FrancophonIA/ELRC3.0 huggingface dataset:
English: This includes certain medicines used to: - Lower cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin) - Treat pain (e.g. fentanyl, tramadol) - Treat cancer (e.g. cabazitaxel) - Treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid) - Treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam,
Maltese: - Ibaxxu l-kolesterol (eż. gemfibrozil, atorvastatin, simvastatin) - Jikkuraw l-uġigħ (eż. fentanyl, tramadol) - Jikkuraw il-kanċer (eż. cabazitaxel) - Jikkuraw l-epilessija (eż. carbamazepine, clonazepam, phenytoin, primidone, valproic acid) - Jikkuraw ċerti disturbi psikjatriċi bħal ansjetà severa jew skiżofrenija (eż. diazepam,
English: Placebo (N = 845)
Maltese: (N = 845)
English: The most prominent of these were benign Leydig cell tumours, urothelium papilloma, and carcinoma of urinary bladder.
Maltese: L-aktar prominenti fost dawn kienu tumuri beninni taċ-ċelluli Leydig, papilloma fl-urotelju, u karċinoma tal-bużżieqa talawrina.
English: Stimulation of tumour cell growth via the androgen receptor requires nuclear localization and DNA binding.
Maltese: androġen teħtieġ lokalizzazzjoni nukleari u twaħħil mad-DNA.
English: Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Xtandi with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).
Maltese: Xtandi ma' prodotti mediċinali magħrufa li jtawlu l-intervall tal-QT jew prodotti mediċinali li jistgħu jwasslu għal Torsade de pointes bħal klassi IA (eż. quinidine, disopyramide) jew klassi III (eż amiodarone, sotalol, dofetilide, ibutilide) prodotti mediċinali antiarritmiċi, methadone, moxifloxacin, antipsikotiċi, eċċ., għandhom jiġu evalwati b'attenzjoni (ara sezzjoni 4.4).
English: In the MDV3100-14 clinical trial (PROSPER) of non-metastatic CRPC, patients receiving enzalutamide demonstrated a significantly higher confirmed PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 76.3% versus 2.4% (difference = 73.9%, p < 0.0001).
Maltese: Fil-prova klinika MDV3100-14 (PROSPER) ta' CRPC mhux metastatiku, il-pazjenti li kienu qed jirċievu enzalutamide wrew rata ta' rispons ikkonfermat għall-PSA sinifikament ogħla (definita bħala tnaqqis ta' ≥ 50% mil-linja bażi), meta mqabbla ma' pazjenti li rċivew plaċebo, 76.3% kontra 2.4%
English: Baseline pain assessment was 0 - 1 (asymptomatic) in 67% of patients and 2 - 3 (mildly symptomatic) in 32% of patients as defined by the Brief Pain Inventory Short Form (worst pain over past 24 hours on a scale of 0 to 10).
Maltese: L-evalwazzjoni tal-uġigħ fil linja bażi kienet ta' 0 - 1 (asintomatika) f'67% tal-pazjenti u 2 - 3 (ftit sintomatika) fi 32% tal-pazjenti kif definita mill-Formula Qasira tal-Inventarju Qasir tal-Uġigħ (Brief Pain Inventory Short Form) (l agħar uġigħ matul l-aħħar 24 siegħa fuq skala minn 0 sa 10).
English: An updated survival analysis was conducted when 784 deaths were observed.
Maltese: Analiżi aġġornata tas-sopravivenza twettqet meta ġew osservati 784 każ ta' mewt.
English: Co-administration of enzalutamide (160 mg once daily) with single oral doses of sensitive CYP substrates in prostate cancer patients resulted in an 86% decrease in the AUC of midazolam (CYP3A4 substrate), a 56% decrease in the AUC of S-warfarin (CYP2C9 substrate), and a 70% decrease in the AUC of omeprazole (CYP2C19 substrate).
Maltese: midazolam (substrat ta' CYP3A4), tnaqqis ta' 56% fl-AUC tal-warfarina-S (substrat ta' CYP2C9), u tnaqqis ta' 70% fl-AUC ta' omeprazole (substrat ta' CYP2C19).
English: Gender differences were noted in rat mammary glands (male atrophy and female lobular hyperplasia).
Maltese: Ġiet innutata differenza bejn is-sessi fil-glandoli mammarji tal-firien (atrofija fil-firien irġiel u iperplażija lobulari fil-firien nisa).
English: The median age at randomisation was 74 years in the enzalutamide arm and 73 years in the placebo arm.
Maltese: L-età medjana fl-għażla każwali kienet ta' 74 sena fil-grupp ta' enzalutamide u 73 sena fil-grupp tal plaċebo.
English: Patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 78.0% versus 3.5% (difference = 74.5%, p < 0.0001).
Maltese: Pazjenti li kienu qed jirċievu enzalutamide urew rata totali ta' rispons għall-PSA ogħla b'mod sinifikanti (definita bħala tnaqqis ta' ≥ 50% mil-linja bażi), meta mqabbla ma' pazjenti li rċivew plaċebo, 78.0% kontra 3.5% (differenza = 74.5%, p < 0.0001).
English: P-value is derived from an unstratified log-rank test.
Maltese: Il-valur p inkiseb minn log-rank test mhux stratifikat
English: CYP2C8 inhibitors
Maltese: Inibituri ta' CYP2C8
English: Not known*: nausea, vomiting, diarrhoea
Maltese: Mhux magħruf*: dardir, rimettar, dijarea
English: No dose adjustment is indicated when a CYP1A2 or CYP2C8 substrate is co-administered with Xtandi.
Maltese: Mhuwa indikat ebda aġġustament tad-doża meta substrat ta'CYP1A2 jew CYP2C8 jiġi koamministrat ma' Xtandi.
English: - Certain medicines for the treatment of pain (e.g. pethidine).
Maltese: - Ċerti mediċini għall-kura tal-uġigħ (eż. pethidine).
English: For the 145 patients who had no previous chemotherapy, median rPFS was 8.1 months (95% CI: 5.7, 8.3).
Maltese: Għall145 pazjent li ma kinux irċivew kimoterapija fil-passat, l-rPFS medjan kien 8.1 xhur (CI ta' 95%: 5.7, 8.3).
English: Common: anxiety Uncommon: visual hallucination
Maltese: Mhux komuni: disturb konoxxittiv, aċċessjoni
English: Oral absorption of film-coated enzalutamide tablets was evaluated in healthy male volunteers after a single 160 mg dose of Xtandi film-coated tablets, and pharmacokinetic modelling and simulation were used to predict the pharmacokinetic profile at steady state.
Maltese: L-assorbiment orali tal-pilloli enzalutamide miksija b'rita ġie evalwat f'voluntiera rġiel b'saħħithom wara doża waħda ta' 160 mg ta' Xtandi - pilloli miksija b'rita, u mmudellar farmakokinetiku u simulazzjoni ntużaw biex ibassru l-profil farmakokinetiku fl-istat fiss.
English: Table 4: Overall survival of patients treated with either enzalutamide or placebo in the AFFIRM study (intent-to-treat analysis)
Maltese: Tabella 4: Sopravivenza globali ta' pazjenti kkurati jew b'enzalutamide jew bi plaċebo fl-istudju AFFIRM (analiżi b'intenzjoni li tikkura)
English: 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.
Maltese: Id-dejta in vitro tindika li enzalutamide mhuwiex substrat għal OATP1B1, OATP1B3 jew OCT1; u N
English: In a 6month study in transgenic rasH2 mice, enzalutamide did not show carcinogenic potential (absence of neoplastic findings) at doses up to 20 mg/kg per day (AUC24h ~317 µg·h/mL), which resulted in plasma exposure levels similar to the clinical exposure (AUC24h 322 µg·h/mL) in mCRPC patients receiving 160 mg, daily.
Maltese: Fi studju ta' 6 xhur fi ġrieden transġeniċi rasH2, enzalutamide ma wera l-ebda potenzjal karċinoġeniku (nuqqas ta' sejbiet neoplastiċi) f'dożi sa 20 mg/kg kuljum (AUC24h ~317 µg·h/mL), li rriżultaw f'livelli ta' esponiment fil-plażma simili għall-esponiment kliniku (AUC24h 322 µg·h/mL) f'pazjenti b'mCRPC li kienu qed jirċievu 160 mg kuljum.
English: 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.
Maltese: L-analiżi kienet tinvolvi 216-il mewt mingħajr progressjoni dokumentata u 645 każ ta' progressjoni dokumentata, li minnhom 303 (47%) kienu dovuti għal progressjoni fit-tessut artab, 268 (42%) kienu dovuti għal progressjoni tal-leżjonijiet flgħadam u 74 (11%) kienu dovuti kemm għat-tessut artab kif ukoll għal-leżjonijiet fl-għadam.
English: Daily fluctuations in plasma concentrations are low (peak-to-trough ratio of 1.25).
Maltese: Il-varjazzjonijiet ta' kuljum fil-konċentrazzjonijiet tal-plażma huma ftit (proporzjon massimu sal-minimu ta' 1.25).
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).
Maltese: Reazzjonijiet ipersensittivi kkawżati minn sintomi inklużi, imma mhux limitati għal, raxx, jew edema tal-wiċċ, tal-ilsien, tax-xoffa jew farinġjali, ġew osservati ma' enzalutamide (ara sezzjoni 4.8).
English: Xtandi 80 mg film-coated tablets enzalutamide
Maltese: Xtandi 80 mg pilloli miksija b'rita enzalutamide
English: The pharmacokinetics of enzalutamide were examined in subjects with baseline mild (N = 6), moderate (N = 8) or severe (N = 8) hepatic impairment (Child-Pugh Class A, B or C, respectively) and in 22 matched control subjects with normal hepatic function.
Maltese: , moderat (N = 8) jew sever (N = 8) fil-linja bażi (Child-Pugh Klassi A, B jew C, rispettivament) u fi
English: The TERRAIN study enrolled 375 chemo- and antiandrogen-therapy naïve patients with metastatic CRPC who were randomised to receive either enzalutamide at a dose of 160 mg once daily (N = 184) or bicalutamide at a dose of 50 mg once daily (N = 191).
Maltese: L-istudju TERRAIN kellu rreġistrati 375 pazjent li qatt ma ħadu kimoterapija u terapija antiandroġen b'CRPC metastatiku li ntgħażlu b'mod każwali biex jirċievu jew enzalutamide f'doża ta' 160 mg darba kuljum (N = 184) jew bicalutamide f'doża ta' 50 mg darba kuljum (N = 191).
English: Women who are or may become pregnant (see sections 4.6 and 6.6).
Maltese: Nisa tqal jew li jistgħu joħorġu tqal (ara sezzjonijiet 4.6 u 6.6).
English: 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.
Maltese: Ir-risponsi kompleti ġew irrappurtati f'19.7% tal-pazjenti kkurati b'enzalutamide meta mqabbla ma' 1.0% tal-pazjenti kkurati bil-plaċebo, u risponsi parzjali ġew irrappurtati f'39.1%
English: Following oral administration of the moderate CYP2C8 and strong CYP3A4 inducer rifampin (600 mg once daily) to healthy male subjects, the AUC of enzalutamide plus the active metabolite decreased by 37% while Cmax remained unchanged.
Maltese: Wara li l-induttur moderat CYP2C8 u l-induttur qawwi CYP3A4 ta' rifampin (600mg darba kuljum) ġew mogħtija mill-ħalq lil individwi rġiel b'saħħithom, l-AUC ta' enzalutamide flimkien mal-metabolit attiv naqas b'37% filwaqt li Cmax baqa' ma nbidilx.
English: Common: headache, memory impairment, amnesia, disturbance in attention, restless legs syndrome Uncommon: cognitive disorder, seizure¥ Not known*: posterior reversible encephalopathy syndrome
Maltese: Disturbi fis-sistema nervuża Komuni: uġigħ ta' ras, indeboliment tal-memorja, amnesija, disturb fl-attenzjoni, sindrome tas-saqajn bla kwiet
English: PSA Response (defined as ≥ 50% decrease from baseline) was 22.4% (95% CI: 17.0, 28.6).
Maltese: Ir-rispons PSA (definit bħala tnaqqis ta' ≥ 50% mil-linja bażi) kien 22.4% (CI ta' 95%:
English: Median rPFS (radiologic progression free survival, the study´s primary endpoint) was 8.1 months (95% CI: 6.1, 8.3).
Maltese: L-rPFS medjan (is-sopravivenza radjoloġika mingħajr progressjoni, il-punt aħħari primarju tal-istudju) kien 8.1 xhur (CI ta' 95%: 6.1, 8.3). L-OS medjan ma ntlaħaqx.
English: An increased half-life of enzalutamide has been observed in patients with severe hepatic impairment, possibly related to increased tissue distribution.
Maltese: Ġiet osservata żieda fil-half-life ta' enzalutamide f'pazjenti b'indeboliment tal-fwied sever, possibbilment relatati ma żieda fid-distribuzzjoni tat-tessuti.
English: Headache, fall, feeling anxious, dry skin, itching, difficulty remembering, blockage of the arteries in the heart (ischemic heart disease), breast enlargement in men (gynaecomastia), symptom of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg), reduced concentration, forgetfulness
Maltese: Uġigħ ta' ras, waqgħa, tħossok ansjuż, ġilda xotta, ħakk, diffikultajiet ta' memorja, imblokk talarterji fil-qalb (mard tal-qalb iskemiku), tkabbir tas-sider fl-irġiel (ġinekomastija), sintomi tas sindromu tar-riġlejn bla kwiet (xewqa inkontrollabbli li ċċaqlaq parti tal-ġisem, normalment irriġel), tnaqqis ta' konċentrazzjoni, tinsa malajr
English: 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).
Maltese: Jekk Xtandi jiġi koamministrat ma' antikoagulant metabolizzat minn CYP2C9 (bħal pereżempju warfarina jew acenocoumarol), għandu jitwettaq monitoraġġ addizzjonali tal-Proporzjon Normalizzat Internazzjonali
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.
Maltese: L-analiżi kienet tinvolvi 448 każ b'rabta skeletrika, li minnhom 277 każ (62%) kienu radjazzjoni fl-għadam, 95 każ (21%) kienu kompressjoni tas-sinsla tad-dahar, 47 każ (10%) kienu ksur patoloġiku tal-għadam, 36 każ (8%) kienu bidla fit-terapija antineoplastika biex jiġi kkurat l-uġigħ fl-għadam, u 7 każijiet (2%) kienu operazzjoni fl-għadam.
English: Each capsule contains 40 mg enzalutamide.
Maltese: Kull kapsula fiha 40 mg ta' enzalutamide.
English: • the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
Maltese: • kura tal-kanċer metastatiku CRPC f'irġiel adulti li huma asintomatiċi jew xi ftit sintomatiċi wara l-falliment tat-terapija tal-privazzjoni ta' androġeni li fihom il-kimoterapija għadha mhijiex klinikament indikata (ara sezzjoni 5.1).
English: The proportion of enzalutamide-treated patients with measurable disease at baseline who had an objective soft tissue response was 58.8% (95% CI: 53.8, 63.7) compared with 5.0% (95% CI: 3.0, 7.7) of patients receiving placebo.
Maltese: Il-proporzjon ta' pazjenti kkurati b'enzalutamide b'mard li jitkejjel fil-linja bażi li kellhom rispons oġġettiv ta' tessut artab kien ta' 58.8% (CI ta' 95%: 53.8, 63.7) meta mqabbla ma' 5.0% (CI ta' 95%:
English: The volume of distribution of enzalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Maltese: Il-volum ta' distribuzzjoni ta' enzalutamide huwa ikbar mill-volum tal-ilma totali fil-ġisem, u dan jindika distribuzzjoni ekstravaskulari estensiva.
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].
Maltese: Enzalutamide wera dewmien statistikament sinifikanti fiż-żmien għall-ewwel użu ta' terapija b'antineoplastiċi ġdida meta mqabbel ma' plaċebo [HR = 0.21 (CI ta' 95%: 0.17, 0.26), p < 0.0001].
English: - Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone) - Treat HIV infection (e.g. indinavir, ritonavir) - Treat bacterial infections (e.g. clarithromycin, doxycycline) - Treat thyroid disorders (e.g. levothyroxine) - Treat gout (e.g. colchicine) - Treat stomach disorders (e.g. omeprazole) - Prevent heart conditions or strokes (e.g. dabigatran etexilate) - Prevent organ rejection (e.g. tacrolimus)
Maltese: - Jikkuraw mard serju relatat mal-infjammazzjoni (eż. dexamethasone, prednisolone) - Jikkuraw l-infezzjoni bl-HIV (eż. indinavir, ritonavir) - Jikkuraw l-infezzjonijiet batteriċi (eż. clarithromycin, doxycycline) - Jikkuraw disturbi tat-tirojde (eż. levothyroxine) - Jikkuraw il-gotta (eż. colchicine) - Jikkuraw disturbi fl-istonku (eż. omeprazole)
English: Consistent rPFS benefit was observed across all pre-specified patient subgroups (e.g. age, baseline ECOG performance, baseline PSA and LDH, Gleason score at diagnosis, and visceral disease at screening).
Maltese: Benefiċċju rPFS konsistenti ġie osservat fis-sottogruppi kollha ta' pazjenti speċifikati minn qabel (eż. età, prestazzjoni ECOG fil-linja bażi, PSA u LDH fil-linja bażi, il-punteġġ
English: Xtandi might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other medicines (e.g. methadone, used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Maltese: quinidine, procainamide, amiodarone u sotalol) jew jista' jżid ir-riskju ta' problemi fir-ritmu tal-qalb meta użat ma' xi mediċini oħra (eż. methadone, użat għal serħan mill-uġigħ u parti midditossifikazzjoni mill-vizzju tad-droga), moxifloxacin (antibijotiku), antipsikotiċi użati għal mard mentali serju).
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 14 film-coated tablets.
Maltese: Kartiera tal-kartun li tinkorpora folja tal-PVC/PCTFE/aluminju b'14-il pillola miksija b'rita.
English: The clinical relevance of this observation remains unknown.
Maltese: Ir-rilevanza klinika ta 'din l-osservazzjoni tibqa' mhux magħrufa.
English: Post-authorisation efficacy study (PAES): In order to investigate the long-term effects of enzalutamide on Overall Survival and relevant secondary endpoints in adult men with high-risk non-metastatic castration-resistant prostate cancer, the MAH should submit the results of the MDV3100-14 (PROSPER) efficacy study:
Maltese: Sabiex jiġu investigati leffetti fit-tul ta' enzalutamide fuq is-Sopravivenza Globali u l-punti aħħarin sekonardji rilevanti f'irġiel adulti b'riskju għoli ta' kanċer mhux metastatiku talprostata reżistenti għall-kastrazzjoni ta' riskju għoli, l-MAH għandu jissottometti r-riżultati tal-istudju dwar l-effikaċja MDV3100-14 (PROSPER):
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.
Maltese: Fl-istat fiss, il-valuri medji tas-Cmax għal enzalutamide u l metabolit attiv tiegħu huma 16.6 μg/mL (koeffiċjent ta' varjazzjoni [CV] ta' 23%) u 12.7 μg/mL (CV
English: - Swallow the tablets whole with water.
Maltese: - Ibla' l-pilloli sħaħ mal-ilma.
English: Elderly No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
Maltese: Ma hemm bżonn ebda aġġustament tad-doża għal pazjenti anzjani (ara sezzjonijiet 5.1 u 5.2).
English: Rare cases of posterior reversible encephalopathy syndrome have been reported in enzalutamidetreated patients (see section 4.4).
Maltese: Każijiet rari tas-sindromu tal-enċefalopatija riversibbli posterjuri ġew irrappurtati f`pazjenti trattati b'enzalutamide(ara sezzjoni 4.4).
English: nicardipine, nifedipine, propranolol, verapamil) - Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone) - Treat HIV infection (e.g. indinavir, ritonavir) - Treat bacterial infections (e.g. clarithromycin, doxycycline) - Treat thyroid disorders (e.g. levothyroxine)
Maltese: - Jikkuraw mard serju relatat mal-infjammazzjoni (eż. dexamethasone, prednisolone) - Jikkuraw l-infezzjoni bl-HIV (eż. indinavir, ritonavir) - Jikkuraw l-infezzjonijiet batteriċi (eż. clarithromycin, doxycycline) - Jikkuraw disturbi tat-tirojde (eż. levothyroxine)
English: Figure 2: Kaplan-Meier curves of time to first use of new antineoplastic therapy in the PROSPER study (intent-to-treat analysis)
Maltese: Kaplan-Meier taż-żmien għall-ewwel użu ta' terapija b'antineoplastiċi ġdida flistudju PROSPER (analiżi b'intenzjoni li tiġi kkurata)
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.
Maltese: Wara doża orali waħda ta' 160 mg ta' enzalutamide, l-AUC u s-Cmax għal enzalutamide f'individwi b'indeboliment ħafif żdiedu b'5% u 24% rispettivament, u l-AUC u s-Cmax ta' enzalutamide f'individwi b'indeboliment moderat żdied b'29% u naqas bi 11% rispettivament, u l
English: The STRIVE study enrolled 396 non-metastatic or metastatic CRPC patients who had serologic or radiographic disease progression despite primary androgen deprivation therapy who were randomised to receive either enzalutamide at a dose of 160 mg once daily (N = 198) or bicalutamide at a dose of 50 mg once daily (N = 198).
Maltese: L-istudju STRIVE kellu rreġistrati 396 pazjent b'CRPC mhux metastatiku jew metastatiku li kellhom progressjoni ta' mard seroloġiku jew radjografiku minkejja t-terapija ta' privazzjoni tal-androġen primarju u li ntgħażlu b'mod każwali biex jirċievu jew enzalutamide f'doża ta' 160 mg darba kuljum (N = 198) jew bicalutamide f'doża ta' 50 mg darba kuljum (N = 198).
English: Figure 6: Kaplan-Meier curves of radiographic progression-free survival in the PREVAIL study (intent-to-treat analysis)
Maltese: Kaplan-Meier tas-sopravivenza mingħajr progressjoni radjografika fl-istudju PREVAIL (analiżi b'intenzjoni li tiġi kkurata)
English: - If you are pregnant or may become pregnant (see ‘Pregnancy, breast-feeding and fertility')
Maltese: - Jekk inti tqila jew tista' toħroġ tqila (ara ‘Tqala, treddigħ u fertilità').
English: Radiographic progression was assessed with the use of sequential imaging studies as defined by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (for bone lesions) and/or Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria (for soft tissue lesions).
Maltese: u/jew kriterji tar-Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) (għal leżjonijiet tattessut artab).
English: Astellas Pharma Ltd. Tel: +44 (0)203 379 8700
Maltese: Tel: + 44 (0)203 379 8700
English: 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').
Maltese: Aċċessjonijiet ġew irrappurtati f'4 minn kull 1,000 persuna li jieħdu Xtandi, u f'inqas minn persuna waħda minn kull 1,000 li kienu qed jieħdu plaċebo (ara ‘Mediċini oħra u Xtandi' hawn taħt u sezzjoni 4 ‘Effetti sekondarji possibbli').
English: The median time to PSA progression per PCWG2 criteria was 11.2 months for patients treated with enzalutamide and 2.8 months for patients who received placebo [HR = 0.17 (95% CI: 0.15, 0.20), p < 0.0001].
Maltese: Il-medjan taż-żmien sal-progressjoni PSA skont il-kriterji PCWG2 kien ta' 11.2 xhur għal pazjenti kkurati b'enzalutamide, u 2.8 xhur għall-pazjenti li rċivew plaċebo [HR=0.17, (CI ta' 95%: 0.15, 0.20), p<0.0001].
English: Fifty-one percent (51%) of patients were on bisphosphonates at baseline.
Maltese: Wieħed u ħamsin fil-mija (51%) tal-pazjenti kienu qed jieħdu bisfosfonati fil-linja bażi.
English: Key Secondary Efficacy Endpoints Time to PSA progression
Maltese: Żmien għall-progressjoni tal-PSA
English: Enzyme induction
Maltese: Enzalutamide/Plaċebo
English: Figure 7: Kaplan-Meier curves of overall survival in the AFFIRM study (intent-to-treat analysis)
Maltese: Kaplan-Meier tas-sopravivenza globali fl-istudju AFFIRM (analiżi b'intenzjoni li tiġi kkurata)
English: ECOG: Eastern Cooperative Oncology Group; BPI-SF: Brief Pain Inventory-Short Form; PSA: Prostate Specific Antigen
Maltese: ECOG: Grupp tal-Onkoloġija Kooperattiva tal-Lvant;