1 bolesnik primio je neoadjuvantnu terapiju, a 1 bolesnik adjuvantnu terapiju imatinibom).
English: These complications are caused by the break-down products of dying cancer cells and may include the following: nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorous levels and low calcium levels in the blood) that can lead to changes in kidney function and acute renal failure.
Croatian: Te komplikacije uzrokuju razgradni produkti umirućih stanica raka, a mogu obuhvaćati: mučninu, nedostatak daha, nepravilne otkucaje srca, grčeve u mišićima, napadaje, zamućenje mokraće i umor udruženi s odstupanjima od normalnih vrijednosti laboratorijskih pretraga (visoka razina kalija, mokraćne kiseline i fosfora te niska razina kalcija u krvi), što može izazvati promjene u radu bubrega i akutno zatajenje bubrega.
English: Patients with seizures and signs/symptoms consistent with posterior reversible leukoencephalopathy syndrome (RPLS), such as hypertension, headache, decreased alertness, altered mental functioning and visual loss, including cortical blindness, should be controlled with medical management including control of hypertension.
Croatian: Bolesnike s napadajima te znakovima/ simptomima koji upućuju na sindrom reverzibilne posteriorne leukoencefalopatije (engl. reversible posterior leukoencephalopathy syndrome, RPLS), kao što su hipertenzija, glavobolja, smanjena budnost, promjene mentalnih funkcija te gubitak vida koji obuhvaća i kortikalnu sljepoću, treba kontrolirati i liječiti, uključujući i kontrolu hipertenzije.
English: The relevance to humans of the neoplastic findings observed in the mouse (rasH2 transgenic) and rat carcinogenicity studies with sunitinib treatment is unclear.
Croatian: Nije jasan značaj nalaza neoplazmi u istraživanjima kancerogenosti na (rasH2 transgeničnim) miševima i štakorima za primjenu sunitiniba u ljudi.
English: One hundred six patients (61 patients in the treatment-naïve cohort and 45 patients in the later-line cohort) received treatment with sunitinib orally at 37.5 mg once a day on a continuous daily dosing (CDD) schedule.
Croatian: Stotinu i šest bolesnika (61 bolesnik u kohorti koja prethodno nije bila liječena i 45 bolesnika u kohorti s kasnijom linijom liječenja) primili su peroralnu terapiju sunitinibom u dozi od 37,5 mg jednom na dan u sklopu kontinuiranog dnevnog rasporeda doziranja (engl. continuous daily dosing, CDD).
English: • Tumour lysis syndrome (TLS) - TLS consists of a group of metabolic complications that can occur during treatment of cancer.
Croatian: • Sindrom lize tumora, koji obuhvaća skupinu metaboličkih komplikacija do kojih može doći tijekom liječenja raka.
English: The following terms have been combined: a Nasopharyngitis and oral herpes.
Croatian: * Uključujući događaje sa smrtnim ishodima Objedinjeni su sljedeći termini: Nazofaringitis i oralni herpes
English: Anaemia has been observed to occur early as well as late during treatment with sunitinib.
Croatian: Opaženo je da se anemija javlja i u ranoj i u kasnoj fazi liječenja sunitinibom.
English: Based on nonclinical findings, male and female fertility may be compromised by treatment with sunitinib (see section 5.3).
Croatian: Na temelju nalaza iz nekliničkih istraživanja liječenje sunitinibom može ugroziti plodnost muškaraca i žena (vidjeti dio 5.3).
English: • Fluid retention including around the lungs.
Croatian: • Nakupljanje tekućine u tijelu, uključujući i područje oko pluća.
English: Using comprehensive serial ECG assessments at times corresponding to either therapeutic or greater than therapeutic exposures, none of the patients in the evaluable or intent-to-treat (ITT) populations were observed to develop QTc interval prolongation considered as “severe” (i.e. equal to or greater than Grade 3 by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).
Croatian: Primjenom opsežnih serijskih EKG procjena u vrijeme koje je odgovaralo terapijskoj izloženosti ili izloženosti većoj od terapijske, ni u jednog bolesnika u procjenjivoj populaciji ili u populaciji svih bolesnika s namjerom liječenja (engl. intent-to-treat, ITT) nije uočeno produljenje QTc-intervala koje bi se smatralo "ozbiljnim" (tj. 3. ili većeg stupnja prema CTCAE verziji 3.0).
English: All findings occurred at clinically relevant sunitinib plasma exposure levels.
Croatian: Svi navedeni učinci pojavili su se pri klinički značajnim razinama izloženosti sunitiniba u plazmi.
English: Evidence from a Phase 1/2 study of oral sunitinib conducted in 6 paediatric patients with GIST aged 13 years to 16 years who received sunitinib on Schedule 4/2, at doses ranging between 15 mg/m daily and 30 mg/m daily, and available published data (20 paediatric or young adult patients with GIST) indicated that sunitinib treatment resulted in disease stabilization in 18 of 26 (69.2%) patients, either after imatinib failure or intolerance (16 patients with stable disease out of 21), or de novo/after surgery (2 patients with stable disease out of 5).
Croatian: Dokazi iz ispitivanja faze 1/2 za peroralni sunitinib, provedenog u 6 pedijatrijskih bolesnika s GIST-om u dobi od 13 do 16 godina koji su primali sunitinib po shemi 4/2 u dozama u rasponu od 15 mg/m2 na dan do 30 mg/m2 na dan, i dostupni objavljeni podaci (20 pedijatrijskih ili mlađih odraslih bolesnika s GIST-om) pokazali su da je liječenje sunitinibom dovelo do stabilizacije bolesti u 18 od 26 (69,2 %) bolesnika nakon neuspješnog liječenja imatinibom ili nepodnošenja imatiniba (od 21 bolesnika 16 je postiglo stabilnu bolest), odnosno de novo/nakon operacije (od 5 bolesnika 2 su postigla stabilnu bolest).
English: Based on this analysis, a dose of approximately 20 mg/m daily in paediatric patients, with BSA values between 1.10 and 1.87 m2, is expected to provide plasma exposures to sunitinib and its active metabolite comparable (between 75 and 125% of the AUC) to those in adults with GIST administered sunitinib 50 mg daily on Schedule 4/2 (AUC 1233 ng.hr/mL).
Croatian: Na temelju ove analize očekuje se da će doza od približno 20 mg/m2 na dan u pedijatrijskih bolesnika s rasponom početne površine tijela od 1,10 m2 do 1,87 m2 dati vrijednosti izloženosti sunitinibu i njegovom djelatnom metabolitu u plazmi (između 75 % i 125 % vrijednosti AUC-a) usporedive s onima u odraslih s GIST-om liječenima dozom sunitiniba od 50 mg na dan po shemi 4/2 (vrijednost AUC-a 1233 ng.hr/ml).
English: • 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.
Croatian: • Žuta koža/promjene boje kože, pojačana pigmentacija kože, promjene boje kose, osip na dlanovima i tabanima, osip, suhoća kože.
English: Sutent was not studied in subjects with severe (Child-Pugh Class C) hepatic impairment.
Croatian: Sutent nije ispitivan u ispitanika s teškim oštećenjem jetre (Child-Pugh stadij C).
English: There are no studies in pregnant women using sunitinib.
Croatian: Nisu provedena ispitivanja sunitiniba u trudnica.
English: Notify your doctor as soon as possible if you experience any signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger and loss of consciousness).
Croatian: Što prije obavijestite svog liječnika ako primijetite bilo kakve znakove ili simptome niske razine šećera u krvi (umor, osjećaj lupanja srca, znojenje, glad i gubitak svijesti).
English: There were 9 deaths in the sunitinib arm and 21 deaths in the placebo arm.
Croatian: Zabilježeno je 9 smrtnih slučajeva u skupini koja je primala sunitinib te 21 slučaj u placebo skupini.
English: 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.
Croatian: Bolesnici koji su u 12 mjeseci prije primjene sunitiniba imali neki srčani događaj, primjerice infarkt miokarda (uključujući tešku/nestabilnu anginu), koronarnu/perifernu arterijsku premosnicu, simptomatsko kongestivno zatajenje srca, cerebrovaskularni incident ili tranzitornu ishemijsku ataku, odnosno plućnu emboliju, nisu bili uključeni ni u jedno kliničko ispitivanje sunitiniba.
English: Temporary interruption of sunitinib therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Croatian: Preporučuje se privremen prekid liječenja sunitinibom kao mjera opreza u bolesnika u kojih se planira veći kirurški zahvat.
English: At approximately twice therapeutic concentrations, the maximum QTcF interval change from baseline was 15.4 msec (90% CI: 22.4 msec).
Croatian: Pri približno dvostrukim terapijskim koncentracijama najveća je promjena QTcF-intervala u odnosu na početne vrijednosti iznosila 15,4 ms (90% CI: 22,4 ms).
English: In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.
Croatian: U bolesnika koji nemaju kardijalne faktore rizika treba razmotriti provjeru istisne frakcije na početku liječenja.
English: For pNET, the recommended dose of Sutent is 37.5 mg taken orally once daily without a scheduled rest period.
Croatian: Za liječenje pNET-a preporučena doza lijeka Sutent je 37,5 mg, a uzima se peroralno jedanput na dan bez predviđenog razdoblja odmora.
English: In vitro, binding of sunitinib and its primary active metabolite to human plasma protein was 95% and 90%, respectively, with no apparent concentration dependence.
Croatian: Sunitinib se za proteine plazme in vitro vezuje 95%, a njegov primarni aktivni metabolit 90%, bez vidljive ovisnosti o koncentraciji.
English: Sutent may affect the way your wounds heal.
Croatian: Sutent može utjecati na cijeljenje rana.
English: In clinical studies of sunitinib and from postmarketing surveillance, there have been few reports (< 1%), some fatal, of subjects presenting with seizures and radiological evidence of RPLS.
Croatian: U kliničkim ispitivanjima sunitiniba i u razdoblju nakon stavljanja lijeka u promet zabilježeno je nekoliko slučajeva (< 1%), od kojih neki sa smrtnim ishodom, ispitanika s napadajima i radiološki dokazanim sindromom reverzibilne posteriorne leukoencefalopatije (RPLS).
English: Patients should be carefully monitored for clinical signs and symptoms of CHF while receiving sunitinib especially patients with cardiac risk factors and/or history of coronary artery disease.
Croatian: Bolesnike treba pažljivo nadzirati dok primaju sunitinib kako bi se uočili klinički znakovi i simptomi kongestivnog zatajenja srca, osobito u bolesnika s kardijalnim faktorima rizika i/ili bolešću koronarnih arterija u anamnezi.
English: Cases of pyoderma gangrenosum, generally reversible after discontinuation of sunitinib, have been reported.
Croatian: Prijavljeni su slučajevi gangrenozne piodermije, općenito reverzibilne nakon prekida uzimanja sunitiniba.
English: In clinical studies of sunitinib and from postmarketing surveillance, seizures have been reported.
Croatian: U kliničkim ispitivanjima sunitiniba i u razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi napadaja.
English: Studies in cancer patients have excluded patients with ALT or AST > 2.5 x ULN (upper limit of normal) or > 5.0 x ULN if due to liver metastasis.
Croatian: U ispitivanja onkoloških bolesnika nisu uključivani bolesnici s vrijednostima ALT-a ili AST-a >2,5 x GGN (gornja granica normale) ilivrijednostima >5,0 x GGN ako je porast bio uzrokovan jetrenim metastazama.
English: Adverse reactions reported in clinical trials
Croatian: Tablica 1 Nuspojave prijavljene u kliničkim ispitivanjima
English: Hypothyroidism has been observed to occur early as well as late during treatment with sunitinib (see section 4.8).
Croatian: Hipotireoza je opažena i u ranoj i u kasnoj fazi liječenja sunitinibom (vidjeti dio 4.8).
English: In this analysis, the placebo arm included those patients randomised to placebo who subsequently received open-label sunitinib treatment.
Croatian: U ovoj je analizi skupina koja je primala placebo obuhvaćala bolesnike koji su bili randomizirani na placebo, ali su kasnije liječeni sunitinibom u otvorenoj fazi.
English: In the pivotal Phase 3 GIST study (N = 312), treatment-related fatal cardiac reactions were reported in 1% of patients on each arm of the study (i.e. sunitinib and placebo arms).
Croatian: U pivotalnom ispitivanju GIST-a faze III (N = 312) smrtonosne srčane reakcije povezane s liječenjem pojavile su se u 1% bolesnika u svakoj skupini ispitivanja (tj. u skupinama koje su primale sunitinib odnosno placebo).
English: Additionally, thyroid-stimulating hormone (TSH) elevations were reported in 4 cytokine-refractory MRCC patients (2%).
Croatian: Osim toga, povišene razine hormona koji stimulira štitnjaču (TSH) prijavljene su u 4 bolesnika (2 %) s MRCC-om refraktornim na citokine.