natgillin/translations-raw huggingface dataset:
The relevance to humans of the neoplastic findings observed in the mouse (rasH2 transgenic) and rat carcinogenicity studies with sunitinib treatment is unclear.
Pomen ugotovitev, ki se nanašajo na neoplastične spremembe opažene pri miših (rasH2 transgenih) in študije kancerogenosti na podganah, zdravljenih s sunitinibom, za človeka ni jasen.
Monitor liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) before initiation of treatment, during each cycle of treatment, and as clinically indicated.
Nadzirati je treba rezultate testov jetrne funkcije (alanin transaminazo [ALT], aspartat transaminazo [AST], ravni bilirubina) pred začetkom zdravljenja, med vsakim ciklom zdravljenja, in kadar je klinično indicirano.
• Decreased in the amount of blood pumped by the heart.
• zmanjšana količina krvi, ki jo prečrpa srce
In patients who have previously received or are receiving intravenous bisphosphonates, invasive dental procedures should be avoided if possible (see section 4.8).
Pri bolnikih, ki so predhodno prejemali ali trenutno prejemajo intravenske bisfosfonate, se je treba, če je le mogoče, izogibati invazivnim zobozdravstvenim posegom (glejte poglavje 4.8).
• Problems with wound healing after surgery.
• težave s celjenjem rane po kirurškem posegu
The dose of sunitinib was reduced or its administration temporarily suspended in approximately 2.7% of the patients who experienced hypertension.
Odmerek sunitiniba so zmanjšali ali začasno odložili odmerjanje pri približno 2,7 % bolnikov s hipertenzijo.
In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.
Pri bolnikih brez kardialnih dejavnikov tveganja je treba razmisliti o izhodiščni oceni iztisnega deleža.
It is unknown whether patients with these concomitant conditions may be at a higher risk of developing sunitinib-related left ventricular dysfunction.
Ni znano, ali je pri bolnikih s temi sočasno prisotnimi boleznimi tveganje za razvoj s sunitinibom povezanega nepravilnega delovanja levega ventrikla lahko povečano.
Cases of overdose have been reported; some cases were associated with adverse reactions consistent with the known safety profile of sunitinib.
Poročali so o primerih prevelikega odmerjanja; nekateri primeri so bili povezani z neželenimi učinki, ki so se ujemali z znanim varnostnim profilom sunitiniba.
If you take more Sutent than you should
Če ste vzeli večji odmerek zdravila Sutent, kot bi smeli
Tell your doctor if you have any bleeding while on treatment with Sutent.
Obvestite zdravnika, če imate krvavitev med zdravljenjem z zdravilom Sutent.
- If you have or have had damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).
Če imate ali ste imeli poškodbe najmanjših krvnih žil, znane kot trombotična mikroangiopatija (TMA).
The observed adverse drug reactions were similar overall to those seen in adults (see section 4.8).
Opaženi neželeni učinki zdravila so bili na splošno podobni tistim pri odraslih (glejte poglavje 4.8).
Population PK analyses of demographic data indicate that no starting dose adjustments are necessary for weight or Eastern Cooperative Oncology Group (ECOG) performance status.
Populacijske FK analize demografskih podatkov kažejo, da začetnega odmerka ni treba prilagajati glede na telesno maso ali stanje zmogljivosti, ocenjeni po lestvici ECOG (Eastern Cooperative Oncology Group).
From a 2-sided log-rank test.
a iz dvostranskega log-rang testa
No subjects experienced an effect on the QTc interval greater than Grade 2 (CTCAE version 3.0) (see section 4.4).
Pri nobenem preskušancu niso ugotovili učinka na interval QTc, ki bi bil večji od stopnje 2 (CTCAE, različica 3.0) (glejte poglavje 4.4).
- Do not use this medicine after the expiry date which is stated on carton, bottle and blister foil after “EXP”.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, plastenki in pretisnem omotu poleg oznake “Uporabno do”.
NA 0.0066
N/A 0,0066
Therefore, the decision to resume sunitinib therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.
Zato mora odločitev o ponovnem začetku zdravljenja s sunitinibom temeljiti na klinični presoji okrevanja po kirurškem posegu.
Similarly, body surface area was a significant covariate on the apparent clearance of the active metabolite (the lower the body surface area, the lower the apparent clearance).
Podobno je bila telesna površina pomembna sospremenljivka navideznega očistka aktivnega presnovka (manjša kot je bila telesna površina, manjši je bil navidezni očistek).
Median overall OS was 5.1 months in the HGG group and 12.3 months in the ependymoma group.
Mediano celokupno OS je bilo 5,1 meseca v skupini s HGG in 12,3 meseca v skupini z ependimomom.
Sutent can be taken with or without food.
Zdravilo Sutent lahko vzamete s hrano ali brez nje.
Sunitinib (0.3, 1.0, 3.0 mg/kg/day) was evaluated in a pre-and postnatal development study in pregnant rats.
Sunitinib (0,3; 1,0; 3,0 mg/kg/dan) so ocenili v študiji pre- in postnatalnega razvoja pri brejih podganah.
Results from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) showed that the overall global health-related quality of life and the 5 functioning domains (physical, role, cognitive, emotional, and social) were maintained for patients on sunitinib treatment as compared to placebo with limited adverse symptomatic effects.
Rezultati iz vprašalnika Evropske organizacije za raziskave in zdravljenje rakavih bolezni, ki se je nanašal na kakovost življenja /European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)/ so pokazali, da so se ohranili celokupna, s splošnim zdravstvenim stanjem povezana kakovost življenja in 5 življenjskih področij (fizično, funkcijsko, kognitivno, čustveno in socialno) pri bolnikih, ki so se zdravili s sunitinibom, v primerjavi s placebom, z omejenimi neželenimi simptomatskimi učinki.
If you experience dizziness or you feel unusually tired, take special care when driving or using machines.
Če vas obide omotica ali nenavadna utrujenost, bodite pri upravljanju vozil in strojev posebno previdni.
Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking Sutent.
Obvestite zdravnika, če ste hitreje utrujeni, če vas ponavadi bolj zebe kot druge ljudi ali se je vaš glas poglobil med jemanjem zdravila Sutent.
Some of the epistaxis events were severe, but very rarely fatal.
Nekatere epistakse so bile hude, vendar so se zelo redko končale s smrtnim izidom.
Sutent can cause abnormality of your heart rhythm.
Zdravilo Sutent lahko povzroči nepravilnosti vašega srčnega ritma.
Caution should therefore be exercised when Sutent and intravenous bisphosphonates are used either simultaneously or sequentially.
Zato je pri sočasnem ali zaporednem dajanju zdravila Sutent in intravenskih bisfosfonatov potrebna previdnost.
Notify your doctor as soon as possible if you have high blood pressure, headache, or loss of sight.
Obvestite zdravnika, kakor hitro je mogoče, če se pri vas pojavi visok krvni tlak, glavobol ali izguba vida.
Severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic) was reported in 4.7% of patients with solid tumours.
Huda hipertenzija (sistolični tlak > 200 mmHg ali diastolični tlak > 110 mmHg) se je pojavila pri 4,7 % bolnikov s čvrstimi tumorji.
• Heart attack caused by an interrupted or decreased blood supply to the heart.
• srčni infarkt zaradi prekinjenega ali zmanjšanega dotoka krvi v srce
Nevertheless, most of these adverse events observed in clinical studies were not considered related to study treatment (see section 4.4).
Kljub temu so ocenili, da večina teh neželenih učinkov, opaženih v kliničnih študijah, ni bila povezana z zdravilom v študiji (glejte poglavje 4.4).
Furthermore, according to the published literatures in paediatric patients with GIST, the calculated starting dose ranged from 16.6 mg/m to 36 mg/m increased to doses as high as 40.4 mg/m
Nadalje je skladno z objavljeno literaturo pri pediatričnih bolnikih z GIST izračunani začetni odmerek znašal od 16,6 mg/m 2 do 36 mg/m 2, ki so ga povečali celo do odmerka 40,4 mg/m
All thyroid-related events reported were Grade 1-2 (see section 4.4).
Vsi s ščitnico povezani dogodki, o katerih so poročali, so bili 1.-2. stopnje (glejte poglavje 4.4).
b Efficacy results for the 99 subjects who crossed over from placebo to Sutent after unblinding.
b Rezultati učinkovitosti za 99 bolnikov, ki so po razkritju zamenjali placebo z zdravilom Sutent.
Demographics were comparable between the sunitinib and placebo groups.
Demografski podatki so bili med skupinama, ki sta prejemali sunitinib oziroma placebo, primerljivi.
Changes in sunitinib PK parameters were of no clinical significance and did not indicate any drug-drug interactions; however, considering the relatively low number of subjects (i.e. N=7+4) and the moderate-large interpatient variability in the pharmacokinetic parameters, caution needs to be taken when interpreting the PK drug-drug interaction findings from this study.
Spremembe FK parametrov sunitiniba niso bile klinično pomembne in niso kazale na medsebojno delovanje zdravil, vendar je, glede na sorazmerno majhno število preskušancev (tj. n = 7 + 4) in zmerno do veliko variabilnost FK parametrov med bolniki, pri interpretaciji izsledkov o FK medsebojnem delovanju zdravil iz te študije potrebna previdnost.
These may be caused by inflammation of the pancreas or gallbladder.
Ti so lahko posledica vnetja trebušne slinavke ali žolčnika.
This analysis was based on data collected from adults with GIST or solid tumours and from paediatric patients with solid tumours.
Ta analiza je temeljila na podatkih, pridobljenih pri odraslih z GIST ali čvrstimi tumorji ter pri pediatričnih bolnikih s čvrstimi tumorji.
Tell your doctor if you experience altered frequency or absence of urination which may be symptoms of kidney failure.
Obvestite zdravnika, če imate spremenjeno frekvenco ali odsotnost uriniranja, kar so lahko simptomi odpovedi ledvic.
Other endpoints included ORR, OS, and safety.
Drugi opazovani dogodki so bili ORR, OS in varnost.
Sunitinib has not been studied in subjects with severe (Child-Pugh class C) hepatic impairment and therefore its use in patients with severe hepatic impairment cannot be recommended (see section 5.2).
Sunitiniba niso preskušali pri bolnikih z resno jetrno okvaro razreda C po Child-Pughu in zato njegova uporaba pri bolnikih z resno jetrno okvaro ni priporočljiva (glejte poglavje 5.2).
No cases with fatal outcome were reported in GIST, MRCC, and pNET registrational studies.
V registracijskih študijah GIST, MRCC in pNET niso poročali o smrtnih izidih.
Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria.
Priporočljiva je izhodiščna analiza urina, bolnike pa je treba spremljati, da bi odkrili pojav ali poslabšanje proteinurije.
The rash may progress to widespread blistering or peeling of the skin and may be life-threatening.
Izpuščaj lahko napreduje do obširnih mehurjev na koži in luščenja kože in je lahko življenjsko ogrožajoč.
• Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• hude reakcije na koži in/ali sluznicah (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem)
All study participants experienced adverse drug reactions; most of these were severe (toxicity grade ≥ 3) and included cardiac toxicity.
Pri vseh preskušancih so se pojavili neželeni učinki zdravila; večina neželenih učinkov je bila hudih (stopnja toksičnosti ≥ 3) in so vključevali kardiotoksičnost.
Effect of Breast Cancer Resistance Protein (BCRP) inhibitors Limited clinical data are available on the interaction between sunitinib and BCRP inhibitors and the possibility of an interaction between sunitinib and other BCRP inhibitors cannot be excluded (see section 5.2).
Učinek zaviralcev beljakovine odpornosti pri raku dojke (BCRP - Breast Cancer Resistance Protein) Klinični podatki o medsebojnem delovanju med sunitinibom in zaviralci BCRP so omejeni; možnosti medsebojnega delovanja med sunitinibom in drugimi zaviralci BCRP ni mogoče izključiti (glejte poglavje 5.2).
Tumour haemorrhage may occur suddenly, and in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage.
Krvavitve tumorjev se lahko pojavijo nenadoma in se lahko v primeru pljučnih tumorjev pokažejo kot huda in življenjsko ogrožajoča hemoptiza ali pljučna krvavitev.
There are no studies in pregnant women using sunitinib.
Študij z uporabo sunitiniba pri nosečnicah ni.
c The interim PFS numbers have been updated based on a recalculation of the original data.
c Vmesne vrednosti PFS (preživetje brez napredovanja bolezni) so posodobili na podlagi preračunanih originalnih podatkov.
Your doctor may check your blood pressure during treatment with Sutent, and you may be treated with medicines to reduce the blood pressure, if needed.
Med zdravljenjem z zdravilom Sutent bo zdravnik morda preverjal vaš krvni tlak in če bo treba, vas bodo zdravili z zdravili za zniževanje krvnega tlaka.
In order to rule out bias in the investigator-based assessment of PFS, a BICR of scans was performed; this review supported the investigator assessment, as shown in Table 4.
Da bi izključili pristranskost pri ocenjevanju PFS, ki so ga izvajali raziskovalci, so opravili slepo neodvisno centralno preverjanje pregledov; to preverjanje je podprlo ocene raziskovalcev, kot je prikazano v Preglednici 4.
a 2-sided unstratified log-rank test b
2-stranski nestratificiran log-rang test
In the 807 patients who received long-term sunitinib treatment, most treatment-related adverse events (TRAEs) occurred initially in the first 6 months-1 year and then were stable or decreased in frequency over time, with the exception of hypothyroidism, which gradually increased over time, with new cases occurring over the 6 year period.
Pri 807 bolnikih, ki so se dolgotrajno zdravili s sunitinibom, se je večina z zdravljenjem povezanih neželenih učinkov (TRAEs - treatment-related adverse events) najprej pojavila v obdobju prvih 6 mesecev do 1 leta, ki so nato ostali nespremenjeni oziroma se je njihova pogostnost s časom zmanjševala, z izjemo hipotiroidizma, katerega pogostnost se je s časom postopno povečala, saj so se v 6-letnem obdobju pojavili novi primeri.
- If you have had a recent problem with blood clots in your veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
- Če ste imeli pred kratkim težave s krvnimi strdki v venah in/ali arterijah (vrste krvnih žil), vključno z možgansko kapjo, srčnim infarktom, embolijo ali trombozo.
Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, and metastatic progression of cancer.
Sunitinib zavira več receptorskih tirozin-kinaz (RTK), vpletenih v rast tumorja, neoangiogenezo in metastatsko napredovanje raka.
• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
• nenormalna razgradnja mišic, ki lahko povzroči težave z ledvicami (rabdomioliza)
Although sunitinib and its primary metabolite were not eliminated through haemodialysis in subjects with ESRD, the total systemic exposures were lower by 47% for sunitinib and 31% for its primary metabolite compared to subjects with normal renal function.
Čeprav se sunitinib in njegov glavni presnovek ne izločata s hemodializo, je pri bolnikih z ESRD celotna sistemska izpostavljenost manjša za 47 % pri sunitinibu in za 31 % pri njegovem glavnem presnovku v primerjavi z osebami z normalnim delovanjem ledvic.
• High blood pressure.
• visok krvni tlak
In these paediatric patients without previous exposure to anthracyclines or cardiac irradiation, the maximum tolerated dose (MTD) has been identified (see section 5.1).
Pri teh pediatričnih bolnikih brez predhodne izpostavljenosti antraciklinom ali obsevanju srca so ugotovili največji odmerek, ki ga bolniki še prenašajo (MTD - maximum tolerated dose) (glejte poglavje 5.1).
The median duration of treatment was 11.1 months (range: 0.4-46.1) for sunitinib treatment and 4.1 months (range: 0.1-45.6) for IFN-α treatment.
Mediano trajanje zdravljenja je bilo 11,1 meseca (razpon: 0,4-46,1) za zdravljenje s sunitinibom in 4,1 meseca (razpon: 0,1-45,6) za zdravljenje z IFN-.
Because active substances are commonly excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants, women should not breast-feed while taking Sutent.
Ker se učinkovine pogosto izločajo v materino mleko in ker obstaja možnost resnih neželenih reakcij pri dojenih otrocih, ženske, ki jemljejo zdravilo Sutent, ne smejo dojiti.
None of these events in the Phase 3 studies were fatal, but rare fatal haematological events, including haemorrhage associated with thrombocytopenia and neutropenic infections, have been reported during postmarketing surveillance.
Pri nobenem od teh dogodkov v študijah 3. faze ni bilo smrtnih izidov, vendar pa so o redkih hematoloških dogodkih s smrtnim izidom, vključno s krvavitvijo, povezano s trombocitopenijo in nevtropeničnimi okužbami, poročali med nadzorom v obdobju trženja zdravila.
Increases in the QTc interval to over 500 msec were reported in 0.5%, and changes from baseline in excess of 60 msec were reported in 1.1% of the 450 solid tumour patients; both of these parameters are recognised as potentially significant changes.
O podaljšanju intervala QTc, daljšemu kot 500 milisekund, so poročali pri 0,5 %, o spremembah od izhodišča, večjih od 60 milisekund, pa pri 1,1 % od 450 bolnikov s čvrstimi tumorji; oba parametra veljata za potencialno pomembni spremembi.
What Sutent is and what it is used for What you need to know before you take Sutent How to take Sutent
Kaj je zdravilo Sutent in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sutent Kako jemati zdravilo Sutent Možni neželeni učinki
No formal clinical studies of the effect of sunitinib on wound healing have been conducted.
Formalne klinične študije o vplivu sunitiniba na celjenje ran niso bile izvedene.
Sunitinib and/or its metabolites are excreted in rat milk.
Sunitinib in/ali njegovi presnovki se pri podganah izločajo v mleko.
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.
V študije pri bolnikih z rakom niso bili vključeni bolniki z ALT ali AST > 2,5 x ZMN (zgornjo mejo normale) oz. > 5,0 x ZMN, če je šlo za posledico jetrnih metastaz.
All findings occurred at clinically relevant sunitinib plasma exposure levels.
Vsi izsledki so se pojavili pri izpostavljenosti klinično pomembnim količinam sunitiniba v plazmi.
• Overproduction of thyroid hormones which increases the amount of energy the body uses at rest.
• prekomerno izločanje ščitničnih hormonov, ki povzročijo, da telo ob mirovanju porabi več energije
Results for ORR are given as percent of subjects with confirmed response with the 95% CI.
d Rezultati za ORR (objektivni odziv na zdravljenje) so podani kot odstotek bolnikov s potrjenim odzivom z IZ 95 %.
- Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib.
- Gastrointestinalni stromalni tumor (GIST), vrsta raka na želodcu in črevesju, kjer zdravljenje z imatinibom (drugim zdravilom proti raku) ni več učinkovito ali imatiniba ne morete jemati.
Hypertension has been reported in association with sunitinib, including severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic).
V povezavi s sunitinibom so poročali o hipertenziji, vključno s hudo hipertenzijo (sistolični tlak > 200 mmHg ali diastolični tlak > 110 mmHg).
• Complication of severe infection (infection is present in the bloodstream) that can lead to tissue damage, organ failure, and death.
• zaplet hude okužbe (okužba je prisotna v krvnem obtoku), ki lahko privede do poškodbe tkiva,
The calculated in vitro Ki values for all cytochrome P450 (CYP) isoforms tested (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, and CYP4A9/11) indicated that sunitinib and its primary active metabolite are unlikely to induce metabolism, to any clinically relevant extent, of other actives substances that may be metabolised by these enzymes.
Na podlagi izračunanih in vitro vrednosti Ki za vse testirane izooblike citokromov P450 - 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 pomemben vpliv na indukcijo presnove učinkovin, ki se presnavljajo s temi encimi.
Data from non clinical (in vitro and in vivo) studies, at doses higher than the recommended human dose, indicated that sunitinib has the potential to inhibit the cardiac action potential repolarisation process (e.g., prolongation of QT interval).
Podatki iz predkliničnih 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).
This analysis provided a conservative estimate of the treatment effect of sunitinib and supported the primary analysis, demonstrating a hazard ratio of 0.507 (95% CI: 0.350, 0.733), p=0.000193.
Ta analiza je prispevala konzervativno oceno učinka zdravljenja s sunitinibom in podprla primarno analizo, pri čemer je izkazovala razmerje ogroženosti 0,507 (95 % IZ: 0,350, 0,733), p = 0,000193.
Sunitinib and its primary active metabolite were the major compounds identified in plasma, urine, and faeces, representing 91.5%, 86.4%, and 73.8% of radioactivity in pooled samples, respectively.
Sunitinib in njegov primarni aktivni presnovek sta glavni spojini v plazmi, urinu in blatu ter predstavljata 91,5 % (plazma), 86,4 % (urin) oz. 73,8 % (blato) radioaktivnosti v kumuliranih vzorcih.
Studies in animals have shown reproductive toxicity including foetal malformations (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, vključno z malformacijami ploda (glejte poglavje 5.3).
If Sutent is used during pregnancy or if the patient becomes pregnant while on treatment with Sutent, the patient should be apprised of the potential hazard to the foetus.
Če se zdravilo Sutent uporablja med nosečnostjo ali če bolnica med zdravljenjem z zdravilom Sutent zanosi, jo moramo seznaniti z možnimi nevarnostmi za plod.
The most frequent events included cerebrovascular accident, transient ischaemic attack, and cerebral infarction.
Med najpogostejšimi dogodki so bili cerebrovaskularni insult, prehodna možganska ishemija in možganski infarkt.
Blood glucose levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicinal product's dosage needs to be adjusted to minimise the risk of hypoglycaemia (see section 4.8).
Pri sladkornih bolnikih je treba redno preverjati ravni glukoze v krvi, da se oceni, če je treba za zmanjšanje tveganja za hipoglikemijo prilagoditi odmerek antidiabetika (glejte poglavje 4.8).
Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice (see section 4.4).
Bolnike z znaki ali simptomi toksičnih učinkov na mišice je treba obravnavati v skladu s standardno zdravniško prakso (glejte poglavje 4.4).
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 3do 4-kratno, njegov primarni aktivni presnovek pa 7- do 10-kratno.
Dose-limiting cardiotoxicity was observed in the first part of the study which was therefore amended to exclude patients with previous exposure to potentially cardiotoxic therapies (including anthracyclines) or cardiac radiation.
V prvem delu študije so opazili kardiotoksičnost, ki je omejevala odmerek, zato so iz študije izključili bolnike, ki so bili predhodno izpostavljeni potencialno kardiotoksičnemu zdravljenju (vključno z antraciklini) ali obsevanju srca.