FrancophonIA/ELRC3.0 huggingface dataset:
English: The grades follow CTCAE Version 3.0 and 4.03.
Maltese: Il-gradi huma skont Verżjoni 3.0 u 4.03 ta' CTCAE.
English: Co-administration of everolimus and exemestane increased exemestane Cmin and C2h by 45% and 64%, respectively.
Maltese: L-għoti flimkien ta' everolimus u exemestane żied is-Cmin u C2h ta' exemestane b'45% u b'64%, rispettivament.
English: (6.9 to 8.5)
Maltese: (6.9 sa 8.5)
English: Kaplan-Meier medians
Maltese: Medji Kaplan--Meier
English: Moderate CYP3A4/PgP inhibitors Erythromycin
Maltese: Impedituri moderati ta' CYP3A4/PgP Erythromycin
English: Common Dyspnoea Uncommon Haemoptysis, pulmonary embolism Rare
Maltese: Mhux komuni Emoptisi, emboliżmu pulmonari Rari
English: The most frequent Grade 3-4 adverse reactions (incidence ≥1/100 to <1/10) were stomatitis, anaemia, hyperglycaemia, infections, fatigue, diarrhoea, pneumonitis, asthenia, thrombocytopenia, neutropenia, dyspnoea, proteinuria, lymphopenia, haemorrhage, hypophosphataemia, rash, hypertension, pneumonia, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased and diabetes mellitus.
Maltese: L-aktar reazzjonijiet avversi tal-Grad 3-4 frekwenti (inċidenza ta' ≥1/100 sa <1/10) kienu stomatite anemija, ipergliċemija, infezzjonijiet, għeja, dijarrea, pulmonite, astenja, tromboċitopenija, newtropenija, dispnea, protenurija, limfopenija, emorraġija, ipofosfatemija, raxx, pressjoni għolja, pulmonite, żieda ta' alanine aminotransferase (ALT), żieda ta' aspartate aminotransferase (AST) u dijabete.
English: The other ingredients are butylhydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.
Maltese: Is-sustanzi mhux attivi huma butylhydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A u lactose anhydrous.
English: Hazard Ratio = 0.74 90% CI [0.57;0.97]
Maltese: Il-proporzjon ta' periklu = 0.74 90% CI [0.57;0.97]
English: Dyslipidaemia (including hypercholesterolaemia and hypertriglyceridaemia) has been reported.
Maltese: Dislipidemija (inklużi iperkolesterolemija u ipertrigliċeridemija) kienu rrappurtati.
English: Supportive/sensitivity analyses All (local review by investigator)
Maltese: Analiżi ta' sapport/sensittività Kollha (reviżjoni lokali mill-investigatur)
English: Treatment with somatostatin analogues was allowed as part of BSC.
Maltese: Kura b'analogi ta' somatostatin kienet permessa bħala parti mill-BSC.
English: Placebo n=139
Maltese: Plaċebo n=139
English: The key secondary objective was to estimate the HR of PFS for everolimus + exemestane versus capecitabine.
Maltese: L-objettiv sekondarju ewlieni kien li jevalwa l-HR ta' PFS għal everolimus + exemestane kontra capecitabine.
English: Moderate hepatic impairment (Child-Pugh B) - the recommended dose is 5 mg daily.
Maltese: Indeboliment moderat tal-fwied (Child-Pugh B) - id-doża rrakkomandata hija 5 mg kuljum.
English: • Increased temperature, chills (signs of infection)
Maltese: • Żieda fit-temperatura, dehxiet (sinjali ta' infezzjoni)
English: Independent radiological review
Maltese: Analiżi radjoloġika indipendenti
English: Impaired wound healing is a class effect of rapamycin derivatives, including everolimus.
Maltese: In-nuqqas ta' fejqan ta' feriti huwa effett tal-klassi tad-derivattivi ta' rapamycin, inkluż everolimus.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE10
Maltese: Aġenti antineoplastiċi, aġenti antineoplastiċi oħrajn, inibituri talproteina kinasi, Kodiċi ATC:
English: Interaction - Change in Everolimus AUC/Cmax Geometric mean ratio (observed range)
Maltese: Interazzjoni - Bidla fl-AUC/Cmax ta' Everolimus Proporzjon medju ġeometriku (firxa osservata)
English: Advanced neuroendocrine tumours of pancreatic origin (pNET) RADIANT-3 (study CRAD001C2324), a phase III, multicentre, randomised, double-blind study of Afinitor plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pNET, demonstrated a statistically significant clinical benefit of Afinitor over placebo by a 2.4-fold prolongation of median progression-free-survival (PFS) (11.04 months versus 4.6 months), (HR 0.35; 95% CI: 0.27, 0.45; p<0.0001) (see Table 5 and Figure 3).
Maltese: III, multiċentriku, randomizzat, double-blind flimkien mal-aħjar kura ta' fejda (BSC) kontra l-plaċebo flimkien ma' BSC lil pazjenti b'pNET avanzat, wera benefiċċju kliniku statistikament qawwi għal Afinitor imqabbel mal-plaċebo bi 2.4 aktar fid-dewmien tas-sopravivenza medja ħielsa mill-progressjoni (PFS) (11.04 xhur kontra 4.6 xhur), (HR 0.35; 95% CI: 0.27, 0.45; p<0.0001) (ara Tabella 5 u Figura 3).
English: Other medicines and Afinitor
Maltese: Mediċini oħra u Afinitor
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda f'kull 1,000)
English: Table 6 RADIANT-4 - Progression-free survival results
Maltese: Tabella 6 RADIANT-4
English: Exposure to everolimus was increased in patients with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment (see section 5.2).
Maltese: L-espożizzjoni għal everolimus żdiedet f'pazjenti b'indeboliment ħafif (Child-Pugh A), moderat (Child-Pugh B) u sever (Child-Pugh C) tal-fwied (ara sezzjoni 5.2).
English: Hepatic impairment Mild hepatic impairment (Child-Pugh A) - the recommended dose is 7.5 mg daily.
Maltese: Indeboliment tal-fwied Indeboliment ħafif tal-fwied (Child-Pugh A) - id-doża rrakkomandata hija 7.5 mg kuljum.
English: Placebo n=203
Maltese: Plaċebo n=203
English: Inhibition of the mTORC1 signalling pathway interferes with the translation and synthesis of proteins by reducing the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic elongation factor 4E-binding protein (4EBP-1) that regulate proteins involved in the cell cycle, angiogenesis and glycolysis.
Maltese: L-impediment tar-rotta tas-sinjali minn mTORC1 tfixkel il-bdil u s-sintesi ta' proteini billi tnaqqas l-attività ta' ribosomal protein kinase S6 (S6K1) u tal-fattur li jtawwal il-proteina li teħel E4 tal-eukaryota (4EBP-1) li jirregola l-proteini involuti fiċ-ċiklu taċ-ċelluli, fl-anġjoġenesi u fil-glikolisi.
English: Table 7 RECORD-1 - Progression-free survival results
Maltese: Tabella 7 RECORD-1 - Riżultati ta' sopravivenza ħielsa minn progressjoni
English: Demographics were well balanced (pooled median age [61 years; range 27-85], 78% male, 88% Caucasian, number of prior VEGFR-TKI therapies [1-74%, 2-26%]).
Maltese: Id-demografiji kienu bbilanċjati tajjeb (età medja tal-pazjenti flimkien [61 sena; medda 27-85], 78% irġiel, 88% Kawkasiċi, numru ta' terapiji
English: Includes (very common) pneumonitis, (common) interstitial lung disease, lung infiltration and (rare) pulmonary alveolar haemorrhage, pulmonary toxicity, and alveolitis d
Maltese: Tinkludi (komuni ħafna) pulmonite, (komuni) disturb tal-interstizju tal-pulmun, infiltrazzjoni tal-pulmun u (rari) emorraġija pulmonari alveolari, tossiċità pulmonari, u alveolite d
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of amenorrhoea (secondary amenorrhoea and other menstrual irregularities).
Maltese: Fi studji kliniċi u rapporti spontanji wara t-tqegħid fis-suq, everolimus ġie assoċjat ma' każijiet ta' amenorrea (amenorrea sekondarja u irregolaritajiet oħra tal-menstrwazzjoni).
English: Musculoskeletal and connective tissue disorders Common Arthralgia
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Komuni
English: Hazard ratio (95% CI) from stratified Cox model
Maltese: Proporzjon ta' periklu (95% CI) sknt il-mudell stratifikat Cox.
English: The safety and efficacy of Afinitor in children aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Afinitor fit-tfal minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: For the key secondary endpoint PFS the estimated HR was 1.26 (90% CI: 0.96, 1.66) in favour of capecitabine over the everolimus + exemestane combination arm based on a total of 148 PFS events observed.
Maltese: Għall-endpoint sekondarju ewlieni tal-PFS l-HR stmat kien ta' 1.26 (90% CI: 0.96, 1.66) favur capecitabine imqabbel mal-grupp mogħti taħlita ta' everolimus + exemestane skont total ta' 148 episodju ta' PFS osservati.
English: In a population pharmacokinetic analysis of 170 patients with advanced solid tumours, no significant influence of creatinine clearance (25-178 ml/min) was detected on CL/F of everolimus.
Maltese: F'analiżi farmakokinetika ta' popolazzjoni ta' 170 pazjent b'tumuri solidi avanzati, l-ebda influwenza sinifikanti ta' tneħħija tal-krejatinina (25-178 ml/min) ma kienet osservata fuq is-CL/F ta' everolimus.
English: Grade 4 Discontinue treatment.
Maltese: Grad 4 Waqqaf t-trattament.
English: Uncommon Hypersensitivity
Maltese: Mhux komuni Ipersensittività
English: Grade 3 Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Maltese: Grad 3 Interrompi d-doża temporanjament sakemm ikun hemm titjib f' Grad 2 (≥1.25x10
English: • Abnormal results of liver blood tests (increased alanine and aspartate aminotransferase)
Maltese: • Riżultati mhux normali tat-testijiet tad-demm tal-fwied (żieda fl-alanina u l-aspartate aminotransferase)
English: Re-initiate treatment at 5 mg daily.
Maltese: Erġa' agħti t-trattament b'5 mg daily.
English: Hazard Ratio = 0.45 95% CI [0.38, 0.54]
Maltese: Il-proporzjon ta' periklu = 0.45 95% CI [0.38, 0.54]
English: Includes all reactions within the ‘infections and infestations' system organ class including (common) pneumonia, urinary tract infection; (uncommon) bronchitis, herpes zoster, sepsis, abscess, and isolated cases of opportunistic infections [e.g. aspergillosis, candidiasis, PJP/PCP and hepatitis B (see also section 4.4)] and (rare) viral myocarditis b
Maltese: Jinkludu r-reazzjonijiet kollha fil-klassi tal-organu tas-sistema ‘infezzjonijiet u infestazzjonijiet' inkluż (komuni) pnewmonja, infezzjoni fil-pajp tal-awrina; (mhux komuni) bronkite, herpes zoster (ħruq ta' Sant'Antnin), sepsis, axxess u każijiet iżolati ta' infezzjonijiet opportunistiċi [e.ż. asperġillożi, kandidjasi, PJP/PCP u epatite B (ara wkoll sezzjoni 4.4)] u (rari) mijokardite virali.
English: In healthy subjects, high fat meals reduced systemic exposure to everolimus 10 mg (as measured by AUC) by 22% and the peak plasma concentration Cmax by 54%.
Maltese: F'individwi b'saħħithom, ikliet li fihom ħafna xaħam naqqsu l-esponiment sistemiku għal everolimus 10 mg (kif imkejjel mill-AUC) bi 22% u l-ogħla konċentrazzjonijiet fil-plażma Cmax b'54%.
English: Afinitor was superior to placebo for the primary endpoint of progression-free survival, with a statistically significant 67% reduction in the risk of progression or death (see Table 7 and Figure 6).
Maltese: Afinitor kien superjuri għall-plaċebo fil-punt aħħari primarju ta' sopravivenza ħielsa minn progressjoni, bi tnaqqis sinifikanti b'mod statistiku ta' 67% fir-riskju ta' progressjoni jew mewt (ara Tabella 7 u Figura 6).
English: The estimated HR for the comparison of OS in the everolimus + exemestane combination arm relative to capecitabine arm was 1.33 (90% CI: 0.99, 1.79).
Maltese: L-HR stmat għat-tqabbil tal-OS fil-grupp mogħti taħlita ta' everolimus + exemestane relattiv għall-grupp mogħti capecitabine kien ta' 1.33 (90% CI: 0.99, 1.79).
English: A total of 309 patients were randomised in a 1:1:1 ratio to the combination of everolimus (10 mg daily) + exemestane (25 mg daily) (n=104), everolimus alone (10 mg daily) (n=103), or capecitabine (1250 mg/m dose twice daily for 2 weeks followed by one week rest, 3-week cycle) (n=102).
Maltese: Total ta' 309 pazjenti ngħażlu kif ġie ġie fi proporzjon ta' 1:1:1 ħalli jieħdu taħlita ta' everolimus (10 mg kuljum) + exemestane (25 mg kuljum) (n=104), everolimus waħdu (10 mg kuljum) (n=103), jew capecitabine (doża ta' 1250 mg/m darbtejn kuljum għal ġimagħtejn u wara ġimgħa mistrieħ, ċiklu ta' 3 ġimgħat) (n=102).
English: No differences in the time to ≥5% deterioration in the global and functional domain scores of QLQ-C30 were observed in the two arms.
Maltese: Ma dehret l-ebda differenza fiż-żmien biex ikun hemm deterjorazzjoni ta' ≥5% fil-punteġġi tal-qasam globali u funzjonali ta' QLQ-C30 fiż-żewġ gruppi.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Opportunistic infections such as pneumocystis jirovecii (carinii) pneumonia (PJP/PCP) should be ruled out in the differential diagnosis of non-infectious pneumonitis (see “Infections” below).
Maltese: Infezzjonijiet opportunistiċi bħal pulmonite kkawżata minn pneumocystis jirovecii (carinii) (PJP/PCP - pneumocystis jirovecii (carinii) pneumonia) għandhom jiġu esklużi fid-dijanjosi differenzjali ta' pulmonite mhux infettiva (ara “Infezzjonijiet” hawn taħt).
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets
Maltese: Afinitor 2.5 mg pilloli Afinitor 5 mg pilloli Afinitor 10 mg pilloli
English: Patients were stratified according to Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic score (favourable- vs. intermediate- vs. poor-risk groups) and prior anticancer therapy (1 vs. 2 prior VEGFR-TKIs).
Maltese: Il-pazjenti kienu stratifikati skont il-punteġġ pronostku Memorial Sloan-Kettering Cancer Center (MSKCC) (gruppi ta' riskju favorevoli- vs. intermedji- vs. mhux tajjeb) u l-kura li ngħatat qabel kontra l-kanċer (kura 1 vs.
English: Functional carcinoid tumours
Maltese: Tumuri karċinojdi funzjonali
English: (9.8 to 15.9)
Maltese: (9.8 sa 15.
English: Demographics were well balanced (median age 58 years, 55% male, 78.5% Caucasian).
Maltese: Id-dermografiċi kienu bbilanċjati sew (età medja 58 sena, 55% rġiel, 78.5
English: Supportive PFS analyses were based on an independent central radiology review.
Maltese: Analiżijiet supportivi PFS kienu bbażati fuq analiżi radjoloġika ċentrali indipendenti.
English: At the time of data cut-off, the median duration of treatment was 27.5 weeks (range 2.0-165.7) in the everolimus + exemestane arm, 20 weeks (1.3-145.0) in the everolimus arm, and 26.7 weeks (1.4-177.1) in the capecitabine arm.
Maltese: Sa dakinhar li ma baqgħetx tinġabar id-data, id-dewmien medju tattrattament kien ta' 27.5 ġimgħat (medda ta' 2.0-165.7) għall-grupp mogħti everolimus + exemestane, 20 ġimgħa (1.3-145.0) għall-grupp mogħti everolimus, u 26.7 ġimgħat (1.4-177.1) għall-grupp mogħti capecitabine.
English: One-sided p-value from a stratified log-rank test
Maltese: Valur p ta' naħa waħda minn test log-rank stratifikat
English: Kaplan-Meier medians Everolimus: 4.90 months Placebo: 1.87 months
Maltese: Everolimus: 4.90 xhur Plaċebo: 1.87 xhur
English: Afinitor 2.5 mg tablets EU/1/09/538/009 EU/1/09/538/010
Maltese: Afinitor 2.5 mg pilloli EU/1/09/538/009 EU/1/09/538/010
English: • Trouble sleeping (insomnia)
Maltese: • Problemi biex torqod (insonnja)
English: Studies in animals have shown reproductive toxicity effects including embryotoxicity and foetotoxicity (see section 5.3).
Maltese: Studji fuq l-annimali wrew effetti tossiċi fuq is-sistema riproduttiva inklużi tossiċità tal-embriju u tossiċità tal-fetu (ara sezzjoni 5.3).
English: The pre-planned OS interim analysis after 101 deaths (out of 191 required for final analysis) and 33 months follow-up favoured the everolimus arm; however, no statistically significant difference in OS was noted (HR= 0.73 [95% CI: 0.48 to 1.11; p=0.071]).
Maltese: L-analiżi interim OS imfassla minn qabel wara 101 mewt (minn 191 meħtieġa għall-analiżi finali) u 33 xahar sussegwenti ffavorixxew il-grupp li ngħata everolimus; madanakollu, ma kenitx innotata differenza qawwija statistikament fl-OS (HR=0.73 [95% CI: 0.48 sa 1.11; p=0.071]).
English: Hazard Ratio = 0.33 95% CI [0.25, 0.43]
Maltese: Proporzjon ta' Periklu = 0.33 95% CI [0.25, 0.43]
English: However products containing alcohol, hydrogen peroxide, iodine and thyme derivatives should be avoided as they may exacerbate the condition.
Maltese: Madanakollu prodotti li fihom alkoħol, hydrogen peroxide, jodju u derivattivi mis-sagħtar għandhom jiġu evitati minħabba li jistgħu jħarrxu l-kundizzjoni.
English: Secondary endpoints included safety, objective tumour response rate, overall survival, disease-related symptoms, and quality of life.
Maltese: Punti aħħarija sekondarji inkludew sigurtà, rata ta' rispons oġġettiv tat-tumur, sopravivenza globali, sintomi relatati mal-marda, u l-kwalità tal-ħajja.
English: Table 4 BOLERO-2 efficacy results
Maltese: Tabella 4 BOLERO-2 riżultati tal-effikaċja
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of PJP/PCP, some with fatal outcome (see section 4.4).
Maltese: Fi studji kliniċi u rapporti spontanji ta' wara t-tqegħid fis-suq, everolimus kien assoċjat ma' każijiet ta' PJP/PCP, uħud b'riżultat fatali (ara sezzjoni 4.4).
English: Hazard Ratio = 0.48 95% CI [0.35, 0.67]
Maltese: Proporzjoni ta' Periklu = 0.48 95% CI [0.35, 0.67]
English: A total of 302 patients were randomised in a 2:1 ratio to receive either everolimus (10 mg daily) (n=205) or placebo (n=97).
Maltese: Total ta' 302 pazjent kienu randomizzati fi proporzjon 2:1 biex jingħataw everolimus (10 mg kuljum) (n=205) jew plaċebo (n=97).
English: Afinitor 10 mg tablets
Maltese: Afinitor 10 mg pilloli
English: Reactivation of infection is an expected event during periods of immunosuppression.
Maltese: Attivazzjoni mill-ġdid tal-infezzjonijiet huwa episodju mistenni matul perijodi ta' immunosuppressjoni.
English: Afinitor 2.5 mg tablets
Maltese: Afinitor 2.5 mg pilloli
English: dysphagia
Maltese: Dispnea
English: Not applicable e p value is obtained from the exact Cochran-Mantel-Haenszel test using a stratified version of the Cochran-Armitage permutation test.
Maltese: Il-valur p jinkiseb mit-test eżatti Cochran-Mantel-Haenszel li juża verżjoni stratifikata tat-test ta' permutazzjoni Cochran-Armitage.
English: Afinitor 2.5 mg tablets everolimus
Maltese: Afinitor 2.5 mg pilloli everolimus
English: Single doses of up to 70 mg have been given with acceptable acute tolerability.
Maltese: Dożi waħdiet sa 70 mg ngħataw b'tollerabilità akuta aċċettabbli.
English: What Afinitor contains The active substance is everolimus.
Maltese: X'fih Afinitor Is-sustanza attiva hi everolimus.
English: Afinitor 5 mg tablets EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
Maltese: Afinitor 5 mg pilloli EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
English: The blood-to-plasma ratio of everolimus, which is concentration-dependent over the range of 5 to 5,000 ng/ml, is 17% to 73%.
Maltese: Il-proporzjon ta' everolimus fid-demm u fil-plażma, li jiddependi fuq il-konċentrazzjoni fuq medda ta' 5 sa 5,000 ng/ml, huwa minn 17% sa 73%.
English: For all analysed subgroups (age, sensitivity to prior hormonal therapy, number of organs involved, status of bone-only lesions at baseline and presence of visceral metastasis, and across major demographic and prognostic subgroups) a positive treatment effect was seen with everolimus + exemestane with an estimated hazard ratio (HR) versus placebo + exemestane ranging from 0.25 to 0.60.
Maltese: Għas-sottogruppi kollha analizzati (età, sensittività għat-terapija ormonali ta' qabel, numru ta'organi involuti, il-qagħda ta' feriti tal-għadam biss fil-linja bażi u l-preżenza ta' metastasi vixxerali, u fost is-sottogruppi demografiċi u prognostiċi ewlenin) kien hemm effett pożittiv tal-kura b'everolimus + exemestane bil-proporzjon ta' periklu (HR) kontra plaċebo + exemestane stmata li kienet ta' bejn 0.25 u 0.60.
English: *Non-ileum: stomach, colon, rectum, appendix, caecum, duodenum, jejunum, carcinoma of unknown primary origin and other gastrointestinal origin
Maltese: *Mhux ilju: l-istonku, il-musrana l-ħoxna, rektum, appendiċi, il-musrana l-għamja, duodenum, jejunum, karċinoma ta' oriġini primarja mhux magħrufa u ta' oriġini gastrointestinali oħra ULN:
English: Post-transplant renal impairment (creatinine clearance range 11-107 ml/min) did not affect the pharmacokinetics of everolimus in transplant patients.
Maltese: Indeboliment tal-kilwa wara trapjant (medda ta' tneħħija tal-krejatinina minn 11-107 ml/min) m'affettwatx il-farmakokinetika ta' everolimus f'pazjenti bi trapjanti.
English: Afinitor 5 mg tablets
Maltese: Afinitor 5 mg pilloli
English: Demographics and disease characteristics were generally balanced (median age 63 years [range 22 to 86], 76% Caucasian, history of prior somatostatin analogue [SSA] use).
Maltese: Il-karatteristiċi demografiċi u tal-mard kienu ġeneralment ibbilanċjati (użu minn età medja ta' 63 sena [medda ta' 22 sa 86], 76% Kawkażjatiċi, bi storja ta' somatostatin analoga minn qabel [SSA]).
English: If stomatitis recurs at Grade 2, interrupt dose until recovery to Grade 1.
Maltese: Jekk jerġa' jkun hemm tossiċità fi Grad 2, interrompi ttrattament sakemm jirkupra f' Grad 1.
English: A total of 724 patients were randomised in a 2:1 ratio to the combination everolimus (10 mg daily) + exemestane (25 mg daily) (n=485) or to the placebo + exemestane arm (25 mg daily) (n=239).
Maltese: Total ta' 724 pazjent ingħażlu b'mod randomizzat skont proporzjon ta' 2:1 biex ikunu fil-grupp ta' everolimus (10 mg kuljum) + exemestane (25 mg kuljum) flimkien (n=485) jew fil-grupp ta' plaċebo + exemestane (25 mg kuljum) (n=239).
English: Hazard ratio (95%CI)
Maltese: Proporzjon ta' periklu (95%CI)
English: Best overall response (%) (95% CI) Objective response rate b
Maltese: L-aħjar rispons ġenerali (%) (95% CI) Rata ta' rispons objettiv b
English: Six-month PFS rates were 36% for Afinitor therapy compared with 9% for placebo.
Maltese: Rati ta' PFS f'sitt xhur kienu ta' 36% għal kura b'Afinitor meta mqabbla ma' 9% għall-plaċebo.
English: The estimated HR was 1.27 (90% CI: 0.95, 1.70) for the comparison of OS in the everolimus alone arm relative to the everolimus + exemestane arm.
Maltese: L-HR stmat kien ta' 1.27 (90% CI: 0.95, 1.70) fejn jidħol it-tqabbil tal-OS fil-grupp mogħti everolimus waħdu relattiv għall-grupp mogħti everolimus + exemestane.
English: Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets everolimus
Maltese: Afinitor 2.5 mg pilloli Afinitor 5 mg pilloli Afinitor 10 mg pilloli everolimus
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported (see section 4.8).
Maltese: Emoglobina, limfoċiti, newtrofili u plejtlits imnaqqsa ġew irrappurtati (ara sezzjoni 4.8).
English: Afinitor 10 mg tablets everolimus
Maltese: Afinitor 10 mg pilloli everolimus
English: Everolimus has immunosuppressive properties and may predispose patients to bacterial, fungal, viral or protozoan infections, including infections with opportunistic pathogens (see section 4.8).
Maltese: Everolimus għandu effetti immunosoppressivi u jista' jippredisponi l-pazjenti għal infezzjonijiet bil-batterji, bil-fungu, bil-viruses jew bil-protozoan, inklużi infezzjonijiet b'patoġeni opportunistiċi (ara sezzjoni 4.8).
English: Median progression-free survival (months) (95% CI) Investigator radiological review
Maltese: Sopravivenza medja ħielsa minn progressjoni (xhur) (95% CI) Analiżi radjoloġiku investigattiva
English: Afinitor 2.5 mg tablets Packs containing 30 or 90 tablets.
Maltese: Afinitor 2.5 mg pilloli Pakketti fihom 30 jew 90 pillola.
English: • High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides)
Maltese: • Livelli għolja ta' lipidi (xaħmijiet) fid-demm (iperlipidemija, trigliċeridi għoljin)
English: Log-rank p value: <0.0001
Maltese: Il-valur log-rank p: <0.
English: Grade 3 Interrupt treatment until symptoms resolve to Grade 1.
Maltese: Grad 3 Waqqaf it-trattament sakemm is-sintomi jitjiebu għal  Grad 1.