FrancophonIA/ELRC3.0 huggingface dataset:
English: Figure 2: Kaplan-Meier curves of time to first use of new antineoplastic therapy in the PROSPER study (intent-to-treat analysis)
Slovenian: Slika 2: Kaplan-Meierjevi krivulji časa do prve uporabe novega antineoplastičnega zdravljenja v študiji PROSPER (analiza z-namenom-zdravljenja)
English: 37.2 (33.1, NR)
Slovenian: 37,2 (33,1, ND)
English: Patients with visceral disease, patients with a history of mild to moderate heart failure (NYHA Class I or II), and patients taking medicinal products associated with lowering the seizure threshold were allowed.
Slovenian: Sodelovanje bolnikov z visceralno boleznijo, bolnikov z blagim do zmernim srčnim popuščanjem (razred I ali II po NYHA) v anamnezi in bolnikov, ki so jemali zdravila, povezana z nižanjem praga za konvulzije, je bilo dovoljeno.
English: N-desmethyl enzalutamide was not metabolised by CYPs in vitro.
Slovenian: N-desmetil enzalutamid se in vitro ni presnovil z encimi skupine CYP.
English: Following oral administration of the soft capsule formulation (Xtandi 160 mg daily) in patients with metastatic CRPC, the steady-state plasma mean Cmax values for enzalutamide and its active metabolite are 16.6 μg/mL (23% CV) and 12.7 μg/mL (30% CV), respectively.
Slovenian: Po peroralni uporabi mehkih kapsul (160 mg zdravila Xtandi na dan) pri bolnikih z metastatskim KORP je bila povprečna Cmax v plazmi v stanju dinamičnega ravnovesja za enzalutamid 16,6 µg/ml (KV 23 %) in za njegov aktivni presnovek 12,7 µg/ml (KV 30 %).
English: At the pre-specified interim analysis for overall survival when 540 deaths were observed, treatment with enzalutamide demonstrated a statistically significant improvement in overall survival compared to treatment with placebo with a 29.4% reduction in risk of death [HR = 0.706 (95% CI: 0.60; 0.84), p < 0.0001].
Slovenian: V vnaprej določenih vmesnih analizah celokupnega preživetja, po opaženih 540 primerih smrti, je zdravljenje z enzalutamidom pokazalo statistično značilno izboljšanje celokupnega preživetja v primerjavi z zdravljenjem s placebom z 29,4-odstotnim zmanjšanjem tveganja smrti [ROg = 0,706 (95 % IZ: 0,60, 0,84), p < 0,0001].
English: In the event of an overdose, treatment with enzalutamide should be stopped and general supportive measures initiated taking into consideration the half-life of 5.8 days.
Slovenian: V primeru prevelikega odmerjanja je potrebno prenehati zdravljenje z enzalutamidom in uvesti splošne podporne ukrepe.
English: Astellas Pharma Puh/Tel: +358 (0)9 85606000
Slovenian: Suomi/Finland Astellas Pharma Puh/Tel: + 358 (0)9 85606000
English: According to prior chemotherapy history, the results proportion of patients with a ≥ 50% decrease in PSA levels were 22.1% and 23.2%, for the no prior chemotherapy and prior chemotherapy patient groups, respectively.
Slovenian: Glede na njihovo zgodovino izpostavljenosti kemoterapiji je bil delež bolnikov z zmanjšanjem vrednosti PSA za ≥ 50%, ki se predhodno še niso zdravili s kemoterapijo 22,1 % in tistih predhodno zdravljenih s kemoterapijo 23,2 %.
English: The usual dose is 160 mg (four 40 mg film-coated tablets or two 80 mg film-coated tablets), taken at the same time once a day.
Slovenian: Priporočeni odmerek je 160 mg (štiri 40-mg filmsko obložene tablete ali dve 80-mg filmsko obloženi tableti), tablete je treba zaužiti hkrati, enkrat na dan.
English: Concomitant use with strong CYP2C8 inhibitors
Slovenian: Sočasna uporaba z močnimi zaviralci CYP2C8
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC and Cmax in subjects with mild impairment increased by 14% and 19%, respectively, the AUC and Cmax in subjects with moderate impairment increased by 14% and decreased by 17%, respectively, and the AUC and Cmax in subjects with severe hepatic impairment increased by 34% and decreased by 27%, respectively, compared to healthy control subjects.
Slovenian: Skupna AUC nevezanega enzalutamida in njegovega aktivnega presnovka se je pri bolnikih z blago okvaro jeter povečala za 14 % in Cmax za 19 %, pri bolnikih z zmerno okvaro jeter se je AUC povečala za 14 % in Cmax zmanjšala za 17 %, pri bolnikih s hudo okvaro jeter pa se je AUC povečala za 34 % in Cmax zmanjšala za 27 % v primerjavi z zdravo kontrolno skupino.
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 77% while Cmax decreased by 19%.
Slovenian: Skupno se je AUC nevezanega enzalutamida in njegovega nevezanega aktivnega presnovka povečala za 77 %, Cmax pa se je zmanjšala za 19 %.
English: Hypersensitivity reactions manifested by symptoms including, but not limited to, rash, or face, tongue, lip, or pharyngeal oedema, have been observed with enzalutamide (see section 4.8).
Slovenian: Preobčutljivostne reakcije, ki so bile opažene pri enzalutamidu, se lahko kažejo med drugim kot izpuščaj ali edem obraza, jezika, ustnic ali žrela (glejte poglavje 4.8).
English: At steady state, the mean Cmax values for enzalutamide and its active metabolite are 16.6 μg/mL (23% coefficient of variation [CV]) and 12.7 μg/mL (30% CV), respectively.
Slovenian: V stanju dinamičnega ravnovesja je bila povprečna Cmax enzalutamida 16,6 µg/ml (koeficient varijacije [KV] 23 %), njegovega aktivnega presnovka pa 12,7 µg/ml (KV 30 %).
English: - If you forget to take Xtandi for the whole day, take your usual dose the following day.
Slovenian: Če zdravila Xtandi niste vzeli že ves dan, vzemite svoj običajni odmerek naslednji dan.
English: A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change of antineoplastic therapy to treat bone pain.
Slovenian: Z okostjem povezan dogodek je bil opredeljen kot obsevanje ali operacija kosti, patološki zlom kosti, kompresija hrbtnega mozga ali sprememba antineoplastičnega zdravljenja za zdravljenje kostnih bolečin.
English: - The ingredients of the ink are iron oxide black (E172) and polyvinyl acetate phthalate.
Slovenian: Sestavini črnila sta črni železov oksid (E172) in polivinilacetatftalat.
English: Table 3: Overall survival of patients treated with either enzalutamide or placebo in the PREVAIL study (intent-to-treat analysis)
Slovenian: Preglednica 3: Celokupno preživetje bolnikov, zdravljenih z enzalutamidom ali placebom v študiji PREVAIL (analiza z-namenom-zdravljenja)
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih pogosti: padci
English: Enzalutamide significantly decreased the risk of the first skeletal-related event by 28% [HR = 0.718 (95% CI: 0.61, 0.84), p < 0.0001].
Slovenian: Enzalutamid je značilno zmanjšal tveganje pojava prvega z okostjem povezanega dogodka za 28 % [ROg = 0,718 (95 % IZ: 0,61, 0,84), p < 0,0001].
English: Enzalutamide is extensively metabolised.
Slovenian: Enzalutamid se izdatno presnovi.
English: Taking Xtandi
Slovenian: Jemanje zdravila Xtandi
English: CYP1A2 and CYP2C8 substrates
Slovenian: Substrati CYP1A2 in CYP2C8
English: The film-coated tablets should not be cut, crushed or chewed but should be swallowed whole with water, and can be taken with or without food.
Slovenian: Filmsko obloženih tablet se ne sme žvečiti ali jih raztopiti, ampak jih je treba zaužiti cele z vodo.
English: The recommended dose is 160 mg enzalutamide (four 40 mg film-coated tablets or two 80 mg film-coated tablets) as a single oral daily dose.
Slovenian: Priporočeni odmerek je 160 mg enzalutamida (štiri 40-mg filmsko obložene tablete ali dve 80-mg filmsko obloženi tableti) v enkratnem peroralnem odmerku na dan.
English: Your doctor may also prescribe other medicines while you are taking Xtandi.
Slovenian: Med jemanjem zdravila Xtandi vam lahko zdravnik predpiše tudi jemanje drugih zdravil.
English: Posterior Reversible Encephalopathy Syndrome (PRES)
Slovenian: preprečevanje zavrnitve presajenih organov (npr. takrolimus)
English: Median time to first use of new antineoplastic therapy was 39.6 months (95% CI: 37.7, NR) on the enzalutamide arm versus 17.7 months (95% CI: 16.2, 19.7) on the placebo arm.
Slovenian: Mediani čas do prve uporabe novega antineoplastičnega zdravljenja je bil v skupini z enzalutamidom 39,6 meseca (95 % IZ: 37,7, ND) in v skupini s placebom 17,7 meseca (95 % IZ: 16,2, 19,7).
English: Each carton contains 112 film-coated tablets (4 wallets).
Slovenian: Ena škatla vsebuje 112 filmsko obloženih tablet (4 ovojnice).
English: Median PFS was 19.4 months (95% CI: 16.5, not reached) in the enzalutamide group versus 5.7 months (95% CI: 5.6, 8.1) in the bicalutamide group [HR = 0.24 (95% CI: 0.18, 0.32), p < 0.0001].
Slovenian: Mediano PFS je bilo v skupini z enzalutamidom 19,4 meseca (95 % IZ: 16,5, ni doseženo) in v skupini z bikalutamidom 5,7 meseca (95 % IZ: 5,6, 8,1) [ROg = 0,24 (95 % IZ: 0,18, 0,32), p < 0,0001].
English: Macrogol (8000) Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: Obloga tablete: hipromeloza smukec makrogol (8000) titanov dioksid (E171) rumeni železov oksid (E172)
English: The following patient demographics and baseline disease characteristics were balanced between the treatment arms.
Slovenian: Naslednje demografske značilnosti bolnikov in izhodiščne značilnosti njihove bolezni so bile med terapevtskima krakoma uravnotežene.
English: Patients were allowed but not required to take prednisone (maximum daily dose allowed was 10 mg prednisone or equivalent).
Slovenian: Bolnikom je bilo dovoljeno uporabljati prednizon (dovoljeni največji dnevni odmerek je bil 10 mg prednizona ali ekvivalenta), ni pa bila uporaba prednizona zahtevana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON WITH BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z MODRIM OKENCEM
English: Studies in lactating rats have shown that enzalutamide and/or its metabolites are secreted in rat milk.
Slovenian: Študije pri podganah v laktaciji so pokazale, da se enzalutamid in/ali njegovi presnovki izločajo v mleko pri podganah.
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 27% while Cmax was again unchanged.
Slovenian: Skupno se je AUC nevezanega enzalutamida in njegovega nevezanega aktivnega presnovka povečala za 27 %, Cmax pa je ostala nespremenjena.
English: A review of concomitant medicinal products should therefore be conducted when initiating enzalutamide treatment.
Slovenian: Pred uvedbo zdravljenja z enzalutamidom je potrebno izvesti pregled sočasno uporabljanih zdravil.
English: • Corticosteroids (e.g. dexamethasone, prednisolone)
Slovenian: • kortikosteroidi (npr. deksametazon, prednizolon)
English: Patients with a history of mild to moderate heart failure (NYHA Class I or II), and patients taking medicinal products associated with lowering the seizure threshold were allowed.
Slovenian: Dovoljena je bila vključitev bolnikov z anamnezo blagega do zmernega srčnega popuščanja (razred I ali II po NYHA) in bolnikov, ki so prejemali zdravila, povezana z nižanjem praga za konvulzije.
English: Each carton contains 112 tablets in 4 blister wallets of 28 tablets each.
Slovenian: Ena škatla vsebuje 112 tablet v 4 pretisnih ovojnicah, od katerih vsaka vsebuje 28 tablet.
English: Xtandi 40 mg soft capsules enzalutamide
Slovenian: Xtandi 40 mg mehke kapsule enzalutamid
English: Caution is advised in patients with severe renal impairment or end-stage renal disease (see section 4.4).
Slovenian: Pri bolnikih s hudo okvaro ledvic ali končno odpovedjo ledvic je priporočljiva previdnost (glejte poglavje 4.4).
English: Studies in pregnant rats have shown that enzalutamide and/or its metabolites are transferred to fetuses.
Slovenian: Študije pri brejih podganah so pokazale, da se enzalutamid in/ali njegovi presnovki prenašajo tudi na zarodke.
English: The analysis involved 448 skeletal-related events, of which 277 events (62%) were radiation to bone, 95 events (21%) were spinal cord compression, 47 events (10%) were pathologic bone fracture, 36 events (8%) were change in antineoplastic therapy to treat bone pain, and 7 events (2%) were surgery to bone.
Slovenian: Analiza je zajela 448 z okostjem povezanih dogodkov; 277 (62 %) od teh dogodkov je bilo obsevanj kosti, 95 dogodkov (21 %) kompresija hrbtnega mozga, 47 dogodkov (10 %) patološki zlom kosti, 36 dogodkov (8 %) sprememba antineoplastičnega zdravljenja za zdravljenje kostnih bolečin in 7 dogodkov (2 %) operacija kosti.
English: CYP2C8 and CYP3A4 inducers
Slovenian: Induktorji CYP2C8 in CYP3A4
English: Following a single oral 160 mg dose of enzalutamide, the AUC and Cmax for enzalutamide in subjects with mild impairment increased by 5% and 24%, respectively, the AUC and Cmax of enzalutamide in subjects with moderate impairment increased by 29% and decreased by 11%, respectively, and the AUC and Cmax of enzalutamide in subjects with severe impairment increased by 5% and decreased by 41%, respectively, compared to healthy control subjects.
Slovenian: Po enkratnem peroralnem odmerku enzalutamida (160 mg) se je pri bolnikih z blago okvaro jeter AUC enzalutamida povečala za 5 %, Cmax pa za 24 %, pri bolnikih z zmerno okvaro jeter se je AUC povečala za 29 %, Cmax pa zmanjšala za 11 %, pri bolnikih s hudo okvaro jeter pa se je AUC povečala za 5 %, Cmax pa zmanjšala za 41 % v primerjavi z zdravo kontrolno skupino.
English: At the updated analysis 52% of enzalutamide-treated and 81% of placebo-treated patients had received subsequent therapies for metastatic CRPC that may prolong overall survival.
Slovenian: V posodobljeni analizi je nadaljnje terapije za zdravljenje metastatskega KORP, ki lahko podaljšajo skupno preživetje, prejemalo 52 % bolnikov, zdravljenih z enzalutamidom, in 81 % bolnikov, ki so dobivali placebo.
English: P-value1
Slovenian: Vrednost p1
English: Xtandi - 40 mg soft capsules Each soft capsule contains 40 mg of enzalutamide.
Slovenian: Xtandi - 40 mg mehke kapsule Ena mehka kapsula vsebuje 40 mg enzalutamida.
English: Dose appears to be an important predictor of the risk of seizure, as reflected by preclinical data, and data from a dose-escalation study.
Slovenian: Kot kažejo predklinični podatki in podatki iz študije povečevanja odmerka, je odmerek pomemben napovednik tveganja za konvulzije.
English: A pre-specified follow-up rPFS analysis based on the investigator assessment of radiographic progression demonstrated a statistically significant improvement between the treatment groups with a 69.3% reduction in risk of radiographic progression or death [HR = 0.31 (95% CI: 0.27, 0.35), p < 0.0001].
Slovenian: Vnaprej določena analiza spremljanja rPFS na podlagi raziskovalčeve ocene radiografskega napredovanja bolezni je dokazala statistično značilno izboljšanje med zdravljenimi skupinami z 69,3-odstotnim zmanjšanjem tveganja radiografskega napredovanja bolezni ali smrti [ROg = 0,31 (95 % IZ: 0,27, 0,35), p < 0,0001].
English: Patients were randomised 2:1 to receive either enzalutamide at a dose of 160 mg once daily (N = 933) or placebo (N = 468).
Slovenian: Bolnike so v razmerju 2:1 randomizirali na prejemanje 160 mg enzalutamida enkrat na dan (N = 933) ali na prejemanje placeba (N = 468).
English: In the study, calculi and crystals were observed in rat urinary bladders.
Slovenian: V študiji so opažali kamne in kristale v podganjih sečnih mehurjih.
English: No clinically relevant effect of age on enzalutamide pharmacokinetics was seen in the elderly population pharmacokinetic analysis.
Slovenian: Populacijska farmakokinetična analiza pri starejši populaciji ni pokazala, da bi starost klinično pomembno vplivala na farmakokinetiko enzalutamida.
English: Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.
Slovenian: Med zdravljenjem je treba pri bolnikih, ki niso bili kirurško kastrirani, nadaljevati medicinsko kastracijo z analogom gonadoliberina (LHRH - luteinising hormone-releasing hormone).
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 soft capsules.
Slovenian: Kartonska ovojnica vsebuje PVC/PCTFE/aluminijaste pretisne zgibanke po 28 mehkih kaspul.
English: Table 4: Overall survival of patients treated with either enzalutamide or placebo in the AFFIRM study (intent-to-treat analysis)
Slovenian: Preglednica 4: Celokupno preživetje bolnikov, zdravljenih ali z enzalutamidom ali s placebom v študiji AFFIRM (analiza z-namenom-zdravljenja [ITT])
English: Xtandi contains the active substance enzalutamide.
Slovenian: Zdravilo Xtandi vsebuje učinkovino enzalutamid.
English: Description of selected adverse reactions
Slovenian: Opis posameznih neželenih učinkov
English: Following oral administration of the strong CYP3A4 inhibitor itraconazole (200 mg once daily) to healthy male subjects, the AUC of enzalutamide increased by 41% while Cmax was unchanged.
Slovenian: Po peroralni uporabi močnega zaviralca CYP3A4 itrakonazola (200 mg enkrat na dan) pri zdravih moških se je AUC enzalutamida povečala za 41 %, vpliva na Cmax pa ni bilo.
English: At the pre-specified rPFS analysis, a statistically significant improvement was demonstrated between the treatment groups with an 81.4% reduction in risk of radiographic progression or death [HR = 0.19 (95% CI: 0.15, 0.23), p < 0.0001].
Slovenian: V vnaprej določenih analizah rPFS je bilo med zdravljenimi skupinami dokazano statistično značilno izboljšanje z 81,4-odstotnim zmanjšanjem tveganja radiografskega napredovanja bolezni ali smrti [ROg = 0,19 (95 % IZ: 0,15, 0,23), p < 0,0001].
English: In a phase 3 clinical trial (AFFIRM) of patients who failed prior chemotherapy with docetaxel, 54% of patients treated with enzalutamide, versus 1.5% of patients who received placebo, had at least a 50% decline from baseline in PSA levels.
Slovenian: V kliničnem preskušanju 3. faze (AFFIRM) pri bolnikih, pri katerih predhodna kemoterapija z docetakselom ni bila uspešna, se je koncentracija PSA zmanjšala za vsaj 50 % v primerjavi z izhodiščem pri 54 % bolnikov, zdravljenih z enzalutamidom, in pri 1,5 % bolnikov, ki so prejemali placebo.
English: Patients may be at increased risk of seizures following an overdose.
Slovenian: Po prevelikem odmerjanju imajo bolniki lahko večje tveganje za konvulzije.
English: Following oral administration of the strong CYP2C8 inhibitor gemfibrozil (600 mg twice daily) to healthy male subjects, the AUC of enzalutamide increased by 326% while Cmax of enzalutamide decreased by 18%.
Slovenian: Po peroralni uporabi močnega zaviralca CYP2C8 gemfibrozila (600 mg dvakrat na dan) pri zdravih moških se je AUC enzalutamida povečala za 326 %, Cmax pa se je zmanjšala za 18 %.
English: P-value is derived from a log rank test stratified by ECOG performance status score (0-1 vs. 2) and mean pain score
Slovenian: Vrednost p je dobljena na podlagi log-rang testa s stratifikacijo po oceni stanja zmogljivosti ECOG (0-1 v primerjavi z 2) in povprečno oceno bolečine (< 4 v primerjavi z ≥ 4).
English: Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate
Slovenian: Jedro tablete: hipromeloza acetat sukcinat mikrokristalna celuloza brezvodni koloidni silicijev dioksid premreženi natrijev karmelozat magnezijev stearat
English: Radiographic progression-free survival as assessed by the investigator using RECIST v 1.1 for soft tissue and appearance of 2 or more bone lesions in bone scan was 8.3 months for patients treated with enzalutamide and 2.9 months for patients who received placebo [HR = 0.40 (95% CI: 0.35, 0.47), p < 0.0001].
Slovenian: Preživetje brez radiografsko potrjenega napredovanja bolezni, ki ga je ocenil raziskovalec na podlagi RECIST v1.1 za mehka tkiva in pojav 2 ali več kostnih lezij na slikanjih kosti, je bilo pri prejemnikih enzalutamida 8,3 meseca in pri prejemnikih placeba 2,9 meseca [ROg = 0,40 (95 % IZ: 0,35, 0,47), p < 0,0001].
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 14 film-coated tablets.
Slovenian: Kartonska ovojnica vsebuje PVC/PCTFE/aluminijaste pretisne omote, v katerih je po 14 filmsko obloženih tablet.
English: Each capsule contains 40 mg enzalutamide.
Slovenian: Ena kapsula vsebuje 40 mg enzalutamida.
English: The demographic and baseline characteristics were well-balanced between the two treatment arms.
Slovenian: Demografske in izhodiščne značilnosti med terapevtskima podskupinama so bile dobro uravnotežene.
English: What you need to know before you take Xtandi Do not take Xtandi:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xtandi
English: Table 1: Adverse reactions identified in controlled clinical trials and post-marketing MedDRA System organ class Adverse reaction and frequency
Slovenian: Preglednica 1: Neželeni učinki, ugotovljeni v nadzorovanih kliničnih preskušanjih in obdobju trženja
English: Figure 4: Kaplan-Meier curves of overall survival based on updated survival analysis in the PREVAIL study (intent-to-treat analysis)
Slovenian: Slika 4: Kaplan-Meierjevi krivulji celokupnega preživetja na podlagi posodobljene analize preživetja v študiji PREVAIL (analiza z-namenom-zdravljenja)
English: There have been rare reports of posterior reversible encephalopathy syndrome (PRES) in patients receiving Xtandi (see section 4.8).
Slovenian: Sindrom posteriorne reverzibilne encefalopatije Pri bolnikih, ki so prejemali zdravilo Xtandi so redko poročali o sindromu posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome) (glejte poglavje 4.8).
English: A total of 1199 patients were randomised 2:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 800) or placebo once daily (N = 399).
Slovenian: Skupno 1199 bolnikov so v razmerju 2:1 randomizirali na prejemanje enzalutamida peroralno v odmerku 160 mg enkrat na dan (n = 800) ali na prejemanje placeba enkrat na dan (n = 399).
English: The decision to continue treatment in patients who develop seizure should be taken case by case.
Slovenian: Pri bolnikih, pri katerih je prišlo do konvulzij, se je potrebno od primera do primera odločiti glede nadaljevanja zdravljenja.
English: No formal renal impairment study for enzalutamide has been completed.
Slovenian: Formalne študije enzalutamida pri okvari ledvic niso izvedli.
English: A total of 1717 asymptomatic or mildly symptomatic chemotherapy-naïve patients were randomised 1:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 872) or placebo orally once daily (N = 845).
Slovenian: Skupaj 1717 asimptomatskih ali blago simptomatskih bolnikov, ki se predhodno še niso zdravili s kemoterapijo, so v razmerju 1:1 randomizirali v skupino, ki je prejemala enzalutamid peroralno v odmerku 160 mg enkrat na dan (N = 872) ali placebo peroralno enkrat na dan (N = 845).
English: Enzalutamide demonstrated a statistically significant delay in the time to first use of new antineoplastic therapy compared to placebo [HR = 0.21 (95% CI: 0.17, 0.26), p < 0.0001].
Slovenian: Enzalutamid je v primerjavi s placebom statistično značilno podaljšal čas do prve uporabe novega antineoplastičnega zdravljenja [ROg = 0,21 (95 % IZ: 0,17, 0,26), p < 0,0001].
English: Number of Events (%) Median, months (95% CI)1
Slovenian: Mediana, meseci (95 % IZ)1
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 film-coated tablets.
Slovenian: Kartonska ovojnica vsebuje PVC/PCTFE/aluminijaste pretisne omote, v katerih je po 28 filmsko obloženih tablet.
English: Patient demographics and baseline disease characteristics were balanced between the treatment arms.
Slovenian: Demografske značilnosti bolnikov in izhodiščne značilnosti njihove bolezni so bile med terapevtskima krakoma uravnotežene.