FrancophonIA/ELRC3.0 huggingface dataset:
English: Certolizumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Maltese: Adalimumab ġie ddisinjat biex jeħel ma' messaġġier kimiku fil-ġisem magħruf bħala fattur tan-nekrożi minn tumur (TNF-alfa).
English: How is CIMZIA expected to work?
Maltese: Għal xiex kien mistenni li jintuża CIMZIA?
English: The Committee was also concerned over CIMZIA's safety: although generally comparable with the safety of other medicines in the same class, there was also some concern over a possible increased risk of bleeding in patients receiving CIMZIA.
Maltese: Il-Kumitat kien konċernat ukoll dwar is-sigurtà ta' CIMZIA. għalkemm meta kumparat b'mod ġenerali mas-sigurtà ta' mediċini oħrajn fl-istess klassi, kien hemm xi tħassib dwar iż-żjieda possibbli ta' riskju ta' emoraġġija fil-pazjenti li jirċievu CIMZIA.
English: The first study looked at the reduction of symptoms during ‘induction treatment' in 660 patients who had not received CIMZIA before.
Maltese: L-ewwel studju kopra t-tnaqqis ta' sintomi matul it-‘trattament tal-bidu' f'660 pazjent li ma kienux irċevew CIMZIA qabel.
English: In March 2008, following the re-examination, the CHMP removed its concern regarding the ability to monitor the medicine's quality.
Maltese: F'Marzu 2008, wara eżami mill-ġdid, is-CHMP warrab it-tħassib tagħha rigward il-kapaċità ta' monitorjar tal-kwalità tal-mediċina.
English: In CIMZIA, certolizumab has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: X'dokumentazzjoni ppreżentat il-kumpanija għas-sostenn ta' l-applikazzjoni tagħha lis-CHMP?
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 19 March 2008.
Maltese: Wara li kkunsidraw ir-raġunijet għal din it-talba, is-CHMP reġa' eżamina l-opinjoni inizjali u kkonferma r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fissuq fid-19 ta' Marzu 2008.
English: The effectiveness of adding CIMZIA to existing treatment was compared with that of placebo (a dummy treatment) in two main studies involving adults with moderate to severe Crohn's disease.
Maltese: L-effikaċja taż-żjieda ta' CIMZIA ma' trattament eżistenti ġie kumparat ma' dak ta' placebo (trattament fint) f'żewġ studji prinċipali li jinvolvu adulti bil-marda ta' Crohn f'forma moderata u severa.
English: The effects of CIMZIA were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' CIMZIA għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: What was CIMZIA expected to be used for?
Maltese: Kif kien mistenni li jaħdem CIMZIA?
English: CIMZIA was expected to be used to treat severe, active Crohn's disease (a disease causing inflammation of the digestive tract).
Maltese: CIMZIA kien mistenni li jintuża għat-trattament tal-marda attiva ta' Crohn f'forma severa (marda li tikkawwża infjammazzjoni tal-musrana diġestiva).
English: It was to be used in patients who had not responded to a full and adequate course of therapy with a corticosteroid or an immunosuppressant medicine (a medicine that reduces the activity of the immune system) or who cannot take these therapies.
Maltese: Kien użat f'pazjenti li rrispondew b'mod sħiħ u b'mod adegwat matul it-terapija b'kortikosterojde jew mediċina immunosuppressanti (mediċina li tnaqqas l-attività tas-sistema immunitorja) jew li ma jistgħux jieħdu dawn it-terapiji.
English: { mm/yyyy}
Maltese: {XX/SSSS}
English: Stevens-Johnson syndrome; Lyell syndrome;
Maltese: Sindrome ta' StevensJohnson;
English: Within the following table, adverse reactions are ranked under the MedDRA frequency classification:
Maltese: Fit-tabella reazzjonijiet avversi huma kklassifikati taħt il-klassifikazzjoni tal-frekwenza ta' MEDRA:
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestinal
English: Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Germany
Maltese: Sit tal-produzzjoni Oranienburg Lehnitzstraße 70-98, 16515
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Luxembourg/Luxemburg Takeda Belgium Tél/Tel: + 32 2 464 06 11 takeda-belgium@takeda.com
Maltese: Luxembourg/Luxemburg Takeda Belgium Tél/Tel: + 32 2 464 06 11 takedabelgium@takeda.com
English: Liver enzymes increased (transaminas es, γ-GT)
Maltese: Żieda fl-enzimi tal-fwied (transaminases, γ-GT)
English: What CONTROLOC Control contains - The active substance is pantoprazole.
Maltese: X'fih CONTROLOC Control - Is-sustanza attiva hi pantoprazole.
English: CONTROLOC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Maltese: CONTROLOC Control hu disponibbli f'folji Alu/Alu bi jew mingħajr cardboard reinforcement.
English: - Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated.
Maltese: - Linka tal-istampar: shellac, red, black and yellow iron oxide (E172), u soluzzjoni tal-ammonja, ikkonċentrata.
English: CONTROLOC Control 20 mg gastro-resistant tablets Pantoprazole
Maltese: CONTROLOC Control 20 mg pilloli gastro-reżistenti Pantoprazole
English: Diarrhoea;
Maltese: Dijarea;
English: CONTROLOC Control 20 mg gastro-resistant tablets
Maltese: CONTROLOC Control 20 mg pilloli gastro-reżistenti
English: However, you may take CONTROLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Maltese: Madankollu, tista' tieħu CONTROLOC Control ma' antaċidi (eż. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, jew kumbinazzjonijiet tagħhom), jekk ikun meħtieġ.
English: To avoid this interference, CONTROLOC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Maltese: Biex din l-interferenza tiġi evitata, il-kura bi CONTROLOC Control għandha titwaqqaf għal mill-inqas 5 ijiem qabel il-kejl ta' CgA (ara sezzjoni 5.1).
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżm u u n-nutrizzjoni
English: Pharmacotherapeutic group: Drugs for acid related disorders Proton pump inhibitors, ATC code: A02BC02
Maltese: Mediċini għal disturbi relatati mal-aċidu, Inibituri tal-pompa tal-proton, Kodiċi ATC:
English: CONTROLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Maltese: CONTROLOC Control jista' jnaqqas l-assorbiment ta' sustanzi attivi li l-bijodisponibiltà tagħhom tiddependi fuq il-pH gastrika (eż. ketoconazole).
English: Influence on Vitamin B12 Absorption
Maltese: Influwenza fuq l-Assorbiment ta' Vitamina
English: Agranulocytosis Thrombocytopenia ; Leukopenia,
Maltese: Agranuloċitosi Tromboċitopen ja;
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skelet riċi u tat-tessuti konnettivi
English: Detailed information on this medicine is available on the European Medicines Agency web site: http:// www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Other medicines and CONTROLOC Control
Maltese: Mediċini oħra u CONTROLOC Control
English: - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. - if you have ever had a skin reaction after treatment with a medicine similar to CONTROLOC
Maltese: Kellem lit-tabib tiegħek qabel tieħu CONTROLOC Control - jekk kont ikkurat/a għal qrusa fl-istonku jew indiġestjoni kontinwament għal 4 ġimgħat jew iktar - jekk għandek iktar minn 55 sena u qed tieħu kura ta' kuljum għall-indiġestjoni mingħajr riċetta tat-tabib - jekk għandek iktar minn 55 sena u għandek sintomi ta' rifless ġodda jew sintomi li nbidlu dan l-aħħar - jekk kellek operazzjoni minħabba ulċera gastrika jew tal-istonku - jekk għandek problemi tal-fwied jew suffejra (sfura tal-ġilda jew fl-għajnejn) - jekk regolarment tara lit-tabib tiegħek għal problemi jew kundizzjonijiet serji - jekk ser ikollok endoskopija jew test tan-nifs imsejjaħ C-urea test - jekk qatt kellek reazzjoni fil-ġilda wara kura b'mediċina simili għal CONTROLOC Control li tnaqqas l-aċtu fl-istonku.
English: What CONTROLOC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Maltese: Kif jidher CONTROLOC Control u l-kontenut tal-pakkett Il-pilloli gastro-reżistenti huma pilloli sofor, ovali, bikonvessi, miksija b'rita u stampati bi “P20” fuq naħa waħda.
English: - if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
Maltese: - inti wasalt biex ikollok test tad-demm speċifiku (Kromogranin A) - jekk qed tieħu impedituri ta' protease ta' HIV bħal atazanavir; nelfinavir (għat-trattament ta'
English: CONTROLOC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Maltese: CONTROLOC Control fih is-sustanza attiva pantoprazole, li timblokka l-'pompa' li tipproduċi l-aċidu fl-istonku.
English: Warnings and precautions Talk to your doctor before taking CONTROLOC Control:
Maltese: Ara “Mediċini oħra u CONTROLOC Control.
English: - Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood, rash, possibly with pain in the joints; feeling of tingling, prickling, pins and needles, burning sensation or numbness, inflammation in the large bowel, that causes persistent watery diarrhoea.
Maltese: - Frekwenza mhux magħrufa: alluċinazzjoni, konfużjoni (speċjalment f'pazjenti bi storja medika ta' dawn is-sintomi); tnaqqis fil-livell ta' sodium fid-demm, tnaqqis fil-livell ta' manjesju fid-demm, raxx, possibbilment b'uġigħ fil-ġogi; sensazzjoni ta' tnemnim, tingiż, qisu xi ħadd qed iniggżek bil-labar, sensazzjoni ta' ħruq jew tmewwit, infjammazzjoni fil-musrana l-kbira, li tikkawża dijarea maħlula persistenti.
English: The most commonly reported adverse reactions are diarrhoea and headache, both occurring in approximately 1% of patients.
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod komuni huma dijarea u wġigħ ta' ras, li t-tnejn iseħħu f'madwar 1% tal-pazjenti.
English: Date of first authorisation: 12 June 2009 Date of latest renewal: 21 February 2014
Maltese: Data tal-aħħar tiġdid: 21 ta' Frar 2014
English: Package leaflet: Information for the patient CONTROLOC Control 20 mg gastro-resistant tablets Pantoprazole
Maltese: Informazzjoni għal min qed jagħmel użu minnu CONTROLOC Control 20 mg pilloli gastro-reżistenti Pantoprazole
English: Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Maltese: Ara ‘Tiħux CONTROLOC Control' - ketoconazole (użat għal infezzjonijiet fungali). - warfarin u phenprocoumon (jintużaw biex iraqqu d-demm u għall-prevenzjoni tal-emboli).
English: Do not take CONTROLOC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Maltese: Tiħux CONTROLOC Control ma' mediċini oħrajn li jillimitaw l-ammont ta' aċidu li jiġi prodott fl-istonku tiegħek, bħal inibitur tal-pompa tal-proton ieħor (omeprazole, lansoprazole jew rabeprazole) jew antagonist ta' H2 (eż. ranitidine, famotidine).
English: - reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body stores of Vitamin B12.
Maltese: B12 jekk diġà għandek ħażna baxxa fil-ġisem ta' Vitamina
English: Takeda GmbH, Podružnica Slovenija Tel: + 386 (0) 59082480
Maltese: Tel: + 386 (0) 59082480
English: You must not use CONTROLOC Control if you are taking HIV protease inhibitors.
Maltese: Għandek tieqaf tieħu CONTROLOC Control meta ma jkollokx aktar sintomi.
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Maltese: Għid lit-tabib tiegħek immedjatament, qabel jew wara li tieħu din il-mediċina, jekk tinnota kwalunkwe mis-sintomi li ġejjin, li jistgħu jkunu sinjal ta' marda oħra li tkun iktar serja: - telf ta' piż mhux intenzjonat (mhux marbut ma' dieta jew programm ta' eżerċizzju) - rimettar, partikularment jekk ikun ripetut - tirremetti d-demm; dan jista' jidher bħala frak tal-kafè skur fir-rimettar tiegħek - tinnota d-demm fl-ippurgar tiegħek; li jista' jidher iswed jew qisu qatran - diffikultà biex tibla' jew uġigħ meta tibla' - tidher musfar u tħossok dgħajjef (anemija) - uġigħ fis-sider - uġigħ fl-istonku - dijarea severa u/jew persistenti, għax din il-mediċina kienet assoċjatama' żieda żgħira ta' dijarea infettiva - jekk ikollok raxx fuq il-ġilda tiegħek, speċjalment f'postijiet li jiġu esposti għax-xemx kellem lit-tabib tiegħek kemm jista' jkun malajr, peress li jista' jkollok bżonn twaqqaf il-kura tiegħek
English: Do not take CONTROLOC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
Maltese: Tiħux CONTROLOC Control: - jekk inti allerġiku għal pantoprazole jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6). - jekk qed tieħu impedituri tal-protease ta' HIV bħal atazanavir; nelfavir (għal kura ta' infezzjoni bl-HIV).
English: Especially medicines containing one of the following active substances: - HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection).
Maltese: Partikolarment mediċini li fihom xi wieħed mis-sustanzi attivi li ġejjin: - impedituri tal-protease tal-HIV bħal atazanavir, nelfinavir (għat-trattament ta' infezzjoni ta'
English: CONTROLOC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Maltese: CONTROLOC Control jintuża għal kura għal żmien qasir ta' sintomi tar-rifluss (per eżempju qrusa fl-istonku, rigurġitazzjoni tal-aċidu) fl-adulti.
English: - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your CONTROLOC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Maltese: jkollok bżonn ta' testijiet tad-demm addizzjonali - methotrexate (użat għat-trattament ta' artrite rewmatojdi, psorjasi, u kanċer) - jekk qed tieħu methotrexate t-tabib tiegħek għandu mnejn iwaqqaf it-trattament tiegħek bi CONTROLOC
English: Taste disorders
Maltese: Mhux applikabbli.
English: - Avoid large meals - Eat slowly - Stop smoking - Reduce alcohol and caffeine consumption - Reduce weight (if overweight) - Avoid tight-fitting clothing or belts - Avoid eating less than three hours before bedtime - Elevate bedhead (if you suffer from nocturnal symptoms) - Reduce intake of food that can cause heartburn.
Maltese: - Evita ikliet kbar - Kul bil-mod - Tpejjipx iżjed - Naqqas il-konsum tal-alkoħol u tal-kafeina - Naqqas il-piż (jekk inti oħxon/ħoxna) - Evita ħwejjeġ jew ċintorini ssikkati - Tikolx inqas minn tliet sigħat qabel tmur torqod - Tella' l-bedhead (jekk tbati minn sintomi ta' bil-lejl)
English: • They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since it may alleviate symptoms and delay diagnosis of a severe condition.
Maltese: • Ikollhom telf ta' piż mhux intenzjonat, anemija, ħruġ ta' demm gastrointestinali, problemi biex jibilgħu, rimettar persistenti jew rimettar bid-demm, għax il-mediċina tista' ttaffi s-sintomi u tittardja d-dijanjosi ta' kondizzjoni severa.
English: Fracture of wrist, hip and spine.
Maltese: Ferita epatoċellulari; Suffejra;
English: 1 After reconstitution, each dose (2 ml) contains 1.4-2.5 x 106 chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells .
Maltese: 1 Wara t-taħlit, kull doża (2 ml) fiha ċelluli staminali mesenkimali derivati minn demm periferali alloġeniċi ekwini indotti minn kondroġeneżi 1.4-2.5 x
English: Suspension (plasma): 1 ml
Maltese: Sospensjoni (plażma): 1 ml
English: Suspension (stem cells): 1 ml
Maltese: Sospensjoni (ċelluli staminali): 1 ml
English: 1 vial of stem cell suspension + 1 vial of plasma suspension
Maltese: Kunjett 1 tassospensjon i ta' ċelluli staminali + kunjett 1 ta' sospensjon i talplażma
English: Suspension (plasma): vial (plastic).
Maltese: Sospensjoni (ċelluli staminali): kunjett (plastik).
English: Intermediate risk
Maltese: Riskju intermedju
English: Stratified log-rank test
Maltese: Test log-rank stratifikat
English: (20.9 to 32.4)
Maltese: (20.9 sa 32.4)
English: No formal statistical comparisons were planned.
Maltese: Ma kien ippjanat ebda tqabbil statistiku formali.
English: Uncommon Amenorrhoea e*
Maltese: Mhux komuni Amenorrea e*
English: Date of first authorisation: 03 August 2009 Date of latest renewal: 16 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 03 t'Awwissu 2009 Data tal-aħħar tiġdid: 16 ta' Mejju 2014
English: Table 3 Adverse reactions reported in clinical studies
Maltese: Tabella 3 Reazzjonijiet avversi rrappurtati fi studji kliniċi
English: Aluminium/polyamide/aluminium/PVC blister containing 10 tablets.
Maltese: Aluminju/poliamide/aluminju/folja tal-PVC li fiha 10 pilloli.
English: Grade 3 & 4 (<50x10
Maltese: Grad 3 & 4 (<50x10
English: CgA: Chromogranin A
Maltese: Kromogranin A
English: (46.8 to 55.9)
Maltese: (46.8 sa 55.9)
English: Grade 2 (<75, ≥50x10
Maltese: Grad 2 (<75, ≥50x10
English: p-value a
Maltese: Valur p a
English: (0.31 to 0.48)
Maltese: (0.31 sa 0.48)
English: No (N=225) Lung (N=90) Ileum (N=71) Non-ileum* (N=141) Grade 1 (N=194) Grade 2 (N=107) ≤10% (N=228) >10% (N=72) >2xULN (N=139) ≤2xULN (N=138) >ULN (N=87) ≤ULN (N=188)
Maltese: Le (N=225) Pulmun (N=90) Ilju (N=71) Mhux ilju* (N=141) Grad 1 (N=194) Grad 2 (N=107) ≤10% (N=228) >10% (N=72) >2xULN (N=139) ≤2xULN (N=138) >ULN (N=87) ≤ULN (N=188)
English: (0.38 to 0.54)
Maltese: (0.38 sa 0.54)
English: Placebo + BSC
Maltese: Plaċebo + BSC
English: (2.8 to 4.1)
Maltese: (2.8 sa 4.1)
English: The median PFS was 8.4 months (90% CI: 6.6, 9.7) and 6.8 months (90% CI: 5.5, 7.2), respectively.
Maltese: Il-PFS medjan kien ta' 8.4 xhur (90% CI: 6.6, 9.7) u 6.8 xhur (90% CI: 5.5, 7.2), rispettivament.
English: (0.5 to 4.2)
Maltese: (0.5 sa 4.2)
English: Butylhydroxytoluene Magnesium stearate Lactose monohydrate Hypromellose Crospovidone type A Lactose anhydrous
Maltese: Magnesium stearate Lactose monohydrate Hypromellose Crospovidone type A Lactose anhydrous
English: Everolimus/Exemestane (n/N=80/104) Everolimus (n/N=74/103)
Maltese: Żminijiet ta' Ċensura Everolimus/Exemestane (n/N=80/104) Everolimus (n/N=74/103)
English: 30 tablets 90 tablets
Maltese: 30 pillola 90 pillola
English: (2.9 to 5.6)
Maltese: (2.9 sa 5.6)
English: Clinical benefit rate c
Maltese: Rata ta' benefiċċju kliniku c
English: Population n
Maltese: Popolazzjoni n
English: Time (weeks) Everolimus/Exemestane Everolimus
Maltese: Everolimus/Exemestane Everolimus
English: MSKCC prognostic score (blinded independent central review) Favourable risk
Maltese: Punteġġ pronostiku MSKCC (analiżi ċentrali u indipendenti blinded) Riskju favorevoli
English: Everolimus 10 mg + exemestane (n/N = 310/485) Placebo + exemestane (n/N = 200/239)
Maltese: Everolimus 10 mg + exemestane (n/N = 310/485) Plaċebo + exemestane (n/N = 200/239)
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Il-kategoriji ta' frekwenza huma ddefiniti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: Active substance by interaction
Maltese: Sustanza attiva b'interazzjoni
English: Efavirenz, nevirapine Not studied.
Maltese: Efavirenz, nevirapine
English: Baseline NSE
Maltese: Linja bażi NSE
English: ULN: Upper limit of normal
Maltese: L-ogħla limitu tan-normal
English: Primary analysis All (blinded independent central review)
Maltese: Analiżi primarja Kollha (reviżjoni blinded indipendenti ċentrali)
English: Everolimus 10 mg + exemestane: 7.82 months Placebo + exemestane: 3.19 months
Maltese: Everolimus 10 mg + exemestane: 7.82 xhur Placebo + exemestane: 3.19 xhur
English: Investigator radiological review a
Maltese: Analiżi radjoloġika indipendenti a
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Reazzjonijiet avversi huma elenkati skont il-kategorija MedDRA tal-klassi ta' sistemi u organi u tal-frekwenza.
English: All (N=302) <65 years (N=159) ≥65 years (N=143) 0 (N=216) 1 (N=86)
Maltese: Kulħadd (N=302) <65 sena (N=159) ≥65 sena (N=143) 0 (N=216) 1 (N=86) Iva (N=157) Le (N=145) Iva (N=77)
English: Placebo a n=239
Maltese: Plaċebo a n=239
English: Censoring Times Everolimus (n/N = 155/277) Placebo (n/N = 111/139)
Maltese: Żmien ta' Ċensura Everolimus (n/N = 155/277) Plaċebo (n/N = 111/139)
English: • Itching (pruritus)
Maltese: • Ħakk (pruritus)
English: Infections and infestations Very common Infections a, *
Maltese: Infezzjonijiet u infestazzjonjiet Komuni ħafna Infezzjonijiet a,
English: Everolimus Placebo
Maltese: Everolimus Plaċebo
English: Angioedema*
Maltese: Anġjodema*
English: Everolimus + BSC (n/N = 113/205) Placebo + BSC (n/N = 65/97)
Maltese: Żminijiet ta' ċensura Everolimus + BSC (n/N = 113/205) Placebo + BSC (n/N = 65/97)
English: No statistically significant treatment-related difference in overall survival was noted (hazard ratio 0.87; confidence interval: 0.65-1.17; p=0.177).
Maltese: Ma ġiet innutata l-ebda differenza sinifikanti b'mod statistiku fis-sopravivenza globali relatata mal-kura (proporzjon ta' periklu 0.87; intervall tal-kunfidenza: 0.65-1.17; p=0.177).
English: Grade 3 Temporary dose interruption.
Maltese: Grad 3 Interrompi d-doża temporanjament.
English: Everolimus + BSC: 11.01 [9.23;13.31] months Placebo + BSC: 3.91 [3.58;7.43] months
Maltese: 01 [9.23;13.31] xhur Plaċebo + BSC: 3.91 [3.58;7.43] xhur
English: Time(months) Everolimus Placebo
Maltese: Żmien (xhur) Everolimus Placebo
English: 10 tablets 30 tablets 90 tablets
Maltese: 10 pilloli 30 pillola 90 pillola
English: Kaplan-Meier medians Everolimus/Exemestane: 36.57 [28.71;42.29] weeks Everolimus: 29.43 [24.00;31.29] weeks
Maltese: 36.57 [28.71;42.29] ġimgħat Everolimus: 29.43 [24.00;31.29] ġimgħat
English: Placebo n=97
Maltese: Plaċebo n=97