natgillin/translations-raw huggingface dataset:
The analysis involved 216 deaths without documented progression and 645 documented progression events, of which 303 (47%) were due to soft tissue progression, 268 (42%) were due to bone lesion progression and 74 (11%) were due to both soft tissue and bone lesions. 
Analiza je zajela 216 smrti brez dokumentiranega napredovanje in 645 dokumentiranih dogodkov napredovanja; od tega jih je bilo 303 (47 %) posledica napredovanja v mehkih tkivih, 268 (42 %) napredovanja kostnih lezij in 74 (11 %) napredovanja tako v mehkih tkivih kot kostnih lezij.
In vivo studies have shown that enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19. 
In vivo študije so pokazale, da je enzalutamid močan induktor CYP3A4 in zmeren induktor CYP2C9 in CYP2C19.
In studies in mice (4 weeks), rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), changes in the reproductive organs associated with enzalutamide were decreases in organ weight with atrophy of the prostate and epididymis. 
V študijah na miših (4 tedni), podganah (4 in 26 tednov) in psih (4, 13 in 39 tednov) so bile z enzalutamidom povezane spremembe reproduktivnih organov zmanjšanje mase organov z atrofijo prostate in epididimisa.
There was no protein binding displacement between enzalutamide and other highly bound medicinal products (warfarin, ibuprofen and salicylic acid) in vitro. 
In vitro ni prišlo do izpodrivanja pri vezavi na beljakovine med enzalutamidom in drugimi zdravili, ki se močno vežejo (varfarin, ibuprofen in salicilna kislina).
Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol. 
Pomožna snov z znanim učinkom Ena mehka kapsula vsebuje 57,8 mg sorbitola.
The median age at randomisation was 74 years in the enzalutamide arm and 73 years in the placebo arm. 
Mediana starost ob randomizaciji je bila v skupini z enzalutamidom 74 let in v skupini s placebom 73 let.
• Hypnotics (e.g. diazepam, midazolam, zolpidem) 
• hipnotiki (npr. diazepam, midazolam, zolpidem)
† As evaluated by narrow SMQs of ‘Myocardial Infarction' and ‘Other Ischemic Heart Disease' including the following preferred terms observed in at least two patients in randomized placebo-controlled phase 3 studies: angina pectoris, coronary artery disease, myocardial infarctions, acute myocardial infarction, acute coronary syndrome, angina unstable, myocardial ischaemia, and arteriosclerosis coronary artery. 
† Ovrednoteno s SMQ "miokardni infarkt" in "druga ishemična srčna bolezen", vključno z naslednjimi prednostnimi izrazi, zabeleženimi pri vsaj dveh bolnikih v randomiziranih, s placebom kontroliranih študijah 3. faze: angina pektoris, bolezni koronarnih arterij, miokardni infarkti, akutni miokardni infarkt, akutni koronarni sindrom, nestabilna angina pektoris, ishemija miokarda in arterioskleroza koronarnih arterij.
Xtandi has moderate influence on the ability to drive and use machines as psychiatric and neurologic events including seizure have been reported (see section 4.8). 
Zdravilo Xtandi ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji; opisani so bili namreč psihiatrični in nevrološki dogodki, vključno s konvulzijami (glejte poglavje 4.8).
• Antibiotics (e.g. clarithromycin, doxycycline) 
• antibiotiki (npr. klaritromicin, doksiciklin)
Patients were stratified by Prostate Specific Antigen (PSA) Doubling Time (PSADT) (< 6 months or ≥ 6 months) and the use of bone-targeting agents (yes or no). 
Bolnike so stratificirali glede na čas podvojitve (PSADT) prostatičnega specifičnega antigena (PSA) (< 6 mesecev ali ≥ 6 mesecev) in uporabo sredstev, usmerjenih na kosti (da ali ne).
Food has no clinically significant effect on the extent of exposure to enzalutamide. 
Hrana nima klinično pomembnega vpliva na obseg izpostavljenosti enzalutamidu.
The median time to degradation in FACT-P was 11.3 months in the enzalutamide group and 5.6 months in the placebo group. 
Mediani čas do upada skupne ocene FACT-P je bil 11,3 meseca v skupini z enzalutamidom in 5,6 meseca v skupini s placebom.
By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing. 
S preprečitvijo delovanja androgenov enzalutamid ustavi rast in delitev celic raka prostate.
CRPC2 (AFFIRM) study (patients with metastatic CRPC who previously received chemotherapy) 
Študija CRPC2 (AFFIRM) (bolniki z metastatskim KORP, ki so predhodno dobivali kemoterapijo)
Complete responses were reported in 19.7% of enzalutamide-treated patients compared with 1.0% of placebo-treated patients, and partial responses were reported in 39.1% of enzalutamide-treated patients versus 3.9% of placebo-treated patients. 
O celovitih odzivih so poročali pri 19,7 % bolnikov, zdravljenih z enzalutamidom, v primerjavi z 1,0 % bolnikov, zdravljenih s placebom, in o delnih odzivih so poročali pri 39,1 % bolnikov, zdravljenih z enzalutamidom, v primerjavi s 3,9 % bolnikov, zdravljenih z placebom.
The study was a single-arm study in 214 patients with progressing metastatic CRPC who received enzalutamide (160 mg once daily) after at least 24 weeks of treatment with abiraterone acetate plus prednisone. 
To je bila neprimerjalna raziskava z enim krakom pri 214 bolnikih z napredujočim mKORP, ki so prejemali enzalutamid (160 mg enkrat dnevno) po vsaj 24 tednih predhodnega zdravljenja z abirateron acetatom in prednizonom.
Based on in vitro data, inhibition of BCRP and MRP2 (in the intestine), as well as organic anion transporter 3 (OAT3) and organic cation transporter 1 (OCT1) (systemically) cannot be excluded. 
Na podlagi podatkov in vitro ni mogoče izključiti inhibicije BCRP in MRP2 (v črevesju), kot tudi prenašalca organskih anionov 3 (OAT3 - organic anion transporter 3) in prenašalca organskih kationov 1 (OCT1organic cation transporter 1) (sistemski).
Efficacy of enzalutamide was established in three randomised placebo-controlled multicentre phase 3 clinical studies [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] of patients with progressive prostate cancer who had failed androgen deprivation therapy [LHRH analogue or after bilateral orchiectomy]. 
Učinkovitost enzalutamida so ugotavljali v treh randomiziranih, s placebom kontroliranih multicentričnih kliničnih študijah 3. faze [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] pri bolnikih s progresivnim rakom prostate, pri katerih zdravljenje z odtegnitvijo androgena ni bilo uspešno [analog LHRH ali po obojestranski orhidektomiji].
• Analgesics (e.g. fentanyl, tramadol) 
• analgetiki (npr. fentanil, tramadol)
Not known (frequency cannot be estimated from the available data) Muscle pain, muscle spasms, muscular weakness, back pain, changes in ECG (QT prolongation), upset stomach including feeling sick (nausea), rash, being sick (vomiting), swelling of the face, lips, tongue and/or throat, reduction in blood platelets (which increases risk of bleeding or bruising), diarrhoea 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) bolečine v mišicah, mišični krči, mišična šibkost, bolečine v hrbtu, spremembe v EKG (podaljšanje QT intervala), razdražen želodec vključno s siljenjem na bruhanje (navzea), izpuščaj, bruhanje, otekanje obraza, ustnic, jezika in/ali žrela, zmanjšanje števila krvnih ploščic (kar poveča tveganje za krvavitve ali modrice), driska
Androgen deprivation therapy may prolong the QT interval In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Xtandi. 
Zdravljenje z odtegnitvijo androgena lahko podaljša interval QT Pri bolnikih z anamnezo podaljšanja intervala QT ali dejavniki tveganja za podaljšanje QT in pri bolnikih, ki so sočasno prejemali zdravila, ki lahko podaljšajo interval QT (glejte poglavje 4.5) mora zdravnik pred začetkom zdravljenja z zdravilom Xtandi oceniti razmerje med koristjo in tveganjem vključno z možnostjo Torsade de pointes.
The protocol pre-specified interim analysis after 520 deaths showed a statistically significant superiority in overall survival in patients treated with enzalutamide compared to placebo (Table 4 and Figures 7 and 8). 
V protokolu vnaprej določena vmesna analiza po 520 smrtih je pri bolnikih, ki so prejemali enzalutamid, pokazala statistično značilno superiornost glede celokupnega preživetja v primerjavi s placebom (preglednica 4 in sliki 7 in 8).
Enzalutamide (N = 872) 
Enzalutamid (N = 872)
Enzalutamide (160 mg once daily) did not cause a clinically relevant change in the AUC or Cmax of caffeine (CYP1A2 substrate) or pioglitazone (CYP2C8 substrate). 
Enzalutamid (160 mg enkrat na dan) ni klinično pomembno spremenil AUC ali Cmax kofeina (substrata CYP1A2) ali pioglitazona (substrata CYP2C8).
The most common adverse reactions are asthenia/fatigue, hot flush, fractures, and hypertension. 
Najpogostejši neželeni učinki so astenija/utrujenost, vročinski oblivi, zlomi in hipertenzija.
Hazard Ratio is derived from an unstratified proportional hazards model. 
Razmerje ogroženosti je dobljeno na podlagi nestratificiranega modela sorazmernih ogroženosti.
The effect of enzalutamide on P-gp substrates has not been evaluated in vivo; however, under conditions of clinical use, enzalutamide may be an inducer of P-gp via activation of the nuclear pregnane receptor (PXR). 
Vpliva enzalutamida na substrate P-gp in vivo niso ocenili, vendar lahko enzalutamid med klinično uporabo inducira P-gp prek aktivacije jedrnega pregnanskega X receptorja (PXR - pregnane X receptor).
Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS). 
Sočasna primarna opazovana dogodka učinkovitosti sta bila celokupno preživetje in preživetje brez radiografsko potrjenega napredovanja bolezni (rPFS - radiographic progression-free survival).
In a clinical study in patients with metastatic CRPC, Xtandi (160 mg once daily) had no clinically relevant effect on the pharmacokinetics of intravenously administered docetaxel (75 mg/m2 by infusion every 3 weeks). 
V klinični študiji pri bolnikih z metastatskim KORP zdravilo Xtandi (160 mg enkrat na dan) ni imelo nobenega klinično pomembnega učinka na farmakokinetiko intravensko uporabljenega docetaksela (75 mg/m2 z infuzijo vsake 3 tedne).
In addition to the observed improvement in overall survival, key secondary endpoints (PSA progression, radiographic progression-free survival, and time to first skeletal-related event) favoured enzalutamide and were statistically significant after adjusting for multiple testing. 
Poleg opaženega izboljšanja celokupnega preživetja so bili v korist enzalutamida tudi ključni sekundarni opazovani dogodki (napredovanje PSA, preživetje brez radiografsko potrjenega napredovanja bolezni in čas do prvega z okostjem povezanega dogodka) in so bili statistično značilni po korekciji za večkratna testiranja.
- Xtandi is not for use in women. 
Zdravilo Xtandi ni namenjeno za uporabo pri ženskah.
Seizures were reported in 4 in every 1,000 people taking Xtandi, and fewer than one in every 1,000 people taking placebo (see ‘Other medicines and Xtandi' below and section 4 ‘Possible side effects'). 
Napad krčev je bil opisan pri 4 od 1.000 bolnikov, ki so jemali zdravilo Xtandi in pri manj kot enem od 1.000 bolnikov, ki so jemali placebo (glejte podpoglavje "Druga zdravila in zdravilo Xtandi" spodaj ter poglavje 4, "Možni neželeni učinki").
In the active treatment arm, Xtandi was administered orally at a dose of 160 mg daily. 
V kraku zdravljenja z učinkovino so zdravilo Xtandi dajali peroralno v odmerkih po 160 mg na dan.
39.6 (37.7, NR) 
39,6 (37,7, ND)
Medicinal products with a narrow therapeutic range that are substrates for P-gp (e.g. colchicine, dabigatran etexilate, digoxin) should be used with caution when administered concomitantly with Xtandi and may require dose adjustment to maintain optimal plasma concentrations. 
Zdravila z ozkim terapevtskim razponom, ki so substrati P-gp (npr. kolhicin, digabatran-eksilat, digoksin), je treba med sočasno uporabo z zdravilom Xtandi uporabljati previdno; potrebna je lahko prilagoditev odmerka za vzdrževanje optimalne koncentracije v plazmi.
What Xtandi looks like and contents of the pack 
Izgled zdravila Xtandi in vsebina pakiranja
Other tumours, which are also potentially related to the primary pharmacology include fibroadenoma of mammary glands and benign thymoma of thymus in males, benign granulosa cell tumours of ovaries in females, and adenoma of pituitary pars distalis in both sexes. 
Med drugimi tumorji, ki so prav tako lahko povezani s primarno farmakologijo, so fibroadenom mlečnih žlez in benigni timom timusa pri samcih, benigni tumorji granuloznih celic jajčnikov pri samicah in adenom distalnega dela hipofize pri obeh spolih.
Fifty-one percent (51%) of patients were on bisphosphonates at baseline. 
Enainpetdeset odstotkov (51 %) bolnikov je ob izhodišču prejemalo difosfonate.
If Xtandi is co-administered with an anticoagulant metabolised by CYP2C9 (such as warfarin or acenocoumarol), additional International Normalised Ratio (INR) monitoring should be conducted (see section 4.5). 
Če je zdravilo Xtandi uporabljeno sočasno z antikoagulantom, ki se presnavlja s CYP2C9 (npr. z varfarinom ali acenokumarolom), je treba izvajati dodatne kontrole mednarodno umerjenega razmerja (INR - International Normalised Ratio) (glejte poglavje 4.5).
In the 9785-CL-0403 (UPWARD) single-arm trial to assess incidence of seizure in patients with predisposing factors for seizure (whereof 1.6% had a history of seizures), 8 of 366 (2.2%) patients treated with enzalutamide experienced a seizure. 
V 9785-CL-0403 (UPWARD) neprimerjalnem preskušanju z enim krakom za oceno pojavnosti konvulzij pri bolnikih s predispozicijskimi dejavniki za pojav konvulzij (od katerih je 1,6 % že imelo konvulzije v anamnezi) so se konvulzije pojavile pri 8 od 366 (2,2 %) bolnikov, zdravljenih z enzalutamidom.
In vitro data indicate that enzalutamide is not a substrate for OATP1B1, OATP1B3, or OCT1; and N-desmethyl enzalutamide is not a substrate for P-gp or BCRP. 
Podatki in vitro kažejo, da enzalutamid ni substrat OATP1B1, OATP1B3 ali OCT1; in N-desmetil enzalutamid ni substrat za P-gp ali BCRP.
¥ As evaluated by narrow SMQs of ‘Convulsions' including convulsion, grand mal convulsion, complex partial seizures, partial seizures, and status epilepticus. 
¥ Ovrednoteno z ozko standardno poizvedbo MedDRA (SMQ) "konvulzije", vključno s konvulzijami, konvulzijami grand mal, kompleksnimi parcialnimi napadi, parcialnimi napadi in epileptičnim statusom.
Enzalutamide is not a substrate of the efflux transporters P-gp or BCRP. 
Enzalutamid ni substrat transporterjev P-gp ali BCRP.
The absolute difference in objective soft tissue response between enzalutamide and placebo arms was [53.9% (95% CI: 48.5, 59.1), p < 0.0001]. 
Absolutna razlika v objektivnem odzivu mehkega tkiva med krakoma z enzalutamidom in placebom je bila [53,9 % (95 % IZ: 48,5, 59,1), p < 0,0001].
Patients taking medicinal products that are substrates of CYP2B6, CYP3A4, CYP2C9, CYP2C19 or UGT1A1 should be evaluated for possible loss of pharmacological effects (or increase in effects in cases where active metabolites are formed) during the first month of enzalutamide treatment and dose adjustment should be considered as appropriate. 
Pri bolnikih, zdravljenih z zdravili, ki so substrati CYP2B6, CYP3A4, CYP2C9, CYP2C19 ali UGT1A1, je treba prvi mesec zdravljenja z enzalutamidom spremljati možno zmanjšanje farmakoloških učinkov (ali povečanja takšnih učinkov v primeru nastanka aktivni presnovkov).
In controlled clinical studies, 13 patients (0.4%) experienced a seizure out of 3179 patients treated with a daily dose of 160 mg enzalutamide, whereas one patient (0.1%) receiving placebo and one patient (0.3%) receiving bicalutamide, experienced a seizure. 
V nadzorovanih kliničnih študijah je 13 (0,4 %) od 3179 bolnikov, zdravljenih z dnevnim odmerkom enzalutamida 160 mg, doživelo konvulzije, medtem ko je konvulzije doživel en bolnik (0,1 %), ki je dobival placebo, in en bolnik (0,3 %), ki je prejemal bikalutamid.
The ECOG performance score was 0 - 1 in 91.5% of patients and 2 in 8.5% of patients; 28% had a mean Brief Pain Inventory score of ≥ 4 (mean of patient's reported worst pain over the previous 24 hours calculated for seven days prior to randomisation). 
Stanje zmogljivosti po ECOG je bilo 0-1 pri 91,5 % bolnikov in 2 pri 8,5 % bolnikov; 28 % je imelo povprečno oceno na osnovi kratkega vprašalnika o bolečini (BPI - Brief Pain Inventory) ≥ 4 (povprečna vrednost bolnikove najhujše bolečine v predhodnih 24 urah, izračunana za sedem dni pred randomizacijo).
An increased half-life of enzalutamide has however been observed in patients with severe hepatic impairment (see sections 4.4 and 5.2). 
Vseeno so pri bolnikih s hudo okvaro jeter opazili podaljšan razpolovni čas enzalutamida (glejte poglavji 4.4 in 5.2).
If you have a seizure during treatment: See your doctor as soon as possible. 
Če doživite napad krčev med zdravljenjem: Nemudoma obiščite zdravnika.
The PROSPER study enrolled 1401 patients with asymptomatic, high-risk non-metastatic CRPC who continued on androgen deprivation therapy (ADT; defined as LHRH analogue or prior bilateral orchiectomy). 
Študija PROSPER je zajela 1401 bolnika z asimptomatskim, nemetastatskim KORP z velikim tveganjem, ki so nadaljevali z zdravljenjem z odtegnitvijo androgenov (ADT, opredeljenim kot uporaba analoga LHRH ali predhodna obojestranska orhidektomija).
The radioactivity in the fetus decreased to 0.08 times the maximum concentration at 72 hours after administration. 
V 72 urah po dajanju je bila radioaktivnost v plodu znižana na 0,08 kratnik maksimalne koncentracije.
This medicine contains 57.8 mg sorbitol (a type of sugar) per soft capsule. 
Ena mehka kapsula tega zdravila vsebuje 57,8 mg sorbitola (vrsta sladkorja).
Study results also have shown that enzalutamide and/or its metabolites are transferred to infant rat tissues via milk and subsequently eliminated. 
Rezultati študije so tudi pokazali, da se enzalutamid in/ali njegovi presnovki z mlekom prenesejo v tkiva mladičev podgan in se posledično izločijo.
Figure 5: Updated overall survival analysis by subgroup: Hazard ratio and 95% confidence interval in the PREVAIL study (intent-to-treat analysis) 
Slika 5: Posodobljena analiza celokupnega preživetja po podskupinah: razmerje ogroženosti in 95 % interval zaupanja v študiji PREVAIL (analiza z-namenom-zdravljenja)
Patients were excluded with a previous history of seizure, a condition that might predispose them to seizure, or certain prior treatments for prostate cancer (i.e., chemotherapy, ketoconazole, abiraterone acetate, aminoglutethimide and/or enzalutamide). 
Izključeni so bili bolniki, ki so imeli v anamnezi konvulzije, kakšno stanje, ki bi jim lahko povečalo nagnjenost h konvulzijam, ali so predhodno prejemali določena zdravila za zdravljenje raka prostate (tj. kemoterapijo, ketokonazol, abirateron-acetat, aminoglutetimid in/ali enzalutamid).
One hundred and eighteen (14%) enzalutamide-treated patients and 321 (40%) of placebo-treated patients had an event. 
Dogodek je imelo sto osemnajst (14 %) bolnikov, zdravljenih z enzalutamidom, in 321 (40 %) bolnikov, ki so dobivali placebo.
9785-CL-0410 study (enzalutamide post abiraterone in patients with metastatic CRPC) 
Študija 9785-CL-0410 (enzalutamid po abirateronu pri bolnikih z mKORP)
In vitro data indicate that enzalutamide may be an inhibitor of the efflux transporter P-gp. 
Podatki in vitro kažejo, da enzalutamid morda zavira efluksni prenašalec P-gp.
Under conditions of clinical use, enzalutamide is a strong inducer of CYP3A4, a moderate inducer of CYP2C9 and CYP2C19, and has no clinically relevant effect on CYP2C8 (see section 4.5). 
V pogojih klinične uporabe enzalutamid močno inducira CYP3A4, zmerno inducira CYP2C9 in CYP2C19 ter nima klinično pomembnega vpliva na CYP2C8 (glejte poglavje 4.5).
Patients with a previous history of seizure or a condition that might predispose to seizure and patients with moderate or severe pain from prostate cancer were excluded. 
Bolniki s konvulzijami v anamnezi ali stanjem, zaradi katerega so nagnjeni h konvulzijam, in bolniki z zmerno ali hudo bolečino zaradi raka prostate, so bili izključeni.
It is not known if enzalutamide is present in human milk. 
Ni znano, če se enzalutamid izloča v materino mleko.
Hazard Ratio is derived from a stratified proportional hazards model. 
Razmerje ogroženosti je dobljeno na podlagi stratificiranega modela sorazmernih ogroženosti.
Metastasis-free survival (MFS) was the primary endpoint defined as the time from randomisation to radiographic progression or death within 112 days of treatment discontinuation without evidence of radiographic progression, whichever occurred first. 
Primarni opazovani dogodek je bilo preživetje brez metastaz (MFS - metastasis-free survival), opredeljeno kot čas od randomizacije do radiografskega napredovanja bolezni ali smrti v 112 dneh po prenehanju zdravljenja, brez znakov radiografskega napredovanja bolezni, kar od tega se je zgodilo najprej.
The phase 3 studies excluded patients with recent myocardial infarction (in the past 6 months) or unstable angina (in the past 3 months), New York Heart Association Class (NYHA) III or IV heart failure except if Left Ventricular Ejection Fraction (LVEF) ≥ 45%, bradycardia or uncontrolled hypertension. 
Študije 3. faze niso vključevale bolnikov z nedavnim miokardnim infarktom (v zadnjih 6 mesecih) ali nestabilno angino pektoris (v zadnjih 3 mesecih), srčnim popuščanjem v III. ali IV. razredu po klasifikaciji Newyorškega združenja za srce (NYHA - New York Heart Association), razen, če je bil iztis deleža levega prekata (LVEF) ≥ 45%, bradikardijo ali neurejeno hipertenzijo.
Prostate cancer is known to be androgen sensitive and responds to inhibition of androgen receptor signalling. 
Znano je, da je rak prostate občutljiv za androgene in se odzove na zavrtje signaliziranja androgenskih receptorjev.
Xtandi should not be handled by persons other than the patient and his caregivers, and especially not by women who are or may become pregnant. 
Z zdravilom Xtandi ne smejo rokovati nobene druge osebe razen bolnika in njegovih negovalcev, še zlasti ne ženske, ki so noseče ali bi lahko zanosile.
Median rPFS (radiologic progression free survival, the study´s primary endpoint) was 8.1 months (95% CI: 6.1, 8.3). 
Mediano preživetje brez radiografsko potrjenega napredovanja bolezni (rPFS), ki je bilo primarni cilj študije, je bilo 8,1 meseca (95 % IZ: 6,1, 8,3).
Women who are or may become pregnant (see sections 4.6 and 6.6). 
Nosečnice in ženske, ki bi lahko zanosile (glejte poglavji 4.6 in 6.6).
Eighty-one percent (81%) of patients had an ECOG performance status score of 0 and 19% patients had an ECOG performance status of 1. 
Enainosemdeset odstotkov (81 %) bolnikov je imelo stanje zmogljivosti po ECOG 0 in 19 % bolnikov je imelo stanje zmogljivosti po ECOG 1.
Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway. 
Enzalutamid je močan zaviralec signaliziranja androgenskih receptorjev, ki blokira več korakov v poti signaliziranja androgenskih receptorjev.
The hazard ratio was 0.24 (95% CI: 0.14, 0.42) and the median time to a PFS event was not reached in the enzalutamide group versus 8.6 months in the bicalutamide group. 
Razmerje ogroženosti je bilo 0,24 (95 % IZ: 0,14, 0,42); mediani čas do dogodka PFS v skupini z enzalutamidom ni bil dosežen, v skupini z bikalutamidom pa je bil 8,6 meseca.
• Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil) 
• zaviralci kalcijevih kanalčkov (npr. diltiazem, felodipine, nikardipin, nifedipin, verapamil)
If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily. 
Če mora bolnik sočasno dobivati močan zaviralec CYP2C8, je treba odmerek enzalutamida zmanjšati na 80 mg enkrat na dan.