FrancophonIA/ELRC3.0 huggingface dataset:
English: In the paediatric population, clearance of temsirolimus was lower and exposure (AUC) was higher than in adults.
Slovenian: Pri pediatrični populaciji je bil očistek temsirolimusa iz organizma manjši, izpostavljenost (AUC) pa večja kot pri odraslih.
English: The primary endpoint of the study was PFS, as assessed by an independent radiologist and oncology review.
Slovenian: Primarni opazovani dogodek je bil PFS, ugotovljen s pregledom neodvisnega radiolog in onkologa.
English: The mean ±standard deviation (SD) dissociation constant (Kd) of binding was 5.1 ± 3.0 ng/ml, denoting the concentration at which 50% of binding sites in blood cells were occupied.
Slovenian: Povprečje ± standardna deviacija (SD) disociacijske konstante (Kd) vezave je bilo 5,1 ± 3,0 ng/ml, kar pomeni koncentracijo, pri kateri je bilo zasedenih 50 % vezavnih mest v krvničkah.
English: Secondary efficacy endpoints included OS and ORR.
Slovenian: Sekundarni opazovani dogodek je bila ocena učinkovitosti, ki je vključevala OS in ORR.
English: Temsirolimus and sirolimus were demonstrated to be substrates for P-gp in vitro.
Slovenian: Dokazali so, da sta temsirolimus in sirolimus substrata za P-gp in vitro.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01X E09
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinske kinaze; oznaka ATC: L01XE09
English: One-year survival rate % (97.5% CI) a Compared with inv choice based on Cox proportional hazard model.
Slovenian: Celokupno preživetje meseci (95 % IZ) Enoletno preživetje % (97,5 % IZ) V primerjavi z inv choice (= zdravljenje po izbiri raziskovalca) na podlagi Coxovega modela proporcionalnega tveganja.
English: In an in vitro study, temsirolimus inhibited the transport of P-glycoprotein (P-gp) substrates with an IC50 value of 2 µM.
Slovenian: V študiji in vitro je temsirolimus zaviral transport substratov P-glikoproteina (P-gp) z vrednostjo IC50 2 µM.
English: Cases of anaemia have been reported in RCC and MCL (see section 4.8).
Slovenian: Pri RCC in MCL so poročali o primerih anemije (glejte poglavje 4.8).
English: For patients with MCL, it is recommended that coadministration of CYP3A4/5 inducers should be avoided due to the higher dose of temsirolimus (see section 4.5).
Slovenian: Pri bolnikih z MCL je priporočljivo izogibanje sočasni uporabi induktorjev CYP3A4/5, zaradi večjega odmerka temsirolimusa (glejte poglavje 4.5).
English: Temsirolimus has been associated with phospholipidosis in rats.
Slovenian: Temsirolimus povezujejo s fosfolipidozo pri podganah.
English: c Compared with inv choice based on log-rank test. d Compared with inv choice alone based on Fisher's exact test.
Slovenian: V primerjavi z inv choice samo na podlagi Fisherjevega eksaktnega testa.
English: In vivo, the effect of P-gp inhibition has not been investigated in a clinical drugdrug interaction study, however, recent preliminary data from a Phase 1 study of combined lenalidomide (dose of 25 mg) and temsirolimus (dose of 20 mg) seem to support the in vitro findings and suggest an increased risk of adverse events.
Slovenian: In vivo učinka zaviranja P-gp v kliničnih študijah medsebojnega delovanja niso raziskali, vendar pa nedavni preliminarni podatki iz študije 1. faze kažejo, da uporaba kombinacije lenalidomida (odmerek 25 mg) in temsirolimusa (odmerek 20 mg) podpira ugotovitve in vitro in kaže na povečano tveganje za pojav neželenih učinkov.
English: c Based on Cochran-Mantel-Hansel test stratified by prior nephrectomy and region.
Slovenian: Na podlagi Cochran-Mantel-Haenszelovega testa, stratificiranega po predhodni nefrektomiji in regiji.
English: In vitro, at high concentrations (10-20 M), temsirolimus can bind and inhibit mTOR in the absence of FKBP-12.
Slovenian: In vitro lahko temsirolimus v velikih koncentracijah (10-20 M) veže in zavre mTOR v odsotnosti FKBP-12.
English: Tell your doctor if you develop any of the following signs and symptoms of liver problems during Torisel treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area.
Slovenian: Povejte zdravniku, če se vam med zdravljenjem z zdravilom Torisel pojavi katerikoli od naslednjih znakov in simptomov težav z jetri: srbenje, porumenelost oči in kože, temen urin, bolečina ali nelagodje v zgornjem desnem predelu trebuha.
English: Treatment with Torisel should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Slovenian: Zdravljenje z zdravilom Torisel je treba nadaljevati, dokler pri bolniku ne preneha klinična korist ali dokler se ne pojavi nesprejemljiva toksičnost.
English: Intestinal puncture, tear or holes
Slovenian: Predrtje črevesa, raztrganine ali luknje
English: Carcinogenicity studies have not been conducted with temsirolimus; however, sirolimus, the major metabolite of temsirolimus in humans, was carcinogenic in mice and rats.
Slovenian: Raziskav kancerogenosti s temsirolimusom niso izvedli; je pa bil sirolimus, ki je glavni presnovek temsirolimusa pri človeku, kancerogen pri miših in podganah.
English: The diluted solution must be administered by intravenous infusion.
Slovenian: Razredčeno raztopino je treba dajati v obliki intravenske infuzije.
English: Summary of efficacy results in temsirolimus MCL clinical trial
Slovenian: Povzetek rezultatov učinkovitosti temsirolimusa v kliničnem preskušanju MCL
English: In contrast, exposure to sirolimus was commensurately reduced in paediatric patients, such that the net exposure as measured by the sum of temsirolimus and sirolimus AUCs (AUCsum) was comparable to that for adults.
Slovenian: Nasprotno pa je bila izpostavljenost sirolimusu pri pediatričnih bolnikih sorazmerno manjša, tako da je bila neto izpostavljenost, merjena z vsoto vrednosti AUC temsirolimusa in sirolimusa (AUCvsota), primerljiva z izpostavljenostjo, ugotovljeno pri odraslih.
English: Torisel may increase the risk of problems with wound healing.
Slovenian: Zdravilo Torisel lahko poveča tveganje za težave pri celjenju ran.
English: The following effects were reported in mice and/or rats in the carcinogenicity studies conducted: granulocytic leukaemia, lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.
Slovenian: Pri miših in/ali podganah so v opravljenih raziskavah kancerogenosti poročali o naslednjih učinkih: granulocitna levkemija, limfom, hepatocelularni adenom in karcinom ter testikularni adenom.
English: In an open-label, dose-escalation Phase 1 study in 110 subjects with advanced malignancies and either normal or impaired hepatic function, concentrations of temsirolimus and its metabolite sirolimus were increased in patients with elevated aspartate aminotransferase (AST) or bilirubin levels.
Slovenian: V odprti študiji večanja odmerka 1. faze pri 110 bolnikih z napredovalimi malignimi tumorji in bodisi normalnim bodisi okvarjenim delovanjem jeter so bile koncentracije temsirolimusa in njegovega presnovka sirolimusa povečane pri bolnikih s povečanimi ravnmi aspartat-aminotransferaze (AST) ali bilirubina.
English: If clinically significant respiratory symptoms develop, temsirolimus administration may be withheld until after recovery of symptoms and improvement of radiographic findings related to pneumonitis.
Slovenian: Če se pojavijo klinično pomembni respiratorni simptomi, lahko zdravljenje s temsirolimusom odložimo, dokler se simptomi ne izboljšajo in na rentgenski sliki ni več videti znakov pljučnice.
English: Temsirolimus also was associated with statistically significant advantages over investigator's choice in the secondary endpoint of ORR.
Slovenian: Temsirolimus je bil povezan tudi s statistično pomembnimi prednostmi pred zdravljenjem, ki ga je izbral raziskovalec, in sicer v sekundarnem opazovanem dogodku ORR.
English: For patients receiving the higher dose of Torisel for the treatment of mantle cell lymphoma, the amount of alcohol in this medicine may impair your ability to drive or use machines (see section below “Torisel contains ethanol [alcohol]”).
Slovenian: Pri bolnikih, ki za zdravljenje limfoma plaščnih celic prejemajo večje odmerke zdravila Torisel, lahko količina alkohola v tem zdravilu vpliva na njihovo sposobnost vožnje in upravljanja strojev (glejte spodnje poglavje “Zdravilo Torisel vsebuje etanol (alkohol)”).
English: In a Phase 1/2 safety and exploratory efficacy study, 71 patients (59 patients, aged from 1 to 17 years, and 12 patients, aged from 18 to 21 years) received temsirolimus as a 60-minute intravenous infusion once weekly in three-week cycles.
Slovenian: faze o varnosti in raziskovalni učinkovitosti, je 71 bolnikov (59 bolnikov, starih od 1 do 17 let, in 12 bolnikov, starih od 18 do 21 let) prejemalo temsirolimus v 60-minutni intravenski infuziji enkrat tedensko v tri tedne trajajočih ciklusih.
English: Unexplained muscle pain, tenderness or weakness which could indicate muscle damage
Slovenian: Nepojasnjena bolečina, občutljivost ali šibkost mišic, ki bi lahko kazala na okvaro mišic (rabdomioliza).
English: Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).
Slovenian: Zdravilo Torisel je indicirano za zdravljenje odraslih bolnikov z recidivnim in/ali proti zdravljenju odpornim limfomom plaščnih celic (MCL - Mantle Cell Lymphoma) (glejte poglavje 5.1).
English: Population PK analysis based on sparse sampling indicated no clinically significant interaction effect on AUC and Cmax of the CYP2D6 substrate desipramine.
Slovenian: Populacijska farmakokinetična analiza na podlagi razpršenega vzorčenja ni pokazala klinično pomembnega vpliva na AUC in Cmax desipramina, ki je substrat CYP2D6.
English: The use of both an in-line and end-filter is not recommended.
Slovenian: Uporaba obeh filtrov, zaporedno vključenega in končnega, ni priporočljiva.
English: Examples of live vaccines are: measles, mumps, rubella, oral polio, Bacillus CalmetteGuérin (BCG), yellow fever, varicella, and TY21a typhoid vaccines.
Slovenian: Primeri živih cepiv so: cepiva za ošpice, mumps, rdečke, peroralni polio, Calmette-Guérinov bacil (BCG), rumeno mrzlico, norice in cepivo za tifus TY21a.
English: if you are receiving Torisel, you may be at increased risk of cancers such as skin cancers and lymph node cancers (lymphoma).
Slovenian: - če prejemate zdravilo Torisel, ste lahko izpostavljeni povečanemu tveganju za vrste raka, kot so kožni raki in raki bezgavk (limfomi).
English: Diarrhoea with mixed cell inflammation of the caecum or colon was observed in monkeys and was associated with an inflammatory response, and may have been due to a disruption of the normal intestinal flora.
Slovenian: Pri opicah so opazili drisko z vnetjem cekuma ali kolona z mešanimi celicami, ki je bila povezana z vnetnim odzivom in bi lahko bila posledica uničenja normalne črevesne flore.
English: No relevant differences in exposure were apparent when data from the Caucasian population was compared with either the Japanese or Black population.
Slovenian: Pri primerjavi podatkov, pridobljenih na populaciji belcev, s populacijo Japoncev ali črncev se niso pokazale pomembne razlike pri izpostavljenosti.
English: See the package leaflet for further information.
Slovenian: Za dodatne informacije glejte navodilo za uporabo.
English: Inhibition of CYP isoforms
Slovenian: Zaviranje izoform CYP
English: This medicine contains ethanol (alcohol), equivalent to 17.6 ml beer, 7.3 ml wine per 25 mg dose.
Slovenian: To zdravilo vsebuje etanol (alkohol), ki ustreza 17,6 ml piva oziroma 7,3 ml vina na 25 mg odmerek.
English: MCL clinical trial
Slovenian: Klinično preskušanje MCL
English: Pharmacokinetic/pharmacodynamic relationship(s)
Slovenian: Farmakokinetično/farmakodinamično razmerje
English: If a suspected reaction is not manageable with dose delays, then temsirolimus may be reduced by 5 mg/week decrements.
Slovenian: Če neželenih učinkov ne moremo obvladati z zakasnitvijo odmerkov, lahko odmerek temsirolimusa zmanjšamo v korakih po 5 mg/teden.
English: Age does not appear to affect temsirolimus and sirolimus pharmacokinetics significantly.
Slovenian: Zdi se, da starost ne vpliva pomembno na farmakokinetiko temsirolimusa in sirolimusa.
English: In male rats, decreased fertility and partly reversible reductions in sperm counts were reported (see section 5.3).
Slovenian: Pri podganjih samcih so poročali o zmanjšani plodnosti in delno reverzibilnem zmanjšanju števila semenčic (glejte poglavje 5.3).
English: In in vitro studies in human liver microsomes, temsirolimus inhibited CYP3A4/5, CYP2D6, CYP2C9 and CYP2C8 catalytic activity with Ki values of 3.1, 1.5, 14 and 27 μM, respectively.
Slovenian: V študijah na mikrosomih človeških jeter in vitro je temsirolimus zavrl katalitično aktivnost CYP3A4/5, CYP2D6, CYP2C9 in CYP2C8 z vrednostmi Ki 3,1; 1,5; 14 oziroma 27 μM.
English: During in vitro temsirolimus metabolism studies, sirolimus, seco-temsirolimus and seco-sirolimus were observed; additional metabolic pathways were hydroxylation, reduction and demethylation.
Slovenian: Med raziskavami presnove temsirolimusa in vitro so našli sirolimus, seko-temsirolimus in seko-sirolimus; druge presnovne poti so bile hidroksilacija, redukcija in demetilacija.
English: 25 mg a In the MCL clinical trial, up to two dose level reductions were allowed per patient.
Slovenian: V kliničnem preskušanju MCL sta bili dovoljeni do dve ravni zmanjšanja odmerka na bolnika.
English: Based on the results of a Phase 3 study in RCC, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including oedema, diarrhoea, and pneumonia.
Slovenian: Rezultati študije 3. faze RCC so pokazali, da so pri starejših bolnikih ( 65 let starosti) verjetnejši nekateri neželeni učinki, med drugim edemi, diareja in pljučnica.
English: Serious reactions of the skin and/or mucous membranes which may include painful blisters and fever
Slovenian: Resne reakcije kože in/ali sluznic, kar lahko vključuje boleče mehurje in vročino (Stevens-Johnsonov sindrom).
English: One hundred eleven (111) patients were randomly assigned in a 1:1:1 ratio to receive 25 mg, 75 mg, or 250 mg intravenous temsirolimus weekly.
Slovenian: Sto enajst (111) bolnikov so v razmerju 1:1:1 randomizirali v tri skupine, ki so prejemale po 25 mg, 75 mg ali 250 mg temsirolimusa intravensko na teden.
English: Sirolimus, an equally potent metabolite to temsirolimus, was observed as the principal metabolite in humans following intravenous treatment.
Slovenian: Sirolimus, ki je enako močan presnovek kot temsirolimus, so pri ljudeh opazili kot glavni presnovek po intravenskem zdravljenju.
English: Among patients receiving 175 mg/week for the treatment of MCL, infections (including Grade 3 and 4 infections) were substantially increased compared to lower doses and compared to conventional chemotherapy.
Slovenian: Med bolniki, ki so prejemali 175 mg/teden za zdravljenje MCL, se je pogostnost okužb (vključno z okužbami 3. in 4. stopnje) v primerjavi z manjšimi odmerki in v primerjavi z običajno kemoterapijo znatno zvečala.
English: Periodical follow-up assessments may be considered.
Slovenian: Razmisliti je treba o rednih kontrolnih pregledih bolnika.
English: Treatment of suspected adverse reactions may require temporary interruption and/or dose reduction of temsirolimus therapy.
Slovenian: Zdravljenje domnevnih neželenih učinkov lahko zahteva začasno prekinitev in/ali zmanjšanje odmerka temsirolimusa.
English: The effect of a 175 or 75 mg temsirolimus dose on CYP3A4/5 substrates has not been studied.
Slovenian: Učinka 175 mg ali 75 mg odmerka temsirolimusa na substrate CYP3A4/5 niso raziskovali.
English: Your doctor may prescribe a visual examination before or during Torisel treatment.
Slovenian: Zdravnik vas lahko pred ali med zdravljenjem z zdravilom Torisel napoti na očesni pregled.
English: Grades 3 and 4 thrombocytopenia and/or neutropenia have been observed in the MCL clinical trial (see section 4.8).
Slovenian: Trombocitopenijo in/ali nevtropenijo 3. in 4. stopnje so opazili v kliničnem preskušanju MCL (glejte poglavje 4.8).
English: Treatment of suspected adverse reactions may require temporary interruption and/or dose reduction of temsirolimus therapy according to the guidelines in the following tables.
Slovenian: Zdravljenje domnevnih neželenih učinkov lahko zahteva začasno prekinitev in/ali zmanjšanje odmerka temsirolimusa v skladu s smernicami v naslednjih preglednicah.
English: Treatment with Torisel should continue until you are no longer benefiting from therapy or until unacceptable side effects occur.
Slovenian: Zdravljenje z zdravilom Torisel naj se nadaljuje, dokler vam ne preneha koristiti ali dokler se ne pojavijo nesprejemljivi neželeni učinki.
English: Therefore, when temsirolimus is co-administered with medicinal products which are P-gp substrates (e.g. digoxin, vincristine, colchicine, dabigatran, lenalidomide, and paclitaxel) close monitoring for adverse events related to the co-administered medicinal products should be observed.
Slovenian: Kadar dajemo temsirolimus sočasno z zdravili, ki so substrati P-gp (npr. digoksin, vinkristin, kolhicin, dabigatran, lenalidomid in paklitaksel), je treba bolnike skrbno spremljati glede neželenih učinkov, povezanih s sočasno dajanimi zdravili.
English: Increased alanine aminotransferase a: One fatal case b: One pleural effusion fatal event occurred in the low-dose (175/25 mg) arm of the MCL study *Most NCI-CTC Grade 3 and above reactions observed in clinical trials of temsirolimus for MCL ** Most NCI-CTC all grades reactions observed in clinical trials of temsirolimus for MCL *** All NCI-CTC Grade 1 and 2 reactions observed in clinical trials of temsirolimus for MCL ****Interstitial lung disease is defined by a cluster of related Preferred Terms: interstitial lung disease (n = 6), pneumonitisa (n = 7), alveolitis (n = 1), alveolitis allergic (n = 1), pulmonary fibrosis (n = 1)
Slovenian: a: en smrtni primer b: en smrtni dogodek zaradi plevralnega izliva se je zgodil v skupini študije MCL z majhnim odmerkom (175/25 mg) * večina reakcij stopnje 3 ali višje po NCI-CTC je bila opažena v kliničnih preskušanjih temsirolimusa pri MCL ** večina reakcij vseh stopenj po NCI-CTC je bila opažena v kliničnih preskušanjih temsirolimusa pri MCL *** vse reakcije stopnje 1 in 2 po NCI-CTC so bile opažene v kliničnih preskušanjih temsirolimusa pri MCL **** intersticijska bolezen pljuč je opredeljena z več povezanimi priporočenimi izrazi po MedDRA: intersticijska bolezen pljuč (n = 6), pljučnica a (n = 7), alveolitis (n = 1), alergijski alveolitis (n = 1), pljučna fibroza (n = 1) in eozinofilna pljučnica (n = 0)
English: In 36 patients with MCL, including 4 poor metabolisers, the effect of CYP2D6 inhibition after administration of single doses of 175 mg and 75 mg temsirolimus was investigated.
Slovenian: Pri 36 bolnikih z MCL, vključno s 4 bolniki s slabo presnovo, so raziskali učinek zaviranja CYP2D6 po enkratnem odmerku 175 mg in 75 mg temsirolimusa.
English: However, in vitro studies in human liver microsomes followed by physiologically-based pharmacokinetic modelling indicate that the blood concentrations achieved after a 175 mg dose of temsirolimus most likely leads to relevant inhibition of CYP3A4/5 (see section 5.2).
Slovenian: Vendar študije in vitro na humanih jetrnih mikrosomih, ki jim je sledilo farmakokinetično modeliranje na osnovi fizioloških lastnosti, kažejo, da so koncentracije v krvi, dosežene po 175 mg odmerku temsirolimusa, najverjetneje povzročile pomembno zaviranje CYP3A4/5 (glejte poglavje 5.2).
English: Thrombocytopenia, neutropenia, and anaemia
Slovenian: Trombocitopenija, nevtropenija in anemija
English: For patients treated weekly with 25 mg temsirolimus OS was 13.8 months (95% CI: 9.0, 18.7 months); ORR was 5.6% (95% CI: 0.7, 18.7%).
Slovenian: Pri bolnikih, ki so se zdravili s 25 mg temsirolimusa na teden, je bilo OS 13,8 meseca (95 % IZ: 9,0, 18,7 meseca); ORR je bil 5,6 % (95 % IZ: 0,7, 18,7 %).
English: Serum cholesterol and triglycerides should be tested before and during treatment with temsirolimus.
Slovenian: Serumski holesterol in trigliceride je treba izmeriti pred zdravljenjem s temsirolimusom in med njim.
English: Temsirolimus was found to be ineffective in paediatric patients with neuroblastoma, rhabdomyosarcoma, and high-grade glioma (n = 52).
Slovenian: Ugotovili so, da je bil temsirolimus neučinkovit pri pediatričnih bolnikih z nevroblastomom, rabdomiosarkomom in gliomom visoke stopnje (n = 52).
English: Renal failure (including fatal outcomes) has been observed in patients receiving temsirolimus for advanced RCC and/or with pre-existing renal insufficiency (see section 4.8).
Slovenian: O odpovedi ledvic (vključno s smrtnimi izidi) so poročali pri bolnikih, ki so prejemali temsirolimus zaradi napredovalega RCC in/ali pri predhodni insuficienci ledvic (glejte poglavje 4.8).
English: The concentrate- solvent mixture is stable below 25°C for up to 24 hours.
Slovenian: Mešanica koncentrata in vehikla je pri temperaturi 25 C stabilna do 24 ur.
English: Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin).
Slovenian: Temsirolimus je selektivni zaviralec mTOR (tarče rapamicina pri sesalcih).
English: For patients who require use of corticosteroids, prophylaxis of PCP should be considered based upon current standard of care.
Slovenian: Pri bolnikih, pri katerih je potrebna uporaba kortikosteroidov, je treba v skladu z veljavnimi smernicami razmisliti o profilaksi proti PCP.
English: In reproduction studies in animals, temsirolimus caused embryo/foetotoxicity that was manifested as mortality and reduced foetal weights (with associated delays in skeletal ossification) in rats and rabbits.
Slovenian: V študijah razmnoževanja na živalih je temsirolimus povzročal toksičnost za zarodek in plod, ki se je odražala v umrljivosti in zmanjšani masi ploda (s pridruženo zakasnitvijo zakostenevanja skeleta) pri podganah in kuncih.
English: Median PFS of the temsirolimus 175/75 mg group (4.8 months) was prolonged by 2.9 months compared to the investigator's choice group (1.9 months).
Slovenian: Mediano PFS skupine, ki je prejemala temsirolimus 175/75 mg (4,8 meseca) je bilo v primerjavi s skupino, ki je prejemala zdravljenje, ki ga je izbral raziskovalec (1,9 meseca), podaljšano za 2,9 meseca.
English: Temsirolimus and sirolimus pharmacokinetics have been investigated in an open-label, dose-escalation study in 110 patients with advanced malignancies and either normal or impaired hepatic function.
Slovenian: Farmakokinetiko temsirolimusa in sirolimusa so raziskovali v odprti študiji večanja odmerka pri 110 bolnikih z napredovalimi malignimi tumorji in bodisi normalnim ali okvarjenim delovanjem jeter.
English: Following a single 25 mg intravenous dose in patients with cancer, sirolimus AUC was 2.7-fold that of temsirolimus AUC, due principally to the longer half-life of sirolimus.
Slovenian: Potem ko so bolnikom z rakom dali en 25 mg intravenski odmerek, je bila AUC sirolimusa 2,7-krat večja od AUC temsirolimusa, kar je bilo predvsem posledica daljše razpolovne dobe sirolimusa.
English: RCC clinical trial 1 was a Phase 3, multi-centre, 3-arm, randomised, open-label study in previously untreated patients with advanced RCC and with 3 or more of 6 pre-selected prognostic risk factors (less than 1 year from time of initial RCC diagnosis to randomisation, Karnofsky performance status of 60 or 70, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dl, lactate dehydrogenase1.5 times the upper limit of normal, more than 1 metastatic organ site).
Slovenian: Klinično preskušanje RCC 1 je bila multicentrična, randomizirana, odprta študija 3. faze s 3 kraki na predhodno nezdravljenih bolnikih z napredovalim RCC in s 3 ali več od 6 vnaprej izbranih prognostičnih dejavnikov tveganja (manj kot 1 leto od časa začetne diagnoze RCC do randomizacije, stanje zmogljivosti po Karnofskem od 60 do 70, hemoglobin pod spodnjo mejo normalnih vrednosti, korigirani kalcij večji od 10 mg/dl, laktatna dehidrogenaza > 1,5-kratna vrednost zgornje meje normalnih vrednosti, zasevki v več kot 1 organu).