FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of patients with DFS events (protocol definition) Hazard ratio1 (99% CI)
Maltese: Numru ta' pazjenti b'episodji DFS (definizzjoni tal-protokoll) Proporzjon tal-periklu1 (99% CI)
English: Events marked * were statistically significantly different in the two treatment arms.
Maltese: Episodji mmarkati bi * kienu statistikament ferm differenti fiż-żewġ gruppi.
English: Sequential Treatments Analysis (STA)
Maltese: Analiżi tat-Trattamenti Sekwenzjali (STA)
English: Patients with severe hepatic impairment (Child-Pugh C) require close supervision (see sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment epatiku gravi (Child-Pugh C) jeħtieġu superviżjoni mill-qrib (ara sezzjonijiet 4.4 u 5.2).
English: Time to progression Median
Maltese: Żmien ta' progressjoni
English: Severe persistent blurred vision.
Maltese: - Viżta mċajpra u gravi b'mod persistenti.
English: Censored analysis of DFS3
Maltese: Analiżi ċċensurata ta' DFS3
English: Its apparent volume of distribution at steady state is about 1.87  0.47 l/kg.
Maltese: Jidher li l-volum ta' distribuzzjoni fi stat stabbli hu ta' madwar 1.87  0.47 l/kg.
English: {Invented Name}>tamoxifen
Maltese: {Isem (Ivvintat)}>tamoxifen
English: Do not be alarmed by this list of possible side effects.
Maltese: Tallarmax ruħek b'din il-lista ta' effetti sekondarji possibbli.
English: Events
Maltese: Episodji
English: Palpitations1, tachycardia, ischaemic cardiac events(including new or worsening angina, angina requiring surgery, myocardial infarction and myocardial ischaemia)
Maltese: Palpitazzjonijiet1, takikardija, episodji kardijaċi iskemiċi (inkluż episodji ġodda jew li ggravaw ta' anġina, anġina li teħtieġ operazzjoni, infart mijokardijaku u iskemija mijokardijaka)
English: Keep this leaflet.
Maltese: Stat ta' menopawża
English: Angioedema, toxic epidermal necrolysis, erythema multiforme Musculoskeletal and connective tissue disorders Very common:
Maltese: Anġjoedima, nekrolożi epidermali tossika, eritema multiformi Disturbi muskoluskeletrali u tat-tessuti konnettivi Komuni ħafna:
English: Censored analysis of OS3
Maltese: Analiżi ċċensurata ta' OS3
English: Thus, glucocorticoid and mineralocorticoid supplementation is not necessary.
Maltese: Għaldaqstant, mhux meħtieġ supplimentazzjoni ta' glucocorticoid u mineralocorticoid.
English: Letrozole showed a low degree of acute toxicity in rodents exposed up to 2000 mg/kg.
Maltese: Letrozole wera livell baxx ta' tossiċità akuta f'rodenti esposti għal 2000 mg/kg.
English: The ACTH stimulation test performed after 6 and 12 weeks of treatment with daily doses of 0.1 mg, 0.25 mg, 0.5 mg, 1 mg, 2.5 mg, and 5 mg did not indicate any attenuation of aldosterone or cortisol production.
Maltese: It-test dwar l-istimulazzjoni tal-ACTH li sar wara 6 u 12-il ġimgħa ta' trattament b'dożi ta' 0.1 mg, 0.25 mg, 0.5 mg, 1 mg, 2.5 mg, u 5 mg kuljum ma indikax xi tnaqqis fil-produzzjoni ta' aldosterone jew cortisol.
English: Dyspnoea, cough Gastrointestinal disorders Common:
Maltese: Qtugħ ta' nifs, sogħla Disturbi gastrointestinali Komuni:
English: Metabolism of letrozole is partly mediated via CYP2A6 and CYP3A4.
Maltese: Parti mill-metaboliżimu ta' letrozole jgħaddi permezz ta' CYP2A6 u CYP3A4.
English: (95% CI for rate) Odds ratio (95% CI for odds ratio) P
Maltese: Odds ratio (95% CI tal-odds ratio) P
English: {Invented Name} N=453
Maltese: {Isem (Ivvintat)} N=453
English: Statistically significant differences were observed in favour of letrozole 2.5 mg compared to megestrol acetate in overall objective tumour response rate (24% vs 16%, P=0.04), and in time to treatment failure (P=0.04).
Maltese: Kienu osservati differenzi qawwija statistikament favur 2.5 mg letrozole imqabbla ma' megestrol acetate fir-rata globali ta' rispons objettiv għat-tumur (24% kontra 16%, P=0.04), u fiż-żmien li matulu falla t-trattament (P=0.04).
English: The frequency category for these adverse reactions is described in Table 1.
Maltese: Il-kategorija tal-frekwenza ta' dawn ir-reazzjonijiet avversi qed tidher f'Tabella 1.
English: Pulmonary embolism, arterial thrombosis, cerebrovascular infarction Respiratory, thoracic and mediastinal disorders Uncommon:
Maltese: Emboliżmu pulmonari, trombożi arterjali, infart ċerebrovaskulari Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni:
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: As the tablets contain lactose, {Invented Name} is not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.
Maltese: Minħabba li l-pilloli fihom il-lactose, {Isem (Ivvintat)} mhuwiex irrakkomandat għal pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-glactose, nuqqas ta' lactase jew malassorbiment tal-glucose-galactose.
English: Hazard ratio (HR) (95% CI for HR) P
Maltese: Proporzjon ta' periklu (HR) (95% CI tal-HR) P
English: Anorexia, appetite increase
Maltese: Anoressija, żieda fl-aptit
English: Tamoxifen>{Invented Name}
Maltese: Tamoxifen->{Isem (Ivvintat)}
English: {Invented Name} N=4003
Maltese: {Isem (Ivvintat)} N=4003
English: • Pregnancy (see section 4.6)
Maltese: • Tqala (ara sezzjoni 4.6).
English: Letrozole is rapidly and completely absorbed from the gastrointestinal tract (mean absolute bioavailability: 99.9%).
Maltese: Letrozole jiġi assorbit b'ħeffa u b'mod sħiħ mill-passaġġ gastrointestinali (il-medja talbijodisponibbiltà assoluta: 99.9%).
English: Time to progression was not significantly different between letrozole 2.5 mg and megestrol acetate (P=0.07).
Maltese: Iż-żmien ta' progressjoni ma kienx wisq differenti għal 2.5 mg letrozole u megestrol acetate (P=0.07).
English: No clinically relevant changes were found in the plasma concentrations of cortisol, aldosterone, 11-deoxycortisol, 17-hydroxyprogesterone, and ACTH or in plasma renin activity among postmenopausal patients treated with a daily dose of letrozole 0.1 to 5 mg.
Maltese: Ma kienx hemmx tibdiliet relevanti klinikament fil-konċentrazzjonijiet tal-plażma ta' cortisol, aldosterone, 11-deoxycortisol, 17-hydroxyprogesterone, u ACTH jew fl-attività tar-renin tal-plażma fost il-pazjenti li qabżu l-menopawża ttrattati b'doża ta' bejn 0.1 u 5 mg letrozole kuljum.
English: The cytochrome P450 isoenzymes 3A4 and 2A6 were found to be capable of converting letrozole to this metabolite.
Maltese: Instab li l-isoenzimi 3A4 u 2A6 taċ-ċitokromu P450 kienu kapaċi jikkonvertu letrozole f'dan il-metabolit.
English: Somnolence, insomnia, memory impairment, dysaesthesia (including paraesthesia, hypoaesthesia), taste disturbance, cerebrovascular accident
Maltese: Ngħas, nuqqas ta' rqad, diffikultà ta' memorja, disastesija (inkluż parestesija, ipoestesija), disturb fit-tegħim, inċident ċerebrovaskulari
English: Food slightly decreases the rate of absorption (median tmax 1 hour fasted versus 2 hours fed; and mean Cmax 129 ± 20.3 nmol/litre fasted versus 98.7 ± 18.6 nmol/litre fed) but the extent of absorption (AUC) is not changed.
Maltese: L-ikel inaqqas bi ftit ir-rata ta' assorbiment (il-medja tat-tmax siegħa sajjem kontra sagħtejn imrejjaq; u l-medja tas-Cmax 129± 20.3 nmol/litru sajjem k 98.7 ± 18.6 nmol/litru mrejjaq) imma l-estensjoni tal-assorbiment (AUC) ma tinbidilx.
English: Cox model Pvalue
Maltese: Valur-P mudell Cox
English: In the extended adjuvant setting for {Invented Name} (median duration of treatment 5 years) and placebo (median duration of treatment 3 years), respectively: angina requiring surgery (0.8% vs. 0.6%); new or worsening angina (1.4% vs. 1.0%); myocardial infarction (1.0% vs. 0.7%); thromboembolic event* (0.9% vs. 0.3%); stroke/transient ischaemic attack* (1.5% vs. 0.8%) were reported.
Maltese: Fis-sitwazzjoni adjuvanti estiża għal {Isem (Ivvintat)} (tul medju ta' żmien ta' trattament ta' 5 snin) u għal plaċebo (tul medju ta' żmien ta' trattament ta' 3 snin), rispettivament: kienu rrappurtati anġina li teħtieġ operazzjoni (0.8% kontra 0.6%); episodju ta' anġina ġdida jew li marret għall-agħar (1.4% kontra 1.0%); infart mijokardijaku (1.0% kontra 0.7%); episodju tromboemboliku* (0.9% kontra 0.3%); puplesija/attakk iskemiku tranżitorju* (1.5% kontra 0.8%).
English: Each film-coated tablet contains 2.5 mg letrozole.
Maltese: Kull pillola miksija b'rita fiha 2.5 mg letrozole.
English: 1 Log rank test, stratified by randomisation option and use of chemotherapy (yes/no) 2 DFS events: loco-regional recurrence, distant metastasis, invasive contralateral breast cancer,
Maltese: 1 Test tal-pożizzjoni tal-logaritmi (log rank test), stratifikat skont għażla randomizzata u l-użu tal kemoterapija (iva/le) 2 Episodji DFS: rikorrenza lokoreġjonali, metastasi distanti, kanċer tas-sider kontralaterali invażiv,
English: General oedema, mucosal dryness, thirst, pyrexia
Maltese: Edima ġenerali, xuttaġni tal-mukuża, għatx, piressija
English: HR (95% CI)2
Maltese: HR (95% C
English: Fatigue (including asthenia, malaise)
Maltese: Għeja (inkluż astenja, mejt)
English: Table 7 Sequential Treatments Analyses from randomisation (STA-R) of disease-free survival (ITT STA-R population)
Maltese: Tabella 7 Analiżi tat-Trattament Sekwenzjali minn randomizzazzjoni (STA-R) tassopravivenza mingħajr mard (popolazzjoni
English: (95% CI for median) (8.9, 11.6 months)
Maltese: (8.9, 11.6 xhur)
English: Hormone antagonist and related agents: aromatase inhibitor, ATC code: L02BG04.
Maltese: Antagonist ormonali u aġenti relatati: inibituri tal-aromotasi, Kodiċi ATC:
English: Table 9 Results at a median follow-up of 32 months
Maltese: Tabella 9 Riżultati minn medja ta' viżti ta' kontroll ta' 32 xahar
English: At 24 months there was a statistically significant difference in the primary end-point; the lumbar spine BMD (L2-L4) showed a median decrease of 4.1% for letrozole compared to a median increase of 0.3% for tamoxifen.
Maltese: Fl-24 xahar kien hemm differenza qawwija statistikament fl-end-point primarju; il-BMD tal-ispina lumbari (L2-L4) wera tnaqqis medju ta' 4.1% għal letrozole imqabbel maż-żieda medja ta' 0.3% għal tamoxifen.
English: Study D2407 is an open-label, randomised, multicentre post approval safety study designed to compare the effects of adjuvant treatment with letrozole and tamoxifen on bone mineral density (BMD) and serum lipid profiles.
Maltese: L-istudju D2407 hu studju open-label, randomizzat u multiċentriku li sar wara l-approvazzjoni tassigurtà u li tħejja sabiex iqabbel l-effetti tat-trattament adjuvanti b'letrozole u tamoxifen fuq id-densità tal-minerali fl-għadam (BMD) u l-profili tal-lipidi fis-serum.
English: Insufficient data are available for patients with severe hepatic impairment.
Maltese: M'hemmx biżżejjed informazzjoni dwar pazjenti b'indeboliment epatiku gravi.
English: Table 3 Sequential treatment versus {Invented Name} monotherapy - adverse events with significant differences
Maltese: Tabella 3 Trattament sekwenzjali kontra monoterapija b'{Isem (Ivvintat)} - episodji avversi b'differenzi qawwija
English: Letrozole 2.5 mg was statistically superior to aminoglutethimide for time to progression (P=0.008), time to treatment failure (P=0.003) and overall survival (P=0.002).
Maltese: 2.5 mg letrozole ma kienx bil-wisq superjuri għal aminoglutethimide fejn jidħol iż-żmien ta' progressjoni (P=0.008), iż-żmien li matulu falla t-trattament (P=0.003) u ssopravivenza globali (P=0.002).
English: The safety and efficacy of {Invented Name} in children and adolescents aged up to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' {Isem (Ivvintat)} fit-tfal u adoloxxenti sa 17-il sena ma ġewx determinati s'issa.
English: In healthy postmenopausal women, single doses of 0.1 mg, 0.5 mg, and 2.5 mg letrozole suppress serum oestrone and oestradiol by 75%, 78% and 78% from baseline, respectively.
Maltese: F'nisa b'saħħithom li qabżu l-menopawża, dożi waħdiena ta' 0.1 mg, 0.5 mg, u 2.5 mg letrozole rażżnu l-oestron fis-serum b'75%, 78% u 78% mil-linja bażi, rispettivament.
English: Medical treatment may be necessary.
Maltese: Jista' jkollok bżonn trattament mediku.
English: In vitro, letrozole inhibits the cytochrome P450 isoenzymes 2A6 and, moderately, 2C19, but the clinical relevance is unkown.
Maltese: In vitro, letrozole jinibixxi l-iżoenzimi 2A6, u b'mod moderat, 2C19 taċ-ċitokromu P450, imma rrelevanza klinika mhijiex magħrufa.
English: In a study involving 19 volunteers with varying degrees of renal function (24-hour creatinine clearance 9116 ml/min) no effect on the pharmacokinetics of letrozole was found after a single dose of 2.5 mg.
Maltese: Fi studju li jinvolvi 19-il voluntier b'livelli varji ta' funzjoni tal-kliewi (tneħħija tal-kreatinina fuq 24 siegħa ta' 9-116 ml/min) ma nstab li kien hemm l-ebda effett fuq il-farmakokinetiċi ta' letrozole wara l-għoti ta' doża singola ta' 2.5 mg.
English: In the adjuvant setting, in addition to the date presented in Table 2, the following adverse events were reported for {Invented Name} and tamoxifen, respectively (at median treatment duration of 60 months plus 30 days): angina requiring surgery (1.0% vs. 1.0%); cardiac failure (1.1% vs. 0.6%); hypertension (5.6% vs. 5.7%); cerebrovascular accident/transient ischaemic attack (2.1% vs. 1.9%).
Maltese: Fis-sitwazzjoni adjuvanti, minbarra l-informazzjoni ppreżentata f'Tabella 2, l-episodji avversi li ġejjin kienu rrappurtati għal {Isem (Ivvintat)} u tamoxifen, rispettivament (it-tul medju ta' żmien ta' trattament kien ta' 60 xahar u 30 jum): anġina li teħtieġ operazzjoni (1.0 kontra 1.0%), disfunzjoni kardijaka (1.% kontra 0.6%), pressjoni għolja (5.6% kontra 5.7%), inċident ċerebrovaskulari/attakk iskemiku tranżitorju (2.1% kontra 1.9%).
English: The only statistically significant difference occurred at 2 years and was in total hip BMD (letrozole median decrease of 3.8% vs placebo median decrease of 2.0%).
Maltese: L-unika differenza qawwija statistikament seħħet wara sentejn u kienet fil-BMD totali tal-ġenbejn (tnaqqis medju b'letrozole ta' 3.8% kontra t-tnaqqis medju bil-plaċebo ta' 2.0%).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally]
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti [Biex timtela mill-pajjiż partikolari]
English: In a study comparing the pharmacokinetics of letrozole after a single oral dose in eight male subjects with liver cirrhosis and severe hepatic impairment (Child-Pugh C) to those in healthy volunteers (N=8), AUC and t½ increased by 95 and 187%, respectively.
Maltese: Fi studju li jqabbel il-farmakokinetiċi ta' letrozole wara l-għoti ta' doża singola orali fi tmien suġġetti rġiel b'ċirrożi fil-fwied u b'indeboliment epatiku gravi (Child-Pugh C) ma' dawk f'voluntiera b'saħħithom (N=8), l-AUC u t-t½ żdiedu b'95 u b'187%, rispettivament.
English: Important additional adverse reactions that may occur with {Invented Name} are: skeletal events such as osteoporosis and/or bone fractures and cardiovascular events (including cerebrovascular and thromboembolic events).
Maltese: Aktar reazzjonijiet avversi importanti li jistgħu jseħħu b'{Isem (Ivvintat)} huma: episodji skelettriċi bħalma huma l-osteoporożi u/jew ksur ta' għadam u episodji kardjovaskulari (inklużi episodji ċerebrovaskulari u tromboemboliċi).
English: There was no significant difference between treatments in the rate of fractures - 15% in the letrozole arm, 17% in the tamoxifen arm.
Maltese: Ma kienx hemm differenza qawwija bejn it-trattamenti fir-rata ta' ksur - 15% fil-grupp mogħti letrozole, 17% fil-grupp mogħti tamoxifen.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common 10%, common 1% to 10%, uncommon 0.1% to 1%, rare 0.01% to 0.1%, very rare 0.01%, not known (cannot be estimated from the available data).
Maltese: L-effetti mhux mixtieqa jinsabu mqiegħda f'ordni skont is-sottotitli bil-frekwenza, bl-aktar frekwenti jitniżżlu l-ewwel, u qed tintuża l-konvenzjoni li ġejja: komuni ħafna 10%, komuni 1% sa 10%, mhux komuni 0.1% sa 1%, rari 0.01% sa 0.1%, rari ħafna 0.01%, mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Both in vitro and in vivo investigations of letrozole's mutagenic potential revealed no indications of any genotoxicity.
Maltese: Investigazzjonijiet kemm in vitro u in vivo tal-potenzjal mutaġeniku ta' letrozole ma wrew l-ebda indikazzjonijiet ta' xi ġenotossiċità.
English: Myalgia, bone pain1, osteoporosis, bone fractures
Maltese: Mjalġja, uġigħ fl-għadam1, osteoporożi, ksur fl-għadam
English: At least 75% of the radioactivity recovered in urine up to 216 hours (84.7 ± 7.8% of the dose) was attributed to the glucuronide of the carbinol metabolite, about 9% to two unidentified metabolites, and 6% to unchanged letrozole.
Maltese: Mill-inqas 75% tar-radjuattività rkuprata fl-awrina sa 216-il siegħa (84.7 ± 7.8% tad-doża) kienet attribwita lill-glucuronide tal-metabolit carbinol, madwar 9% lil żewġ metaboliti mhux identifikati, u 6% lil letrozole mhux mibdul.
English: {Invented Name}
Maltese: {Isem (Ivvintat)}
English: The primary endpoint was disease-free survival (DFS); secondary efficacy endpoints were time to distant metastasis (TDM), distant disease-free survival (DDFS), overall survival (OS), systemic disease-free survival (SDFS), invasive contralateral breast cancer and time to breast cancer recurrence.
Maltese: L-endpoint primarju kien is-sopravivenza mingħajr mard (DFS); l-endpoint sekondarju ta' effikaċja kien id-distanza bejn iż-żmien u l-metastasi (TD), is-sopravivenza distanti mingħajr mard (DDFS), issopravivenza globali (OS), is-sopravivenza sistemika mingħajr mard (SDFS), kanċer tas-sider kontralaterali invażiv għal rikorrenza tal-kanċer tas-sider.
English: {Invented Name} is contraindicated during breast-feeding (see section 4.3).
Maltese: {Isem (Ivvintat)} hu kontraindikat waqt treddigħ (ara sezzjoni 4.3).
English: Cimetidine, a weak, unspecific inhibitor of CYP450 enzymes, did not affect the plasma concentrations of letrozole.
Maltese: Cimetidine, inibitur dgħajjef u mhux speċifiku tal-enzimi ta' CYP450, ma affettwax il-konċentrazzjonijiet tal-plażma ta' letrozole.
English: In the adjuvant setting a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered depending on the patient`s safety profile (see sections 4.2, 4.8 and 5.1).
Maltese: F'sitwazzjoni adjuvanti wieħed jista' jikkunsidra wkoll skema ta' trattament sekwenzjali (letrozole għal sentejn segwit b'tamoxifen għal 3 snin) skont il-profil ta' sigurtà tal-pazjent (ara sezzjonijiet 4.2, 4.8 u 5.1).
English: The final analysis included 1,551 women who switched from placebo to {Invented Name} at a median of 31 months (range 12 to 106 months) after completion of tamoxifen adjuvant therapy.
Maltese: L-analiżi finali kienet tinkludi 1,551 mara li għaddew minn plaċebo għal {Isem (Ivvintat)} bejn wieħed u ieħor wara 31 xahar (medda ta' bejn 12 u 106 xhur) wara li ntemmet it-terapija adjuvanti b'tamoxifen.
English: Urinary tract infection Neoplasms, benign, malignant and unspecified (including cysts and polyps) Uncommon:
Maltese: Infezzjoni tal-apparat urinarju Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Mhux komuni:
English: Time to distant metastasis (secondary)
Maltese: Żmien sal-metastasi distanti
English: The most frequently reported adverse reactions in clinical studies were hot flushes, hypercholesterolaemia, arthralgia, fatigue, increased sweating and nausea.
Maltese: L-aktar reazzjonijiet avversi rrappurtati bi frekwenza waqt studji kliniċi kienu fwawar, iperkolesterolemija, artralġja, għeja, żieda fl-għaraq u dardir.
English: Maximum suppression is achieved in 48-78 hours.
Maltese: It-trażżin massimu jinkiseb fi żmien 48 u 78 siegħa.
English: Hazard ratio2 (97.5% confidence interval)
Maltese: episodji1 Proporzjon ta' Periklu1 (97.5% ta' intervalli N
English: Table 2 Adjuvant {Invented Name} monotherapy versus tamoxifen monotherapy - adverse events with significant differences
Maltese: Tabella 2 Monoterapija adjunvanti b'{Isem (Ivvintat)} kontra monoterapija b'tamoxifenepisodji avversi b'differenzi qawwija
English: This finding was consistently confirmed by ultrasound ({Invented Name} 35% vs tamoxifen 25%, P=0.04) and mammography ({Invented Name} 34% vs tamoxifen 16%, P<0.001).
Maltese: Dan ir-riżultat kien ikkonfermat b'mod konsistenti permezz tal-ultrasound ({Isem (Ivvintat)} 35% kontra tamoxifen 25%, P=0.04) u l-mammograph ({Isem (Ivvintat)} 34% kontra tamoxifen 16%, P<0.001). B'kollox 45% tal-pazjenti fil-grupp mogħti {Isem (Ivvintat)} kontra 35% tal-pazjenti fil-grupp mogħti tamoxifen (P=0.02) ingħataw terapija li ssalva s-sider).
English: Adjusted by chemotherapy use (yes/no) 624 (40%) patients selectively crossed to letrozole after tamoxifen arm unblinded in 2005
Maltese: 1 Aġġustata skont l-użu kemoterapewtiku (iva/le) 2 624 (40%) pazjent għaddew b'mod selettiv għal letrozole wara li l-grupp mogħti tamoxifen kien unblinded fl-2005.
English: It belongs to a group of medicines called aromatase inhibitors.
Maltese: Jappartjeni għal grupp ta' mediċini msejħin inibituri tal-aromatasi.
English: In 907 women, letrozole was superior to tamoxifen in time to progression (primary endpoint) and in overall objective response, time to treatment failure and clinical benefit.
Maltese: F'907 nisa, letrozole kien superjuri għal tamoxifen fejn jidħol iż-żmien ta' progressjoni (endpoint primarju) u r-rispons objettiv sħiħ, iż-żmien li matulu t-trattament falla u l-benefiċċji kliniċi.
English: Efficacy results at a median follow-up of 26 and 60 months Data in Table 4 reflect the results of the Primary Core Analysis (PCA) based on data from the monotherapy arms (A and B) and from the two switching arms (C and D) at a median treatment duration of 24 months and a median follow-up of 26 months and at a median treatment duration of 32 months and a median follow-up of 60 months.
Maltese: Ir-riżultati dwar l-effikaċja wara medja ta' viżti ta' kontroll ta' 26 u 60 xahar It-tagħrif f'Tabella 4 jirrifletti r-riżulati tal-Primary Core Analysis (PCA) skont l-informazzjoni millgruppi ta' monoterapija (A u B) u miż-żewġ gruppi li jaqilbu (C u D) b'tul medju ta' trattament ta' 24 xahar u b'medja ta' viżti ta' kontroll ta' 26 xahar u b'tul medju ta' trattament ta' 32 xahar u b'ammont medju ta' viżti ta' kontroll ta' 60 xahar.
English: In the extended adjuvant setting, significantly more patients treated with {Invented Name} experienced bone fractures or osteoporosis (bone fractures, 10.4% and osteoporosis, 12.2%) than patients in the placebo arm (5.8% and 6.4%, respectively).
Maltese: 4% u osteoporożi, 12.2%) milli kien hemm pazjenti li ħadu l-plaċebo (5.8% u 6.4%, rispettivament).
English: Eldery
Maltese: Treddigħ
English: The first planned interim analysis at a median follow-up of around 28 months (25% of patients being followed up for at least 38 months), showed that {Invented Name} significantly reduced the risk of breast cancer recurrence by 42% compared with placebo (HR 0.58; 95% CI 0.45, 0.76; P=0.00003).
Maltese: L-ewwel analiżi interim ippjanata waqt medja ta' viżti ta' kontroll ta' madwar 28 xahar (25% talpazjenti jibqgħu segwiti għal mill-inqas 38 xahar), uriet li {Isem (Ivvintat)} naqqas b'mod qawwi rriskju ta' rikorrenza ta' kanċer tas-sider bi 42% mqabbel mal-plaċebo (HR 0.58; 95% CI 0.45, 0.76; P=0.00003).
English: It is not known whether this was an indirect consequence of the pharmacological properties (inhibition of oestrogen biosynthesis) or a direct drug effect (see sections 4.3 and 4.6).
Maltese: Mhuwiex magħruf jekk dan kienx konsegwenza indiretta tal-proprjetajiet farmakoloġiċi (inibizzjoni tal-bijosintesi tal-oestroġenu) jew effett dirett talmediċina (ara sezzjonijiet 4.3 u 4.6).
English: Vascular disorders Very common:
Maltese: Disturbi vaskulari Komuni ħafna: