natgillin/translations-raw huggingface dataset:
The study was double blinded (neither the doctor nor the patient knew which treatment the patient was receiving), and it measured the time taken for the disease to get worse.
Študija je bila dvojno slepa (niti zdravnik niti bolnik nista vedela, katero zdravilo bolnik prejema), v njej pa so merili čas do napredovanja bolezni.
In RCC, Sutent was studied in 750 patients whose cancer had not been treated before.
Pri RCC so zdravilo Sutent preučevali pri 750 bolnikih, ki še niso bili zdravljeni.
The study compared the effects of Sutent and interferon alfa (the standard first-line treatment for this type of cancer).
V študiji so primerjali učinke zdravila Sutent z učinki interferona alfa (standardnega zdravila prve izbire za to vrsto raka).
The main measure of effectiveness was ‘ progression-free survival ’ (the length of time until the cancer got worse or the patient died).
Glavno merilo učinkovitosti je bilo „ preživetje brez napredovanja bolezni “ (čas do napredovanja raka ali smrti bolnika).
Sutent was more effective than placebo in GIST: it took 27.3 weeks for the disease to get worse in patients who received Sutent and 6.4 weeks in patients who received placebo.
Zdravilo Sutent je bilo pri GIST učinkovitejše od placeba: bolezen je napredovala v 27, 3 tedna pri bolnikih, ki so prejemali zdravilo Sutent, ter 6, 4 tedna pri bolnikih, ki so prejemali placebo.
The interim results (results calculated before the study was finished) were sufficiently good for the study to be stopped early and for the patients who were receiving placebo to be switched to Sutent.
Vmesni rezultati (rezultati, izračunani preden je bila študija zaključena) so bili dovolj dobri, da so študijo predčasno končali in bolnikom, ki so prejemali placebo, začeli dajati zdravilo Sutent.
In RCC, progression-free survival was longer in the patients taking Sutent.
Pri RCC je bilo obdobje preživetja brez napredovanja bolezni daljše pri bolnikih, ki so jemali zdravilo Sutent.
It took 47.3 weeks for the disease to get worse or the patient to die in the Sutent group, compared with 22.0 weeks in the group taking interferon alfa.
V skupini, ki je jemala zdravilo Sutent, je trajalo 47, 3 tedna, da je bolezen napredovala ali da je bolnik umrl, v primerjavi z 22, 0 tedna v skupini, ki je jemala interferon alfa.
In clinical studies, the most common side effects with Sutent (seen in more than 1 patient in 10) were anaemia (low red blood cell counts), neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), hypothyroidism (underactive thyroid gland), decreased appetite, taste disturbance, headache, hypertension (high blood pressure), epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), dyspepsia (heartburn), abdominal (tummy) pain or distension (bloating), constipation, glossodynia (burning or tingling sensation around the mouth), flatulence (gas), oral (mouth) pain, dry mouth, yellow skin or skin discoloration, palmar-plantar erythrodysaesthesia syndrome (swelling and numbness of the palms and soles of the feet), hair colour changes, rash, dry skin, alopecia (hair loss), pain in the extremities (hands and feet) or limbs, fatigue or asthenia (tiredness or weakness), mucosal inflammation (inflammation of the moist body surfaces), oedema (swelling) decreased ejection fraction (reduced amount of blood pumped out in each heartbeat) and decreased weight.
V kliničnih študijah so bili najpogostejši neželeni učinki zdravila Sutent (opaženi pri več kot 1 bolniku od 10) anemija (nizko število rdečih krvničk), nevtropenija (nizko število belih krvničk), trombocitopenija (nizko število krvnih ploščic), hipotiroidizem (nezadostno delovanje ščitnice), manjši tek, motnje okušanja, glavobol, hipertenzija (visok krvni tlak), epistaksa (krvavitve iz nosu), driska, navzeja (občutek slabosti), bruhanje, stomatitis (vnetje ustne sluznice), dispepsija (zgaga), bolečine ali napetost v trebuhu (napenjanje), zaprtje, glosodinija (pekoč občutek ali mravljinčenje okoli ust), vetrovi, bolečina v ustih, suha usta, rumena koža ali razbarvanje kože, sindrom palmarno- plantarne eritrodizestezije (otekanje in otrplost dlani in podplatov na stopalih), sprememba barve las, izpuščaji, suha koža, alopecija (izpadanje las), bolečine v okončinah (rokah in nogah), utrujenost ali astenija (šibkost), vnetje sluznice (vnetje vlažnih površin telesa), edem (otekanje), zmanjšanje iztisnega deleža (količine krvi, iztisnjene z enim utripom srca) in izguba teže.
For the full list of all side effects reported with Sutent, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sutent, glejte navodilo za uporabo.
Sutent should not be used in people who may be hypersensitive (allergic) to sunitinib or any of the other ingredients.
Zdravila Sutent ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) sunitinib ali katero koli drugo sestavino zdravila.
Caution should be taken when it is given with some medicines, such as rifampicin (used in tuberculosis) or ketoconazole (an antifungal medicine).
Pri sočasnem jemanju z nekaterimi drugimi zdravili, kot sta rifampicin (ki se uporablja pri tuberkulozi) in ketokonazol (zdravilo proti glivicam), je potrebna previdnost.
See the Package Leaflet for the list of the medicines that may interact with Sutent.
Za seznam zdravil, ki utegnejo medsebojno delovati z zdravilom Sutent, glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Sutent’ s benefits are greater than its risks for the treatment of unresectable and/ or metastatic malignant GIST after failure of imatinib mesilate treatment due to resistance or intolerance, and for the treatment of advanced and/ or metastatic RCC.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Sutent za zdravljenje neresektabilnega in/ ali metastatskega malignega GIST, če zdravljenje z imatinibijevim mesilatom zaradi odpornosti ali neprenašanja ni bilo uspešno, ter za zdravljenje napredovalnega in/ ali metastatskega RCC večje od z njim povezanih tveganj.
The Committee recommended that Sutent be given marketing authorisation.
Odbor je priporočal, da se za zdravilo Sutent odobri dovoljenje za promet.
Sutent was originally given ‘ Conditional Approval’.
Zdravilo Sutent je bilo najprej „ pogojno odobreno “.
This means that there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
To pomeni, da so pričakovali več dokazov o zdravilu, zlasti glede zdravljenja karcinoma ledvičnih celic.
As the company had supplied the additional information necessary, the authorisation was switched from ‘ conditional ’ to ‘ normal’ approval on 11 January 2007.
Ker je družba priskrbela dodatne zahtevane podatke, je bilo dne 11. januarja 2007 dovoljenje iz „ pogojnega “ spremenjeno v „ običajno “.
Other information about Sutent:
Druge informacije o zdravilu Sutent:
The European Commission granted a marketing authorisation valid throughout the European Union for Sutent to Pfizer Ltd on 19 July 2006.
Evropska komisija je dovoljenje za promet z zdravilom Sutent, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Ltd dne 19. julija 2006.
The full EPAR for Sutent can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sutent je na voljo tukaj.
SUTENT 12.5 mg hard capsules
SUTENT 12, 5 mg trde kapsule
Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
Vsaka kapsula vsebuje 12, 5 mg sunitiniba (v obliki sunitinibijevega malata).
80.0 mg of mannitol For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Hard capsules.
Trde kapsule.
Gelatin capsules with orange cap and orange body, printed with white ink “ Pfizer” on the cap, “ STN 12.5 mg” on the body, and containing yellow to orange granules.
Na zgornjem delu je z belim črnilom natisnjeno "Pfizer", na spodnjem delu pa "STN 12, 5 mg".
Gastrointestinal Stromal Tumour (GIST) SUTENT is indicated for the treatment of unresectable and/ or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.
Gastrointestinalni stromalni tumor (GIST - Gastrointestinal Stromal Tumour) SUTENT je indiciran za zdravljenje neizrezljivega in/ ali metastatskega malignega gastrointestinalnega stromalnega tumorja (GIST), če zdravljenje z imatinibijevim mesilatom zaradi odpornosti ali neprenašanja ni bilo uspešno.
Metastatic Renal Cell Carcinoma (MRCC) SUTENT is indicated for the treatment of advanced and/ or metastatic renal cell carcinoma (MRCC).
Metastatski karcinom ledvičnih celic (MRCC - Metastatic Renal Cell Carcinoma) SUTENT je indiciran za zdravljenje napredovalega in/ ali metastatskega karcinoma ledvičnih celic (MRCC).
Therapy should be initiated by a physician experienced in the treatment of renal cell carcinoma or GIST.
Terapijo mora uvesti zdravnik, ki ima izkušnje z zdravljenjem karcinoma ledvičnih celic ali GIST.
The recommended dose of SUTENT is one 50 mg dose orally, taken daily for 4 consecutive weeks, followed by a 2-week rest period (schedule 4/ 2) to comprise a complete cycle of 6 weeks.
Priporočeni odmerek SUTENTA je 50 mg peroralno vsak dan 4 tedne zapored; temu sledi 2- tedenski premor (shema 4/ 2), tako da celotni ciklus traja 6 tednov.
Dose adjustments Safety and Tolerability Dose modifications in 12.5-mg steps may be applied based on individual safety and tolerability.
Prilagajanje odmerka Varnost in prenašanje Odmerek je mogoče prilagajati v povečanjih po 12, 5 mg, upoštevaje individualno varnost in prenašanje.
CYP3A4 Inhibitors/ Inducers Co-administration of potent CYP3A4 inducers such as rifampin, should be avoided (see sections 4.4 and 4.5).
Zaviralci/ induktorji CYP3A4 Izogniti se je treba sočasni uporabi močnih induktorjev CYP3A4, npr. rifampina (glejte poglavji 4. 4 in 4. 5).
If this is not possible, the dose of SUTENT may need to be increased in 12.5 mg increments (up to 87.5 mg per day) based on careful monitoring of tolerability.
Če to ni mogoče, bo morda potrebno povečevanje odmerka SUTENTA po 12, 5 mg (do 87, 5 mg na dan), pri čemer moramo bolnikovo prenašanje stalno spremljati.
Co-administration of SUTENT with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5).
Izogniti se je treba sočasni uporabi SUTENTA z močnimi zaviralci CYP3A4, npr. s ketokonazolom (glejte poglavji 4. 4 in 4. 5).
If this is not possible the doses of SUTENT may need to be reduced to a minimum of 37.5 mg daily, based on careful monitoring of the tolerability.
Če to ni mogoče, bo morda potrebno zmanjšanje odmerkov SUTENTA na ne manj kot 37, 5 mg na dan, pri čemer moramo bolnikovo prenašanje stalno spremljati.
Selection of an alternate concomitant medication 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.
2 SUTENT should not be used in paediatric population until further data become available.
Varnost in učinkovitost SUTENTA pri pediatričnih bolnikih nista ugotovljeni.
Elderly patients use:
Uporaba pri starejših bolnikih:
Approximately 34% of the subjects in clinical studies of SUTENT were 65 or over.
Približno 34% preiskovancev v kliničnih študijah SUTENTA je bilo starih 65 let ali več.
No significant differences in safety or effectiveness were observed between younger and older patients.
Med starejšimi in mlajšimi bolniki niso opazili pomembnih razlik v varnosti in učinkovitosti.
No dose adjustment is recommended when administering SUTENT to patients with mild or moderate (Child-Pugh Class A and B) hepatic impairment.
Pri bolnikih z blago ali zmerno jetrno okvaro (razred A in B po Child- Pughu), ki jemljejo SUTENT, prilagoditev odmerka ni potrebna.
SUTENT has not been studied in subjects with Child-Pugh Class C hepatic impairment (see section 5.2).
SUTENT ni bil preizkušen pri bolnikih z jetrno okvaro razreda C po Child- Pughu (glejte poglavje 5. 2).
(see section 5.2).
Kliničnih študij pri bolnikih z okvarjenim delovanjem ledvic niso izvedli (glejte poglavje 5. 2).
SUTENT may be taken with or without food.
Bolnik lahko SUTENT vzame s hrano ali brez nje.
Hypersensitivity to sunitinib malate or to any of the excipients.
Preobčutljivost za sunitinibijev malat ali katerokoli pomožno snov.
Co-administration of potent CYP3A4 inducers such as rifampin, may decrease sunitinib plasma concentrations.
Sočasna uporaba močnih induktorjev CYP3A4, npr. rifampina, lahko zniža koncentracijo sunitiniba v plazmi.
Combination with inducers should therefore be avoided.
Kombinaciji z induktorji se je zato treba izogniti.
If this is not possible, the dosage of SUTENT may need to be increased (see sections 4.2 and 4.5).
Če to ni mogoče, bo morda potrebno povečanje odmerka SUTENTA (glejte poglavji 4. 2 in 4. 5).
Co-administration of strong CYP3A4 inhibitor such as ketoconazole may increase sunitinib plasma concentrations.
Sočasna uporaba močnih zaviralcev CYP3A4, npr. ketokonazola, lahko poveča koncentracijo sunitiniba v plazmi.
Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended.
Priporočljivo je, da izberemo druga sočasna zdravila, ki nimajo potenciala za zaviranje encima oz. je njihov potencial v tem pogledu minimalen.
If this is not possible, the dosage of SUTENT may need to be reduced (see sections 4.2 and 4.5).
Če to ni mogoče, bo morda potrebno zmanjšanje odmerka SUTENTA (glejte poglavji 4. 2 in 4. 5).
Skin and tissues Skin discolouration, possibly due to the active substance colour (yellow) is a common treatment-related adverse event occurring in approximately 30% of patients.
Koža in tkiva Pogost z zdravljenjem povezan neželen učinek, ki je morda posledica barve zdravilne učinkovine (rumena), je obarvanje kože; pojavi se pri približno 30% bolnikov.
Patients should be advised that depigmentation of the hair or skin may also occur during treatment with SUTENT.
Bolnikom je treba povedati, da se lahko med zdravljenjem s SUTENTOM pojavi tudi depigmentacija las ali kože.
Other possible dermatologic effects may include dryness, thickness or cracking of the skin, blisters or occasional rash on the palms of the hands and soles of the feet.
Med drugimi možnimi dermatološkimi učinki so suha, zadebeljena ali razpokana koža, mehurji ali, občasno, izpuščaj na dlaneh in podplatih.
Mouth pain/ irritation was reported in approximately 14% of patients.
Bolečine/ draženje v ustih so opisani pri približno 14% bolnikov.
Dysgeusia (taste disturbance) was reported in approximately 28% of patients.
Disgevzija (motnje okušanja) je opisana pri približno 28% bolnikov.
Haemorrhage Haemorrhagic events, some of which were fatal, reported through post-marketing experience, have included GI, respiratory, tumour, urinary tract and brain haemorrhages.
Krvavitev Med opisanimi krvavitvami v pomarketinškem obdobju, v nekaterih primerih s smrtnim izidom, so bile krvavitve v prebavilih, dihalih, sečilih in možganih ter krvavitve tumorjev.
In clinical trials treatment-related tumour haemorrhage occurred in approximately 2% of patients with GIST.
V kliničnih preskušanjih so se z zdravljenjem povezane krvavitve tumorjev pojavile pri približno 2% bolnikov z GIST.
These events may occur suddenly, and in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage.
Pojavi se lahko nenadoma in se lahko v primeru pljučnih tumorjev pokaže kot huda in smrtno nevarna hemoptiza ali pljučna krvavitev.
Fatal pulmonary haemorrhage occurred in 2 patients receiving SUTENT on a clinical trial of patients with metastatic non-small cell lung cancer (NSCLC).
Med kliničnim preskušanjem pri bolnikih z metastatskim nedrobnoceličnim pljučnim rakom je do pljučne krvavitve s smrtnim izidom prišlo pri 2 bolnikih, ki sta dobivala SUTENT.
Both patients had squamous cell histology.
Oba bolnika sta imela histološko skvamocelularen tip.
SUTENT is not approved for use in patients with NSCLC.
SUTENT ni odobren za uporabo pri bolnikih z nedrobnoceličnim pljučnim rakom.
Bleeding events occurred in 18% of patients receiving SUTENT in a phase 3 GIST Study compared to 17% of patients receiving placebo.
V študiji 3. faze pri GIST so pojave krvavitev zabeležili pri 18% bolnikov, ki so dobivali SUTENT, in pri 17% bolnikov, ki so dobivali placebo.
In patients receiving SUTENT for treatment-naïve MRCC, 28% had bleeding events compared to 7% of patients receiving IFN-α.
Med bolniki, ki so dobivali SUTENT za še nezdravljen MRCC, je imelo pojave krvavitev
Seven (1.9%) patients on sunitinib malate versus 0% of patients on IFN-α experienced Grade 3 or greater treatment-related bleeding events.
3 28%, med bolniki, ki so dobivali IFN- α, pa 7%.
Of patients receiving sunitinib malate for cytokine-
Z zdravljenjem povezane krvavitve 3. ali višje stopnje so se pojavile pri 7 (1, 9%) od bolnikov, ki so dobivali sunitinibijev malat, in pri nobenem od bolnikov (0%), ki so dobivali IFN- α.
3 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.
Epistaxis was the most common treatment-related haemorrhagic adverse event, having been reported for approximately half of the patients with solid tumours who experienced haemorrhagic events.
Najpogostejši z zdravljenjem povezani hemoragični neželeni učinek je bila epistaksa; zabeležili so jo pri približno polovici tistih bolnikov s čvrstimi tumorji, pri katerih se je pojavila kakšna krvavitev.
Some of these events were severe, but very rarely fatal.
Nekatere od teh krvavitev so bile hude, vendar so se zelo redko končale s smrtnim izidom.
Gastrointestinal events Nausea, diarrhoea, stomatitis, dyspepsia and vomiting were the most commonly reported treatment-related gastrointestinal events.
Učinki na prebavila Najpogosteje opisani z zdravljenjem povezani učinki na prebavilih so bili navzea, diareja, stomatitis, dispepsija in bruhanje.
Supportive care for gastrointestinal adverse events requiring treatment may include medication with an anti- emetic or anti-diarrhoeal medication.
Če neželeni učinki na prebavilih zahtevajo zdravljenje, lahko podporna oskrba vključuje uporabo antiemetikov ali antidiaroikov.
Gastrointestinal 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.
Treatment-related fatal gastrointestinal bleeding occurred in 0.5% of patients receiving placebo in the GIST Phase 3 study.
V študiji 3. faze pri GIST je pri 0, 5% bolnikov, ki so prejemali placebo, prišlo do smrtnih z zdravljenjem povezanih krvavitev v prebavilih.
Hypertension Treatment-related hypertension was reported in approximately 16% of patients with solid tumours.
Hipertenzija Z zdravljenjem povezano hipertenzijo so ugotovili pri približno 16% bolnikov s čvrstimi tumorji.
SUTENT dosing was reduced or temporarily delayed in approximately 2.7% of this patient population.
Odmerek SUTENTA so zmanjšali ali začasno odložili pri približno 2, 7% te populacije.
None of these patients were discontinued from treatment with SUTENT.
Pri nobenem bolniku pa zdravljenja s SUTENTOM niso prekinili.
Severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic) occurred in 4.7% of this patient population.
Huda hipertenzija (sistolični tlak > 200 mmHg ali diastolični tlak > 110 mmHg) se je pojavila pri 4, 7% te populacije bolnikov.
Treatment-related hypertension was reported in approximately 24% of patients receiving sunitinib malate for treatment-naïve MRCC compared to 1% of patients receiving IFN-α.
Z zdravljenjem povezana hipertenzija se je pojavila pri približno 24% bolnikov, ki so prejemali sunitinibijev malat za še nezdravljen MRCC, in pri 1% bolnikov, ki so prejemali IFN- α.
Severe hypertension occurred in 5% of treatment-naïve patients on sunitinib malate and 1% of patients on IFN-α.
Huda hipertenzija se je pojavila pri 5% predhodno nezdravljenih bolnikov, ki so prejemali sunitinibijev malat, ter pri 1% bolnikov, ki so prejemali IFN- α.
Patients should be screened for hypertension and controlled as appropriate.
Pri bolnikih je treba opraviti presejanje za hipertenzijo in jih ustrezno kontrolirati.
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 patientson 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.
None of these events in the phase 3 studies were fatal, but rare fatal haematological events have been reported through post-marketing experience.
Pri nobenem od teh dogodkov v študijah 3. faze ni bilo smrtnih izidov, a redki hematološki dogodki s smrtnim izidom so bili opisani med obdobjem postmarketinške uporabe.
Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.
Bolnikom, zdravljenim s SUTENTOM, je treba na začetku vsakega ciklusa zdravljenja pregledati celotno krvno sliko.
Cardiovascular Cardiovascular events, some of which were fatal, reported through post-marketing experience, have included left ventricular ejection fraction (LVEF) decrease and cardiac failure.
Bolezni srca in ožilja Med opisanimi srčno- žilnimi dogodki v pomarketinškem obdobju, v nekaterih primerih s smrtnim izidom, sta bila zmanjšanje iztisnega deleža levega prekata (LVEF) in srčno popuščanje.
In clinical trials, decreases in LVEF of ≥ 20% and below the lower limit of normal occurred in approximately 2% of SUTENT-treated GIST patients, 4% of cytokine-refractory MRCC patients, 2% of placebo-treated patients.
V kliničnih preskušanjih se je zmanjšanje LVEF za ≥ 20% in pod spodnjo mejo normalnega območja se je med zdravljenjem s SUTENTOM pojavilo pri približno 2% bolnikov z GIST in 4% bolnikov z MRCC, odpornem proti citokinom, med uporabo placeba pa pri 2% bolnikov.
These LVEF declines do not appear to have been progressive and often improved as treatment continued.
Zmanjšanje LVEF ni napredovalo in se je med nadaljevanjem zdravljenja pogosto izboljšalo.
In the treatment-naïve MRCC study, 21% patients on SUTENT and 12% of patients on interferon-α (IFN-α), had an LVEF value below the lower limit of normal.
V študiji še nezdravljenega MRCC je imelo LVEF pod spodnjo normalno vrednostjo 21% bolnikov, ki so dobivali SUTENT, in
One (< 1%) patient who received SUTENT was diagnosed with congestive heart failure (CHF).
Pri enem bolniku (< 1%), ki je dobival SUTENT, so diagnosticirali kongestivno srčno popuščanje.
Treatment-related adverse events of ‘ cardiac failure’, ‘ cardiac failure congestive’ or ‘ left ventricular failure’ were reported in 0.7% of patients with solid tumours and 1% of patients treated with placebo.
Z zdravljenjem povezani neželeni učinki "srčno popuščanje", "kongestivno srčno popuščanje" oz. "popuščanje levega prekata" so bili opisani pri 0, 7% bolnikov s čvrstimi tumorji in pri 1% bolnikov, ki so prejemali placebo.
All patients had GIST.
Vsi bolniki so imeli GIST.